Tozinameran - BioNTech/Pfizer
Alternative Names: BNT 162; BNT 162b2; Bnt-162b2; BNT162b2 vaccine; BNT162b2SA; COMIRNATY; COVID-19 Vaccine, mRNA - BioNTech/Pfizer; PF-07302048; Pfizer-BioNTech COVID-19 vaccine; Pfizer-BioNTech vaccine; SARS-CoV-2 RNA vaccine - BioNTech/PfizerLatest Information Update: 27 Mar 2024
At a glance
- Originator BioNTech; University of Roma La Sapienza
- Developer BioNTech; Pfizer; Pfizer Japan; Shanghai Fosun Pharmaceutical
- Class COVID-19 vaccines; RNA vaccines; Viral vaccines
- Mechanism of Action Immunostimulants
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Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Marketed COVID 2019 infections
- Phase II SARS-CoV-2 acute respiratory disease
Most Recent Events
- 18 Mar 2024 BioNTech withdraws a phase I trial in COVID-19 (In Children, In Infants, Prevention) prior to enrollment (IM, Injection) (NCT05630352)
- 07 Mar 2024 Launched for COVID-2019 infections (Prevention) in Germany (IM) (Prior to March 2024)
- 07 Mar 2024 Launched for COVID-2019 infections (Prevention) in Turkey (Parenteral) (Prior to March 2024)
Development Overview
Introduction
Tozinameran (also known as BNT 162b2) is an intramuscularly administered mRNA vaccine, being developed by BioNTech, in collaboration with Pfizer, for the prevention of COVID-2019 infections and SARS-COV-2 acute respiratory disease. The vaccine is being developed as part of "Project Lightspeed" which leverages BioNTech's proprietary mRNA platform for infectious diseases. Tozinameran is a lipid nanoparticle formulated, nucleoside-modified messenger RNA (mod RNA) that encodes an optimized SARS-CoV-2 full-length spike glycoprotein antigen. Tozinameran is administered as a series of two doses, three weeks apart. The vaccine registered and launched is available in the multiple countries world wide. Tozinameran is preregistration in EU and India. Clinical development is ongoing world wide.
Tozinameran is the lead candidate from a research programme for coronavirus vaccines [see AdisInsight Drug profile 800058144].
A combination vaccine [see Adis Insight drug profile800071403] consisting of tozinameran and BNT 161 [see Adis Insight drug profile800052769] is in clinical development [1] .
In April 2023, the US FDA amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 bivalent mRNA vaccine (original and omicron BA.4/BA.5 strains) [see AdisInsight drug profile800073634] and authorized it to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations in the US. The monovalent Pfizer-BioNTech COVID-19 vaccine (tozinameran) is no longer authorized for use in the US [2] .
Company Agreements
In June 2022, Pfizer and BioNTech entered in an agreement with the U.S. government for the supply of 105 million doses (30 µg, 10 µg and 3 µg) BNT 162 for the treatment of COVID-19 infections. This will also include adult Omicron-adapted COVID-19 vaccines. The U.S. government will pay the companies $US3.2 billion upon receipt of the first 105 million doses. Under this agreement, the U.S. government also has the option to purchase up to 195 million additional doses, bringing the total number of potential doses to 300 million. [3]
In May 2022, Pfizer and BioNTech they have reached an agreement with the European Commission (EC) to amend their originally agreed contractual delivery schedules for the Pfizer-BioNTech COVID-19 Vaccine. This amendment rephases planned deliveries to help support the European Commission and Member States' ongoing immunisation programs, and was aligned to the companies’ commitment to working collaboratively to identify pragmatic solutions to address the evolving pandemic needs. Doses scheduled for delivery in June through August 2022, will now be delivered in September through fourth quarter 2022. In May 2021, Pfizer and BioNTech signed a new agreement with the European Commission (EC) to supply 900 million doses of tozinameran, to the European Union (EU), with an option to request up to an additional 900 million doses. The doses are expected to be delivered beginning December 2021 and continuing into 2023. Pfizer and BioNTech have now committed a total of up to 2.4 billion doses since the beginning of the pandemic to EC. In April 2021, BioNTech and Pfizer announced that, supply an additional 100 million doses of BNT 162b2 mRNA- based vaccine (COMIRNATY®) for the treatment of SARS-CoV-2 infection to the 27 European Union countries in 2021. This brings the total number of doses to be delivered to the European Union to 600 million and this purchasing agreement comes under expanded advanced purchase agreement signed on February 2021. Previously, in February 2021, BioNTech and Pfizer announced a new agreement addition to earlier signed agreement to supply an additional 200 million doses of BNT 162b2 mRNA-based vaccine to supply in European Union (EU) Member States. The agreement bring the total number of doses to be delivered to the EU to 500 million with the potential to increase to 600 million based on the option granted in the new agreement. Earlier in December 2020, European Commission exercised its option with BioNTech and Pfizer to purchase an additional 100 million doses to supply in European Union (EU) Member States. Earlier in November 2020, BioNTech and Pfizer signed an agreement with the European Commission to supply 200 million doses of BNT162b2 mRNA-based vaccine candidate against SARS-CoV-2 to European Union (EU) Member States, with an option for the European Commission to request an additional 100 million doses. Deliveries are anticipated to start by the end of 2020. In December 2021, Pfizer and BioNTech announced an agreement has been reached with the European Commission (EC) and its member states to exercise an option to purchase more than 200 million additional doses of tozinameran. The 200 million optional doses are in addition to the 450 million doses already planned to be delivered in 2022 based on previously signed agreements. The number of doses to be delivered to the EC member states by the companies in 2022 will now total more than 650 million doses. [4] [5] [6] [7] [8] [9] [10]
In January 2022, Pfizer and Acuitas Therapeutics entered into a Development and Option agreement under which Pfizer will have the option to license, on a non-exclusive basis, Acuitas’ LNP technology for up to 10 targets for vaccine or therapeutic development. The LNP technology is used in the vaccine, tozinameran. Financial details were not disclosed. [11]
In October 2021, the US government entered into an agreement with Pfizer and BioNTech and purchased 50 million more doses of the companies’ COVID-19 vaccine. USA will receive these additional doses to continue to support preparedness for pediatric vaccinations, including securing vaccines for children under 5 years of age upon receival of regulatory authorization. The companies expect to deliver the vaccine doses by April 30, 2022. Earlier, in September 2021, Pfizer and BioNTech announced plans to expand collaboration with the US government by providing an additional 500 million doses of the companies COVID-2019 vaccine (BNT 162). This expanded agreement brings the total number of doses to be supplied to the US government to one billion and are expected to be delivered by the end of September 2022. In July 2021, BioNTech and Pfizer entered into an agreement with the US government to supply an additional 200 million doses of the companies COVID-2019 vaccine (BNT 162). The companies expects to deliver an additional 200 million doses from October 2021 through April 2022. This brings the total number of doses to be supplied by the companies to the US government to 500 million consistent with the original supply agreement. Also, the companies expects to deliver 110 million of the additional doses by December 31, 2021, with the remaining 90 million doses to be delivered no later than April 30, 2022. In addition, the US government can exercised an option to acquire an updated version of the vaccine to address potential variants as well as new formulations of the vaccine, on subject to clinical success and regulatory approval. In December 2020, BioNTech and Pfizer entered into second agreement with the US government to supply an additional 100 million doses of the companies COVID-2019 vaccine (BT 162) from production facilities in the US. The US government exercised the option for additional 100 million doses, in February 2021, bringing the total number of doses to be delivered to the US to 300 million. The companies expect to deliver the full 200 million doses to Operation Warp Speed (OWS) by July 31, 2021. Consistent with the original agreement announced in July 2020, the US government will pay US$1.95 billion for the additional 100 million doses. The companies announced commercial supply agreements for 2020 and 2021 (and beyond) - totaling more than 570 million doses, including options to purchase an additional 600 million doses - with multiple governments, including Canada, Israel, Japan, the UK, the U.S. and the EU. All agreements are subject to clinical success and regulatory approval. The companies entered into an agreement to supply millions of doses to Isreal in 2022, in addition to a supply agreement to deliver up to 125 million doses in Canada in 2022 and 2023, with options to purchase up to 60 million additional doses in 2024. In July 2020, Pfizer and BioNTech announced an agreement with the US Department of Health and Human Services and the Department of Defense to meet the US government’s Operation Warp Speed program goal to begin delivering 300 million doses of COVID 2019 vaccine in 2021. Under the terms of the agreement, the US government will receive 100 million doses of the COVID 2019 vaccine (BNT 162) after Pfizer successfully manufactures and obtains approval or emergency use authorization from the US FDA. The US government will pay the companies US$1.95 billion upon the receipt of the first 100 million doses, following FDA authorization or approval. The US government also can acquire up to an additional 500 million doses. [12] [13] [14] [15] [16] [17] [18]
In August 2021, Pfizer and BioNTech announced the signing of a letter of intent with Eurofarma Laboratories to manufacture tozinameran (COMIRNATY®) for distribution within Latin America. Eurofarma will perform manufacturing activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network. As per the agreement Eurofarma will obtain drug product from facilities in the US and manufacturing of finished doses will commence in 2022. [19]
In July 2021, BioNTech SE, Pfizer and Biovac entered into collaboration agreement to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. Biovac will perform manufacturing and distribution activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span three continents and include more than 20 manufacturing facilities [20]
In February 2021, Merck and BioNTech entered intro an agreement, expanding their strategic partnership. Under the terms of the agreement, Merck, in close collaboration with BioNTech, will significantly accelerate the supply of urgently needed lipids and increase the amount of lipid delivery towards the end of 2021. The lipids will be used for the production of the Pfizer-BioNTech Covid-19 Vaccine (Tozinameran). [21]
In January 2021, BioNTech and Novartis entered in a manufacturing agreement for tozinameran. According to the terms of the agreement, Novartis will be provided with bulk mRNA acive ingredient that will be filled into the vials under aseptic conditions for shipment back to BioNTech for their distribution. Once the final agreement is reached, Novartis will commence production in the second quarter of 2021 and the finished products initial shipment is expected to occur in the third quarter of 2021. [22]
In January 2021, Sanofi and BioNTech entered into an agreement under which Sanofi will support manufacturing and supply of BioNTech’s COVID-19 vaccine which is being co-developed with Pfizer [23]
In August 2020, BioNTech SE and Shanghai Fosun Pharmaceutical entered into an intended collaboration to supply 10 million doses of their BNT 162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval, to Hong Kong and Macao. Later, in December 2020, BioNTech and Shanghai Fosun Pharmaceutical reported an agreement to supply Mainland China with an initial 100 million doses of tozinameran vaccine against COVID-2019 infections in 2021, subject to regulatory approval. Initial supply will be delivered from BioNTech’s production facilities in Germany. [24] [25]
In March 2020, BioNTech SE and Pfizer agreed to a letter of intent regarding the co-development and distribution (excluding China) of an mRNA-based coronavirus vaccines including BNT 162, for the prevention of COVID-2019 infections. Under the collaboration terms, BioNTech will be entitled to receive $US185 million in upfront payments, including a cash payment of $US72 million and an equity investment of $US113 million from Pfizer. BioNTech is also eligible to receive future milestone payments of up to $US563 million for a total consideration of $US748 million. Both the parties agreed to share development costs equally. Initially, Pfizer will fund 100 percent of the development costs, and BioNTech will repay Pfizer its 50 percent share of these costs during the commercialisation of the vaccine. BioNTech and its partners will manufacture the vaccine candidates including BNT 162 for clinical studies from its GMP-certified mRNA manufacturing facilities in Europe. BioNTech and Pfizer will work together to scale-up manufacturing capacity later for commercialisation. BioNtech and Pfizer together commercialise the approved vaccines worldwide (excluding China). The companies executed a material transfer and collaboration agreement to enable the parties to start working together on vaccines for COVID-2019 infections. [26] [27]
In March 2020, BioNTech entered into a research and development agreement with Shanghai Fosun Pharma, to jointly develop BNT 162 vaccine, for the prevention of COVID-2019 infections, in China. Under the terms of the agreement, the two companies will work jointly on the development of BNT162 in China. The companies will collaborate to conduct clinical trials in China leveraging Fosun Pharma’s extensive clinical development, regulatory, and commercial capabilities in the country. If approved, Fosun Pharma will commercialise the vaccine in China. BioNTech will supply the mRNA vaccine for clinical trials from GMP manufacturing facilities in Europe along with its partner Polymun. BioNTech will retain full rights to develop and commercialise the vaccine in the rest of the world. Under the terms of the agreement, Fosun Pharma agreed to make an equity investment of $US50 million for 1,580,777 ordinary shares in BioNTech, subject to execution of share subscription documentation and approval from regulatory authorities in China. [28] [29]
In January 2021, Pfizer and BioNTech entered into a purchase agreement with COVAX, a global initiative coordinated by the Global Alliance for Vaccines and Immunization (GAVI), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO), to ensure equitable access to COVID-2019 vaccines for all countries, regardless of income levels. The companies announced an advance purchase agreement with COVAX for up to 40 million doses, which will be delivered throughout 2021. First deliveries are expected to take place in Q1 2021 subject to the execution of supply agreements under the COVAX Facility structure. For the COVAX Advanced Market Commitment 92 countries, Pfizer and BioNTech will provide the vaccine to COVAX at a not-for-profit price. Importantly, COVAX includes an Advanced Market Commitment (AMC) financial mechanism that ensures the 92 low- and lower-middle-income countries will be able to secure access to COVID-2019 vaccines at the same time as higher-income countries. Financial terms of the agreement were not disclosed.
Key Development Milestones
As of March 2024, BioNTech and Pfizer launched Tozinameran in Germany and Turkey for the prevention of COVID-2019 infections [30] .
As of August 2022, BioNTech and Pfizer launched Tozinameran in the UK, France, Spain, Poland, Sweden, Netherlands, and Switzerland for the prevention of COVID-2019 infections (BioNTech Pipeline, May 2023).
In April 2023, the US FDA amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 bivalent mRNA vaccine (tozinameran/famtozinameran) [see AdisInsight drug profile800073634], simplifying the vaccination schedule for most individuals and authorizing the use of the current bivalent vaccine (original and omicron BA.4/BA.5 strains) for all doses administered to individuals 6 months of age and older, including additional doses for certain populations. The monovalent Pfizer-BioNTech Covid-19 vaccine is no longer authorized for use in the United States [2] .
In September 2023, Health Canada has approved the use of the Comirnaty COVID-19 vaccine for individuals six months and older, following submission on June 29, 2023 [31] . Earlier, in September 2022, Health Canada approved the use of tozinameran in children ages through 6 months to 4 years. Previously, In June 2022, Pfizer and BioNTech filed an application to Health Canada for the approval of tozinameran in children of the age range 6 months to 4 years. Health Canada has placed terms and conditions on the authorization requiring Pfizer-BioNTech to continue providing information to Health Canada on the safety and efficacy of the vaccine in this younger age group [32] . In November 2021, Pfizer and BioNTech received Health Canada authorization of tozinameran (COMIRNATY) in children ages 5 through <12 years. Health Canada based its decision on data from a phase II/III randomized, controlled trial that included ~4600 children 5 to under 12 years of age (2,268 from the original group and 2,379 from the supplemental safety group) [33] . In October 2021, Pfizer-BioNTech submits regulatory application to the Health Canada to authorise the use of Comirnaty COVID-19 vaccine in children aged 5 to 11 years of age [34] . In September 2021, Pfizer and BioNTech announced that the Health Canada approved the New Drug Submission (NDS) and granted Notice of Compliance (NOC) for tozinameran (COMIRNATY®) to prevent COVID-19 in 12 years of age and older. The approval is based on a comprehensive data package that included longer-term follow-up data from the phase III trial [see below], where the vaccine’s efficacy and safety profile were observed up to six months after the second dose [35] [36] . In May 2021, BioNTech and Pfizer Canada announced that Health Canada has expanded the Interim Order authorization for tozinameran to include individuals 12 to 15 years of age [37] . In December 2020, Health Canada granted Authorisation under Interim Order for the emergency use of the mRNA vaccine tozinameran for prevention against COVID-2019 infections. Health Canada’s decision is based on data filed through the rolling submission initiated in October 2020, and includes data from the phase II/III clinical trial [38] [39] [40] .
As of August 2022, tozinameran is approved in Philippines for the prevention of COVID-2019 infections [41] .
In August 2023, Pfizer and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for COVID-19 bivalent mRNA vaccine (tozinameran/famtozinameran) administered as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history. The Committee has also recommended the updated vaccine for children 6 months through 4 years of age as part or all of the primary three-dose vaccination series, depending on how many prior doses they received, or as single dose for those with a history of completion of a COVID-19 primary vaccination course or prior SARS-CoV-2 infection. The CHMP’s recommendation is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the COVID-19 vaccines by Pfizer and BioNTech [42] .
In October 2022, Pfizer and BioNTech announced that they have received a positive opinion on conditional market authorization from the Committee for Medicinal Products for Human Use (CHMP) of EMA for a 3-µg dose of COMIRNATY® (COVID-19 vaccine, mRNA), as a three-dose series for children ages 6 months to less than 5 years. The recommendation is based on the data from a phase II/III randomized, controlled trial that included 4,526 children aged 6 months to less than 5 years [43] . In September 2022, The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended that an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5, as well as the original strain of SARS-CoV-2, be approved for use in people aged 12 and up who have received at least one primary course of COVID-19 vaccination. The CHMP's opinion for Comirnaty Original/Omicron BA.4-5 is also based on Comirnaty Original/Omicron BA.1 immunogenicity data [44] . Earlier in September 2022, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended converting the conditional Marketing Authorization (cMA) for COMIRNATY® to standard Marketing Authorization (MA) for all authorized indications and formulations. The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. The recommendation to convert the cMA to full MA was based on the totality of available efficacy and safety data provided by Pfizer and BioNTech, which confirm the benefits of the vaccine continue to outweigh its potential risks. The conversion, if approved by the EC, applies to all existing COMIRNATY® indications and formulations authorized in the EU, including Pfizer and BioNTech’s bivalent vaccines as booster doses for individuals aged 12 and older in the EU. This recommendation covers all existing and upcoming adapted Comirnaty including the recently-approved adapted Comirnaty Original/Omicron BA.1, Comirnaty Original/Omicron BA.4/5 [45] [46] . In July 2022, Pfizer and BioNTech announced that they have submitted a variation to the European Medicines Agency (EMA) requesting that the Conditional Marketing Authorization (CMA) in the European Union (EU) be updated with data supporting the vaccination of children aged 6 months to less than 5 years with a three dose series of COMIRNATY® (COVID-19 vaccine, mRNA). Based on safety, tolerability, and immunogenicity data, the 3-µg dose was carefully selected as the preferred dose for children under the age of five. Data from a Phase II/III trial involving 4,526 children aged 6 months to less than 5 years were included in the submission [47] . Later, in July 2022, Pfizer and BioNTech completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 sub-lineage, for individuals 12 years of age and older. This application follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to work towards introducing an Omicron-adapted bivalent vaccine candidate to address the continued evolution of SARS-CoV-2 [48] .
In June 2022, the EMA initiated a rolling review of a version of the tozinameran (Comirnaty) vaccine for prevention of COVID-2019 infections caused by specific variant or variants of SARS-CoV-2. The review will initially consider chemistry, manufacturing and controls (CMC) of vaccine followed by data on the immune response to the vaccine as well as data on its efficacy against Omicron subvariants. The EMA will notify further on the outcome of the rolling review or an eventual application [49] .
In June 2022, tozinameran as a three 3-µg dose series received Emergency Use Authorisation (EUA) from US FDA for children aged 6 months to 4 years (also referred as 6 months to less than 5 years of age) in the US. The authorisation is based on safety, tolerability, and immunogenicity data from a Phase II/III trial [50] . Previously in February 2022, following a request from the US FDA, a rolling submission seeking to amend the Comirnaty EUA to include children 6 months through 4 years of age (6 months to <5 years of age) was initiated. This application is for authorization of the first two 3 µg doses of a planned three-dose primary series in this age group. Data on a third dose given at least 8 weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of this requested EUA [51] . Earlier in February 2022, Pfizer and BioNTech announced plans to extend their rolling submission to the US FDA seeking to amend the Emergency Use Authorization of the tozinameran to include children 6 months through 4 years of age, which had been requested by FDA [52] .
In September 2023, the US FDA approved the supplemental Biologics license application for the new seasonal COMIRNATY 2023-2024 Formulation for individuals 12 years and older and granted emergency use authorization for individuals 6 months through 11 years of age for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. This season’s vaccine is indicated as a single dose for most individuals 5 years of age and older. Children under the age of 5 may be eligible to receive additional doses of this season’s vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine. This decision follows guidance from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), which recommended an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for the 2023-2024 fall and winter season.
Previously in August 2023, the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) had also received marketing authorization by the European Commission for individuals 6 months of age and older [53] . In July 2022, Pfizer and BioNTech announced that the US FDA approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® to include individuals 12 through 15 years of age [54] . In December 2021, Pfizer and BioNTech had submitted long-term follow-up data from the pivotal phase III clinical trial in 2228 participants aged 12 to 15 years [see below], to the US FDA to further support the favorable safety and efficacy profile in this age group [55] [56] . In November 2021, the US FDA authorised the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorisation was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group. The dose will be administered as a two-dose primary series, three weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is planning to meet next week to discuss further clinical recommendations. The FDA today also authorized a manufacturing change for the vaccine to include a formulation that uses a different buffer; buffers help maintain a vaccine’s pH (a measure of how acidic or alkaline a solution is) and stability [57] . In October 2021, Pfizer and BioNTech announced that the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 0, with 1 abstention, to recommend the FDA grant Emergency Use Authorization (EUA) for tozinameran in children 5 to <12 years of age. The committee reviewed results from a phase II/III conducted in the same age group [see below]. In October 2021, US FDA announced open session to discuss a request to amend Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age [58] . In October 2021, The US FDA anticipate to receive a request from Pfizer to amend its emergency use authorisation to allow the use of its COVID-19 vaccine in children 5 through 11 years of age. In anticipation of the request, the FDA is moving forward with scheduling an advisory committee meeting to inform the agency’s decision-making [59] .As of October 2021, tozinameran as a single booster dose has received EUA from FDA to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine [60] . In August 2021, the US FDA authorized a third dose of tozinamera under the current amended Emergency Use Authorization for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. This authorisation is based on information from an independent report evaluating safety and effectiveness of a third dose in people who received solid organ transplants [61] . In August 2021, Pfizer and BioNTech announced that the US Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for tozinameran (COMIRNATY®) to prevent COVID-19 in individuals 16 years of age and older as a two-dose series. The approval is based on a comprehensive data package that included longer-term follow-up data from the phase III trial [see below], where the vaccine’s high efficacy and favorable safety profile were observed up to six months after the second dose. The BLA submission package also included the manufacturing and facilities data required for licensure. BioNTech is the Marketing Authorization Holder in the United States, the European Union and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), Canada and other countries [62] . In July 2021, Pfizer and BioNTech announced that Priority Review designation was granted by the US FDA for the Biologics License Application (BLA) for tozinamera (BNT162b2) to prevent COVID-2019 infections in individuals aged 16 years and older. The US FDA has assigned PDUFA goal date for a decision in January 2022. Earlier in May 2021, the companies completed the rolling submission of the BLA, which was supported by the data from the phase III trial [see below] that evaluated the safety and efficacy of the vaccine up to six months after the second dose [63] [64] . In May 2021, Pfizer and BioNTech announced that tozinameran received authorization for emergency use for prevention of COVID-2019 infections in individuals 12 to 15 years of age as a two-dose primary series. The decision was based on the efficacy and safety data from a phase III trial [See below] [65] [66] . In December 2020, more than 7,000 Northwell frontline healthcare employees had been vaccinated in the US within Emergency Use Authorization [67] . In December 2020, the US Centers for Disease Control and prevention's (CDC) advisory committee on immunization practices (ACIP) voted to recommend the use of tozinamera (BNT162b2) vaccine for prevention of COVID 2019 infection in individuals 16 years of age and older under the Emergency Use Authorization (EUA) granted by the US FDA [see below]. The vote for recommendation was based on data from a pivotal phase III trial [see below], interim guidance of the ACIP related to allocation of initial vaccine doses (phase Ia rollout). This recommendation will be passed on to the director of CDC and the Department of Health and Human Services (HHS), for further review and adoption. Earlier in the same month, the ACIP recommended a phased allocation of vaccine distribution with initial phase Ia rollout focusing on the front-line workers as first priority, such as healthcare personnel treating patients as well as residents in nursing homes and other long-term care facilities [68] . In September 2021, data from the trial was presented at Conference on Infectious Diseases (IDWeek-2021) [69] [70] .
In May 2022, the US FDA amended the emergency use authorisation (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorising the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine. The decision is based on FDA’s analysis of immune response data in a subset of children from the ongoing randomized placebo-controlled trial that supported the October 2021 authorisation of the Pfizer-BioNTech COVID-19 Vaccine primary series in this age group [71] .
In November 2022, tozinameran received conditional marketing authorization (CMA) from the European Medicines Agency (EMA) for children aged 5 to 11 years in the European Union [51] . In December 2021, Pfizer and BioNTech submitted long-term follow-up data from the pivotal phase III clinical trial in 2228 participants aged 12 to 15 years [see below], to the EMA to further support the favorable safety and efficacy profile in this age group [55] . In November 2021, Committee for Medicinal Products for Human Use (CHMP) of the EMA issued a positive opinion on the administration of tozinameran in children 5 to under 12 years of age. The positive opinion adopted by the CHMP is based on scientific evidence from a phase I/III randomized, controlled trial [see below] [72] . In October 2021, Pfizer and BioNTech announced submission of data to the European Medicines Agency to support the vaccination of children 5 to <12 years of age [18] . As of October 2021, Pfizer and BioNTech submitted requests for authorisation of tozinameran in children 5 to <12 years to European Medicines Agency [60] . In May 2021, Pfizer and BioNTech reported that the CMA for tozinameran (COMIRNATY®) in the EU had been expanded to include patients, aged 12 to 15 years. This followed the EMA's CHMP positive opinion to authorise the vaccine in the age group. The extended indication for the CMA is valid in all 27 EU member states, including Liechtenstein, Norway, Iceland. The EU decision was based on data from a pivotal phase III trial [see trial below] [73] . Earlier, in April 2021, Pfizer and BioNTech submitted the variation to the conditional marketing authorization to EMA for extension of indication to use in 12 to 15 years old adolescents [74] . In December 2020, the EMA granted a CMA to tozinameran (BNT 162b2), for active immunisation to prevent COVID-2019 infection caused by SARS-CoV-2 virus, in individuals 16 years of age and older [75] . In the same month the CHMP of the EMA had issued a positive opinion to recommend the CMA of tozinameran (BNT 162b2), for active immunisation to prevent COVID-2019 caused by SARS-CoV-2 virus, in individuals 16 years of age and older. Earlier in the same month, the EMA received an application for conditional marketing authorisation (CMA) for tozinameran. The assessment of tozinameran was proceed under an accelerated timeline. In the same month, Pfizer and BioNTech had submitted the application for CMA to the EMA for tozinameran, against COVID-19, following rolling submissions. In October 2020, BioNTech and Pfizer had initiated a rolling submission to the European Medicines Agency, for the candidate. The EMA started rolling review of the submission evaluating the first batch of data on the vaccine from laboratory studies [76] [77] [78] [79] [80] . The EMA reported in January 2021, that its safety committee (PRAC) will evaluate monthly safety reports submitted by marketing authorization holders for COVID-2019 vaccines, starting with that for tozinameran, in line with the risk management plan. The monthly reports will include information on reported suspected adverse reactions, and will complement the periodic safety update reports [81] . In January 2021, the Committee for Medicinal Products for Human Use of the European Medicines Agency updated the product information for tozinameran to clarify its position on the interval between the first and second dose and recommended the administration of the second dose 3 weeks after the first dose. Previously, the product information stated that the interval should be at least 21 days [82] . In February 2022, EMA’s safety committee (PRAC) was assessing reported cases of heavy menstrual bleeding (heavy periods) and absence of menstruation (amenorrhea) with the COVID-19 vaccines Comirnaty and Spikevax. The PRAC decided to request an in-depth evaluation of all available data, including reports from spontaneous reporting systems, clinical trials and the published literature. At this stage, it was not yet clear whether there is a causal link between the COVID-19 vaccines and the reports of heavy periods or amenorrhea [83] .
In November 2021, Pfizer and BioNTech received authorisation for prophylactic use of tozinameran in children ages 5 to 11 years [84] .
In September 2023, Health Canada announced that it is actively reviewing submissions from Pfizer-BioNTech seeking authorization of their COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant for people six months of age and older [85] .
In November 2021, Pfizer announced that plans to submit supplementary biological license application (sBLA) to pursue regulatory approvals for use in individuals 12 years and older in several countries where emergency use authorizations or equivalents were initially granted for tozinameran in prevention of COVID-2019 infections [56] .
In April and May 2021, BioNTech and Pfizer submitted new stability data of tozinameran to the US FDA and EMA in order to update the product’s label to extend the storage at standard refrigerator temperatures of 2°C to 8°C to four weeks. As of March 2021, Both the US FDA and the European Medicines Agency (EMA) approved the transportation and storage of undiluted frozen vials of tozinameran at temperatures (-20°C) commonly found in pharmaceutical freezers for a period of up to two weeks [37] .
In March 2021, Pfizer announced new stability data which showed that the vaccine can be stored at -25°C to -15°C for a total of two weeks, and the European Medicines Agency (EMA) subsequently approved the new storage conditions [86] . In February 2021, Pfizer and BioNTech submitted new data demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F), temperatures more commonly found in pharmaceutical freezers and refrigerators to the US FDA. The data will support a proposed update to the U.S. Emergency Use Authorization (EUA) Prescribing Information, that will allow vaccine vials to be stored at these temperatures for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer [87] . In December 2020, the US FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of the FDA granting Emergency Use Authorization (EUA) for BNT162b2 vaccine. There was one member of the committee whose vote was not included in the 4 vote decision. The VRBPAC decision was based from the results of a pivotal phase III trial [see below] that demonstrated an efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. In the same month, the US FDA issued an Emergency Use Authorization (EUA) for emergency use of tozinameran (BNT 162b2) for the prevention of coronavirus disease 2019 (COVID-19) for individuals 16 years of age and older. Pfizer and BioNTech had submitted a request for Emergency Use Authorisation with the US FDA in November 2020. The submission was based on the a efficacy and safety data of tozinameran from the phase III trial [See below]. Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application (BLA) with the US FDA for a possible full regulatory approval in 2021. In April 2021, Pfizer and BioNTech submitted the variation to the emergency use authorization to US FDA for an extension of indication to use in 12 to 15 years old adolescents [74] [88] [89] [90] [91] [92] [78] [93] .
In February 2021, the Pharmaceuticals and Medical Devices Agency in Japan granted special approval for emergency to tozinameran (Comirnaty) for prevention of COVID-2019 infections [94] .
In September 2022, the TGA granted provisional approval to intramuscular tozinameran (COMIRNATY) injection for prevention against COVID-2019 infections in children aged 6 months to 4 years [95] . In July 2021, the TGA granted provisional approval to intramuscular tozinameran (COMIRNATY) injection for prevention against COVID-2019 infections in individuals 12 years of age and older [96] . In January 2021, the Therapeutic Goods Administration (TGA) of Australia granted provisional approval to intramuscular tozinameran (COMIRNATY) injection for prevention against COVID-2019 infections in individuals 16 years of age and older. The decision has been made on the basis of short term efficacy and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment. In November 2020, BioNTech and Pfizer initiated a rolling submission to Australia for tozinameran [97] [93] .
In August 2022, The Australian Technical Advisory Group on Immunisation (ATAGI) recommended the use of intramuscular tozinameran (COMIRNATY) injection for prevention against COVID-2019 infections in children aged 6 months to 4 years [95] .
In January 2023, the self-paid vaccination service of tozinameran bivalent vaccine was launched in Hong Kong and vaccine is open to people including mainland chinese residents [98] . In December 2022, Fosun Pharma announced that its subsidiary received the certificates of Drug/Product Registration in relation to the official registration of COMIRNATY® BNT162b2 vaccine and COMIRNATY® bivalent vaccine in Hong Kong SAR, pursuant to which, COMIRNATY® BNT162b2 registered to be used for primary course of vaccination for individuals of 12 years of age and older and COMIRNATY® bivalent vaccine has been registered for use as a booster dose for individuals of 12 years of age and older [99] . As of March 2023, BNT162b2 vaccine and original/omicron BA.4/BA.5 bivalent COVID-19 vaccine were granted Emergency Use Authorization (EUA) in Hong Kong SAR and Macao SAR for the prevention of COVID-19 infections in children and infants [100] . In January 2021, BioNTech and Shanghai Fosun Pharmaceutical announced that tozinameran received authorisation for emergency use for prevention of COVID-2019 infections in Hong Kong. The vaccine will be produced for administration under the Hong Kong SAR Government's COVID-19 vaccination programme [101] .
In December 2020, tozinameran was approved by Health Sciences Authority of Singapore for prevention of COVID-2019 infections for in use in COVID-19 pandemic [102] .
In December 2020, the Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK granted a temporary authorisation under Regulation 174 to tozinameran for emergency use against COVID-2019 infections. The MHRA’s decision is based on a rolling submission, including data from the phase III clinical study, which demonstrated a vaccine efficacy rate of 95% and also based on a review of chemistry, manufacturing and control (CMC) data for tozinameran [78] [86] .
As of December 2020, tozinameran was registered in Chile under emergency use authorization for the prevention of COVID-2019 infections [103] .
As of December 2020, Ecuadorian Minister of Health approved tozinameran for the prevention of COVID-2019 infections in Ecuador. The Ministry of Health reported that, Ecuador will receive its first 50,000 doses by January 2021 [103] .
As of December 2020, tozinameran has been approved for emergency use in Bahrain for prevention against COVID-2019 infections [40] .
As of December 2020, tozinameran has been approved for emergency use in Saudi Arabia and Mexico for prevention against COVID-2019 infections [104] .
In December 2020, Swissmedic in Switzerland granted a conditional marketing authorisation to tozinameran (COMIRNATY) for prevention against COVID-2019 infections. The Swissmedic decision is based on a rolling submission, including data from the phase III clinical study, which demonstrated a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection. In October 2020, Pfizer submitted an application for the authorisation of tozinameran to Swissmedic, which was reviewed in a "rolling submission" procedure [105] [106] .
Pfizer, in December 2020, submitted a request for emergency use authorisation with the Central Drugs Standard Control Organisation(CDSCO) of India for BNT 162b [107] .
As of June 2022, Fosun reported that a total of more than 30 million doses of COMIRNATY® BNT162b2 have been sold in Hong Kong SAR, Macau SAR and Taiwan region. In November 2022, Hong Kong SAR and Macau SAR introduced the COMIRNATY® bivalent vaccine, which can protect against the Omicron variant, and vaccination became available on 1 December for local residents under the government vaccination programs in Hong Kong SAR and Macau SAR, respectively. As regards the self-paid COMIRNATY® COVID-19 mRNA vaccine, in May 2022, the COMIRNATY® BNT162b2 COVID-19 mRNA vaccine indicated for active immunization of people aged 12 or above was approved by the Pharmaceutical Administration Bureau of Macau SAR as a regular imported vaccine. The University Hospital of Macau has then announced that the self-paid COVID-19 vaccination service of the COMIRNATY® COVID-19 mRNA vaccine has been officially rolled out as of 1 November 2022 [99] .
In November 2020, BioNTech and Pfizer initiated a rolling submission to Japan for tozinameran [93] .
In March 2021, the Israel Ministry of Health received real-world data for BNT 162b, indicating an at least 97% effectiveness in preventing symptomatic disease, severe/critical disease and death, at two weeks post the second dose [108] [109] .
In September 2020, BioNTech and Pfizer announced that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the phase II/III clinical trial of tozinameran vaccine candidate for the prevention of COVID-2019 infections in Germany [110] .
In March 2021, the EMA approved the manufacturing of tozinameran at its facility in Marburg, Germany [37] .
In April 2021, the EMA accepted a modification of an agreed paediatric investigation plan for tozinameran for prevention of COVID-2019 infections [111] .
In July 2020, the US FDA granted fast track designation to tozinameran for prevention of COVID-2019 infections. The decision was based on data from the phase I/II trial [see below] and immunogenicity studies in animals [112] . After extensive review of preclinical and clinical data from phase I/II clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, BioNTech and Pfizer selected the tozinameran vaccine candidate to move forward into a phase II/III study [see below] [110] .
In February 2021, Pfizer and BioNTech announced that the companies are in discussion with regulatory authorities including the US FDA and EMA regarding a registration-enabling clinical trial to evaluate a variant-specific vaccine having a modified mRNA sequence. This proposed trial would use a new construct of the Pfizer-BioNTech vaccine based on the B.1.351 lineage, first identified in South Africa. [113] .
As at November 2020, the safety milestone required by the FDA for Emergency Use Authorization (EUA) had been achieved. The company, in addition to the FDA, plan to submit all relevant data to other regulatory authorities worldwide [114] .
In February 2021, Pfizer and BioNTech reported the publication in Nature Medicine of data from in vitro studies, that demonstrated sera from individuals vaccinated with the vaccine, neutralised SARS-CoV-2 with key mutations, present in the UK and South African variants [115] .
In October 2022, Pfizer completed a phase III trial which evaluated the safety and immunogenicity of BNT162b2 when co-administered with seasonal inactivated influenza vaccine(SIIV) in adults 18 through 64 years of age (NCT06137001, C4591030). The randomised, parallel, double-blind trial was initiated in April 2022 and enrolled 1134 participants in Australia and New Zealand
In September 2022, BioNTech in collaboration with Pfizer initiated a phase-III trial to evaluate the safety, extent of the side effects, and immune responses of the bivalent BNT162b2 Omicron containing vaccine in healthy children (NCT05543616; C4591048). The non-randomised trial intends to enrol approximately 3692 participants in the US [116] .
In December 2021, BioNTech in collaboration with Pfizer completed phase III trial to evaluate the safety, tolerability, and immunogenicity of multiple formulations formulation of tozinameran against COVID-2019 infections in healthy volunteers (C4591020; NCT04816669). The randomised, observer-blind trial was initiated in April 2021 and enrolled 629 patients in the US. Part 1 of the study is comparing the safety and tolerability of lyophilised (or freeze-dried) tozinameran to the current frozen-liquid formulation of tozinameran and is evaluating non-inferiority of the immune response. Part 2 of the study will evaluate the safety and immunogenicity of a ready-to-use formulation of tozinameran [117] .
In December 2023, Pfizer and BioNTech completed a phase I/II/III trial which evaluated the safety, tolerability, and immunogenicity of intramuscularly administered tozinameran in for prevention of COVID-19 in participants, aged 6 months to 18 years (C4591007; NCT04816643; EudraCT2020-005442-42). The phase I portion is designed to identify preferred dose level(s) of tozinameran from up to three different dose levels in each age group and phase II/III portion will evaluate the safety, tolerability, and immunogenicity in each age group at the selected dose level. The trial which was initiated in March 2021 enrolled 11837 participants in the US, Spain, Poland, Finland, Brazil and Mexico. Based on the outcome of the trial, the companies are planning to conduct more trials with the vaccine to assess potential of vaccine to prevent COVID-19 infections in participants with <6 months of age. In the same month the US FDA approved an additional amendment to the study protocol of the global phase I/II/III trial for an additional dose of tozinameran or its modified version carrying the spike protein sequence of the South African variant (BNT162b2SA) in order to further describe duration of protection, and protection against the emerging variants. In September 2021, immunogenicity data from a phase II/III trial in COVID-2019 infections released by Pfizer and the 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. In September 2021, Pfizer and BioNTech submitted data to the US FDA from the trial in children 5 to <12 years of age. In October 2021, Pfizer and BioNTech announced that in a phase II/III trial in children 5 to <12 years, tozinameran showed a favourable safety profile and robust immune responses, the Data Monitoring Committee for the study reviewed the data and did not identify any serious safety concerns related to the vaccine. In November 2021, the US FDA evaluated immune response of 264 participants from this study to 253 participants 16 through 25 years of age who had two higher doses of the vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. The immune responses of the younger age participants were comparable to the older participants. As of November 2021, study enrolled approximately 4 700 children, 5 through 11 years of age. In April 2022, data were released by the company. The US FDA evaluated safety data trial. Phase II/III trial enrolled 4,526 children aged 6 months to 4 years of age. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. In June 2022, adverse events and immunogenicity data from a phase II/III trial in COVID-2019 infections for children aged 6 months to 4 years released by Pfizer [50] [57] [118] [119] [120] [60] [121] . In August 2022, the company released additional data from the trial [122] .
In July 2021, Pfizer and BioNTech completed the phase III trial that assessed the safety, tolerability, and immunogenicity of the tozinameran in healthy volunteers for prevention of COVID-2019 infections and SARS-CoV-2 infections (C4591017; NCT04713553). The randomised trial was initiated in February 2021, and enrolled 1 530 volunteers in the US [123] .
As at August 2023, Pfizer and BioNTech initiated a phase II/III trial to learn about the safety, tolerability, and immunogenicity of tozinameran (new BNT162b2 RNA-based vaccine candidates) targeting new variants of SARS-CoV-2 in healthy volunteers (NCT05997290; C4591054). The multicentre, open, prospective trial aims to enroll 731 volunteers, aged 12 years and older in the US [124]
In July 2022, Pfizer and BioNTech completed the phase II/III trial that was designed to evaluate the safety, tolerability, and immunogenicity of tozinameranin preventing COVID-19 in healthy pregnant women (18 years and older age) (NCT04754594; C4591015; EudraCT2020-005444-35). The enrollment in the trial was stopped in November 2021. The trial was initiated in February 2021, and enrolled 343 healthy pregnant women in the US, Brazil, South Africa, UK, and Spain. The first volunteer was dosed in the US in the trial [51] [125] [126] .
In April 2021, The University of Hong Kong initiated a phase II trial immunogenicity, safety and tolerability of intradermal covid-19 vaccination strategy in immunocompromised patients (NCT05736913; UW 21-214). The open-label, parallel group, prospective, randomised trial intends to enrol 130 participants in Hong Kong [127]
In July 2023, BioNTech in collaboration with Pfizer completed a phase II trial to evaluate the safety, tolerability and immunogenicity of vaccine tozinameran for prevention of COVID-2019 infections in immunocompromised patients of age ≥2 years (NCT04895982; EudraCT2021-001290-23; C4591024). The multicentre, open, randomized trial was initiated in October 2021 and enrolled 124 patients in Germany, USA, Brazil and Mexico [128] .
In October 2023, BioNTech completed a phase II trial that evaluated the safety and immunogenicity of the multivalent vaccine tozinameran in healthy volunteers for prevention of COVID-2019 infections (BNT162-17; EudraCT2021-003458-22; NCT05004181). The open-label, non-randomised trial was initiated in August 2021 and enrolled 1 383 healthy volunteers in the US, Germany, south Africa an Turkey [129] .
In April 2021, University of Oxford's initiated a phase II Com-COV2 trial to determine the reactogenicity and immunogenicity of heterologous prime/boost COVID-19 vaccine schedules (OVG2021/01; EudraCT2021-001275-16; 27841311). The randomised homologous/heterologous-boost vaccine administration study intends to enrol approximately 1050 patients in the UK [130] .
In August 2021, National Institute of Allergy and Infectious Diseases (NIAID) and PPD initiated a phase II CPATtrial to assess the immunogenicity of tozinameran of a third dose of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine for prevention of COVID-2019 infections, in kidney transplant recipients who failed to respond after two previous doses of either vaccine (DAIT COVID19-TB-02; NIAID CRMS ID 38865; NCT04969263). This open label, non-randomised study is enrolling approximately 200 patients in the US [131] .
In May 2021, Medical University initiated a phase II HeVacc trial to analyze the safety and efficacy of the heterologous vaccination with Vaxzevria followed by Comirnaty (NCT04907331; 2021-002171-19). The randomised trial intends to enrol approximately 3000 participants in Austria [132] .
In January 2022, Shanghai Fosun Pharmaceutical and BioNTech a phase II trial to assess the safety and immunogenicity of tozinameran for the prevention of COVID-2019 infections (BNT162-06; NCT04649021). The trial was initiated in November 2020, and enrolled 950 healthy volunteers, aged 18 to 85 years, in China [25] [133] . In November 2020, BioNTech and Fosun submitted an IND application with the National Medical Products Administration (NMPA) in China for this phase II trial [12] [134] .
In February 2023, BioNTech and Pfizer completed the phase I/II/III trial that was designed to assess the safety, efficacy and immunogenicity of SARS-COV-2 vaccine candidates BNT 162b1 and tozinameran against COVID-2019 infections(C4591001; NCT04368728; EudraCT2020-002641-42). Phase I/II portion of the study evaluated both BNT162b1 and tozinameran. This portion of the study aimed to identify the preferred candidate, as well as the dose level, to be evaluated further in the phase II/III portion [135] . The randomized, observer-blinded, global, prospective trial enrolled 47079 patients in the US, Argentina, Brazil, Germany and South Africa and Turkey. In July 2020, preliminary results from the trial were released by BioNTech and Pfizer. Also, safety and immunogenicity results from the phase I portion of the trial were released by the company. Based on the results, the company reported that phase II/III portion of the study, will evaluate tozinameran, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein, at 30 µg dose level in a two-dose regimen.In November 2020, Pfizer and BioNTech release first interim safety and efficacy analysis from this study. This data demonstrated that vaccine is 90% effective in preventing COVID-2019 infections and also no serious safety concerns observed [136] . The companies reported data from the final efficacy analysis, that demonstrated that the study met the primary efficacy endpoints. The Data Monitoring Committee has not reported any vaccine related safety concerns. In September 2020, Pfizer and BioNTech submitted an amended protocol to the US FDA to expand the enrolment of their phase III pivotal COVID-19 vaccine trial [see below] to up to approximately 44 000 participants which also allows for the enrolment of new populations. The proposed expansion will further increase trial population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), hepatitis C, or hepatitis B infection, as well as provide additional safety and efficacy data [137] . The companies plan to submit these data to the US FDA and EMA for a requested amendment to the Emergency Use Authorization and the EU Conditional Marketing Authorization for tozinameran to expand use in adolescents 12-15 years of age. All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose. As of May 2021, the US FDA approved an additional amendment to the study protocol of the global phase I/II/III trial which includes: (1) an assessment of the impact of a third dose of tozinameran in prolonging immunity against COVID-19 and in protecting against COVID-19 caused by potential newly emerging SARS-CoV-2 variants, and (2) an assessment of a modified, variant-specific version of tozinameran. In April 2021, updated results from the trial were released by Pfizer and BioNTech [138] [139] [114] [140] [80] [141] [135] [142] [143] [110] [144] . In October 2021, Pfizer and BioNTech released updated topline efficacy and safety results of a 30 µg booster dose of the vaccine. The companies plan to submit these data to FDA, EMA and other regulatory agencies to further support licensure in the US and other countries [145] . In November 2021, Pfizer announced topline results from a longer-term analysis of the trial [56] . In September 2021, the company presented updated safety data from the trial at the 46th European Society for Medical Oncology Congress (ESMO-2021) [146] . Later, in December 2021, the company released topline efficacy data from the trial [147]
In March 2024, BioNTech in collaboration with Pfizer withdrew a phase I trial prior to enrollment as the bivalent vaccine was no longer epidemiologically relevant. The trial was designed to study the safety, tolerability and immunogenicity of the bivalent BNT162b2 vaccine in healthy infants and children (NCT05630352; C4591023). The open-label, non-randomized trial enrolled 0 subjects in unknown location [148] .
In November 2021, Pfizer completed a phase I/II trial to evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (tozinameran) for the prevention of COVID-2019 infections( NCT04588480; C4591005). The randomised, placebo-controlled, study was initiated in October 2020 and enrolled to 160 volunteers in Japan [149]
In April 2022, BioNTech completed a phase I/II study that evaluated the safety and immunogenicity of four BNT 162 vaccines, BNT 162a1 [see Adis Insight Drug profile800061412], BNT 162b1 [see Adis Insight Drug profile800061409], tozinameran, and BNT 162c2 [see Adis Insight Drug profile800061418] using different regimens, for the prevention of COVID-2019 infection (EudraCT2020-001038-36; NCT04380701; BNT162-01). The open label study was initiated in April 2020 and enrolled 512 participants in Germany. BioNTech completed dosing in first cohort (n = 12) in Germany in April 2020. The company also intends to extend the trial in the US upon regulatory approval. In July 2020, data was released by the company [150] [151] [152] [153] [154] . In December 2020, updated results from the trial were released by the company [104] .
In March 2020, BioNTech reported that the company has intended to manufacture the vaccine for clinical trials, along with it's partner Polymun, in Europe [28] .
In January 2022, Pfizer and BioNTech released results from two laboratory studies demonstrating that three doses of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) elicited antibodies that neutralise the Omicron variant (B.1.1.529) [155] .
In February 2021, BioNTech announced results of an in vitro study conducted with 20 sera samples from previously tozinameran-vaccinated humans from a phase III trial. A full set of South African variant (E484K+N501Y+D614G, also known as B.1.351 lineage) spike mutations was tested, along with three genetically engineered recombinant viruses. One virus had the full set of spike glycoprotein mutations found in the South African variant and the other two had subsets of these mutations. A reduction in neutralization of virus with all the South African variant spike glycoprotein mutations was observed, and all the sera neutralized all the viruses tested. This finding is consistent with recent reports of the neutralization of variant SARS-CoV-2 or corresponding pseudoviruses by convalescent or post-immunization sera [156] .
In January 2021, Pfizer announced data from an in vitro study done on 20 samples of sera obtained from humans who were previously vaccinated with tozinameran in a phase III trial. The data indicated that the vaccine neutralised all the SARS-CoV-2 strains tested (N501Y, UK variant Δ69/70+N501Y+D614G and South Africa variant E484K+N501Y+D614G). However, the neutralisation against the South African variant was slightly lower compared to other variants [157] .
In February 2021, results from preclinical studies were released by Pfizer and BioNTech [158] .
In January 2021, Pfizer in collaboration with BioNTech released results of an in vitro study that demonstrated the capability of sera from individuals immunized with tozinameran to neutralize the SARS-CoV-2 UK strain (also known as B.1.1.7 lineage or VOC 202012/01), which is a mutated strain with higher transmission rate. The studies were conducted with a pseudovirus bearing the UK strain SARS-CoV-2 spike, and indicated efficient neutralization of the mutated N501Y spike bearing virus by sera of individuals who had received tozinameran [159] [160] .
In September 2020, results from the studies conducted in SARS-CoV-2 challenged rhesus macaques and murine model were released by Pfizer and BioNTech [161] .
Respiratory tract infections
In January 2024, Pfizer completed a phase II trial which evaluated safety and effects of a combined vaccine for RSV and COVID-19 [see AdisInsight drug profile 800057858] when given with a seasonal flu vaccine or when given alone (NCT05886777; C5481001). The randomised trial was initiated in June 2023, enroled 1084 healthy volunteers in the US [162]
Supply arrangement
In August 2020, Pfizer and BioNTech agreed to supply doses of BNT 162 vaccine for COVID-2019 infection, under an agreement with the Government of Canada. The supply is subjected to regulatory approval from Health Canada approval and is planned in 2021. Financial details of the agreement were not disclosed [163] .
Safety Information
In In April 2022, multiple regulatory agencies, including the EMA and the US FDA authorised the extension of the shelf-life of the BNT 162 vaccine from nine months to twelve months when stored at -90°C to -60°C [164] .
The US FDA approved package insert for tozinameran contains a warning about the risk of myocarditis [165] .
Events of anaphylaxis has been reported, vaccination with BNT 162 for COVID-2019 infection [7] .
Financing information
In September 2020, BioNTech received a grant of up to $US455 million from the German Federal Ministry of Education and Research (BMBF) to support the development of BNT 162 vaccines [166] .
In July 2020, Pfizer and BioNTech announced an agreement with the U.S. Department of Health and Human Services and the Department of Defense, under which the US government will pay the companies $US1.95 billion upon the receipt of the first 100 million doses of BNT 162, subject to regulatory approval or emergency use authorization from the FDA and successful manufacture and delivery of the vaccine by Pfizer. The U.S. government can acquire up to 500 million additional doses. In February 2021, the US government exercised its option for an additional 100 million doses of BNT 162, for which the US government will pay the companies $US1.95 billion [167] [141] .
In June 2020, BioNTech raised $US121 million through a debt financing agreement with The European Investment Bank (EIB). The proceeds from this financing will support the development of BNT 162. The proceeds will also used to expand BioNTech's manufacturing capacity in order to supply the vaccine fast worldwide in response to the pandemic [168]
Patent Information
Patent litigation
As of August 2023, Alnylam's claims of infringement in its two lawsuits against Pfizer were unaffected by the Delaware Court's claim interpretation decision. For as long as Pfizer uses Alnylam's technology in their COVID-19 vaccine, COMIRNATY®, Alnylam will continue to sue Pfizer under six patents for reasonable compensation [169] .
In June 2023, Promosome LLC filed major patent infringement actions against Pfizer and BioNTech for willful infringement of US Patent No. 8 853 179 (the "179 patent") entitled "Reengineering mRNA primary structure for enhanced protein production" which relates to messenger RNA technology utilized for Comirnaty vaccine. The lawsuit describes how Promosome shared its technology with BioNTech scientist, but neither BioNTech nor Pfizer pursued a license for Comirnaty®, which generated revenues exceeding $S75 billion [170] .
In May 2023, Arbutus Biopharma filed patent infringement lawsuit against Pfizer and BioNTech seeking compensation for use of unlicensed patented technologies in COVID-19 mRNA-LNP vaccines [171] .
Drug Properties & Chemical Synopsis
- Route of administration IM, Parenteral
- Formulation Injection, unspecified
- Class COVID-19 vaccines, RNA vaccines, Viral vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X (Other viral vaccines)
-
EPhMRA code
J7E9 (All other viral vaccines)
- CAS Registry Number 2417899-77-3
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
COVID 2019 infections |
Arm Group Label |
B-lymphocyte antigen CD19 |
|
|
COVID 2019 infections |
Outcome Measure |
vitronectin tumor necrosis factor receptor superfamily member 9 Tumor necrosis factor alpha (TNF-alpha) Thromboxane T-cell surface antigen CD4 T-cell receptor T3 delta chain (CD3d) T-cell receptor CD3-epsilon (CD3e) T-Cell differentiation antigen CD8 SSB (La) seryl-tRNA synthetase Protein S prion protein (testis specific) Picolinic acid PD-1/CD279 Nuclear protein Ki67 Monocyte differentiation antigen CD14 Monocyte chemoattractant protein-1 (MCP-1/CCL2) MIP-1 alpha lunapark, ER junction formation factor KIR3DL1 Interleukin-8 (IL-8) Interleukin-6 (IL-6) Interleukin-4 (IL-4) Interleukin-3 (IL-3) Interleukin-23 (IL-23) Interleukin-2 (IL-2) Interleukin-18 (IL-18) Interleukin-17 (IL-17) Interleukin-10 (IL-10) interleukin 37 interleukin 33 Interleukin 1 Beta (IL-1β) Interferon Gamma (IFNg) Interferon alpha (IFN-alpha) Inositol-P-ceramide HLA-DR heat shock 27kDa protein 3 GTP binding protein overexpressed in skeletal muscle fuzzy planar cell polarity protein FK506 binding protein 4 Fc gamma RIIIa Fc fragment of IgG, low affinity IIIb, receptor (CD16b) Eotaxin (CCL11) elaC ribonuclease Z 1 CXCL9 CXCL1 Creatinine Creatine colony stimulating factor 2 receptor, alpha, low-affinity (granulocyte-macrophage) Chemokine IFN-γ-inducible protein 10 (IP-10/CXCL10) CD40/TNFRSF5 CD38 CD3 gamma chain (CD3G) CBLIF Cardiac Troponin I C-X-C motif chemokine ligand 5 C-X-C motif chemokine ligand 11 C-reactive protein (CRP) C-C motif chemokine ligand 8 C-C motif chemokine ligand 20 C-C motif chemokine 5 (CCL5 C-C motif chemokine 4 (CCL4 Bilirubin ACE2 |
|
|
COVID 2019 infections |
Brief Title |
seryl-tRNA synthetase Gut Microbiome |
|
|
COVID 2019 infections |
Arm Group Description |
T cell receptor beta variable 20/OR9-2 (non-functional) PARP-1 Human Microbiome Cytokeratin 20 Cyclin-dependent kinase 4 (CDK4) collagen, type XI, alpha 2 CD22 B-lymphocyte antigen CD20 B-lymphocyte antigen CD19 B-cell lymphoma 2 (Bcl-2) Androgen Receptor (AR) |
|
|
COVID 2019 infections |
Detailed Description |
vitronectin T-cell surface antigen CD4 T-Cell differentiation antigen CD8 seryl-tRNA synthetase Renin KIR3DL1 Interleukin-2 (IL-2) Interferon Gamma (IFNg) GTP binding protein overexpressed in skeletal muscle Fumaric acid elaC ribonuclease Z 1 dipeptidyl-peptidase 4 D-dimer Cytokeratin 20 CBLIF Calprotectin C-reactive protein (CRP) B-lymphocyte antigen CD20 ACE2 24,25-Dihydroxyvitamin D |
|
|
COVID 2019 infections |
Eligibility Criteria |
Tumor necrosis factor alpha (TNF-alpha) T-cell surface antigen CD4 T-box 1 PD-1/CD279 Interleukin-17 (IL-17) Interleukin-12B (IL-12p40) Interleukin-12A (IL-12p35) interleukin 6 receptor GNPTAB cytotoxic T-lymphocyte-associated protein 4 Apolipoprotein H antibodies |
|
|
COVID 2019 infections |
Official Title |
Gut Microbiome dipeptidyl-peptidase 4 ACE2 |
|
|
COVID 2019 infections |
Brief Summary |
T-cell surface antigen CD4 T-Cell differentiation antigen CD8 seryl-tRNA synthetase KIR3DL1 GTP binding protein overexpressed in skeletal muscle dipeptidyl-peptidase 4 Cardiac Troponin I ACE2 |
|
|
hepatitis B |
Arm Group Description |
B-cell lymphoma 2 (Bcl-2) |
|
|
herpes zoster |
Arm Group Description |
B-cell lymphoma 2 (Bcl-2) |
|
|
influenza virus infections |
Arm Group Description |
B-cell lymphoma 2 (Bcl-2) |
|
|
pneumococcal infections |
Arm Group Description |
Cytokeratin 20 B-lymphocyte antigen CD20 B-cell lymphoma 2 (Bcl-2) |
|
|
SARS-CoV-2 acute respiratory disease |
Eligibility Criteria |
GNPTAB |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Tozinameran - BioNTech/Pfizer | Androgen Receptor (AR) | Arm Group Description |
| Apolipoprotein H antibodies | Eligibility Criteria | |
| B-lymphocyte antigen CD19 | Arm Group Label | |
| B-lymphocyte antigen CD20 | Arm Group Description, Detailed Description | |
| Bilirubin | Outcome Measure | |
| C-reactive protein (CRP) | Outcome Measure | |
| Cardiac Troponin I | Brief Summary, Outcome Measure | |
| CBLIF | Detailed Description, Outcome Measure | |
| collagen, type XI, alpha 2 | Arm Group Description | |
| colony stimulating factor 2 receptor, alpha, low-affinity (granulocyte-macrophage) | Outcome Measure | |
| Creatine | Outcome Measure | |
| Creatinine | Outcome Measure | |
| Cyclin-dependent kinase 4 (CDK4) | Arm Group Description | |
| Cytokeratin 20 | Arm Group Description, Detailed Description | |
| elaC ribonuclease Z 1 | Detailed Description, Outcome Measure | |
| Fc fragment of IgG, low affinity IIIb, receptor (CD16b) | Outcome Measure | |
| Fc gamma RIIIa | Outcome Measure | |
| Fumaric acid | Detailed Description | |
| GNPTAB | Eligibility Criteria | |
| Gut Microbiome | Brief Title, Official Title | |
| heat shock 27kDa protein 3 | Outcome Measure | |
| Human Microbiome | Arm Group Description | |
| Interferon alpha (IFN-alpha) | Outcome Measure | |
| Interferon Gamma (IFNg) | Detailed Description, Outcome Measure | |
| Interleukin 1 Beta (IL-1β) | Outcome Measure | |
| Interleukin-2 (IL-2) | Detailed Description | |
| Interleukin-3 (IL-3) | Outcome Measure | |
| Interleukin-6 (IL-6) | Outcome Measure | |
| lunapark, ER junction formation factor | Outcome Measure | |
| Monocyte differentiation antigen CD14 | Outcome Measure | |
| PARP-1 | Arm Group Description | |
| prion protein (testis specific) | Outcome Measure | |
| seryl-tRNA synthetase | Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Outcome Measure | |
| SSB (La) | Outcome Measure | |
| T-box 1 | Eligibility Criteria | |
| T-Cell differentiation antigen CD8 | Detailed Description, Outcome Measure | |
| T-cell surface antigen CD4 | Detailed Description, Eligibility Criteria, Outcome Measure | |
| Thromboxane | Outcome Measure | |
| Tumor necrosis factor alpha (TNF-alpha) | Outcome Measure | |
| vitronectin | Detailed Description, Outcome Measure |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | conditional marketing approval | Prevention | Marketed | France, Germany, Netherlands, Poland, Spain, Sweden | IM / Injection | BioNTech | 07 Mar 2024 |
| COVID 2019 infections | conditional marketing authorisation | Prevention | Marketed | Switzerland | IM / Injection | Pfizer | 24 Aug 2022 |
| COVID 2019 infections | Emergency use authorisation under regulation 174 | Prevention | Marketed | United Kingdom | IM / Injection | BioNTech, Pfizer | 12 Oct 2022 |
| COVID 2019 infections | - | Prevention | Marketed | Turkey | Parenteral / unspecified | BioNTech, Pfizer | 07 Mar 2024 |
| COVID 2019 infections | Under Emergency Use Authorisation in 16 years of age and older conditional marketing approval provisional approval, in individuals 16 years and older emergency approval Emergency use authorisation under regulation 174 emergency use authorisation | Prevention | Registered | Australia, Bahrain, Chile, Ecuador, Iceland, Israel, Liechtenstein, Mexico, Norway, Philippines, Saudi Arabia, Singapore | IM / Injection | BioNTech, Pfizer | 23 Aug 2022 |
| COVID 2019 infections | special approval for emergency | Prevention | Registered | Japan | IM / Injection | Pfizer Japan | 14 Feb 2021 |
| COVID 2019 infections | conditional marketing approval | Prevention | Registered | European Union | IM / Injection | BioNTech | 21 Dec 2020 |
| COVID 2019 infections | Full authorization for 12 years of age and above | In adolescents, In adults, In the elderly, Prevention | Registered | Canada | IM / Injection | BioNTech, Pfizer | 16 Sep 2021 |
| COVID 2019 infections | - | In adolescents, Prevention | Registered | Hong Kong, Macau | IM / Injection | Shanghai Fosun Pharmaceutical | 19 Dec 2022 |
| COVID 2019 infections | - | Prevention | Registered | Macau, Taiwan | IM / Injection | Shanghai Fosun Pharmaceutical | 01 Jun 2022 |
| COVID 2019 infections | - | In adolescents, In adults, In children, In the elderly, Prevention | Registered | Australia | IM / Injection | BioNTech, Pfizer | 23 Jul 2021 |
| COVID 2019 infections | for children six months to four years of age | In children, In infants, Prevention | Registered | Canada | IM / Injection | BioNTech, Pfizer | 09 Sep 2022 |
| COVID 2019 infections | children aged 6 months to 4 years | In children, In infants, Prevention | Registered | Australia | IM / Injection | Pfizer | 29 Sep 2022 |
| COVID 2019 infections | 12 to 15 years of age; Conditional Marketing Authorization | In adolescents, Prevention | Registered | European Union, Iceland, Liechtenstein, Norway | IM / Injection | BioNTech, Pfizer | 28 May 2021 |
| COVID 2019 infections | Children 5 to under 12 years of age Age, 5 to 11 years children 5 to 11 years | In children, Prevention | Registered | Canada, European Union, Israel | IM / Injection | BioNTech, Pfizer | 25 Nov 2021 |
| COVID 2019 infections | - | In adolescents, In adults, In children, In infants, In the elderly, Prevention | Registered | USA | IM / Injection | BioNTech, Pfizer | 11 Sep 2023 |
| COVID 2019 infections | Emergency Use Authorization in children and infants | In children, In infants | Registered | Hong Kong, Macau | IM / Injection | Shanghai Fosun Pharmaceutical | 27 Mar 2023 |
| COVID 2019 infections | - | Prevention | Registered | Hong Kong | IM / Injection | BioNTech, Shanghai Fosun Pharmaceutical | 25 Jan 2021 |
| COVID 2019 infections | In children aged 6 months to less than 5 years | In children, In infants, Prevention | Preregistration | European Union | IM / Injection | BioNTech, Pfizer | 19 Oct 2022 |
| COVID 2019 infections | - | Prevention | Preregistration | India | IM / Injection | Pfizer | 09 Dec 2020 |
| COVID 2019 infections | 12 years and older | In adolescents, In adults, In the elderly, Prevention | Preregistration | European Union | IM / Injection | BioNTech, Pfizer | 19 Jul 2022 |
| COVID 2019 infections | 65 years and older | In adults, In the elderly, Prevention | Phase III | Unknown | IM / Injection | Pfizer | 24 May 2021 |
| COVID 2019 infections | - | Prevention | Phase III | New Zealand | IM / Injection | Pfizer | 20 Apr 2022 |
| COVID 2019 infections | ≥2 years of age | In adolescents, In adults, In children, In the elderly, Prevention | Phase II/III | Mexico | IM / Injection | BioNTech, Pfizer | 24 Mar 2021 |
| COVID 2019 infections | 12 years and older | In adolescents, In adults, In the elderly, Prevention | Phase II/III | Argentina, Brazil, South Africa, Turkey | IM / Injection | BioNTech, Pfizer | 14 Oct 2020 |
| COVID 2019 infections | ≥2 years of age | In adolescents, In adults, In children, In the elderly, Prevention | Phase II | USA | IM / Injection | 15 Oct 2021 | |
| COVID 2019 infections | ≥2 years of age | In adolescents, In adults, In children, In the elderly, Prevention | Phase II | Brazil, Germany | IM / Injection | BioNTech | 15 Oct 2021 |
| COVID 2019 infections | 18-85 years | Prevention | Phase II | China | IM / Injection | BioNTech, Shanghai Fosun Pharmaceutical | 24 Nov 2020 |
| COVID 2019 infections | EUA amended, monovalent vaccine no longer authorized for use in the US | Prevention | Discontinued (Registered) | USA (fast track) | IM / Injection | BioNTech, Pfizer | 18 Apr 2023 |
| COVID 2019 infections | 6 months to 4 years of age; EUA amended, monovalent vaccine no longer authorized for use in the US | In children, In infants, Prevention | Discontinued (Registered) | USA | IM / Injection | BioNTech, Pfizer | 18 Apr 2023 |
| COVID 2019 infections | for 12 years of age and older in certain immunocompromised individuals such as those with solid organ transplantation; EUA amended, monovalent vaccine no longer authorized for use in the US | In adolescents, In adults, In the elderly, Prevention | Discontinued (Registered) | USA | IM / Injection | BioNTech, Pfizer | 18 Apr 2023 |
| COVID 2019 infections | for children 5 through 11 years of age; EUA amended, monovalent vaccine no longer authorized for use in the US | In children, Prevention | Discontinued (Registered) | USA | IM / Injection | BioNTech, Pfizer | 18 Apr 2023 |
| COVID 2019 infections | 6 Months to 30 Years; EUA amended, monovalent vaccine no longer authorized for use in the US | In adolescents, In adults, In children, In infants, Prevention | Discontinued (Registered) | USA | IM / Injection | BioNTech, Pfizer | 18 Apr 2023 |
| SARS-CoV-2 acute respiratory disease | - | In adults, In the elderly, Prevention | Phase II | Germany, South Africa, Turkey, USA | IM / Injection | BioNTech | 25 Aug 2021 |
Priority Development Status
| Type | Region | Indication |
|---|---|---|
| Fast Track | USA | COVID 2019 infections |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| BioNTech | Originator | Germany |
| University of Roma La Sapienza | Originator | Italy |
| University of Roma La Sapienza | Owner | Italy |
| BioNTech | Owner | Germany |
| Shanghai Fosun Pharmaceutical | Licensee | China, Hong Kong, Macau |
| Pfizer | Licensee | USA |
| Acuitas Therapeutics | Technology Provider | Canada |
| National Institute of Allergy and Infectious Diseases | Collaborator | USA |
| Merck KGaA | Collaborator | Germany |
Brand Names
| Brand Name | Organisations | Indications | Countries |
|---|---|---|---|
| COMIRNATY | Pfizer | COVID 2019 infections | USA, Japan, Canada, United Kingdom, Israel, Australia, Switzerland, European Union |
Credit Suisse Market Status
| Indication | Region | Company | Phase | Expected Launch Year | Probability of Success% | Patent Expiry Year | Expected Generic Entry | Last Update |
|---|---|---|---|---|---|---|---|---|
| COVID mRNA vaccine | ex US | Pfizer | Marketed | 2020 | 100 | - | - | 05 Nov 2023 |
| COVID mRNA vaccine | US | Pfizer | Marketed | 2020 | 100 | - | - | 05 Nov 2023 |
Credit Suisse Financial Forecast
| Indication | Region | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | Last Update |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| COVID mRNA vaccine | ex US | 28972 | 29032 | 9581 | 3832 | 2683 | 2146 | 1824 | 1642 | 1478 | 1463 | 05 Nov 2023 |
| COVID mRNA vaccine | US | 7809 | 8775 | 3800 | 6300 | 5800 | 5200 | 5100 | 4500 | 4200 | 4158 | 05 Nov 2023 |
| Total | 36781 | 37807 | 13381 | 10132 | 8483 | 7346 | 6924 | 6142 | 5678 | 5621 |
Scientific Summary
Adverse Events
In additional analysis from the pivotal phase III trial, tozinameran was well tolerated whithout any serious safety issues through six months post seven days after second dose in 12 000 participants with aged 16 years and older. Side effects were generally consistent as previously reported. Earlier reported positive top-line results from the trial showed that tozinameran in adolescents (n = 2 260) 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, was well tolerated with side effects generally consistent with those observed in participants 16 to 25 years of age [138] [139] [144] .
Updated data from a phase III trial in patients (n= 1647) with cancer, showed that tozinameran was well tolerated whithout any serious safety issues up to 6 months of follow-up. of ptcpts ≥16, AEs were reported at IRs of 94.0 (vaccine) and 49.3 (placebo) per 100-person-y; most common AEs were reactogenicity events (injection-site pain [IR: 40.2 vaccine; 4.2 placebo]; fatigue [IR: 21.4 vaccine; 7.6 placebo]; pyrexia [IR: 19.8 vaccine; 0.7 placebo]). 1 vaccine ptcpt withdrew due to a vaccine-related AE. No vaccine-related deaths were reported. Among ptcpts ≥12 y with cancer, 3 vaccine and 27 placebo recipients developed COVID-19 from 7 days post-Dose 2; vaccine efficacy (VE) was observed to be 89.7% (95% CI 66.5-98.0%). These results were comparable favorably with overall VE of 91.1% [146] . Updated topline data from a phase III trial showed that the adverse event profile was generally consistent with other clinical safety data for the vaccine, with no safety concerns identified [145] . The earlier data from final analysis of the phase I/II/III trial demonstrated that BNT 172b2 was well tolerated, with most solicited adverse events resolved shortly post vaccination. Grade 3 solicited adverse event (frequency ≥2%) was fatigue (3.8%) and headache (2%) after the second dose. Solicited adverse events were fewer and milder in older adults. Preliminary results from a phase I/II trial in patients with COVID 2019 infections demonstrated adverse reactions, including low grade fever, were more common after the second dose than the first dose at the 10µg or 30µg dose levels. Following dose 2, 8.3% of participants who received 10 µg and 75.0% of participants who received 30µg BNT 162b1 reported fever = 38.0 °C. Local reactions and systemic events after injection with 10µg and 30µg of BNT 162b1 were dose-dependent, generally mild to moderate, and transient, with occasional severe events (Grade 3) of flu-like symptoms and injection site reactions. The most commonly reported local reaction were injection site pain, which was mild to moderate, except in one of 12 patients who received a 100µg dose, which was severe. No serious adverse events were reported. All adverse events resolved spontaneously and were managed with simple measures. There were no withdrawals due to adverse events related to the vaccine [56] [114] [175] [144] .
Results from phase I trial demonstrated milder systemic events after administration of BNT162b2 compared to those with BNT162b1. Similar systemic events were observed after administration of dose 1 of BNT162b2 and placebo in patients with 65-85 years old. Mild to moderate fever was reported in fewer than 20% of participants. After administration of dose 2 of 30µg BNT162b2, only 17% of participants of age 18 to 55 years and 8% of participants of 65 to 85 years old reported fever (=38.0 to 38.9 °C). However, 75% of 18 to 55 year old participants and 33% of 65 to 85 year old participants reported fever after administered a second dose of 30µg of BNT162b1. Severe systemic events including fatigue, headache, chills, muscle pain, and joint pain were reported in small numbers of younger BNT162b2 recipients and were transient and manageable. No severe systemic events were reported by older BNT162b2 recipients. There were no grade 4 systemic events reported by any BNT162 recipient [143] [144] .
In phase II/III trial, commonly reported side effects in the clinical trial included injection site pain (sore arm), redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite. More children reported side effects after the second dose than after the first dose. Side effects were generally mild to moderate in severity and occurred within two days after vaccination, and most went away within one to two days. The data was analyzed for 1 444 vaccine recipients of age 5 through 11 years [57]
In phase III trial in allogeneic stem cell transplant (SCT) recipients local and systemic reactions were reported by 67% and 22% of participants, respectively, after dose 1, and 63% and 50% after dose 2. All reported events were mild [70]
In a phase II/III trial, tozinameran was safe, for the prevention of COVID-2019 infections, in infants and children (6 to 11 years of age). In the booster data readout (n=401), the vaccine was well tolerated with no new safety signals observed [172] [121] .
In a phase II/III trial in children 6 months through 4 years of age, tozinameran demonstrated a favorable safety and tolerability profile comparable to placebo. No new safety signals were identified. The frequency of adverse reactions observed were lower in children 6 months through 4 years than in children 5 through 11 years. 30.3% (6 through 23 months age group) of children reported adverse events in the tozinameran group and 27.3% of children reported adverse events in the placebo group. 18.8% and 18.9% of participants who received the tozinameran or placebo respectively reported adverse events in the 2 through 4-year age group. Reactogenicity events were mostly mild to moderate and short lived for both age groups with systemic events comparable to placebo.The randomized, controlled phase II/III trial enrolled 4,526 children (aged 6 months through 4 years) [50] [121]
Immunogenicity
Summary
Results from a phase III booster dose trial demonstrated a relative vaccine efficacy of 95.6% in the booster grop when compared to those who did not receive a booster. The observed relative vaccine efficacy of 95.6% (95% CI: 89.3, 98.6) reflects the reduction in disease occurrence in the boosted group versus the non-boosted group in those without evidence of prior SARS-CoV-2 infection. There were 5 cases of COVID-19 in the booster group, and 109 cases in the non-booster group. Multiple subgroup analyses showed that efficacy was consistent irrespective of age, sex, race, ethnicity, or comorbid conditions. The results were obtained from more than 10,000 individuals of 16 years of age and older who previously completed the primary two-dose series of the tozinameran vaccine, and then were randomised 1:1 to receive either a 30 µg booster dose (the same dosage strength as those in the primary series) or placebo with a median time between the second dose and booster of 11 months [145] [144] .
In phase III clinical trial Solid Organ Transplant (SOT) recipients had a significantly decreased humoral response to mRNA COVID-19 vaccines compared to the healthy cohort, with those further out from transplant more likely to respond. Low titers of anti-N IgG at all timepoints indicate no natural infection with COVID-19 during the study. There were significantly lower magnitudes for anti-S (p< 0.0001), anti-S1 (p< 0.0001), and anti-RBD (p< 0.0001) IgG titers on the day of dose 2 and day 28 post second dose for SOT recipients compared to healthy controls. Using the internally validated threshold of anti-S IgG >1.07 based on pre-pandemic controls, only 50% of the SOT sub-cohort responded to vaccine after series completion. There was a positive trend between months from transplant and anti-S IgG titer [69] . Among Stem Cell Transplant (SCT) recipients, mRNA COVID-19 vaccines were well-tolerated but less immunogenic than in healthy controls. Significantly lower anti-S (p< 0.0001), S1 (p< 0.0001), and RBD (p< 0.0001) IgG responses were reported as compared to healthy controls, both at the time of dose 2 and 28 days post-vaccine series. Overall, 62.5% of SCT recipients were responders after vaccine series completion, as compared to 100% of healthy controls. While no patients had a reported history of COVID-19 diagnosis, 2 patients in the SCT cohort had elevated anti-S IgG levels and 1 showed elevated anti-N at baseline. Allogeneic stem cell transplant recipients showed significantly lower anti-S, S1, and RBD IgG responses as compared to healthy controls. Low titers of anti-N IgG demonstrated no history of COVID-19 natural infection during the course of the study [70]
In additional analysis from the pivotal phase III trial, tozinameran elicited strong immune response against SARS-CoV-2 virus through six months post seven days after second dose in 46 307 participants. Analysis from the 927 confirmed symptomatic cases of COVID-19 showed 91.3% efficacy of the vaccine (850 cases in placebo vs. 77 in tozinameran group). In subgroup of patients with severe disease, the vaccine showed 100% efficacy as defined by the US Centers for Disease Control and Prevention (CDC) (32 cases in placebo vs. 0 in tozinameran group) (95% CI, [88.0,100.0]). By the FDA definition, the vaccine showed 95.3% efficacy (21 cases in placebo vs. 01 in tozinameran group; 95% CI, [71,99.9]). Across the age, gender, race and ethnicity demographics, and with a variety of underlying conditions, the efficacy was similar. The efficacy of vaccine was 92.6% (647 cases in placebo vs. 50 in tozinameran group; 95% CI, [90.1, 94.5]) in US population and 100% in patients enrolled in South Africa in the trial (95% CI, [53.5, 100.0]). Positive top-line results from a phase III study of tozinameran in adolescents (n = 2 260) 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old. Vaccination with BNT 162b2 elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compares well (was non-inferior) to GMTs elicited by participants aged 16 to 25 years old (705.1 GMTs) in an earlier analysis. In the trial, 18 cases of COVID-19 were observed in the placebo group (n=1129) versus none in the vaccinated group (n=1131). Vaccination with tozinameran elicited high SARS-CoV-2 neutralizing antibody titers, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. In an exploratory analysis of 800 trial participants enrolled in South Africa, nine cases of COVID-19 were observed, all in the placebo group, indicating vaccine efficacy of 100%. Of these cases, eight were of the B.1.351 lineage [37] [138] [139] [144] .
Results from a phase II/III trial showed a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older. The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose. This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age [119] [144]
The final efficacy analysis from the phase I/II/III study of BNT 162b2 demonstrated that the study met all the primary efficacy endpoints. Efficacy of the vaccine was deemed to be 95% (p<0.0001) in subjects without prior SARS-CoV-2 infection and those with or without prior SARS-CoV-2 infection, assessed seven days post second dose; of the 170 confirmed cases, 162 were in the placebo and eight in the active intervention cohorts. Efficacy in subjects aged over 65 years was 94%, with efficacy found to be consistent across age, gender, race and ethnicity. Preliminary results from a phase I/II trial in patients with COVID 2019 infections demonstrated that highest neutralising titers within seven days after the second dose of 10µg or 30µg on day 28 after vaccination. The neutralising geometric mean titers (GMTs) were 168 and 267 for the 10µg and 30µg dose levels, respectively, corresponding to 1.8- and 2.8-times the neutralising GMT of 94 observed in a panel of 38 sera from patients who had contracted SARS-CoV-2. Neutralising titers continued to rise, as indicated by BMT that was 4.6 times the convalescent serum panel GMT, by 14 days post the second dose of 30µg. In patients who received 2 vaccinations at 10 µg and 30 µg dose levels of BNT 162b1, elevation of RBD-binding IgG concentrations was observed after the second injection with respective geometric mean concentrations (GMCs) of 4,813 and 27,872 units/ml at day 28, seven days after immunisation. These concentrations were 8- and 46.3-times the GMC of 602 units/ml in a panel of 38 sera from patients who had contracted SARS-CoV-2. At day 21 after a single injection, the 12 patients who received 100 µg of BNT 162b1 had an RBD-binding IgG GMC of 1,778 units/ml and a SARS-CoV neutralising GMT of 33, which are 3-times and 0.35-times, respectively, the GMC and GMT of the convalescent serum panel. The vaccine elicited receptor binding domain (RBD) binding IgG concentrations after the second dose, compared to baseline. SARS-CoV-2 neutralising geometric mean titers were in the range of 0.7-fold (1 µg) to 3.2-fold (50 µg) compared to that of a panel of SARS-CoV-2 infection convalescent human sera, at day 43. Furthermore, sera of vaccinated subjects displayed broadly neutralising activity in pseudovirus neutralizstion assays across a panel of sixteen SARS-CoV-2 RBD variants represented in publicly available SARS-CoV-2 sequences and against the newly dominant D614G strain. In addition, BNT 162 showed a concurrent induction of high level CD4+ and CD8+ T cell responses against the SARS-CoV-2 RBD. There was no clear dose level dependency of the T cell response between 1µg to 50µg, indicating that stimulation and robust expansion of T cells might be accomplished at low mRNA dose levels. All participants in the prime-boost cohorts, except for two at the lowest dose level, had CD4+ T cell responses. Cytokine profiling of the RBD-specific CD4+ T cells demonstrated a TH1-dominant profile for these cells. During the study, 29 of the 36 tested participants also mounted an RBD-specific functional, CD8+ T cell response that was comparable to memory responses observed against cytomegalovirus (CMV), Epstein Barr virus (EBV) and influenza virus. From the 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior infection with SARS-CoV-2, 30 cases of COVID-19 were in the placebo group and 0 cases were in the Pfizer-BioNTech vaccine group, corresponding to vaccine efficacy of 100% (95% confidence interval [CI, 87.5, 100.0]). Efficacy was consistently high across gender, race and ethnicity demographics, obesity and comorbidity status [56] [114] [173] [150] [175] [144] .
Updated results from phase I/II trial demonstrated combined adaptive humoral and cellular immune response against SARS-CoV-2 and induced T cell immunity. Vaccination with tozinameran showed newly generated spike protein-specific CD4+ T cell responses with almost 92% of participants demonstrated CD8+ T cell responses. Most of the vaccinated participants elicited robust expansion of CD4+ and CD8+ T cells even with lowest dose of 1 µg. Vaccination with tozinameran showed expression of cytokines, interferon and interleukin-2, however demonstrated low levels of interleukin-4 in tozinameran-induced CD4+ T cells indicated a TH1 profile. Tozinameran showed CD8+ T cell response against multiple region of spike proteins and against multiple epitopes of the virus. Induced T cell response was comparable or significantly higher than memory responses of the same individuals against common viruses, such as cytomegalovirus (CMV), Epstein Barr virus (EBV) and the influenza virus. Vaccine also gave protection against pseudo-viruses representing 19 diverse SARS-CoV-2 variants [104] . Earlier results from the trial in patients receiving tozinameran demonstrated strong immunogenicity in younger and older adults. Treatment with tozinameran showed 3.8 times geometric mean titters (GMT) of 38 sera of SARS-CoV2 convalescent patients in younger adult (18-55 years of age) and 1.6 times the GMT of same panel in older adult (65-85 year of age) after 7 days of treatment. In both younger and older adults, BNT162b1 and tozinameran elicited similar dose-dependent SARS-CoV-2–neutralizing antibody GMTs, which were substantially elevated after the second dose, showing clear benefit of a 2-dose regimen. The 50% GMT for BNT 162b2 and BNT 162b1 at the 30µg dose on day 28 or day 35 was 1.7 to 4.6 times for subjects aged 18-55 years, and was 1.1 to 2.2 times for subjects aged 65-85 years, than the GMT of a panel of SARS-CoV-2 human convalescent sera. Although both vaccine candidates elicited lower antigen-binding IgG and neutralizing responses in older adults (65 to 85 years of age), compared to younger adults (18 to 55 years of age), the neutralizing antibody GMTs measured 7 days after Dose 2 of 30µg of BNT162b1 or tozinameran in participants 65 to 85 years old were comparable to or higher than the GMT of a panel of SARS-CoV-2 convalescent sera from 38 patients (18 to 83 years of age) who had contracted SARS-CoV-2. Vaccination with tozinameran in human participants displayed a favorable breadth of epitopes recognised in T cell responses specific to the SARS-CoV-2 spike antigen, as compared to the BNT162b1 candidate. Also, vaccination with tozinameran demonstrated high induction of high CD4+ and CD8+ T cell responses against the receptor binding domain and against the remainder of the spike glycoprotein that is not contained in the BNT162b1 vaccine candidate [142] [143] [154] .
Tozinameran showed potent anti-viral effects in rhesus macaques, and elicited SARS-CoV-2 neutralizing geometric mean titers 8.2 to 18.2 times that of a SARS-CoV-2 convalescent human serum panel. The drug also protected the macaques with no evidence of disease enhancement following SARS-CoV-2 challenge. An intramuscular dose of tozinameran elicited a dose-dependent antibody response with high virus-entry inhibition titers and strong TH1 CD4+ and IFNg + CD8+ T-cell responses in mice. In a viral infection model, after 55 days of 100 µg tozinameran treatment in macaques, compared to macaques that received saline control injections, immunisation with tozinameran reduced viral infection with no viral RNA detected in the lower respiratory tract of the immunized animals, while in most non-immunized (saline) animals, had evidence of viral RNA. Tozinameran treatment also induced potent viral antigen-specific CD4+ and CD8+ T cells in vaccinated-macaques. After two immunizations, neutralisation titers were detectable in rhesus macaques sera with geometric mean titers of 962 (on Day 35 for the 30 µg group) or 1,689 (on Day 28 for the 100 µg group). BNT 162b2 vaccination elicited a high frequency of CD4+ T cells that produced interferons, IL-2, and TNF-a, and almost no IL-4 producing CD4+ cells were detectable, indicating vaccine safety. Tozinameran also elicited spike-specific interferons producing CD8+ T cell responses, which is thought to promote an anti-viral effect. B-cell and T-cell immune responses in BALB/c mice were noted in a preclinical murine model, a single intramuscular immunisation of BNT 162b2 (0.2, 1, or 5 µg). Immunisation also showed increased SARS-CoV-2 pseudovirus neutralising activity to Day 28. CD4+ and CD8+ T-cells from splenocytes isolated from tozinameran -immunised mice showed interferons and IL-2, producing high levels of the TH1 cytokines but minute amounts of TH2 cytokines, suggesting a robust, TH1-biased T cell adaptive immune response [158] [161] .
Results of in vitro studies showed that sera from individuals immunized with tozinameran was capable of neutralising the SARS-CoV-2 UK strain (B.1.1.7 lineage or VOC 202012/01), which is a mutated strain with higher transmission rate. These studies were conducted with a pseudovirus bearing the UK strain SARS-CoV-2 spike with N501Y mutation, and showed efficient neutralization by tozinameran elicited human sera. This was consistent with preserved neutralisation of a panel of 15 pseudoviruses bearing spikes with other mutations found in circulating SARS-CoV-2 strains [179] [160] .
Results of an in vitro study conducted with sera of previously tozinameran-vaccinated humans from a phase III trial demonstrated that reduction in neutralization of virus with all the South African variant spike glycoprotein mutations was observed, and all the sera neutralized all the viruses tested. A full set of South African variant (E484K+N501Y+D614G, also known as B.1.351 lineage) spike mutations was tested, along with three genetically engineered recombinant viruses. One virus had the full set of spike glycoprotein mutations from the South African variant and the other two had subsets of these mutations [156] .
Results from clinical studies, real-world evidences and published literature showed that a booster dose of tozinameran elicited significantly higher neutralising antibody titers against the wild type SARS-CoV-2 virus and the Beta and Delta variants, when compared with the levels observed after the first and second dose in adults (Age, 18 years and older) [177] .
In a phase II/III trial, children 6 months through 4 years of age, demonstrated vaccine efficacy of 73.2% (2-sided 95% CI: 43.8%, 87.6%) with tozinameran, without evidence of prior COVID-19 infection. Among children ages 6 through 23 months, the vaccine was 75.8% (2-sided 95% CI: 9.7%, 94.7%) effective at preventing COVID-19, based on 4 cases in the vaccine group (n=296) and 8 cases in the placebo group (n=147), after a median of 1.9 months (range: 0.0, 4.9) follow-up after the third dose. For children ages 2 through 4 years of age, the vaccine was 71.8% (2-sided 95% CI: 28.6%, 89.4%) effective at preventing COVID-19, based on 9 cases in the vaccine group (n=498) and 13 cases in the placebo group (n=204), after a median of 2.4 months (range: 0.0, 4.9) follow-up after the third dose [122] . Earlier results, in children, aged 6 to <12 years, tozinameran demonstrated a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose, during a period when Delta was the prevalent strain. Updated data demonstrated an increase in SARS-CoV-2 Omicron variant and wild-type strain neutralizing titers following a booster dose of tozinameran vaccine, compared with two doses. These data reinforced the potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group. In the trial, data were analyzed from 140 children, 5 through 11 years of age, received a booster dose approximately 6 months after the second dose of the vaccine 10µg primary series. Data from a sub analysis of 30 sera from this study indicated that serum antibodies induced by a third dose neutralize the SARS-CoV-2 Omicron variant in this age group, as demonstrated by a 36-fold increase in neutralizing antibody titers compared with levels seen after two doses of the vaccine. A robust response was observed regardless of prior SARS-CoV-2 infection. Further, immunogenicity data from 140 participants in the trial with who had no evidence of prior SARS-CoV-2 infection, showed a 6-fold increase (95% CI: 5.0, 7.6) in SARS-CoV-2 wild-type strain–neutralizing geometric mean titers (GMTs) one month after the booster, compared with the SARS-CoV-2–neutralizing GMTs one month after the second dose of the vaccine, demonstrating a strong immune response in this age group [172] [60] [121] .
In a phase II/III trial in children 6 months through 4 years of age tozinameran elicited a strong immune response following third dose. The SARS-CoV-2-neutralizing antibody geometric mean titer (GMT) one month after the third dose was 1535.2 (95% CI, 1,388.2, 1,697.8) in children 2 through 4 years of age and 1406.5 (95% CI, 1,211.3, 1,633.1) in infants 6 through 23 months .This compares well (was non-inferior) to the antibody responses from volunteers aged 16 to 25 years of age immunized with two 30-µg doses. The randomized, controlled phase II/III trial enrolled 4,526 children [50] [121] .
Clinical trials with Comirnaty Original/Omicron BA.1 demonstrated that the vaccine was more effective than Comirnaty at eliciting an immune response against the BA.1 subvariant and was as effective as Comirnaty against the original strain. Comirnaty Original/Omicron BA.4-5 induces sufficient immunity against the strains it targets [44]
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 06 Dec 2022 | Trial Update | BioNTech SE plans a phase I trial for COVID-19 infections (Prevention, In infants) (IM) in December 2022 (NCT05630352) (700359048) | 02 Dec 2022 |
| 28 Sep 2022 | Trial Update | BioNTech in collaboration with Pfizer plans a phase-III trial for COVID-2019 infections (In infants, In children, Prevention) (IM) (NCT05543616) (700356910) | 13 Oct 2022 |
| 31 Jul 2022 | Regulatory Status | Pfizer and BioNTech plan to submit requests for authorisation of tozinameran for COVID-2019 infections (Prevention, In infants, In children) to European Medicinces Agency and other regulators around the world in early July 2022. [50] | 24 Jun 2022 |
| 30 Apr 2022 | Regulatory Status | Pfizer and BioNTech plan to submit a request for Emergency Use Authorization (EUA) of a booster dose of tozinameran for children ages 5 through 11 in USA, in 2022 [172] | 19 May 2022 |
| 31 Mar 2022 | Trial Update | Murdoch Childrens Research Institute, PATH, Coalition for Epidemic Preparedness Innovations and The Peter Doherty Institute for Infection and Immunity plans a phase III trial in COVID-2019 infections (Prevention, In adults, In the elderly) in Australia in March 2022 (IM) (NCT05228730) | 26 May 2022 |
| 31 Dec 2021 | Regulatory Status | Pfizer and BioNTech announces intention to submit BLA to the US FDA for COVID-2019 infections (Prevention) in 2021 [88] | 16 May 2021 |
| 31 Dec 2021 | Regulatory Status | BioNTech and Pfizer announces intention to submit application for full marketing authorization to EMA and in the UK for COVID-2019 infections [86] | 27 May 2021 |
| 31 Dec 2021 | Regulatory Status | BioNTech and Pfizer announces intention to submit application for full marketing authorization to Health Canada for COVID-2019 infections [86] | 21 Sep 2021 |
| 31 Dec 2021 | Regulatory Status | Pfizer and BioNTech expect to submit application for the cohort of patients, aged 6 months to 2 years, for COVID-2019 infections (Prevention, In infants, In children), in the fourth quarter of 2021 [73] | 01 Jun 2021 |
| 22 Nov 2021 | Company Name Changes | Clifford Craig Medical Research Trust plans a clinical COVULPOP trial for COVID-19 infections in Australia in November 2021 (IM) (ACTRN12621001492842) | 07 Apr 2022 |
| 14 Nov 2021 | Regulatory Status | The Centers for Disease Control and Prevention’s anticipates to meet for discussion of further clinical recommendation on emergency use of vaccine in children 5 through 11 Years of Age [57] | 03 Nov 2021 |
| 08 Oct 2021 | Trial Update | Pfizer and BioNTech plans a phase IIb trial for COVID-2019 infections(In children, In adolescents, In adults, In the elderly, Prevention) in USA, Brazil, Germany, in October 2021 (IM) (NCT04895982) (700337447) | 19 Nov 2021 |
| 30 Sep 2021 | Regulatory Status | Pfizer and BioNTech expect to submit for an Emergency Use Authorization in USA or a variation to Conditional Marketing Authorizations in European Union for two cohorts, including patients 2 to 5 years of age and 5 to11 years of age for COVID-2019 infections (Prevention, In infants, In children), in September 2021 [73] | 03 Nov 2021 |
| 31 Aug 2021 | Trial Update | National Institute of Allergy and Infectious Diseases plans a phase II trial COVID-2019 infections (Prevention) in USA (IM) in August 2021 (NCT04969263) | 23 Aug 2021 |
| 31 Aug 2021 | Trial Update | BioNTech plans a phase II trial for COVID-2019 infections and SARS-COV-2 acute respiratory disease (Prevention, In adults, In the elderly) in August 2021 (IM) (NCT05004181) (700341427) | 21 Sep 2021 |
| 29 Aug 2021 | Trial Update | Pfizer and BioNtech announces intention to complete rolling submission of supplemental Biologics License Application by the end of this week (9333515) | 27 Aug 2021 |
| 30 Jun 2021 | Regulatory Status | BioNTech and Pfizer plan to file for regulatory approval for COVID-2019 infections (In adolescent, In adults, In the elderly, Prevention) in the second quarter of 2021 [125] | 27 Aug 2021 |
| 19 Apr 2021 | Trial Update | University of Oxford plans a phase II trial for COVID-2019 infections (Prevention) in United Kingdom in April 2021 (27841311) | 21 Sep 2021 |
| 21 Jan 2021 | Trial Update | BioNTech in collaboration with Pfizer plans a phase III trial for COVID-2019 infections (Prevention, In adults) in January 2021 (IM, Injection) (NCT04713553) (700332789) | 01 Mar 2021 |
| 31 Dec 2020 | Regulatory Status | Pfizer and BioNTech plan to launch the vaccine for COVID-2019 infections by the end of 2020, subject to technical success of the development program and approval of regulatory authorities [176] | 15 Apr 2020 |
| 31 Dec 2020 | Trial Update | BioNTech and Shanghai Fosun Pharmaceutical plans a phase II trial for COVID-2019 infections in China [12] | 20 Jan 2021 |
| 29 Dec 2020 | Regulatory Status | Pfizer and BioNTech expects EMA’s Committee for Medicinal Products for Human Use will conclude its assessment of safety and effectiveness of BNT 162 during an extraordinary meeting, in December 2020, which is based on the context of the rolling review and may be subject to change as evaluation proceeds [77] | 23 Dec 2020 |
| 21 Dec 2020 | Company Name Changes | EMA's the Committee for Medicinal Products for Human Use (CHMP) schedule an exceptional meeting to conclude assessment of safety and effectiveness of tozinameran, in the EU, in December 2020 (9311462) | 23 Dec 2020 |
| 24 Nov 2020 | Regulatory Status | Pfizer and BioNTech plans to submit Emergency Use Authorisation request for COVID-2019 infections (Prevention) (IM) to the US FDA (9309423) [136] | 02 Dec 2020 |
| 31 Oct 2020 | Regulatory Status | BioNTech and Pfizer plan to file for market authorisation or regulatory approval for COVID-2019ninfections in October 2020 [174] | 23 Dec 2020 |
| 31 Jul 2020 | Trial Update | Pfizer and BioNTech plans a phase IIb/III trial for COVID-2019 infections in July 2020 [175] | 01 Aug 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 18 Mar 2024 | Trial Update | BioNTech withdraws a phase I trial in COVID-19 (In Children, In Infants, Prevention) prior to enrollment (IM, Injection) (NCT05630352) Updated 27 Mar 2024 |
| 07 Mar 2024 | Phase Change - Marketed | Launched for COVID-2019 infections (Prevention) in Germany (IM) (Prior to March 2024) [30] Updated 13 Mar 2024 |
| 07 Mar 2024 | Phase Change - Marketed | Launched for COVID-2019 infections (Prevention) in Turkey (Parenteral) (Prior to March 2024) [30] Updated 13 Mar 2024 |
| 01 Feb 2024 | Trial Update | Pfizer plans a phase-I/II trial for COVID-2019 infections and Influenza virus infections (Prevention, Combination therapy) in USA (Parenteral), (NCT06237049) Updated 07 Feb 2024 |
| 01 Jan 2024 | Trial Update | Pfizer completes a phase II trial for Respiratory tract infections (Prevention, In elderly) in USA (NCT05886777) Updated 13 Feb 2024 |
| 08 Dec 2023 | Trial Update | BioNTech SE and Pfizer completes a phase II/III trial in COVID-2019 infections (In adolescents, In children, In the elderly, Prevention, In adults) in Mexico, Brazil (IM) (NCT04816643) Updated 29 Dec 2023 |
| 05 Nov 2023 | Financial Update | Credit Suisse financial data update Updated 05 Nov 2023 |
| 10 Oct 2023 | Trial Update | BioNTech SE plans a phase II/III trial for COVID-2019 infections and SARS-COV-2 acute respiratory disease (In children, In adolescents, In adult, In the elderly, Prevention) in the US (Parenteral) (NCT05997290) Updated 16 Oct 2023 |
| 04 Oct 2023 | Trial Update | BioNTech completes a phase II trial for COVID-2019 infections (In adults, In the elderly, Prevention) and SARS-COV-2 acute respiratory disease (In adults, In the elderly, Prevention) in USA, Germany, South Africa and Turkey (IM) (NCT05004181) (EudraCT2021-003458-22) Updated 28 Nov 2023 |
| 28 Sep 2023 | Regulatory Status | Health Canada approves Tozinameran (Omicron XBB.1.5 subvariant) for individuals six months and older (Prevention) [31] Updated 05 Oct 2023 |
| 12 Sep 2023 | Regulatory Status | BioNTech filed regulatory application with Health Canada for Omicron XBB.1.5 subvariant COVID-2019 infections (In adults, In adolescents, In children, In infants, Prevention) prior to September 2023 [85] Updated 14 Sep 2023 |
| 11 Sep 2023 | Phase Change - Registered | Registered for COVID-2019 infections (In adolescents, In children, In the elderly, In infants, Prevention, In adults) in USA (IM) [53] Updated 13 Sep 2023 |
| 30 Aug 2023 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention, In adults, In children, In infants, In the elderly, In adolescents) in USA, prior to August 2023 (IM) [42] Updated 01 Sep 2023 |
| 30 Aug 2023 | Regulatory Status | Pfizer and BioNTech receive positive CHMP opinion for omicron XBB.1.5-adapted COVID-19 vaccine in the European Union [42] Updated 01 Sep 2023 |
| 25 Aug 2023 | Patent Information | Alnylam's claims of infringement in its two lawsuits against Pfizer were unaffected by the Delaware Court's claim interpretation decision [169] Updated 30 Aug 2023 |
| 10 Aug 2023 | Trial Update | BioNTech and Pfizer initiates a phase II/III trial in COVID-2019 infections (Prevention, In adolescents, In adults, In the elderly) in USA (NCT05997290) Updated 02 Nov 2023 |
| 23 Jul 2023 | Trial Update | BioNTech completes a phase II trial in COVID-19 infections(In adolescents, In adults, In children, In the elderly, Prevention) in Mexico (IM) (NCT04895982) Updated 06 Sep 2023 |
| 07 Jun 2023 | Patent Information | Promosome files a lawsuit against Pfizer and BioNTech for infringement of patent related to mRNA sequence reverse engineering technology [170] Updated 13 Jun 2023 |
| 05 Jun 2023 | Trial Update | Pfizer initiated a phase II trial for Respiratory tract infections (Prevention, In elderly) in USA (NCT05886777) Updated 04 Jul 2023 |
| 02 Jun 2023 | Trial Update | Pfizer plans a phase II trial for Respiratory tract infections (Prevention, In elderly) in June 2023 (NCT05886777) Updated 06 Jun 2023 |
| 09 May 2023 | Patent Information | 9388327: patent info and HE updates Updated 09 May 2023 |
| 05 May 2023 | Patent Information | Arbutus Biopharma files patent infringement lawsuit against Pfizer and BioNTech seeking compensation for use of unlicensed patented technologies in COVID-19 mRNA-LNP vaccines [171] Updated 09 May 2023 |
| 18 Apr 2023 | Phase Change - Discontinued(Registered) | Discontinued - Registered for COVID-2019 infections (In adolescents, In children, In infants, Prevention, In adults) in USA (IM) [2] Updated 10 May 2023 |
| 18 Apr 2023 | Phase Change - Discontinued(Registered) | Discontinued - Registered for COVID-2019 infections (In adolescents, In the elderly, Prevention, In adults) in USA (IM) [2] Updated 10 May 2023 |
| 18 Apr 2023 | Phase Change - Discontinued(Registered) | Discontinued - Registered for COVID-2019 infections (In children, In infants, Prevention) in USA (IM) [2] Updated 10 May 2023 |
| 18 Apr 2023 | Phase Change - Discontinued(Registered) | Discontinued - Registered for COVID-2019 infections (In children, Prevention) in USA (IM) [2] Updated 10 May 2023 |
| 18 Apr 2023 | Phase Change - Discontinued(Registered) | Discontinued - Registered for COVID-2019 infections (Prevention) in USA (IM) [2] Updated 10 May 2023 |
| 18 Apr 2023 | Regulatory Status | The US FDA amends emergency use authorization (EUA), simplifying vaccination schedule for most individuals, authorizing bivalent vaccine (tozinameran/famtozinameran) for all doses administered to individuals 6 months of age and older, and discontinuing the use of monovalent Pfizer-BioNTech COVID-19 vaccine in the USA [2] Updated 22 Apr 2023 |
| 27 Mar 2023 | Phase Change - Registered | Registered for COVID-2019 infections (In infants, In children) in Hong Kong (IM) as of March 2023 [100] Updated 30 Mar 2023 |
| 27 Mar 2023 | Phase Change - Registered | Registered for COVID-2019 infections (In infants, In children) in Macau (IM) as of March 2023 [100] Updated 30 Mar 2023 |
| 10 Feb 2023 | Trial Update | BioNTech completes a phase-II/III trials in COVID-2019 infections (In adolescents, In the elderly, In adults, Prevention) in USA, Argentina, Brazil, Germany, South Africa and Turkey (IM) (NCT04368728) Updated 10 Mar 2023 |
| 19 Dec 2022 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention, In adolescents) in Hong Kong (IM) [99] Updated 29 Dec 2022 |
| 29 Nov 2022 | Trial Update | BioNTech SE plans a phase I trial for COVID-19 infections (Prevention, In infants) (IM) in December 2022 (NCT05630352) Updated 02 Dec 2022 |
| 19 Oct 2022 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention, In infants, In children) in European Union (IM) [43] Updated 21 Oct 2022 |
| 19 Oct 2022 | Regulatory Status | CHMP of the EMA issues positive opinion recommending approval of tozinameran for COVID-19 infections (In infants, In children, Prevention) in European Union [43] Updated 21 Oct 2022 |
| 12 Oct 2022 | Phase Change - Marketed | Launched for COVID-2019 infections (Prevention) in United Kingdom (IM) (BioNTech Pipeline, May 2023) Updated 21 May 2023 |
| 29 Sep 2022 | Phase Change - Registered | Registered for COVID-2019 infections (In children, In infants, Prevention) in Australia (IM) [95] Updated 22 Dec 2022 |
| 23 Sep 2022 | Trial Update | BioNTech in collaboration with Pfizer initiates a phase-III trial for COVID-2019 infections (In infants, In children, Prevention) in USA (IM)(NCT05543616) Updated 13 Oct 2022 |
| 20 Sep 2022 | Trial Update | BioNTech in collaboration with Pfizer plans a phase-III trial for COVID-2019 infections (In infants, In children, Prevention) (IM) (NCT05543616) Updated 13 Oct 2022 |
| 16 Sep 2022 | Regulatory Status | The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends converting the conditional Marketing Authorization to Marketing Authorization (MA) for Tozinameran for all authorized indications and formulations [46] [45] Updated 23 Sep 2022 |
| 12 Sep 2022 | Scientific Update | Immunogenicity data from a clinical trial in COVID-2019 infections released by BioNTech [44] Updated 07 Oct 2022 |
| 12 Sep 2022 | Regulatory Status | Tozinameran (Comirnaty Original/Omicron BA.4-5) receives positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for COVID-2019 infections [44] Updated 04 Oct 2022 |
| 09 Sep 2022 | Phase Change - Registered | Registered for COVID-2019 infections (In children, In infants, Prevention) in Canada (IM) [32] Updated 13 Sep 2022 |
| 24 Aug 2022 | Phase Change - Marketed | Launched for COVID-2019 infections (Prevention) in Switzerland (IM) (BioNTech Pipeline, May 2023) Updated 21 May 2023 |
| 23 Aug 2022 | Scientific Update | Immunogenicity data from a phase II/III trial in COVID-19 infections released by Pfizer [122] Updated 08 Sep 2022 |
| 23 Aug 2022 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Philippines (IM), prior to August 2022 [41] Updated 23 Aug 2022 |
| 08 Aug 2022 | Phase Change - Marketed | Launched for COVID-2019 infections (Prevention) in France (IM) (BioNTech Pipeline, May 2023) Updated 21 May 2023 |
| 08 Aug 2022 | Phase Change - Marketed | Launched for COVID-2019 infections (Prevention) in Netherlands (IM) (BioNTech Pipeline, May 2023) Updated 21 May 2023 |
| 08 Aug 2022 | Phase Change - Marketed | Launched for COVID-2019 infections (Prevention) in Poland (IM) (BioNTech Pipeline, May 2023) Updated 21 May 2023 |
| 08 Aug 2022 | Phase Change - Marketed | Launched for COVID-2019 infections (Prevention) in Spain (IM) (BioNTech Pipeline, May 2023) Updated 21 May 2023 |
| 08 Aug 2022 | Phase Change - Marketed | Launched for COVID-2019 infections (Prevention) in Sweden (IM) (BioNTech Pipeline, May 2023) Updated 21 May 2023 |
| 03 Aug 2022 | Regulatory Status | The Australian Technical Advisory Group on Immunisation (ATAGI) recommends approval of Tozinameran for COVID-2019 infections (Prevention, In children, In infants) in Australia (IM) [95] Updated 22 Dec 2022 |
| 27 Jul 2022 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (In adolescents, In adults, In children, In the elderly, Prevention) in Mexico (IM) (NCT04895982) Updated 06 Sep 2023 |
| 19 Jul 2022 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (In adolescents, In the elderly, Prevention, In adults) in European Union (IM) [48] Updated 26 Jul 2022 |
| 15 Jul 2022 | Trial Update | Pfizer and BioNTech completes a phase II/III trial for COVID-2019 infections (Prevention) in Brazil, South Africa, Spain and United Kingdom (IM) (NCT04754594) Updated 31 Aug 2022 |
| 08 Jul 2022 | Regulatory Status | US FDA approves sBLA application for COMIRNATY® in COVID-2019 infections (Prevention) in children aged 12 through 15 years of age [54] Updated 14 Jul 2022 |
| 08 Jul 2022 | Regulatory Status | Pfizer and BioNTech Submits a Variation to European Medicines Agency (EMA) for the Vaccination of Children 6 Months to less than 5 Years with Tozinameran [47] Updated 13 Jul 2022 |
| 23 Jun 2022 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (In children, Prevention, In infants) in Canada (IM) [32] Updated 13 Sep 2022 |
| 17 Jun 2022 | Regulatory Status | Pfizer and BioNTech plan to submit requests for authorisation of tozinameran for COVID-2019 infections (Prevention, In infants, In children) to European Medicinces Agency and other regulators around the world in early July 2022. [50] Updated 24 Jun 2022 |
| 17 Jun 2022 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (In adolescents, In children, In infants, Prevention, In adults) in USA (IM) Updated 21 Jun 2022 |
| 17 Jun 2022 | Phase Change - Registered | Registered for COVID-2019 infections under Emergency Use Authorization (In adolescents, In children, In infants, Prevention, In adults) in USA (IM) Updated 21 Jun 2022 |
| 17 Jun 2022 | Phase Change - Registered | Registered for COVID-2019 infections under Emergency Use Authorization (In children, In infants, Prevention) in USA (IM) in June 2022 [50] Updated 21 Jun 2022 |
| 17 Jun 2022 | Scientific Update | Adverse events and immunogenicity data from a phase II/III trial in Covid-19 infection released by Pfizer [50] Updated 21 Jun 2022 |
| 15 Jun 2022 | Regulatory Status | The EMA initiates a rolling review of a version of tozinameran for prevention of COVID-2019 infections due to specific variant or variants of SARS-CoV-2 virus [49] Updated 30 Jun 2022 |
| 01 Jun 2022 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Macau (IM) [99] Updated 29 Dec 2022 |
| 01 Jun 2022 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Taiwan (IM) [99] Updated 29 Dec 2022 |
| 18 May 2022 | Regulatory Status | The US FDA amends the emergency use authorization (EUA) for use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with COVID-19 Vaccine [71] Updated 19 May 2022 |
| 01 May 2022 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention, In adolescents) in Macau (IM) [99] Updated 29 Dec 2022 |
| 20 Apr 2022 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (Prevention) in New Zealand (IM) (NCT06137001) Updated 21 Nov 2023 |
| 14 Apr 2022 | Regulatory Status | Pfizer and BioNTech plan to submit a request for Emergency Use Authorization (EUA) of a booster dose of tozinameran for children ages 5 through 11 in USA, in 2022 [172] Updated 19 May 2022 |
| 14 Apr 2022 | Regulatory Status | Pfizer and BioNTech expects regulatory approvals in USA, European Union, United Kingdom, Canada and other countries where emergency use authorizations or equivalent were initially granted [172] Updated 21 Apr 2022 |
| 14 Apr 2022 | Regulatory Status | Pfizer and BioNTech plan to share the clinical data with the European Medicines Agency (EMA) and other regulatory bodies around the world for tozinameran [172] Updated 21 Apr 2022 |
| 14 Apr 2022 | Scientific Update | Updated safety and immunogenicity data from a phase I/II/III trial in COVID-2019 infections released by Pfizer and BioNTech [172] Updated 21 Apr 2022 |
| 13 Apr 2022 | Trial Update | BionNTech SE completes the phase-I/II clinical trials in COVID-2019 infections (Prevention) in Germany (IM) (NCT04380701) (EudraCT2020-001038-36) Updated 06 Jun 2022 |
| 11 Feb 2022 | Regulatory Status | Pfizer and BioNTech announces plans to extend rolling submission to the US FDA seeking to amend the Emergency Use Authorization COVID-2019 infections for 6 months to 4 years of age [52] Updated 15 Feb 2022 |
| 08 Feb 2022 | Trial Update | Murdoch Childrens Research Institute, PATH, Coalition for Epidemic Preparedness Innovations and The Peter Doherty Institute for Infection and Immunity plans a phase III trial in COVID-2019 infections (Prevention, In adults, In the elderly) in Australia in March 2022 (IM) (NCT05228730) Updated 26 May 2022 |
| 08 Feb 2022 | Phase Change - Preregistration | Preregistration for COVID-2019 infections for 6 months to 4 years of age (In infants, In children, Prevention) in USA (IM) [51] Updated 17 Feb 2022 |
| 11 Jan 2022 | Licensing Status | Pfizer enters into agreement with Acuitas Therapeutics for use of Lipid Nanoparticle Delivery System for its mRNA vaccine tozinameran [11] Updated 13 Jan 2022 |
| 09 Jan 2022 | Trial Update | BioNTech and Shanghai Fosun Pharmaceutical Industrial Development completed the phase II trial in COVID-2019 infections (Prevention) in China (IM) (NCT04649021) Updated 26 May 2022 |
| 04 Jan 2022 | Biomarker Update | Biomarkers information updated Updated 06 Jan 2022 |
| 01 Dec 2021 | Trial Update | BioNTech in collaboration with Pfizer completes phase III trial in healthy volunteers in US (NCT04816669) Updated 29 Dec 2021 |
| 25 Nov 2021 | Phase Change - Registered | Registered for COVID-2019 infections (In children, Prevention) in European Union (IM) [51] Updated 25 Feb 2022 |
| 25 Nov 2021 | Trial Update | BioNTech and Pfizer completes a phase I/II trial in COVID-2019 infections (Prevention) in Japan (IM) (NCT04588480) Updated 30 Dec 2021 |
| 25 Nov 2021 | Regulatory Status | Pfizer and BioNTech receives positive opinion from the CHMP for the administration of tozinameran in COVID-2019 infections (In children, Prevention) (5 to under 12 years) in European Union [72] Updated 29 Nov 2021 |
| 24 Nov 2021 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Ecuador (IM) [103] Updated 24 Nov 2021 |
| 22 Nov 2021 | Regulatory Status | Pfizer plans to submit supplementary biological license application (sBLA) of tozinameran for COVID-2019 infections (12 years and older) in USA and other countries [56] Updated 30 Nov 2021 |
| 22 Nov 2021 | Scientific Update | Topline safety and efficacy data from long-term follow-up of phase III trial in COVID-2019 infections released by Pfizer [56] Updated 30 Nov 2021 |
| 22 Nov 2021 | Phase Change - Registered | Registered for COVID-2019 infections (In children, Prevention) in Canada (IM) [33] Updated 23 Nov 2021 |
| 18 Nov 2021 | Phase Change - Registered | Registered for COVID-2019 infections (In children, Prevention) in Israel (IM) [84] Updated 07 Jan 2022 |
| 02 Nov 2021 | Company Involvement | Clifford Craig Medical Research Trust plans a clinical COVULPOP trial for COVID-19 infections in Australia in November 2021 (IM) (ACTRN12621001492842) Updated 07 Apr 2022 |
| 02 Nov 2021 | Trial Update | Pfizer and BioNTech stpos a phase II/III trial for COVID-2019 infections (Prevention) in Brazil, South Africa, Spain, USA and United Kingdom (IM) in the fourth quarter of 2021 (NCT04754594) [51] Updated 18 Feb 2022 |
| 02 Nov 2021 | Regulatory Status | Pfizer and BioNTech submit data to the European Medicines Agency (EMA) to support the vaccination of children 5 to <12 years of age [18] Updated 02 Nov 2021 |
| 01 Nov 2021 | Phase Change - Registered | Registered for COVID-2019 infections (In children, Prevention) in USA for children 5 through 11 Years of Age (IM) [57] Updated 03 Nov 2021 |
| 01 Nov 2021 | Scientific Update | Safety data from phase II/III trial in COVID-2019 infections released by Pfizer and BioNTech [57] Updated 03 Nov 2021 |
| 29 Oct 2021 | Regulatory Status | The Centers for Disease Control and Prevention’s anticipates to meet for discussion of further clinical recommendation on emergency use of vaccine in children 5 through 11 Years of Age [57] Updated 03 Nov 2021 |
| 26 Oct 2021 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (In children, Prevention) in European Union (IM) in 5 to <12 years of age before October 2021 [60] Updated 28 Oct 2021 |
| 26 Oct 2021 | Regulatory Status | The US FDA' s Vaccines and Related Biological Products Advisory Committee (VRBPAC) votes in favour of grating Emergency Use Authorization for tozinameran in COVID-2019 infections in children 5 to <12 Years [60] Updated 28 Oct 2021 |
| 26 Oct 2021 | Regulatory Status | Tozinameran receives Emergency Use Authorization from US FDA as a single booster dose in individuals who have completed primary vaccination with a different authorised COVID-19 vaccine before October 2021 [60] Updated 28 Oct 2021 |
| 26 Oct 2021 | Scientific Update | Immunogenicity data from a phase II/III trial in COVID-2019 infections released by Pfizer and BioNTech [60] Updated 28 Oct 2021 |
| 22 Oct 2021 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (In children, Prevention) in USA (IM) [58] Updated 03 Nov 2021 |
| 21 Oct 2021 | Scientific Update | Immunogenicity and safety data from a phase III trial in COVID-2019 infections released by Pfizer and BioNTech [145] Updated 25 Oct 2021 |
| 18 Oct 2021 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (In children, Prevention) in Canada (IM) [34] Updated 21 Oct 2021 |
| 18 Oct 2021 | Regulatory Status | Pfizer and BioNTech submits regulatory approval application to the Health Canada for Tozinameran (In Children 5 to 11 years of age, Prevention), In Canada [34] Updated 21 Oct 2021 |
| 15 Oct 2021 | Phase Change | Investigation in COVID-2019 infections (In adolescents, In adults, In children, In the elderly, Prevention) in Brazil (IM) (NCT04895982) Updated 19 Nov 2021 |
| 15 Oct 2021 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (In adolescents, In adults, In children, In the elderly, Prevention) in Germany (IM) (EudraCT2021-001290-23) Updated 19 Nov 2021 |
| 15 Oct 2021 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (In adolescents, In adults, In children, In the elderly, Prevention) in USA (IM) (NCT04895982) Updated 19 Nov 2021 |
| 29 Sep 2021 | Scientific Update | immunogenicity data from a phase III trial in COVID-2019 infections presented at the Conference on Infectious Diseases (IDWeek-2021) [69] Updated 06 Feb 2022 |
| 29 Sep 2021 | Scientific Update | Safety and immunogenicity data from a phase III trial in COVID-2019 infections presented at the Conference on Infectious Diseases (IDWeek-2021) [70] Updated 06 Feb 2022 |
| 24 Sep 2021 | Trial Update | Pfizer and BioNTech plans a phase IIb trial for COVID-2019 infections(In children, In adolescents, In adults, In the elderly, Prevention) in USA, Brazil, Germany, in October 2021 (IM) (NCT04895982) Updated 19 Nov 2021 |
| 20 Sep 2021 | Scientific Update | Immunogenicity data from a phase II/III trial in COVID-2019 infections released by Pfizer [119] Updated 27 Sep 2021 |
| 16 Sep 2021 | Scientific Update | Updated safety data from a phase II/III trial in COVID-2019 infections presented at the 46th European Society for Medical Oncology Congress [146] Updated 03 Dec 2021 |
| 16 Sep 2021 | Regulatory Status | Health Canada approves New Drug Submission (NDS) of tozinameran for COVID-2019 infections (In adolescents, In adults, In the elderly, Prevention) in 12 years of age and older (IM) [35] [36] Updated 21 Sep 2021 |
| 27 Aug 2021 | Trial Update | Pfizer and BioNtech announces intention to complete rolling submission of supplemental Biologics License Application by the end of this week Updated 27 Aug 2021 |
| 25 Aug 2021 | Phase Change - II | Phase-II clinical trials in SARS-COV-2 acute respiratory disease (Prevention, In adults, In the elderly) in Germany, South Africa, Turkey (IM), after August 2021 (NCT05004181) (EudraCT2021-003458-22) Updated 28 Nov 2023 |
| 25 Aug 2021 | Trial Update | BioNTech initiates a phase II trial for COVID-2019 infections (In adults, In the elderly, Prevention) in Germany, South Africa and Turkey (IM), after August 2021 (NCT05004181) (EudraCT2021-003458-22) Updated 28 Nov 2023 |
| 25 Aug 2021 | Phase Change - II | Phase-II clinical trials in SARS-COV-2 acute respiratory disease (In adults, In the elderly, Prevention) in USA (IM) (NCT05004181) (EudraCT2021-003458-22) Updated 21 Sep 2021 |
| 25 Aug 2021 | Trial Update | BioNTech initiates enrolment in a phase II trial for COVID-2019 infections (In adults, In the elderly, Prevention) in USA (IM) (NCT05004181) (EudraCT2021-003458-22) Updated 21 Sep 2021 |
| 23 Aug 2021 | Regulatory Status | US FDA approves Biologics License Application of tozinameran for COVID-2019 infections (Prevention) in 16 years of age and older (IM) [62] Updated 25 Aug 2021 |
| 17 Aug 2021 | Trial Update | BioNTech plans a phase II trial for COVID-2019 infections and SARS-COV-2 acute respiratory disease (Prevention, In adults, In the elderly) in August 2021 (IM) (NCT05004181) Updated 21 Sep 2021 |
| 17 Aug 2021 | Regulatory Status | BioNTech and Pfizer announces intention to submit sBLA to the US FDA for licensure of the third dose for COVID-2019 infections (In adolescents, In adults, In the elderly, Prevention) (individuals 16 years of age and older) [61] Updated 18 Aug 2021 |
| 12 Aug 2021 | Phase Change - Registered | Registered for COVID-2019 infections (In adolescents, In the elderly, Prevention, In adults) (third dose in who have undergone solid organ transplantation) in USA (IM) [61] Updated 25 Aug 2021 |
| 11 Aug 2021 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (In adolescents, In the elderly, Prevention, In adults) (third dose in who have undergone solid organ transplantation) in USA (IM) before August 2021 [61] Updated 25 Aug 2021 |
| 10 Aug 2021 | Trial Update | National Institute of Allergy and Infectious Diseases initiates enrolment in a phase II CPAT trial for COVID-2019 infections (Prevention) in USA (IM) (NCT04969263) Updated 23 Aug 2021 |
| 28 Jul 2021 | Regulatory Status | FDA assigns PDUFA action date of 31/01/2022 for tozinameran for COVID-2019 infections (Prevention) [63] Updated 02 Aug 2021 |
| 28 Jul 2021 | Regulatory Status | Tozinameran receives priority review status for COVID-2019 infections (Prevention) in USA [63] Updated 02 Aug 2021 |
| 23 Jul 2021 | Phase Change - Registered | Registered for COVID-2019 infections (In children, In adults, In adolescents, In the elderly, Prevention) in Australia (IM) [96] Updated 22 Sep 2022 |
| 22 Jul 2021 | Trial Update | BioNTech and Pfizer completed the phase III trial in COVID-2019 infections (Prevention, In adults, In adolescents) in USA (IM) (NCT04713553) Updated 23 Aug 2021 |
| 22 Jul 2021 | Trial Update | National Institute of Allergy and Infectious Diseases plans a phase II trial COVID-2019 infections (Prevention) in USA (IM) in August 2021 (NCT04969263) Updated 23 Aug 2021 |
| 09 Jul 2021 | Trial Update | BioNTech and Pfizer plans a phase III trial for COVID-2019 infections (In adolescents, In adults) in USA, Brazil and South Africa (IM) in June 2021 (NCT04955626) Updated 14 Jul 2021 |
| 28 May 2021 | Regulatory Status | Pfizer and BioNTech expect to submit for an Emergency Use Authorization in USA or a variation to Conditional Marketing Authorizations in European Union for two cohorts, including patients 2 to 5 years of age and 5 to11 years of age for COVID-2019 infections (Prevention, In infants, In children), in September 2021 [73] Updated 03 Nov 2021 |
| 28 May 2021 | Phase Change - Registered | Registered for COVID-2019 infections (In adolescents, Prevention) in European Union, Liechtenstein, Norway, and Iceland under conditional marketing authorisation in 12 to 15 years of age (IM) [73] Updated 01 Jun 2021 |
| 28 May 2021 | Regulatory Status | Pfizer and BioNTech expect to submit application for the cohort of patients, aged 6 months to 2 years, for COVID-2019 infections (Prevention, In infants, In children), in the fourth quarter of 2021 [73] Updated 01 Jun 2021 |
| 28 May 2021 | Regulatory Status | Pfizer and BioNTech receive first conditional marketing authorisation for tozinameran in COVID-2019 infections (In adolescents, Prevention) in European Union, Liechtenstein, Norway, and Iceland (IM) [73] Updated 01 Jun 2021 |
| 13 May 2021 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (In children, In infants, Prevention) in USA (IM) (Pfizer pipeline, May 2021) Updated 13 May 2021 |
| 10 May 2021 | Trial Update | Medical University initiated a phase II HeVacc trial in COVID-2019 infections (Prevention) in Austria (IM, Injection) (NCT04907331) Updated 02 Jun 2021 |
| 07 May 2021 | Regulatory Status | Pfizer and BioNTech initiates rolling BLA submission to US FDA for approval in COVID-2019 infections [64] Updated 11 May 2021 |
| 06 May 2021 | Regulatory Status | Pfizer and BioNTech files amendment for conditional marketing authorization of tozinameran to the US FDA for COVID-2019 infections (In adolescents, Prevention) to expand use in adolescents 12-15 years of age [74] Updated 06 May 2021 |
| 05 May 2021 | Phase Change - Registered | Registered for COVID-2019 infections (In adolescents, Prevention) in 12 to 15 years in Canada (IM) [37] Updated 16 May 2021 |
| 04 May 2021 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (In adolescents, Prevention) in 12 to 15 years of age in Canada (IM) [37] Updated 16 May 2021 |
| 30 Apr 2021 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (In adolescents, Prevention) in European Union in 12 to 15 years (IM) [74] Updated 16 May 2021 |
| 23 Apr 2021 | Regulatory Status | EMA accepts modified Paediatric Investigation Plan for tozinameran in COVID-2019 infections (Prevention) [111] Updated 29 Sep 2022 |
| 14 Apr 2021 | Trial Update | Assistance Publique - Hopitaux de Paris plans the COVIVAC-ID clinical trial for COVID-2019 infections (Prevention) in France (IM, Injection) in April 2021 (NCT04844489) Updated 19 Apr 2021 |
| 12 Apr 2021 | Trial Update | University of Oxford plans a phase II trial for COVID-2019 infections (Prevention) in United Kingdom in April 2021 Updated 21 Sep 2021 |
| 09 Apr 2021 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (In adolescents, Prevention) in USA in in 12 to 15 years (IM) [74] Updated 16 May 2021 |
| 01 Apr 2021 | Trial Update | The University of Hong Kong initiates a phase II trial for COVID 2019 infections (Prevention) in Hong Kong (Intradermal, Injection) (NCT05736913) Updated 27 Feb 2023 |
| 01 Apr 2021 | Trial Update | BioNTech in collaboration with Pfizer initiates a phase III trial for COVID-2019 infections (Prevention) in USA (IM) (NCT04816669) Updated 19 Apr 2021 |
| 01 Apr 2021 | Scientific Update | Additional immunogenicity and adverse events data from a phase III trial in COVID-2019 infections released by Pfizer and BioNTech [138] Updated 06 Apr 2021 |
| 31 Mar 2021 | Regulatory Status | Pfizer and BioNTech announces intention to submit an amendment to the Emergency Use Authorization of tozinameran to the US FDA for COVID-2019 infections (In adolescents, Prevention) to expand use in adolescents 12-15 years of age [139] Updated 05 Apr 2021 |
| 31 Mar 2021 | Regulatory Status | Pfizer and BioNTech announces intention to submit an amendment to the EU Conditional Marketing Authorization of tozinameran to the EMA for COVID-2019 infections (In adolescents, Prevention) to expand use in adolescents 12-15 years of age [139] Updated 05 Apr 2021 |
| 31 Mar 2021 | Scientific Update | Positive top-line immunogenicity and adverse events data from a phase III trial in COVID-2019 infections released by Pfizer and BioNTech [139] Updated 05 Apr 2021 |
| 31 Mar 2021 | Trial Update | BioNTech in collaboration with Pfizer plans a phase I trial for COVID-2019 infections (Prevention, In Infants, In children) in USA (IM) (NCT04816643) (EudraCT2020-005442-42) Updated 31 Mar 2021 |
| 30 Mar 2021 | Regulatory Status | USFDA approves additional amendments for study protocol of phase I/II/III trial for COVID-2019 infections (Prevention) [120] Updated 06 Jun 2021 |
| 30 Mar 2021 | Trial Update | BioNTech and Pfizer plans clinical trials for COVID-2019 infections (Prevention) in immunocompromised patients [120] Updated 06 Jun 2021 |
| 26 Mar 2021 | Regulatory Status | BioNTech and Pfizer announces intention to submit application for full marketing authorization to Health Canada for COVID-2019 infections [86] Updated 21 Sep 2021 |
| 26 Mar 2021 | Regulatory Status | BioNTech and Pfizer announces intention to submit application for full marketing authorization to EMA and in the UK for COVID-2019 infections [86] Updated 27 May 2021 |
| 25 Mar 2021 | Trial Update | BioNTech SE and Pfizer plans phase III trials for COVID-2019 infections (Prevention) in USA in April 2021 (IM) (NCT04816669) Updated 05 Apr 2021 |
| 24 Mar 2021 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections (In adolescents, In children, In the elderly, Prevention, In adults) in Mexico, Brazil (IM) (NCT04816643) Updated 29 Dec 2023 |
| 24 Mar 2021 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections (Prevention, In infants, In children, In adults, In adolescents) in Spain, Poland, Finland (IM) (NCT04816643) Updated 03 Nov 2021 |
| 24 Mar 2021 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (In children, In infants, In adolescents, In adults, Prevention) in USA (IM) (NCT04816643) Updated 14 Apr 2021 |
| 12 Mar 2021 | Trial Update | University of Oxford initiates a phase II Com-COV2 trial in COVID-2019 infections (Prevention) in United Kingdom (ISRCTN27841311) Updated 21 Sep 2021 |
| 26 Feb 2021 | Trial Update | Pfizer and BioNTech plans a registration-enabling clinical trial using variant-specific vaccine having a modified mRNA sequence [113] Updated 01 Mar 2021 |
| 18 Feb 2021 | Regulatory Status | BioNTech and Pfizer plan to file for regulatory approval for COVID-2019 infections (In adolescent, In adults, In the elderly, Prevention) in the second quarter of 2021 [125] Updated 27 Aug 2021 |
| 18 Feb 2021 | Trial Update | Pfizer and BioNTech initiates a phase II/III trial for COVID-2019 infections (Prevention) in USA (IM) [125] (NCT04754594) Updated 22 Feb 2021 |
| 17 Feb 2021 | Scientific Update | Updated immunogenicity data from preclinical studies in COVID-2019 infections released by BioNTech [156] Updated 19 Feb 2021 |
| 16 Feb 2021 | Trial Update | Pfizer and BioNTech initiates a phase II/III trial for COVID-2019 infections (Prevention) in Brazil, South Africa, Spain and United Kingdom (IM) (NCT04754594) Updated 18 Feb 2022 |
| 15 Feb 2021 | Trial Update | Pfizer and BioNTech initiates enrolment in a phase III clinical trial for COVID-2019 infections (Prevention, In adults, In adolescents) in USA (NCT04713553) Updated 04 Mar 2021 |
| 15 Feb 2021 | Trial Update | BioNTech and Pfizer plans a phase II/III trial for COVID-2019 infections (Prevention) in US (NCT04754594) Updated 17 Feb 2021 |
| 14 Feb 2021 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Japan (IM) [94] Updated 18 Feb 2021 |
| 01 Feb 2021 | Scientific Update | Immunogenicity data from preclinical studies in COVID-2019 infections released by Pfizer and BioNTech [158] Updated 03 Feb 2021 |
| 28 Jan 2021 | Regulatory Status | The Committee for Medicinal Products for Human Use of the European Medicines Agency recommends the administration of the second dose 3 weeks after the first dose for tozinameran for COVID-2019 infections [82] Updated 03 Feb 2021 |
| 25 Jan 2021 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Australia (IM) [97] Updated 05 Feb 2021 |
| 25 Jan 2021 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) (approved under EUA) in Hong Kong (IM) [101] Updated 28 Jan 2021 |
| 25 Jan 2021 | Regulatory Status | BioNTech and Shanghai Fosun Pharmaceuticals announces intention to launch Tozinameran for COVID-2019 infections (Prevention) in Hong Kong [101] Updated 28 Jan 2021 |
| 20 Jan 2021 | Scientific Update | Updated immunogenicity data from preclinical studies in COVID-2019 infections released by Pfizer [159] Updated 22 Jan 2021 |
| 19 Jan 2021 | Trial Update | BioNTech in collaboration with Pfizer plans a phase III trial for COVID-2019 infections (Prevention, In adults) in January 2021 (IM, Injection) (NCT04713553) Updated 01 Mar 2021 |
| 08 Jan 2021 | Scientific Update | Immunogenicity data from a preclinical trial in COVID-2019 infections released by BioNTech [160] Updated 12 Jan 2021 |
| 04 Jan 2021 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Israel (IM) [109] Updated 18 Mar 2021 |
| 21 Dec 2020 | Regulatory Status | Dosing initiated in USA for COVID-2019 infections (Prevention) under Emergency use authorisation [67] Updated 24 Dec 2020 |
| 21 Dec 2020 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Liechtenstein, Norway, Iceland, European Union (IM) [75] Updated 23 Dec 2020 |
| 21 Dec 2020 | Regulatory Status | The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopts positive opinion for conditional marketing authorisation for COVID-2019 infections (Prevention) [76] Updated 23 Dec 2020 |
| 19 Dec 2020 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Switzerland (IM) [105] Updated 24 Dec 2020 |
| 18 Dec 2020 | Company Involvement | EMA's the Committee for Medicinal Products for Human Use (CHMP) schedule an exceptional meeting to conclude assessment of safety and effectiveness of tozinameran, in the EU, in December 2020 Updated 23 Dec 2020 |
| 17 Dec 2020 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Chile (IM) [103] Updated 24 Nov 2021 |
| 16 Dec 2020 | Regulatory Status | BioNTech intends to submit a Biologic License Application (BLA) for COVID-2019 infections in China [25] Updated 18 Dec 2020 |
| 16 Dec 2020 | Regulatory Status | BioNTech intends to launch tozinameran for COVID-2019 infections in China [25] Updated 18 Dec 2020 |
| 14 Dec 2020 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Singapore (IM) [102] Updated 08 Dec 2021 |
| 14 Dec 2020 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Saudi Arabia, Mexico (IM) [104] Updated 17 Dec 2020 |
| 14 Dec 2020 | Scientific Update | Immunogenicity data from a phase I/II trial in COVID-2019 infections released by Pfizer [104] Updated 17 Dec 2020 |
| 12 Dec 2020 | Regulatory Status | The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommends use of tozinameran in COVID-2019 (Prevention) under EUA of the US FDA Updated 16 Dec 2020 |
| 11 Dec 2020 | Regulatory Status | Pfizer and BioNTech announces intention to submit BLA to the US FDA for COVID-2019 infections (Prevention) in 2021 [88] Updated 16 May 2021 |
| 11 Dec 2020 | Phase Change - Registered | Registered (emergency use authorisation) for COVID-2019 infections (Prevention) in USA (IM) [90] [91] Updated 14 Dec 2020 |
| 10 Dec 2020 | Regulatory Status | The US FDA' s Vaccines and Related Biological Products Advisory Committee (VRBPAC) votes 17 to 4 unanimously in favor to support Emergency Use Authorization for BNT162b2 vaccine against COVID-2019 infections in USA [89] Updated 15 Dec 2020 |
| 09 Dec 2020 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention) in India (IM) [107] Updated 11 Dec 2020 |
| 09 Dec 2020 | Phase Change - Registered | Registered (under Interim Order for the emergency use) for COVID-2019 infections (Prevention) in Canada (IM) [40] [38] Updated 11 Dec 2020 |
| 04 Dec 2020 | Phase Change - Registered | Registered (emergency use authorisation) for COVID-2019 infections (Prevention) in Bahrain (IM) [40] Updated 11 Dec 2020 |
| 02 Dec 2020 | Regulatory Status | Pfizer and BioNTech intends to submit marketing authorisation for BNT 162 to other regulatory agencies around the world Updated 04 Dec 2020 |
| 02 Dec 2020 | Phase Change - Registered | Registered (emergency use authorisation) for COVID-2019 infections (Prevention) in United Kingdom (IM) [78] Updated 02 Dec 2020 |
| 02 Dec 2020 | Regulatory Status | Pfizer and BioNTech submit Emergency Use Authorisation request for COVID-2019 infections (Prevention) (IM) to the US FDA before December 2020 [78] Updated 02 Dec 2020 |
| 02 Dec 2020 | Regulatory Status | Pfizer and BioNTech submit conditional marketing authorisation application with the European Medicines Agency for COVID-2019 infections (Prevention) (IM) before December 2020 [78] Updated 02 Dec 2020 |
| 01 Dec 2020 | Regulatory Status | Pfizer and BioNTech expects EMA’s Committee for Medicinal Products for Human Use will conclude its assessment of safety and effectiveness of BNT 162 during an extraordinary meeting, in December 2020, which is based on the context of the rolling review and may be subject to change as evaluation proceeds [77] Updated 23 Dec 2020 |
| 01 Dec 2020 | Regulatory Status | The CDC's ACIP recommends phase Ia rollout or allocation of tozinameran vaccine for COVID-2019 (Prevention) in USA [68] Updated 16 Dec 2020 |
| 01 Dec 2020 | Regulatory Status | European Medicines Agency (EMA) receives an application for conditional marketing authorisation by Pfizer and BioNTech for BNT 162 for COVID-2019 infections [77] Updated 03 Dec 2020 |
| 24 Nov 2020 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (Prevention) in China (IM) [25] (NCT04649021) Updated 18 Dec 2020 |
| 20 Nov 2020 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention) in USA (IM) [78] [92] Updated 11 Dec 2020 |
| 20 Nov 2020 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention) in Australia (IM) [93] Updated 24 Nov 2020 |
| 20 Nov 2020 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention) in Japan (IM) [93] Updated 24 Nov 2020 |
| 18 Nov 2020 | Scientific Update | Immunogenicity and adverse events data from a phase I/II/III trial in COVID-2019 infections released by Pfizer and BioNTech [114] Updated 20 Nov 2020 |
| 10 Nov 2020 | Trial Update | BioNTech and Shanghai Fosun Pharmaceutical plans a phase II trial for COVID-2019 infections in China [12] Updated 20 Jan 2021 |
| 10 Nov 2020 | Regulatory Status | BioNTech and Shanghai Fosun Pharmaceutical files an IND application with the National Medical Products Administration (NMPA) in China for COVID-2019 infections [12] Updated 19 Nov 2020 |
| 09 Nov 2020 | Regulatory Status | Pfizer and BioNTech plans to submit Emergency Use Authorisation request for COVID-2019 infections (Prevention) (IM) to the US FDA [93] [136] Updated 02 Dec 2020 |
| 21 Oct 2020 | Trial Update | BioNTech and Pfizer initiated a phase-I/II clinical trials in COVID-2019 infections (Prevention) in Japan (IM) (NCT04588480) Updated 27 Nov 2020 |
| 19 Oct 2020 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention) in Switzerland (IM) [106] Updated 27 Oct 2020 |
| 19 Oct 2020 | Trial Update | Pfizer and BioNTech plan a phase I trial for COVID-2019 infections (Prevention) in Japan (IM) in October 2020 (NCT04588480) Updated 23 Oct 2020 |
| 14 Oct 2020 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (In children, In adolescents, In the elderly, In adults, Prevention) in South Africa, Brazil, Argentina (IM) [142] (NCT04368728) Updated 16 Oct 2020 |
| 14 Oct 2020 | Scientific Update | Updated immunogenicity data from a phase I trial in COVID-2019 infections released by Pfizer [142] Updated 16 Oct 2020 |
| 09 Oct 2020 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention) in Canada (IM) [39] Updated 13 Oct 2020 |
| 06 Oct 2020 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections (Prevention) in South Africa (IM) [80] Updated 08 Oct 2020 |
| 06 Oct 2020 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention) in European Union (IM) [80] Updated 08 Oct 2020 |
| 06 Oct 2020 | Regulatory Status | BioNTech announces intention to submit MAA to EMA for COVID-2019 infections [80] Updated 08 Oct 2020 |
| 14 Sep 2020 | Regulatory Status | Pfizer and BioNTech submits an amended protocol to the US FDA for expansion of enrolment in its phase III trial in COVID-2019 infections and also for inclusion of other infections including HIV infections, Hepatitis B infections, Hepatitis C infections [137] Updated 16 Sep 2020 |
| 10 Sep 2020 | Scientific Update | Immunogenicity data from preclinical studies in COVID-2019 infections (Prevention) released by Pfizer and BioNTech [161] Updated 11 Sep 2020 |
| 07 Sep 2020 | Regulatory Status | BioNTech receives approval from the Paul-Ehrlich-Institut, for phase II/III clinical trial for COVID-2019 infections in Germany [110] Updated 10 Sep 2020 |
| 04 Sep 2020 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections (Prevention) in Germany (IM) (EudraCT2020-002641-42) Updated 10 Sep 2020 |
| 20 Aug 2020 | Scientific Update | Immunogenicity and adverse events data from a phase I trial in COVID-19 infections released by Pfizer [143] Updated 24 Aug 2020 |
| 12 Aug 2020 | Scientific Update | Updated immunogenicity data from a phase I/II trial in COVID-2019 infections released by Pfizer [173] Updated 20 Aug 2020 |
| 11 Aug 2020 | Regulatory Status | BioNTech and Pfizer plan to file for market authorisation or regulatory approval for COVID-2019ninfections in October 2020 [174] Updated 23 Dec 2020 |
| 27 Jul 2020 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections (Prevention) in Brazil, Argentina (IM), after July 2020 [140] (NCT04368728) Updated 20 Aug 2020 |
| 27 Jul 2020 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections (Prevention) in USA (IM) [140] Updated 01 Aug 2020 |
| 20 Jul 2020 | Scientific Update | Updated immunogenicity data from a phase I/II trial in COVID-2019 infections released by Pfizer and BioNTech [150] Updated 22 Jul 2020 |
| 14 Jul 2020 | Regulatory Status | Tozinameran receives Fast Track designation for COVID-2019 infections [IM,Injection] (Prevention) in USA [112] Updated 15 Jul 2020 |
| 01 Jul 2020 | Trial Update | Pfizer and BioNTech plans a phase IIb/III trial for COVID-2019 infections in July 2020 [175] Updated 01 Aug 2020 |
| 01 Jul 2020 | Scientific Update | Preliminary immunogenicity and adverse events data from a phase I/II trial in COVID -2019 infections released by Pfizer and BioNTech [175] Updated 08 Jul 2020 |
| 29 Apr 2020 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections (In adolescents, In the elderly, In adults, Prevention) in USA (IM) (NCT04368728) [125] Updated 22 Feb 2021 |
| 29 Apr 2020 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections (Prevention) in Turkey (IM) (NCT04368728) Updated 20 Nov 2020 |
| 29 Apr 2020 | Phase Change - I/II | Phase-I/II clinical trials in COVID-2019 infections (Prevention, In volunteers, In adults, In the elderly) in USA (IM, Injection) (NCT04368728) Updated 10 May 2020 |
| 29 Apr 2020 | Regulatory Status | BioNTech awaits for regulatory approval in USA to conduct phase I/II trial in COVID-19 infections (Prevention) [151] Updated 05 May 2020 |
| 29 Apr 2020 | Trial Update | BioNTech and Shanghai Fosun Pharmaceutical plans to conduct clinical trial in China for COVID-19 infections [151] Updated 05 May 2020 |
| 29 Apr 2020 | Trial Update | BioNTech plans a phase I/II trial in COVID-19 infections (Prevention) in USA [151] [153] Updated 05 May 2020 |
| 28 Apr 2020 | Trial Update | Biontech in collaboration with Pfizer plans a phase I/II trial in COVID-19 infections (Prevention) (IM, Injection) in April 2020 (NCT04368728) Updated 05 May 2020 |
| 22 Apr 2020 | Regulatory Status | BioNTech announces intention to submit regulatory applications for a clinical trial for COVID-2019 infections in USA [153] Updated 24 Apr 2020 |
| 20 Apr 2020 | Phase Change - I/II | Phase-I/II clinical trials in COVID-2019 infections (Prevention) in Germany (IM) (EudraCT2020-001038-36) (NCT04380701) Updated 05 May 2020 |
| 09 Apr 2020 | Regulatory Status | Pfizer and BioNTech plan to launch the vaccine for COVID-2019 infections by the end of 2020, subject to technical success of the development program and approval of regulatory authorities [176] Updated 15 Apr 2020 |
| 01 Apr 2020 | Regulatory Status | BioNTech receives approval from the the Paul-Ehrlich-Institut, for a phase I/II trial for COVID-2019 infections [153] Updated 24 Apr 2020 |
| 17 Mar 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in USA (IM), prior to March 2020 [26] Updated 22 Mar 2020 |
| 17 Mar 2020 | Licensing Status | BioNTech and Pfizer agree to co-develop BNT 162 in China for COVID-2019 infections [26] Updated 20 Mar 2020 |
| 16 Mar 2020 | Licensing Status | BioNTech and Shanghai Fosun Pharmaceutical agree to co-develop BNT 162 in China for COVID-2019 infections [28] Updated 20 Mar 2020 |
| 16 Mar 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in Germany (IM), prior to March 2020 [28] Updated 20 Mar 2020 |
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Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval.
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Fosun International Granted Three Awards from Global Banking and Finance Review in the United Kingdom.
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Singapore approves use of Pfizer's COVID-19 vaccine.
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Chile and Ecuador go ahead in South America and authorize the Pfizer vaccine.
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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS.
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Real-World Evidence Confirms High Effectiveness of Pfizer-BioNTech COVID-19 Vaccine and Profound Public Health Impact of Vaccination One Year After Pandemic Declared.
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Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants.
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Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints.
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Pfizer and BioNTech Publish Data from In Vitro Studies in Nature Medicine Demonstrating COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with Key Mutations Present in U.K. and South African Variants.
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A MASTER PHASE 1/2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VARIANT-ADAPTED BNT162b2 RNA-BASED VACCINE CANDIDATE(S) IN HEALTHY CHILDREN
ctiprofile -
A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162B2 AGAINST COVID 19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE
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Pfizer and BioNTech Submit Initial Data to U.S. FDA From Pivotal Trial of COVID-19 Vaccine in Children 5 to <12 Years of Age.
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PFIZER AND BIONTECH ANNOUNCE POSITIVE TOPLINE RESULTS FROM PIVOTAL TRIAL OF COVID-19 VACCINE IN CHILDREN 5 TO 11 YEARS.
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BioNTech Announces Full Year 2020 Financial Results and Corporate Update.
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A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN
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Pfizer and BioNTech Announce Updated COVID-19 Vaccine Data Supporting Efficacy in Children 6 Months through 4 Years of Age.
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A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE PRODUCTION LOTS AND DOSE LEVELS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEALTHY PARTICIPANTS 12 THROUGH 50 YEARS OF AGE AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED COVID-19 VACCINE CANDIDATES AS A BOOSTER DOSE IN HEALTHY PARTICIPANTS 18 THROUGH 50 YEARS OF AGE
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A PHASE 2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED VACCINE CANDIDATES FOR SARS-CoV-2 NEW VARIANTS IN HEALTHY INDIVIDUALS
ctiprofile -
Pfizer and BioNTech Commence Global Clinical Trial to Evaluate COVID-19 Vaccine in Pregnant Women.
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A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER
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Immunogenicity, Safety and Tolerability of Intradermal COVID-19 Vaccination Strategy in Immunocompromised Patients: a Prospective, Randomized Trial.
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A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS ≥2 YEARS OF AGE
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A Phase II Trial to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Monovalent and Multivalent RNA-based Vaccines in Healthy Subjects
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A single-blind, randomized, phase II UK multi-centre study to determine the reactogenicity and immunogenicity of heterologous prime/boost COVID-19 vaccine schedules – stage 2
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Immunogenicity of a Third Dose of Either the Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine in Kidney Transplant Recipients Who Failed to Respond After Two Previous Doses
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Comparison of Heterologous Vaccination With an Vaxzevria (ChAdOx1-S) Prime and a Comirnaty (BNT162b2) Boost to Homolog Vaccination
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BioNTech and Fosun Pharma Announce the Start of Phase 2 Clinical Trial of Lead mRNA COVID-19 Vaccine BNT162b2 in China.
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Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population: A Phase II, Randomized, Placebo-controlled, Observer-blinded Study
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Pfizer and BioNTech Dose First Participants in the U.S. as Part of Global COVID-19 mRNA Vaccine Development Program.
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Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study.
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Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial.
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Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study.
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Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents.
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Global Phase 2/3 Clinical Trial for COVID-19 Vaccine Starts at NYU Langone Health.
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Pfizer Reports Second-Quarter 2020 Results.
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Pfizer and BioNTech Announce New England Journal of Medicine Publication of Phase 1 Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19.
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Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19.
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A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS
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Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine.
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Thomas SJ, Perez JL, Lockhart SP, Hariharan S, Kitchin N, Bailey R, et al. COVID-19 vaccine in participants (ptcpts) with cancer: Subgroup analysis of efficacy/safety from a global phase III randomized trial of the BNT162b2 (tozinameran) mRNA vaccine. ESMO-2021 2021; abstr. 1558O.
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Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older.
Media Release -
A MASTER PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BIVALENT BNT162b2 RNA-BASED VACCINE CANDIDATE(S) IN HEALTHY INFANTS AND CHILDREN
ctiprofile -
A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, AND OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY JAPANESE ADULTS
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Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data.
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BioNTech and Pfizer announce completion of dosing for first cohort of Phase 1/2 trial of COVID-19 vaccine candidates in Germany.
Media Release -
NYU Langone Among First Centers to Enroll Patients in US Clinical Trial for COVID-19 mRNA Vaccine.
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BioNTech and Pfizer announce regulatory approval from German authority Paul-Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine candidates.
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A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-2019 Using Different Dosing Regimens in Healthy and Immunocompromised Adults
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Pfizer and BioNTech Publish Data from Two Laboratory Studies on COVID-19 Vaccine-induced Antibodies Ability to Neutralize SARS-CoV-2 Omicron Variant.
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In Vitro Study Published in The New England Journal of Medicine Demonstrates Sera from Individuals Immunized with the Pfizer-BioNTech COVID-19 Vaccine Neutralize SARS-CoV-2 with South African Variant Spike Mutations.
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IN VITRO STUDIES DEMONSTRATE PFIZER AND BIONTECH COVID-19 VACCINE ELICITS ANTIBODIES THAT NEUTRALIZE SARS-COV-2 WITH KEY MUTATIONS PRESENT IN U.K. AND SOUTH AFRICAN VARIANTS.
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Pfizer and BioNTech Publish Preclinical Data from Investigational COVID-19 Vaccine Program in Nature.
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Pfizer and BioNTech Publish Results of Study Showing COVID-19 Vaccine Elicits Antibodies that Neutralize Pseudovirus Bearing the SARS-CoV-2 U.K. Strain Spike Protein in Cell Culture.
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An In Vitro Study Shows Pfizer-BioNTech COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with a Mutation Associated with Rapid Transmission.
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Pfizer and BioNTech Announce Data from Preclinical Studies of mRNA-based Vaccine Candidate Against COVID-19.
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A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED VACCINE CANDIDATE(S) AGAINST INFECTIOUS RESPIRATORY ILLNESSES, INCLUDING COVID-19 AND RSV, IN HEALTHY INDIVIDUALS
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Pfizer and BioNTech to Supply Canada with their BNT162 mRNA- Based Vaccine Candidate.
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BioNTech Announces First Quarter Financial Results and Corporate Update.
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Association of American Physicians and Surgeons (AAPS) Releases Statement on FDA Approval Letter for COVID-19 Vaccine.
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BioNTech to Receive up to 375M in Funding from German Federal Ministry of Education and Research to Support COVID-19 Vaccine Program BNT162.
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Pfizer and BioNTech to Supply the United States with 100 Million Additional Doses of COVID-19 Vaccine.
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Investment Plan for Europe: European Investment Bank to provide BioNTech with up to 100 million in debt financing for COVID-19 vaccine development and manufacturing.
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Alnylam to Appeal Claim Construction Ruling on Two Patents Asserted Against Moderna.
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Promosome LLC Sues Moderna, Pfizer, and BioNTech for COVID-19 Vaccine Patent Infringement.
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Arbutus Reports First Quarter 2023 Financial Results and Corporate Update.
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Pfizer and BioNTech Announce Data Demonstrating High Immune Response Following a Booster Dose of their COVID-19 Vaccine in Children 5 Through 11 Years of Age.
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Pfizer and BioNTech Announce Publication of Peer-Reviewed Data from Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate, BNT162b1, Against SARS-CoV-2 in Nature.
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BioNTech Announces Second Quarter 2020 Financial Results and Corporate Progress.
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Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate Against SARS-CoV-2.
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Pfizer Advances Battle Against COVID-19 on Multiple Fronts.
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Pfizer and BioNTech Receive CHMP Positive Opinion for COVID-19 Vaccine Booster in the European Union.
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Pfizer and BioNTech Announce an Agreement with U.S. Government for up to 600 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2.
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F-star Granted Composition of Matter Patent for FS118, a Bispecific Antibody Targeting LAG-3 and PD-L1.
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