Ad26 COV2 S - Johnson & Johnson Innovative Medicine
Alternative Names: 'Wuhan coronavirus vaccine - Johnson & Johnson Innovative Medicine; 2019-nCoV vaccine - Johnson & Johnson Innovative Medicine; Ad26 COVS1; Ad26-S.PP; Ad26.COV2 S; Ad26.COV2-S recombinant - Johnson & Johnson Innovative Medicine; Ad26.COV2.S; Coronavirus vaccine - Johnson & Johnson Innovative Medicine; Janssen COVID-19 Vaccine; Jcoviden; JNJ-78436735; Johnson & Johnson COVID-19 vaccine; Single-dose COVID-19 vaccine - Johnson & Johnson Innovative Medicine; Single-Shot Janssen COVID-19 Vaccine; VAC 31518Latest Information Update: 16 Feb 2024
At a glance
- Originator Janssen Pharmaceuticals
- Developer Janssen Vaccines and Prevention B.V; Johnson & Johnson Innovative Medicine
- Class COVID-19 vaccines; DNA 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
- Registered COVID 2019 infections
Most Recent Events
- 24 Nov 2023 Janssen Vaccines & Prevention B.V.completes a phase II trial for COVID-2019 infection (Prevention) in South Africa, Spain, and USA (IM) (NCT04765384)
- 01 Oct 2023 Janssen Pharmaceuticals is now called Johnson & Johnson Innovative Medicine (Janssen Pharmaceuticals website, October 2023)
- 14 Aug 2023 Janssen Vaccines & Prevention completes a phase II trial in COVID-2019 infections (In adolescents, Prevention) in Brazil, Argentina, India, Mexico, South Africa (IM) (NCT05007080)
Development Overview
Introduction
Ad26 COV2 S is a recombinant, single-shot vaccine designated as VAC 31518, being developed by Johnson & Johnson Innovative Medicine (formerly Janssen Pharmaceuticals), for the prevention of COVID-2019 infections. The vaacine is developed using AdVac® and PER.C6® technologies. The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive spike protein of the SARS-CoV-2 virus. The Ad26 has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After vaccination, the body temporarily makes the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2. The COVID-19 vaccine has received approval through emergency use authorisation in the US, the EU, Norway, Iceland, Liechtenstein and Canada. The vaccine is approved in Japan. The COVID-19 vaccine is under regulatory review for emergency use authorisation in the US for adolescent population. The vaccine has been granted provisional approval in Australia and Switzerland. The vaccine is approved under emergency use authorisation for a single booster dose in the US. Clinical development is underway in several countries worldwide.
In October 2023, Janssen Pharmaceuticals changed its name to Johnson & Johnson Innovative Medicine (Janssen Pharmaceuticals website, October 2023).
Company Agreements
In March 2022, Janssen Pharmaceuticals announced the completion of a landmark agreement between Janssen Pharmaceuticals and manufacturer Aspen Pharmacare to enable the first COVID-19 vaccine to be manufactured and made available by an African company for people living in Africa, with the goal of increasing COVID-19 vaccination rates across the continent. The agreement enables Aspen, using COVID-19 vaccine drug substance supplied by Johnson & Johnson, to produce Aspen-branded finished vaccine and make doses available to the public sector in Africa, including all 55 Member States of the African Union and key multilateral entities supporting Africa's COVID-19 vaccination drive, inclusive of the African Vaccine Acquisition Trust (AVAT), and the COVAX Facility. Earlier in October 2020, Aspen Pharmacare and Janssen Pharmaceuticals entered in a manufacturing agreement for Ad26.COV2-S. According to the terms of the agreement the formulation, filling and secondary packaging of the vaccine will be done by Aspen Pharmacare and will be supplied to Johnson & Johnson. After the relevant technology transfer activities and after the finalisation of the terms related to commercial manufacturing, the deal will be successfuly completed. The facility where the vaccine will be manufactured, Aspen invested R3 billion in it and has the capacity to produce more than 300 million doses per annum.
[1] [2]
In November 2021, Johnson & Johnson entered into an agreement with the US Government and Gavi, the Vaccine Alliance (Gavi), to enable access to its single-shot COVID-19 vaccine through a novel mechanism – the COVAX Humanitarian Buffer. Governments and national and international humanitarian agencies are eligible to apply to receive doses from the COVAX Humanitarian Buffer. If applications are granted and the doses allocated, the governments or humanitarian agencies that filed the application will carry out the vaccination campaigns to ensure people are protected from COVID-2019 infections. Earlier, in December 2020, Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine) entered into an agreement with Gavi Vaccine Alliance to supply Janssen’s COVID-19 vaccine Ad26.COV2 S to lower-income countries in 2021. As part of the agreement, Janssen will provide up to 500 million doses of its COVID-19 vaccine candidate to Gavi,. These doses will be distributed through 2022, if the vaccine is proven to be safe and effective. Janssen and Gavi expect to enter into an Advance Purchase Agreement (APA) that would provide the COVAX Facility with 100 million doses of Janssen’s COVID-19 vaccine candidate in 2021, assuming the vaccine candidate receives regulatory approvals. Gavi also has the opportunity to order another 100 million doses in 2021, and up to 300 million doses in 2022, for a combined total of up to 500 million doses through 2022. [3] [4]
In March 2021, Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine) entered into a purchase agreement with the African Vaccine Acquisition Trust (AVAT) to make available up to 220 million doses of its single-shot COVID-19 vaccine candidate to African Union's 55 member states with delivery beginning in the third quarter of 2021. AVAT also has the potential to order an additional 180 million doses, for a combined total of up to 400 million doses through 2022. The availability of the vaccine candidate is subject to its successful approval or authorization by the national regulatory authorities of AU member states. [5]
In March 2021, Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine) entered into a manufacturing agreement with Merck to support the manufacturing and supply of Johnson & Johnson’s SARS-CoV-2/COVID-19 vaccine. Merck will use its facilities in the US to produce drug substance, formulate and fill vials of Johnson & Johnson’s vaccine. Financial terms of the agreement were not disclosed.
[6]
Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine) and Sanofi, in February 2021, entered into an agreement, under which the latter, following vaccine approval, will provide manufacturing support for Janssen's single dose COVID-2019 vaccine candidate, in 2021. [7]
In November 2020, Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine) expanded its existing collaboration with Biomedical Advanced Research and Development Authority (BARDA) to support the ongoing phase III ENSEMBLE trial. Under the amendment, Janssen will commit approximately $US604 million and BARDA will commit approximately $US454 million to support the ongoing phase III trial evaluating Ad26.COV2 S vaccine candidate as a single-dose in up to 60,000 healthy volunteers worldwide. In February 2020, Janssen Pharmaceutical expanded its existing collaboration with Biomedical Advanced Research and Development Authority (BARDA) to seek treatment solutions for COVID-2019 infections. The collaboration will enhance Janssen's ongoing work with global partners to screen a library of existing antiviral molecules, with the aim of identifying compounds with promising antiviral activity against coronavirus. Earlier, in the same month, Janssen Pharmaceutical entered into a collaboration with the BARDA to expedite its new coronavirus vaccine programme. Under the terms of the agreement, Janssen and BARDA will both contribute to the research and development costs and mobilise resources to rapidly advance the initial stages of Janssen's COVID-19 vaccine development programme. BARDA will provide funding to support accelerated development of a vaccine candidate into phase I studies, with options for additional funding to progress a promising candidate. The company will work with the Rega Institute for Medical Research (KU Leuven), in Belgium. The arrangement couples the Institute's infrastructure, breadth of high throughput screening experience, and capabilities for studying special pathogens with Janssen's drug development resources and antiviral expertise. In parallel, Janssen will work to upscale the production and manufacturing capacities required to meet public health needs.
[8] [9] [10]
In July 2020, Janssen Pharmaceutical and Emergent BioSolutions entered into a five-year manufacturing services agreement for Ad26.COV2-S. Under the terms of agreement, Emergent will responsible to provide contract development and manufacturing (CDMO) services to produce drug substance at large scale over five years, with an approximate value of $US480 million for the first two years. Emergent will begin providing large-scale drug substance manufacturing in 2021, upon successful completion of the activities under the previously executed Technology Transfer Agreement. Agreement clarifies that for the subsequent years beginning 2023, Emergent will be responsible for providing a flexible capacity deployment model to support additional drug substance batches annually. This agreement is incremental to the agreement announced in April 2020. In April 2020, Janssen Pharmaceutical and Emergent BioSolutions entered into an agreement to support manufacturing of COVID-2019 vaccine. The agreement designed to accelerate manufacturing of the vaccine. Johnson & Johnson will invest to expand drug substance capacity related to the vaccine candidate. Emergent will provide drug substance manufacturing services, valued at approximately $US135 million, beginning in 2020, and will reserve operations capacity to potentially support commercial manufacturing of the vaccine leveraging Janssen's proven AdVac® and PER.C6® technologies beginning in 2021. Financial terms of the agreement were not disclosed. [11] [12] [13]
In April 2020, Catalent entered into a manufacturing agreement with the Janssen Pharmaceutical (now Johnson & Johnson Innovative Medicine), to accelerate availability of manufacturing capacity and prepare for large-scale commercial manufacturing for COVID-19 vaccine. The collaboration commits joint investment to accelerate rapid scale-up of segregated manufacturing capacity to support dedicated production of the vaccine [14]
Key Development Milestones
In June 2022, Ad26 COV2 S vaccine (Jecovden) was approved by the Japan health ministry (MHLW) against the novel coronavirus for those aged 18 and older in Japan. In May 2021, Janssen had filed the BLA for Ad26 COV2 S vaccine, and was subject to priority review. The application was based on top-line efficacy and safety data obtained from the phase III ENSEMBLE study [15] .
In October 2021, the US FDA authorised the emergency use of a single booster dose of Ad26 COV2 S vaccine for 18 years of age and older. The approval was based on the FDA’s evaluation of immune response data in 39 participants from a clinical trial including 24 participants who were 18 through 55 years of age and 15 participants who were 65 years of age and older. The study participants received a booster dose approximately 2 months after their first dose, and the results demonstrated a booster response and did not show new safety concerns [16] . In February 2021, the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the US FDA. Earlier, the US FDA had granted emergency use authorisation to COVID-19 vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vaccine will be available on not-for-profit basis for emergency pandemic use. The EUA is followed by a unanimous vote by the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). Earlier in the same month, Janssen had submitted an application to the US FDA requesting emergency use authorisation (EUA) for Ad26.COV2 S vaccine. The EUA decision was based on efficacy and safety data from phase III ENSEMBLE clinical trial [see below]. The company intends to distribute 100 million doses to the U.S in first half of 2021, following authorisation [17] [18] [19] [20] . The company plans to file for a biologics license application (BLA) with the US FDA subsequently [21] .
In April 2021, following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices (ACIP), the US FDA and the US Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the vaccine in the US should be lifted and use of the vaccine should resume. The two agencies have determined that the use of the vaccine should be resumed in the US, the US FDA and CDC have confidence that the vaccine is safe and effective in preventing COVID-19. The US FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older. They also reported that at this time, the available data suggest that the chance of TTS occurring is very low, but the US FDA and CDC will remain vigilant in continuing to investigate this risk [22] . In April 2021, Janssen announced that the US CDC and US FDA are reviewing data for six cases of rare and severe type of blood clot in individuals in USA, after receiving the vaccine. A type of blood clot called cerebral venous sinus thrombosis (CVST) was observed in combination with low levels of blood platelets (thrombocytopenia), and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered, such as an anticoagulant. CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until the review process is complete, the organisations recommended a pause in the use of vaccine as a precaution [23] .
In April 2021, Johnson & Johnson announced that the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) provided updated guidance for use of the Company's single-shot COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive. The guidance follows PRAC review of a small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the Company's COVID-19 vaccine. Following the PRAC recommendation, the Company will resume shipment of the Janssen COVID-19 vaccine in the European Union (EU), Norway and Iceland. PRAC committee suggested to include information about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. These events should be listed as very rare side effects of the vaccine [24] [25] .
In December 2022, Committee for Medicinal Products for Human Use (CHMP) recommended converting the conditional marketing authorisation of Ad26 COV2 S vaccine (Jcovden), the COVID-19 vaccine to standard marketing authorisarion [26] . In March 2021, the European Commission (EC) granted a Conditional Marketing Authorization (CMA) for its single-dose COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older. In the same month the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the conditional marketing authorisation (CMA) of the single-dose COVID-19 vaccine. The opinion is based on positive results from the phase III ENSEMBLE clinical trial [see below]. The conditional marketing authorisation application (cMAA) to the European Medicines Agency (EMA) was submitted in February 2021. In January 2020, the rolling review was started by EMA’s human medicines committee (CHMP), submission for which was initiated by Janssen in December 2020 [27] [28] [29] .
In December 2021, the Committee for Medicinal Products for Human Use (CHMP) of the EMA issued a positive opinion for use of Johnson & Johnson's COVID-19 vaccine as a booster for adults, aged 18 and older, at least two months after primary vaccination with a single-shot of this vaccine, and as a mix and match booster following primary vaccination with an approved two-shot mRNA COVID-19 vaccine regimen (known as heterologous boosting). The CHMP opinion was based on a comprehensive data package that included results from the phase III ENSEMBLE 2 study, and from multiple real-world evidence (RWE) studies [30] .
In June 2021, the Therapeutic Goods Administration (TGA), Australia, granted provisional approval to single dose Ad26 COV2 S COVID-19 vaccine for active immunisation to prevent COVID-2019 infections in adults 18 years of age and older. The decision was made on the basis of short term efficacy and safety data. Continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment. The evaluation of the vaccine commenced in December 2020 [31] [32] [33] .
In November 2021, Johnson & Johnson announced that Health Canada has approved Ad26 COV2 S single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older. The decision was made on the basis of initial data from the phase III ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease, and showed protection against COVID-19 related hospitalization and death [34] . In March 2021, Health Canada granted an Interim Order (IO) authorisation for emergency use of the single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical to prevent COVID-19 in individuals 18 years of age and older. The decision was based on scientific evidence, including data from the phase III ENSEMBLE study. [see below]In December 2020, Janssen initiated a rolling submission with Health Canada. Health Canada announced a rolling review of the vaccine candidate based on positive non-clinical data showing that the vaccine elicits a robust immune response, as demonstrated by neutralising antibodies [35] [27] [36] .
In March 2021, Swissmedic granted temporary authorisation to the COVID-19 vaccine in adults, in Switzerland. The Human Medicines Expert Committee had supported the decision. The application was submitted in December 2020, by johnson and Johnson healthcare group [37] .
In September 2021, Johnson and Johnson provided data to the US FDA and planned to submit the data to other regulators, the World Health Organization (WHO) and National Immunization Technical Advisory Groups (NITAGs) worldwide to inform decision-making on local vaccine administration strategies. The data is from the real-word evidence study results of which were consistent with phase III ENSEMBLE trial [see below], phase III ENSEMBLE 2 trial [see below] and the phase II VAC31518COV2001 trial [see below] [38] .
In March 2021, Johnson and Johnson received interim recommendation from Strategic Advisory Group of Experts (SAGE) for use of single shot COVID-19 vaccine to WHO to prevent COVID-19 in people aged 18 years and above. SAGE advices WHO to provide guidance on the use of vaccines supplied through the COVAX facility. The SAGE recommendation was based on results from phase III ENSEMBLE trial [see below] [39] .
In March 2021, Johnson and Johnson announced that the World Health Organization (WHO) granted Emergency Use Listing (EUL) for single-dose Janssen COVID-19 vaccine for active immunisation to prevent COVID-19 in individuals of 18 years of age and older. The EUL is granted based on interim efficacy and safety results from the phase III ENSEMBLE clinical trial [see below] [40] . Earlier, in February 2021, Janssen Vaccines & Prevention B.V submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s rolling submission of clinical data to WHO is completed [41] .
In February 2021, Johnson and Johnson initiated rolling submissions for the single-dose COVID-19 vaccine candidate in several countries worldwide [18] .
Prior to March 2021, Janssen Research & Development completed an Pre-approval access (PAA) program that provided access to COVID-19 vaccine VAC 31518 (Ad26.CoV2.S) for the prevention of COVID-19 infection (NCT04817657; CR109001; VAC31518COV4006) [42] .
In April 2022, Janssen Scientific Affairs initiated a phase III trial to evaluate the augmenting of anti-SARS-CoV2 immunity in kidney transplant recipients via a heterologous additional dose with Ad26.CoV2.S vaccine (21-008036; NCT05220397). The open-label, randomized study intends to enroll 1200 patients in the USA [43] .
In November 2021, Wits Health Consortium, in collaboration with Janssen Vaccines and Prevention, initiated a phase IIIb Sisonke Boost trial to evaluate efficacy, safety and immunogenicity of Ad26.COV2.S vaccine as a homologous boost on severe COVID, hospitalizations and deaths in Sisonke participants, when compared with vaccinated and unvaccinated populations of essential workers in South Africa (VAC31518COV30XX; NCT05148845). This Sisonke boost open-label study is being conducted in collaboration with the National Department of Health of South Africa, National Institute of Communicable Diseases (NICD), KwaZulu-Natal Research Innovation and Sequencing Platform (KRISP), Fred Hutchinson Cancer Research Center, Hutchinson Center Research Institute of South Africa (HCRISA), and Institute of Infectious Disease and Molecular Medicine. This open-label, single-arm, vaccine implementation study is enrolling approximately 500,000 healthy volunteers in South Africa. In December 2021, preliminary results from this trial were released by Johnson and Johnson [44] [45] .
In September 2021, Janssen Vaccines & Prevention initiated a phase III trial to evaluate safety, reactogenicity, and immunogenicity of co-administration of Ad26.COV2.S and influenza vaccines (EudraCT 2021-003953-43; VAC31518COV3005). This randomised, double-blind trial will recruit approximately 1 680 healthy adults in Belgium, and will be extended to Poland, Spain and the US [46]
In July 2023, Janssen Vaccines and Prevention B.V completed a phase III trial to evaluate safety of COVID-19 vaccine for the prevention of COVID-2019 infections in healthy volunteers (EudraCT2020-005801-14; NCT04908722; VAC31518COV3003). The randomised, double blind trial was initiated in June 2021 and enrolled 1609 patients in Poland, Germany, Brazil, South Africa and the US [47] .
Prior to February 2022, Janssen Vaccines and Prevention B.V. in collaboration with Wits Health Consortium completed a phase III trial which monitored the effectiveness of the single-dose Ad26 COV2 S COVID-19 vaccine among healthy participants (healthcare workers) (NCT04838795; VAC31518COV3012). Earlier in February 2021, the trial was initiated, and the open-label trial enrolled 477234 participants in South Africa [48] [49] .
In June 2023, Janssen Vaccines & Prevention B.V. completed a phase III ENSEMBLE 2 trial that evaluated efficacy and safety of a two-dose vacine regimen given at 56 days interval for the prevention of SARS-CoV-2 mediated COVID-19 in adults (CR108916; EudraCT2020-003643-29; NCT04614948). The randomised, double blind trial was initiated in November 2020 and completed enrolment of 31836 participants in the US, the UK, Belgium, Brazil, Colombia, France, Germany, Phillipines, South Africa and Spain in April 2021 [50] . In September 2021, Johnson & Johnson released data from the trial. Solicited and unsolicited adverse events following this second dose were similar to those seen in single-dose studies and was generally well-tolerated. [38] .
In January 2021, Johnson and Johnson announced that, the phase III ENSEMBLE study to evaluate safety and efficacy of COVID-19 vaccine in healthy volunteers met all its primary and key secondary endpoints (NCT04505722, CR108876, VAC31518COV3001). In March 2023, Janssen Vaccines & Prevention B.V. completed the trial which was resumed in October 2020. The randomised, parallel, double-blind, placebo controlled study in healthy volunteers was initiated in September 2020, in collaboration with Biomedical Advanced Research and Development Authority (BARDA) under Other Transaction Agreement HHSO100201700018C and National Institute of Allergy and Infectious Diseases (NIAID). The trial was suspended in the US, Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, South Africa, Ukraine, before October 2020. However the Independent Data Safety Monitoring Committee of the US FDA recommended to resume the recruitment for clinical trials. The company is in talks with regulators outside of the US to resue clinical trial programme In January 2020, Johnson & Johnson announced that the phase III trial ENSEMBLE is now fully enrolled with approximately 45,000 participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, South Africa, Ukraine, USA. Additional results from trial were released by the company in April 2021 [51] [52] [53] [54] [55] [56] . Later, in June 2021, immunogenicity data from the trial were released by Janssen Pharmaceuticals [57] . In July 2021, updated data regarding immunogenicity against Delta variant of SARS-COV-2 virus were released by Johnson & Johnson [58] . In September 2021, Johnson and Johnson released additional data from the trial [38] .
In November 2022, Janssen Vaccines & Prevention completed a phase III trial that evaluated safety, reactogenicity, and immunogenicity of co-administration of Ad26.COV2.S and influenza vaccines in healthy adults (CR109083; NCT05091307; EudraCT2021-003953-43). The randomized, double-blind trial enrolled 861 volunteers in Belgium, Poland, Spain and US [46] .
In November 2023, Janssen Vaccines and Prevention B.V completed a phase II trial that evaluated the safety, reactogenicity, and immunogenicity of Ad26.COV2.S in healthy pregnant participants (NCT04765384, CR108962, EudraCT2020-005330-14). The open-label trial was initiated in August 2021 and enrolled 98 participants in USA, Brazil and South Africa [59] .
In August 2023, Janssen Vaccines & Prevention completed a phase II trial designed to evaluate the safety, reactogenicity, and humoral immune response of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule or as a 2-dose schedule (56-day interval) in adolescents (NCT05007080; EudraCT2020-005720-11; CR108966; VAC31518COV3006; P059-2021). The randomized, observer-blind trial was initiated in September 2021 and enrolled 304 participants in Argentina, Brazil, India, Mexico and South Africa [60] .
In March 2022, Janssen Vaccines & Prevention, completed a phase IIa study which was earlier initiated in August 2020, to evaluate the safety and effectiveness of COVID-19 vaccine, in healthy subjects (NCT04535453; EudraCT2020-002584-63; VAC31518COV2001; CR108854). The randomized, double blind, placebo controlled study enrolled 635 volunteers, aged 18 years and older, in Germany, Netherlands, Spain and the United Kingdom [61] . In April 2021, company announced expansion of ongoing trial to include adolescents 12-17 years of age [62] . In September 2021, Johnson & Johnson announced that when a booster of Ad26 COV2 S was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. All rises were irrespective of age [38] . In February 2022, Immunogenicity data was presented at 31st Annual Congress of the European Respiratory Society [63] [61] .
In February 2023, Janssen Pharmaceutical completed a first-in-human phase I/IIa study which was initiated earlier in July 2020, to evaluate the safety, reactogenicity and immunogenicity of COVID-19 vaccine in healthy volunteers (NCT04436276; VAC31518COV1001; EudraCT2020-001483-28; CR108828). The randomised, double-blind, placebo-controlled trial enrolled 1085 participants in Belgium and the US [64] [65] [66] . In September 2020, Janssen Pharmaceuticals announced interim results from the phase I/IIa trial that demonstrated strong humoral and cell-mediated immune response in all elderly volunteers and was found to be well tolerated [67] . This trial was funded in part with federal funds from the US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under other transaction authority (OTA) agreement. In July 2021, Johnson & Johnson released updated data from this study [68] [58] . In September 2021, Updated immunogenicity data from the trial were presented at the 31st Annual Congress of the European Respiratory Society-2021 [69] [70] .
In September 2021, pooled results from phase I/IIa and phase III trial were presented by the company at ID Week 2021 (IDW-2021) [71] .
In August 2021, pooled results from phase I/IIa and phase IIa trial were released by the Johnson & Johnson [72] .
In December 2021, Janssen Vaccines & Prevention, completed a phase I trial which assessed the safety and reactogenicity of Ad26.COV2.S (0.3 milliliter [mL] versus 0.5 mL) and to demonstrate non-inferiority (NI) of Ad26.COV2.S (0.3 mL versus 0.5 mL), 28 days after vaccination (NCT04894305; CR109013; EudraCT 2021-001374-30; VAC31518COV1003). This randomised, observer-blind trial initiated in May 2021 enroled 380 patients in the Netherlands [73] .
In November 2021, Janssen Pharmaceutical completed a phase I trial that evaluated the safety and reactogenicity of Ad26.COV2 S vaccine to immunogenicity in healthy volunteers (NCT04509947; VAC31518COV1002; CR108871). The randomised, double-blind trial was initiated in August 2020 and enrolled 250 adults and the elderly volunteers in Japan [74] [75] .
In September 2020, Janssen Pharmaceutical in collaboration with Beth Israel Deaconess Medical Center (BIDMC) reported preclinical data from Syrian golden hamsters [76] .
In preclinical studies, COVID-19 vaccine elicited a strong immune response and developed neutralising antibodies against SARS-CoV-2 viruses that provided near complete protection against lung injuries in non-human primates (NHPs) [64] .
In March 2020, Janssen Pharmaceutical announced the selection of a lead COVID-19 vaccine candidate from various constructs. The company also announced its intention to initiate vaccine production at risk imminently to make it available on a not-for-profit basis for emergency pandemic use. Earlier in the same month Janssen reported initiation of preclinical testing of multiple vaccine prospects, to identify a coronavirus vaccine for clinical trials [77] [78] .
In January 2020, Janssen Pharmaceutical initiated research on coronavirus vaccine [79] .
Supply arrangements
As of December 2021, Johnson & Johnson announced that, it has entered in to commitment to make available up to 900 million doses of its COVID-19 vaccine to the African Union (via the African Vaccine Acquisition Trust) and COVAX, combined, through 2022 [80] .
Prior to April 2021, Johnson & Johnson agreed to supplying 200 million doses of its COVID-19 vaccine to the European Union, Norway and Iceland [25] .
In August 2020, Janssen agreed in principle to supply the Government of Canada with doses of COVID-19 vaccine. The availability of the vaccine candidate is subject to its successful development and Health Canada regulatory approval [81] .
In August 2020, Janssen Pharmaceutical Companies entered into an agreement with the US government for the large scale domestic manufacturing and delivery in the US of 100 million doses of Janssen's SARS-CoV-2 investigational vaccine, COVID-19 vaccine, for use in the United States following approval or Emergency Use Authorization by the US FDA. The Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, in collaboration with the US Department of Defense, is committing over $1 billion for this agreement. The vaccine will be provided at a global not-for-profit basis for emergency pandemic use. The US government may also purchase an additional 200 million doses of Ad26.COV2.S under a subsequent agreement [82] .
Financing information
The development of the COVID-19 vaccine is funded by Bill & Melinda Gates Foundation (INV- 226 006131); Janssen Vaccines & Prevention BV; Ragon Institute of MGH, MIT, and Harvard, Mark and Lisa Schwartz Foundation, Massachusetts Consortium on Pathogen Readiness (MassCPR); the National Institutes of Health (OD024917, AI129797, AI124377, AI128751, AI126603 to D.H.B.; AI007387 to L.H.T, AI146779 to A.G.S.; AI135098 to A.J.M.; and OD011092, OD025002 to J.D.E.); the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) under contract HHS0100201700018C; a Fast Grant, Emergent Ventures, Mercatus Center at George Mason University to A.J.M [83] .
In March 2020, Johnson & Johnson and BARDA together committed more than $US1 billion for research and development of the coronavirus vaccine. Both the organisations independently provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against coronavirus [77] .
Drug Properties & Chemical Synopsis
- Route of administration IM
- Formulation Injection
- Class COVID-19 vaccines, DNA vaccines
- Mechanism of Action Immunostimulants
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WHO ATC code
J07B-X (Other viral vaccines)
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EPhMRA code
J7E (Viral Vaccines)
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 alpha (TNF-alpha) T-Cell differentiation antigen CD8 seryl-tRNA synthetase Prothrombin (PT) PF4 Interleukin-5 (IL-5) Interleukin-4 (IL-4) Interleukin-13 (IL-13) HCY Fibrinogen D-dimer CBLIF Cardiolipins Cardiolipin auto-antibodies C-reactive protein (CRP) ADAMTS13 |
|
|
cOVID 2019 infections |
Arm Group Description |
T cell receptor beta variable 20/OR9-2 (non-functional) Cytokeratin 20 B-lymphocyte antigen CD20 |
|
|
cOVID 2019 infections |
Detailed Description |
vitronectin T-cell surface antigen CD4 Renin Fumaric acid Cytokeratin 20 B-lymphocyte antigen CD20 |
|
|
cOVID 2019 infections |
Eligibility Criteria |
Apolipoprotein H antibodies |
|
|
pneumococcal infections |
Arm Group Description |
Cytokeratin 20 B-lymphocyte antigen CD20 |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Ad26 COV2 S - Johnson & Johnson Innovative Medicine | ADAMTS13 | Outcome Measure |
| Apolipoprotein H antibodies | Eligibility Criteria | |
| B-lymphocyte antigen CD19 | Arm Group Label | |
| B-lymphocyte antigen CD20 | Arm Group Description, Detailed Description | |
| C-reactive protein (CRP) | Outcome Measure | |
| calcineurin binding protein 1 | Arm Group Description | |
| Cardiolipin auto-antibodies | Outcome Measure | |
| Cardiolipins | Outcome Measure | |
| CBLIF | Outcome Measure | |
| Cytokeratin 20 | Arm Group Description, Detailed Description | |
| D-dimer | Outcome Measure | |
| Fibrinogen | Outcome Measure | |
| Fumaric acid | Detailed Description | |
| HCY | Outcome Measure | |
| Interferon Gamma (IFNg) | Outcome Measure | |
| Interleukin-13 (IL-13) | Outcome Measure | |
| Interleukin-4 (IL-4) | Outcome Measure | |
| Interleukin-5 (IL-5) | Outcome Measure | |
| PF4 | Outcome Measure | |
| Prothrombin (PT) | Outcome Measure | |
| seryl-tRNA synthetase | Eligibility Criteria | |
| T cell receptor beta variable 20/OR9-2 (non-functional) | Arm Group Description | |
| T-Cell differentiation antigen CD8 | Outcome Measure | |
| T-cell surface antigen CD4 | 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 | provisional approval conditional marketing authorisation Emergency use authorisation Interim order for emergency use | Prevention | Registered | Australia, Canada, European Union, Iceland, Japan, Liechtenstein, Norway, Switzerland, USA | IM / Injection | Johnson & Johnson Innovative Medicine | 20 Jun 2022 |
| COVID 2019 infections | Emergency Use Authorization | In adolescents, Prevention | Preregistration | USA | IM / Injection | Johnson & Johnson Innovative Medicine | 05 Oct 2021 |
| COVID 2019 infections | - | Prevention | Phase III | Argentina, Brazil, Chile, Colombia, Germany, Mexico, Peru, Philippines, Poland, South Africa, Ukraine, United Kingdom | IM / Injection | Johnson & Johnson Innovative Medicine | 18 Jun 2021 |
| COVID 2019 infections | - | Prevention | Phase III | Spain | IM / Injection | Janssen Vaccines and Prevention B.V | 02 Nov 2022 |
| COVID 2019 infections | - | In volunteers | Phase III | Belgium | IM / Injection | Janssen Vaccines and Prevention B.V | 23 Sep 2021 |
| COVID 2019 infections | - | In adolescents, Prevention | Phase II | Argentina | IM / Injection | Janssen Vaccines and Prevention B.V | 16 Dec 2021 |
| COVID 2019 infections | 12 to 17 | In adolescents, Prevention | Phase II | Brazil, India, Mexico, South Africa | IM / Injection | Johnson & Johnson Innovative Medicine | 27 Sep 2021 |
| COVID 2019 infections | - | Prevention | Phase I | Netherlands | IM / Injection | Janssen Vaccines and Prevention B.V | 25 May 2021 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Janssen Pharmaceuticals | Originator | USA |
| Johnson & Johnson Innovative Medicine | Owner | USA |
| African Vaccine Acquisition Trust | Market Licensee | Africa |
| Emergent Ventures | Funder | USA |
| Bill & Melinda Gates Foundation | Funder | USA |
| National Institutes of Health (USA) | Funder | USA |
| Mercatus Center at George Mason University | Funder | USA |
| The Ragon Institute of MGH, MIT and Harvard | Funder | USA |
| Massachusetts Consortium on Pathogen Readiness | Funder | USA |
| Mark and Lisa Schwartz Foundation | Funder | USA |
| Janssen Vaccines and Prevention B.V | Collaborator | Netherlands |
| National Institute of Allergy and Infectious Diseases | Collaborator | USA |
| Rega Institute for Medical Research | Collaborator | Belgium |
| Beth Israel Deaconess Medical Center | Collaborator | USA |
| Biomedical Advanced Research and Development Authority | Collaborator | USA |
Brand Names
| Brand Name | Organisations | Indications | Countries |
|---|---|---|---|
| Jcoviden | Johnson & Johnson Innovative Medicine | COVID 2019 infections | Japan |
Scientific Summary
Adverse Events
Interim data from phase I/IIa trial showed mild to moderate (grade 1, 2) adverse events. Two serious adverse events were reported, one was hypotension and was determined to be unrelated to the vaccine. The second was fever, who was hospitalised on suspicion of COVID-19, but recovered within 12 hours. No Grade 4 (life-threatening) adverse events were reported in any cohort, and no subjects discontinued the study due to adverse events [67] [66] .
Phase III ENSEMBLE trial did not report any significant safety concerns relating to the Ad26.COV2 S and single-dose of the vaccine was generally well-tolerated with fewer local and systemic reactions as compared with the phase I/II data. The safety profile was consistent with other vaccine candidates. Overall fever rates were 9% and grade 3 fever 0.2%. Overall serious adverse events (SAEs) reported were higher in participants who received placebo as compared to the vaccine candidate. No anaphylaxis was observed. [52] [56]
Pharmacodynamics
In preclinical study, single-dose of Ad26.COV2 S elicited a strong immune response with generation of neutralising antibodies against SARS-CoV-2 viruses in non-human primates (NHPs). The vaccine provided complete or near-complete protection in the lungs from the virus in the animals. Ad26 COV2 S prevented severe clinical disease in Syrian golden hamsters, upon challenge with SARS-CoV-2 virus. When animals were exposed to a high dose of SARS-CoV-2 virus after 4 weeks, the vaccinated animals lost less weight and had less virus in their lungs and other organs than unvaccinated control animals. Mortalities were absent in vaccinated animals. The neutralizing antibody responses were inversely correlated with weight loss and viral replication in the lung. The vaccine elicited an immune response as demonstrated by 'neutralising antibodies' and prevented virus replication in the lungs, weight loss, pneumonia and mortality [76] [64] .
Immunogenicity
Summary
Results from a phase III ENSEMBLE trial demonstrated that, the trial met all primary and key secondary endpoints. The single dose vaccine was found to be 85% effective against severe/critical disease. Vaccine was effective against severe/critical COVID-19 disease as early as seven days after vaccination, with efficacy continuing to increase eight weeks post-vaccination. Among all participants from different geographies and including those infected with an emerging viral variant, the COVID-19 vaccine was approximately 67% effective in preventing moderate to severe COVID-19 occurring at least 14 days after vaccination and 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The vaccine was approximately 77% effective in preventing critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing critical COVID-19 occurring at least 28 days after vaccination. 116 cases of COVID-19 in the vaccine group were reported at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time period. 66 cases of COVID-19 in the vaccine group were reported at least 28 days after vaccination and 193 cases of COVID-19 in the placebo group during this time period. There were 14 severe cases in the vaccinated group versus 60 in the placebo group starting 14 days after vaccination,, and starting 28 days after vaccination, there were 5 severe in the vaccine group versus 34 cases in the placebo group. In the Phase 3 ENSEMBLE study, a single dose of Ad26 COV2 S offered strong and durable overall efficacy (75%; CI, 65%-82%; n=46 cases vaccine arm, n=176 cases placebo arm) against severe/critical COVID-19, across all age cohorts and all countries included in the study, after at least 28 days post-vaccination. While efficacy against severe/critical COVID-19 caused by the initial circulating SARS-COV-2 reference strain (Wuhan) remained high (93%; CI, 54%-99%; n=1 case vaccine arm, n=14 cases placebo arm), there was somewhat lower vaccine efficacy (72%; CI, 56%-82%; n=27 cases vaccine arm, n=93 cases placebo arm) against severe/critical disease caused by variants. The single-dose regimen had 53 percent (CI, 47%-58%; n=433 cases vaccine arm, n=883 cases placebo arm) efficacy against moderate to severe/critical infection with 58 percent (CI, 35%-74%; n=30 cases vaccine arm, n=69 cases placebo arm) efficacy against the reference strain. Efficacy against hospitalisations related to COVID-19 in the ENSEMBLE trial was 76 percent (CI, 54%-88%; n=16 cases vaccine arm, n=64 cases placebo arm), and efficacy against COVID-19-related deaths was 83 percent (CI, 41%-97%; n=3 cases vaccine arm, n=17 cases placebo arm). In the US, the ENSEMBLE trial demonstrated vaccine efficacy against moderate to severe/critical COVID-19 infection of 70 percent 28-days post-vaccination (CI, 61%-77%; n=77 cases vaccine arm, n=239 cases placebo arm), 74 percent against severe/critical infection (CI, 39%-91%; n=7 cases vaccine arm, n=26 cases placebo arm) and 89 percent against hospitalisation (CI, 24%-100%; n=1 case vaccine arm, n=9 cases placebo arm). Median follow-up time in the ENSEMBLE study was four months. Earlier results showed that the level of protection against moderate to severe COVID-19 infection was 72% in the US, 66% in Latin America and 57% in South Africa, 28 days post-vaccination. Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49. The vaccine demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination. There was a clear effect of the vaccine on COVID-19 cases requiring medical intervention (hospitalization, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO)), with no reported cases among participants who had received the vaccine, 28 days post-vaccination. Protection against severe disease across geographies, ages, and multiple virus variants, including the SARS-CoV-2 variant from the B.1.351 lineage was observed in South Africa. In South Africa, vaccine efficacy was maintained at 64% against moderate to severe/critical disease, and 81.7% against severe/critical disease as of day 28 post-vaccination. Efficacy was also maintained in participants in Brazil, with 68.1% efficacy against moderate to severe/critical disease, and 87.6% against severe/critical disease. A 75 percent overall efficacy (CI, 65%-82%) against severe/critical COVID-19, across all age cohorts and all countries included in the study was observed at least 28 days post-final vaccination. A 74 percent efficacy in the US against severe/critical COVID-19 (CI, 39%-91%); 89 percent against hospitalisation (CI, 24%-100%); 83 percent against COVID-19-related death (CI, 41%-97%) at least 28 days post-final vaccination [38] [51] [19] [52] [56] . In the phase III trial ENSEMBLE trial, treatment with Ad26.COV2 S vaccine demonstrated immune response against B.1.1.7, CAL.20C, P.1., and B.1.351 variants. The results showed that the levels of neutralizing antibodies were diminished against the variants, but that the T-cell immune response was preserved, suggesting T cells may provide protection against these emerging strains [57] . In blood samples of eight patients who were infected with Delta variant of SARS-COV-2, the single-dose of COVID-19 vaccine generated higher antibody levels against the Delta variant than observed against the Beta (B.1.351) variant [58] .
In the phase III ENSEMBLE 2 trial for prevention of COVID-2019 infections second shot of Ad26 COV2 S given 56 days after the first provided 100% protection (95% CI: 33%, 100%; n=0 cases vaccine arm, n = 8 cases placebo arm) against severe/critical COVID-19 infections at least 14 days post-final vaccination. A 75% protection against symptomatic (moderate to severe/critical) COVID-19 infections globally (95% CI: 55%, 87%; n = 14 cases vaccine arm, n = 52 cases placebo arm) and a 94% protection against symptomatic (moderate to severe/critical) COVID-19 infections in the US (95% CI: 58%, 100%). When a booster of Ad26 COV2 was given two months after the first shot, antibody levels rose to four to six times higher than observed after the single shot. Median follow-up time in the ENSEMBLE 2 study was 36 days since second vaccination [38] [50] .
Phase I/IIa:
Updated results in the first-in-human, randomized, double-blind, placebo-controlled, phase I/IIa trial (cohort 1a [C1a], 18–≤55 y, n=300; cohort 3 [C3], ≥65 y, n=322), in C1a and C3, neutralizing and non-neutralizing antibody functions were elicited after the 1st vaccine dose, including against variants of concern (VOC) beta (B.1.351) and alpha (B.1.1.7) in C1a, albeit lower than for the original strain (41- and 8.9-fold, respectively). By day 71 PD1, neutralizing titers against VOC increased ~2-fold vs day 29 PD1 and were 14- and 3-fold lower for beta and alpha vs the original strain. A second dose at day 56 increased antibody responses in both cohorts; 14 days PD2, neutralizing activities increased ~3–4-fold vs day 71 PD1 for all strains. Ad26.COV2.S also elicited a high proportion of spike-specific polyfunctional and memory CD4 and CD8 T-cells in both cohorts that were maintained until at least 71 days PD1 and 2 weeks PD2 [70] . Earlier in a sub-study in healthy volunteers in from cohort 1b demonstrated that both humoral (antibody) and cellular (T-cell) immune responses generated by the single-shot COVID-2019 vaccine were strong and stable through eight months after immunization. T-cell responses including the CD8+ T-cells responses persisted over the eight-months. COVID-2019 vaccine demonstrated neutralising antibody activity against the Delta variant (B.1.617.2) over time. COVID-2019 vaccine elicited dual mechanisms of protection against COVID-19 infections, including against disease caused by the Delta variant (B.1.617.2) and other SARS-CoV-2 variants of concern, including the Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Epsilon (B.1.429) and Kappa (B.1.617.1) variants, and the original SARS-CoV-2 strain (WA1/2020) [69] [68] . Interim data from preprint phase I/IIa trial showed that 99% volunteers confirmed seroconversion (detectable antibody expression). On day 29th after vaccination, 98% of the subjects were positive for neutralising antibodies against SARS-CoV-2, eliciting a strong antibody response, a strong T cell response, and a Th1 response, and is considered to have a low risk of enhancing vaccine-related respiratory disease. Updated data from sub-study (n=20) of the trial showed that humoral as well as cellular immune response including CD8+ T cells generated post single-dose vaccine was lasted for eight months. Single-dose of the vaccine generated neutralising antibodies against a range of SARS-CoV-2 variants of concern, which increased over time (the average neutralising titer at eight months exceeded that average at 29 days) [58] [67] [66] .
In preclinical study, single-dose of Ad26.COV2 S elicited a strong immune response with generation of neutralising antibodies against SARS-CoV-2 viruses in non-human primates (NHPs). After receiving the vaccine, six animals has no detectable virus in their lower respiratory tract after exposure to SARS-CoV-2, and only one of six showed very low levels of the virus in a nasal swab at two time points. The vaccine provided complete or near-complete protection in the lungs from the virus in the animals [64] .
In a phase II trial, immunogenicity at different booster dose levels and schedule intervals in adults demonstrated doses as low as 1.25×1010 vp, Ad26 COV2 S induced neutralizing and binding antibodies after 1 dose. Independent of dose level, boosting with a second dose increased antibody responses, which were further enhanced by an extended dosing interval. After dose 1, neutralizing antibodies were induced at different dose levels, including 1.25×1010 vp. Across dose levels, neutralizing titers were higher with younger age at day 15 (wtVNA geometric mean titer [GMT] range, 99-242 vs 61-125 for ages 18-55 vs =65 y) and day 29 (160-311 vs 113-187). After dose 2, titers were higher than after dose 1. Dose 2 induced a stronger antibody response when given at day 85 (Group 9, GMT=694) vs day 57 (Groups 1-3, GMT=420, 496, and 348). A similar trend was observed for binding antibody responses. Priming and boosting with 2.5×1010 vp appears to perform as well as 5×1010 vp [63] . Earlier, results from pooled analysis from phase I/IIa and phase IIa trials demonstrated increase in spike binding antibodies supporting booster shot of Ad26 COV2 S COVID-19 vaccine. Vaccine generated nine-fold higher spike binding antibodies than 28 days after the primary single dose vaccination. Significant increases in binding antibody responses were observed in participants between age 18 and 55 and in those 65 years and older who received a lower booster dose [72] [66] [61] .
In the phase II study, boosting with Ad26 COV2 S after a primary vaccine regimen of tozinameran appears to lead to a greater increase in CD8+ T-cell responses than boosting with tozinameran. Both Ad26 COV2 S and tozinameran as boosters led to similar neutralizing and binding antibody levels against the original SARS-CoV-2 strain, as well as the Delta and Beta variants, four weeks following the boost. However, after a mix-and-match booster dose of Ad26 COV2 S, antibodies continued to increase for at least four weeks whereas in individuals who received a homologous boost with tozinameran, antibodies declined from week two to week four post-boost [84] [86]
The preliminary results from the South African phase IIIb Sisonke study showed that a homologous (same vaccine)booster shot of COVID-19 vaccine (Ad26.COV2.S) demonstrated 85 percent effectiveness against COVID-19-related hospitalisation and reduced the risk of hospitalisation from COVID-19 among healthcare workers in South Africa after omicron became the dominant variant. A second, separate analysis of the immune response to different vaccine regimens, demonstrated that a heterologous booster (different vaccine) COVID-19 vaccine in individuals who initially received the BNT 162b2 mRNA vaccine generated a 41-fold increase in neutralising antibody responses by four weeks following the boost and a 5-fold increase in CD8+ T-cells to omicron by two weeks. A homologous boost with BNT 162b2 generated a 17-fold increase in neutralising antibodies by four weeks following the boost and a 1.4-fold increase in CD8+ T-cells by two weeks. When a booster shot was administered six to nine months after a primary single dose, VE increased over time from 63 percent (95% CI, 31-81%) at 0-13 days, to 84 percent (95% CI, 67-92%) at 14-27 days and 85 percent (95% CI, 54-95%) at 1-2 months’ post-boost. An analysis of 65 individuals who received primary vaccination with two doses of an mRNA COVID-19 vaccine (BNT162b2), followed by a homologous booster shot of BNT 162b2 (n=24) or a heterologous booster with the Johnson & Johnson COVID-19 vaccine (n=41) after at least six months, found both regimens increased humoral and cellular responses against omicron. Antibody responses against omicron were boosted by both the Johnson & Johnson COVID-19 vaccine and the BNT 162b2 vaccine, with the Johnson & Johnson COVID-19 vaccine increasing neutralising antibody titers by 41-fold at four weeks post-boost.The BNT 162b2 vaccine was found to increase antibody titers to a higher level at week two post-boost, before declining to represent a 17-fold increase at week four post-boost. The progressive increase in antibodies the weeks following a vaccination of a booster is similar to that seen following the first vaccine. The rapid immune response followed by waning of the antibody response after the BNT 162b2 booster is also similar to that seen following the two-dose priming regimen. The Johnson & Johnson COVID-19 vaccine boosted median omicron-reactive CD8+ T-cells by 5.5-fold, and omicron-reactive CD4+ T-cells by 3.1-fold, while the homologous (BNT162b2) regimen boosted both omicron-reactive CD4+ and CD8+ T-cells by 1.4-fold [44] [45]
Results from pooled analysis from phase I/IIa and phase III trials which evaluated Ad26.COV2.S-elicited antibody neutralizing activity against variants of concern (VOC) B.1.1.7 (Alpha), B.1.351 (Beta), and B.1.617.2 (Delta) in sera from patients in clinical trials following a single dose of Ad26.COV2.S, showed that Ad26.COV2.S-elicited serum neutralizing activity against VOC showed an overall decrease in titers relative to the original strain that was largest for the Beta variant, even though vaccine efficacy against severe–critical COVID-19 was maintained in countries where these variants were circulating versus in countries where they were not circulating. Over time, titers against variants increased, suggesting B-cell affinity maturation leading to increasing coverage of VOC. Results in serum samples from phase I/IIa participants (n = 6), at Day 29 after 1 dose of Ad26.COV2.S, wtVNA titers against VOC were lower than for the original strain (GMT = 573), with GMT = 65, 14, and 15 for Alpha, Beta, and Delta, respectively, representing 8.8-, 40.9-, and 37.7-fold decreases. By Day 71 after vaccination (n = 14), fold differences between the original strain (GMT = 375) and VOC (GMT = 113, 27, and 28) were smaller (3.3-, 13.9-, and 13.4-fold) than at Day 29, suggestive of B-cell maturation. Day 71 titers against the Delta variant were maintained for at least 8 months following a single dose of Ad26.COV2.S. In serum samples from phase III patients (n = 8), psVNA titers against VOC were lower than the original strain at Day 71 after vaccination, with the lowest titers observed for the Beta variant (3.6-fold decrease vs original strain). Smaller reductions in Nab titers for VOC were observed in the psVNA assay compared to wtVNA. Neutralization of B.1.1.7 (Alpha), B.1.351 (Beta), and B.1.617.2 (Delta) lineages in serum samples from patients who received Ad26.COV2.S. n = 6 samples at Day 29 and n = 14 (n = 14 for Alpha and Beta; n = 6 for Delta, comprising the same 6 patients at Day 29) samples at Day 71 after vaccination with a single dose of Ad26.COV2.S (5 x 10^10 vp dose level) were analyzed in wild-type virus neutralization assays against the SARS-CoV-2 Victoria strain (D614, black dots), the B.1.1.7 (Alpha; green dots) the B.1.351 (Beta; blue dots), and the B.1.617.2 (Delta; purple dots) lineages. Dots represented the IC50 (inhibitory concentration) titers per patient [71] .
Therapeutic Trials
Results from a phase III ENSEMBLE trial demonstrated that, the trial met all primary and key secondary endpoints. The single dose vaccine was found to be 85% effective against severe/critical disease. Vaccine was effective against severe/critical COVID-19 disease as early as seven days after vaccination, with efficacy continuing to increase eight weeks post-vaccination. Among all participants from different geographies and including those infected with an emerging viral variant, the COVID-19 vaccine was approximately 67% effective in preventing moderate to severe COVID-19 occurring at least 14 days after vaccination and 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The vaccine was approximately 77% effective in preventing critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing critical COVID-19 occurring at least 28 days after vaccination. 116 cases of COVID-19 in the vaccine group were reported at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time period. 66 cases of COVID-19 in the vaccine group were reported at least 28 days after vaccination and 193 cases of COVID-19 in the placebo group during this time period. There were 14 severe cases in the vaccinated group versus 60 in the placebo group starting 14 days after vaccination,, and starting 28 days after vaccination, there were 5 severe in the vaccine group versus 34 cases in the placebo group. Earlier results showed that the level of protection against moderate to severe COVID-19 infection was 72% in the US, 66% in Latin America and 57% in South Africa, 28 days post-vaccination. Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49. The vaccine demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination. There was a clear effect of the vaccine on COVID-19 cases requiring medical intervention (hospitalization, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO)), with no reported cases among participants who had received the vaccine, 28 days post-vaccination. Protection against severe disease across geographies, ages, and multiple virus variants, including the SARS-CoV-2 variant from the B.1.351 lineage was observed in South Africa. In South Africa, vaccine efficacy was maintained at 64% against moderate to severe/critical disease, and 81.7% against severe/critical disease as of day 28 post-vaccination. Efficacy was also maintained in participants in Brazil, with 68.1% efficacy against moderate to severe/critical disease, and 87.6% against severe/critical disease [51] [19] [52] [56] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 30 Jun 2022 | Trial Update | ANRS, Emerging Infectious Diseases plans a phase II trial for COVID-2019 infections (In adults, In elderly, Prevention) in Mali (IM) in June 2022 (NCT05409261) | 14 Jun 2022 |
| 31 Mar 2022 | Trial Update | Janssen Scientific Affairs and Mayo Clinic plan a phase III trial for COVID-2019 infections (Prevention) in USA (IM, Injection), in March 2022 (700348314), (NCT05220397) | 22 Apr 2022 |
| 31 Dec 2021 | Regulatory Status | Janssen Pharmaceuticals announces intention to submit BLA to the US FDA for COVID-2019 infections for single-shot COVID-19 vaccine in 2021 [18] | 14 Jul 2021 |
| 15 Oct 2021 | Regulatory Status | The US FDA plans to hold an advisory meeting to discuss amendment of the emergency use authorisation to Janssen COVID-19 Vaccine for the administration of a booster dose (In adults) (9336832) | 25 Oct 2021 |
| 08 Sep 2021 | Trial Update | Janssen plans a phase II/III HORIZON 2 trial in COVID-2019 infections (Prevention, In adolescent, In adults, In children, In infants, In neonates) in Argentina, Australia, Brazil, Canada, Colombia, Finland, Italy, Mexico, Poland, South Africa, Spain, Sweden, Turkey, in UK and in USA, (IM) in September 2021(700336315) (EudraCT2020-005720-11) (NCT05007080) | 16 Dec 2021 |
| 30 Jun 2021 | Regulatory Status | Johnson & Johnson plans to launch Ad26.COV2 S vaccine within the European Union in the second quarter of 2021 [28] | 22 Feb 2021 |
| 28 Feb 2021 | Regulatory Status | Johnson & Johnson intends to submit a conditional marketing authorisation application to EMA in February 2021 [20] | 22 Feb 2021 |
| 26 Feb 2021 | Trial Update | Janssen Vaccines & Prevention B.V.plans a phase II trial for COVID-2019 infection (Prevention) in South Africa, Spain, United Kingdom and in US (IM) (NCT04765384) (700333973) | 16 Feb 2024 |
| 31 Jan 2021 | Regulatory Status | Janssen Pharmaceuticals expects to submit an Emergency Use Authorization application to the USFDA in February 2021 (9314092) [77] | 08 Feb 2021 |
| 31 Dec 2020 | Trial Update | Janssen Pharmaceuticals plans a phase III trial (a two-dose regimen) for COVID-2019 infections later in 2020 (Parenteral) (700326235) [67] | 05 Oct 2020 |
| 05 Sep 2020 | Trial Update | Janssen Vaccines & Prevention plans the phase III ENSEMBLE trial for COVID-2019 infections (Prevention, In volunteers) in USA, Brazil, Chile, Colombia, Mexico, Peru, Philippines, South Africa and Ukraine, in September 2020 (NCT04505722) (700326231) | 25 Sep 2020 |
| 20 Aug 2020 | Trial Update | Janssen Pharmaceutical plans a phase I trial in healthy volunteers in Japan (NCT04509947) (700326620) | 03 Sep 2020 |
| 31 Jul 2020 | Trial Update | Janssen Pharmaceuticals plans phase I/IIa trial for COVID-2019-infections (In volunteers) in USA and Belgium, in late July 2020 (700318563) [85] | 04 Aug 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 24 Nov 2023 | Trial Update | Janssen Vaccines & Prevention B.V.completes a phase II trial for COVID-2019 infection (Prevention) in South Africa, Spain, and USA (IM) (NCT04765384) Updated 16 Feb 2024 |
| 01 Oct 2023 | Company Involvement | Janssen Pharmaceuticals is now called Johnson & Johnson Innovative Medicine (Janssen Pharmaceuticals website, October 2023) Updated 10 Oct 2023 |
| 14 Aug 2023 | Trial Update | Janssen Vaccines & Prevention completes a phase II trial in COVID-2019 infections (In adolescents, Prevention) in Brazil, Argentina, India, Mexico, South Africa (IM) (NCT05007080) Updated 26 Oct 2023 |
| 10 Jul 2023 | Trial Update | Janssen Vaccines & Prevention completes a phase III trial for COVID-19 infections (Prevention) in Brazil, Poland, Germany, USA and South Africa (IM) (NCT04908722) (EudraCT2020-005801-14) Updated 25 Oct 2023 |
| 18 Jun 2023 | Trial Update | Janssen Vaccines & Prevention completes ENSEMBLE 2 phase III trial in COVID-2019 infections (Prevention) in USA, United Kingdom, Belgium, Brazil, Colombia, France, Germany, Phillipines, South Africa and Spain (IM, Injection) (NCT04614948) Updated 02 Aug 2023 |
| 31 Mar 2023 | Trial Update | Janssen Vaccines & Prevention completes the phase III ENSEMBLE trial for COVID-2019 infections (Prevention) in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, USA (NCT04505722) Updated 21 May 2023 |
| 21 Feb 2023 | Trial Update | Phase-I/II clinical trials in COVID-2019 infections (Prevention) in USA and Belgium (IM) (NCT04436276) Updated 24 Apr 2023 |
| 28 Dec 2022 | Regulatory Status | CHMP recommends standard conditional marketing approval of Ad26 COV2 S for COCID 19 infections in EU [26] Updated 10 Feb 2023 |
| 02 Nov 2022 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (Prevention) in Spain (IM) (NCT05091307) Updated 28 Dec 2022 |
| 02 Nov 2022 | Trial Update | Janssen Vaccines & Prevention initiates enrolment in a phase-III clinical trials in COVID-2019 infections (Prevention) in Belgium, Poland and USA (IM) (NCT05091307) Updated 28 Dec 2022 |
| 20 Jun 2022 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Japan (IM) [15] Updated 19 Jul 2022 |
| 08 Jun 2022 | Trial Update | ANRS, Emerging Infectious Diseases plans a phase II trial for COVID-2019 infections (In adults, In elderly, Prevention) in Mali (IM) in June 2022 (NCT05409261) Updated 14 Jun 2022 |
| 01 May 2022 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention) in Japan (IM) [15] Updated 19 Jul 2022 |
| 01 May 2022 | Regulatory Status | Ad26 COV2 S receives priority review status for COVID-2019 infections in Japan [15] Updated 19 Jul 2022 |
| 11 Apr 2022 | Trial Update | Janssen Scientific Affairs initiates a phase III trial for COVID-2019 infections (Prevention) in USA (IM, Injection) in April 2022 (NCT05220397) Updated 22 Apr 2022 |
| 09 Mar 2022 | Trial Update | Janssen Vaccines & Prevention B.V completes phase-II clinical trial in COVID-2019 infections (Prevention) in Spain, Netherlands, Germany and the United Kingdom (IM) (NCT04535453) Updated 25 Apr 2022 |
| 08 Feb 2022 | Scientific Update | Immunogenicity data from a phase II trial in COVID-2019 infections presented at 31st Annual Congress of the European Respiratory Society [63] Updated 08 Feb 2022 |
| 02 Feb 2022 | Trial Update | Janssen Scientific Affairs and Mayo Clinic plan a phase III trial for COVID-2019 infections (Prevention) in USA (IM, Injection), in March 2022 , (NCT05220397) Updated 22 Apr 2022 |
| 01 Feb 2022 | Trial Update | Janssen Vaccines and Prevention B.V. in collaboration with Wits Health Consortium completes a phase III trial for COVID-2019 infections (prevention) (IM, Injection) in South Africa, prior to February 2022 [48] (NCT04838795) Updated 06 Apr 2022 |
| 04 Jan 2022 | Biomarker Update | Biomarkers information updated Updated 06 Jan 2022 |
| 30 Dec 2021 | Scientific Update | Preliminary immunogenicity data from a phase IIIb Sisonke Boost in COVID-2019 infections released by Johnson & Johnson [44] Updated 05 Jan 2022 |
| 16 Dec 2021 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (In adolescents) in Argentina (IM) (NCT05007080) Updated 16 Dec 2021 |
| 15 Dec 2021 | Regulatory Status | The Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended approval of Ad26 COV2 S as a booster for adults for COVID-2019 infections (Prevention) in the EU [30] Updated 21 Dec 2021 |
| 08 Dec 2021 | Trial Update | Janssen Vaccines & Prevention BV completes a Phase-I trial in COVID-2019 infections (Prevention) in Netherlands (IM) (NCT04894305) (EudraCT2021-001374-30) ) Updated 06 Jan 2022 |
| 05 Dec 2021 | Scientific Update | Immunogenicity data from a phase II trial in COVID-2019 infections (Prevention) released by Janssen Pharmaceuticals in December 2021 [84] Updated 09 Dec 2021 |
| 24 Nov 2021 | Regulatory Status | Health Canada approves Ad26 COV2 S for prevention of COVID-19 in individuals 18 years of age and older in Canada [34] Updated 26 Nov 2021 |
| 16 Nov 2021 | Trial Update | Janssen Pharmaceutical completes a phase I trial in COVID-2019 infections (In adults, In the elderly, In volunteers) in Japan (IM) (NCT04509947) Updated 02 Dec 2021 |
| 10 Nov 2021 | Trial Update | Wits Health Consortium and Janssen Vaccines & Prevention initiates enrolment in a phase III trial for COVID-2019 infections (Prevention) in South Africa (IM)(NCT05148845) Updated 13 Dec 2021 |
| 20 Oct 2021 | Regulatory Status | The US FDA approves emergency use of a single booster dose of the Ad26 COV2 S Vaccine in COVID 2019 infections (In adults, In the elderly, Prevention) [16] Updated 25 Oct 2021 |
| 08 Oct 2021 | Regulatory Status | The US FDA plans to hold an advisory meeting to discuss amendment of the emergency use authorisation to Janssen COVID-19 Vaccine for the administration of a booster dose (In adults) Updated 25 Oct 2021 |
| 05 Oct 2021 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (In adolescents, In adults, Prevention) in USA (IM) Updated 11 Oct 2021 |
| 29 Sep 2021 | Scientific Update | Pooled immunogenicity data from a phase I/IIa and III trial in COVID-2019 infections presented at ID Week 2021 (IDW-2021) [71] Updated 07 Feb 2022 |
| 27 Sep 2021 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (In adolescents, Prevention) in Brazil, India, Argentina, Mexico, South Africa (IM) (NCT05007080) Updated 29 Jul 2022 |
| 23 Sep 2021 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (In volunteers) in Belgium (IM) (EduraCT 2021-003953-43) Updated 12 Oct 2021 |
| 21 Sep 2021 | Scientific Update | Immunogenicity data from the phase III ENSEMBLE 2 trial in COVID-19 infections released by Johnson & Johnson [38] Updated 26 Sep 2021 |
| 21 Sep 2021 | Scientific Update | Immunogenicity data from the phase III ENSEMBLE trial in COVID-19 infections released by Johnson & Johnson [38] Updated 26 Sep 2021 |
| 05 Sep 2021 | Scientific Update | Updated immunogenicity data from a phase-I/II clinical trial in COVID-2019 infections were presented at the 31st Annual Congress of the European Respiratory Society-2021 [70] Updated 08 Feb 2022 |
| 30 Aug 2021 | Trial Update | Janssen plans a phase II/III HORIZON 2 trial in COVID-2019 infections (Prevention, In adolescent, In adults, In children, In infants, In neonates) in Argentina, Australia, Brazil, Canada, Colombia, Finland, Italy, Mexico, Poland, South Africa, Spain, Sweden, Turkey, in UK and in USA, (IM) in September 2021 (EudraCT2020-005720-11) (NCT05007080) Updated 16 Dec 2021 |
| 27 Aug 2021 | Trial Update | Janssen Vaccines & Prevention B.V.initiates a phase II trial for COVID-2019 infection (Prevention) in South Africa, Spain, and USA (IM) (NCT04765384) Updated 16 Feb 2024 |
| 25 Aug 2021 | Scientific Update | Pooled immunogenicity data from a phase I/IIa and IIa trial in COVID-2019 infections released by Johnson & Johnson [72] Updated 27 Aug 2021 |
| 04 Aug 2021 | Trial Update | Janssen Vaccines & Prevention plans a phase II trial in COVID-2019 infections (Prevention) in USA (IM, Injection) Updated 17 Aug 2021 |
| 15 Jul 2021 | Scientific Update | Updated immunogenicity data from a phase I/IIa trial in COVID-19 infections released by Johnson & Johnson [68] [69] Updated 19 Jul 2021 |
| 01 Jul 2021 | Scientific Update | Updated immunogenicity data from a phase I/IIa trial in COVID-19 infections released by Johnson & Johnson [58] Updated 09 Jul 2021 |
| 01 Jul 2021 | Scientific Update | Updated immunogenicity data from the phase III ENSEMBLE trial in COVID-19 infections released by Johnson & Johnson [58] Updated 09 Jul 2021 |
| 25 Jun 2021 | Phase Change - Registered | Registered (provisional approval) for COVID-2019 infections (Prevention) in Australia (IM) [31] Updated 14 Jul 2021 |
| 18 Jun 2021 | Trial Update | Janssen Vaccines & Prevention initiates enrolment in a phase III trial for COVID-19 infections (Prevention) in Brazil and South Africa (IM) (NCT04908722) Updated 16 Sep 2021 |
| 18 Jun 2021 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (Prevention) in Germany (IM) (NCT04908722) Updated 06 Sep 2021 |
| 09 Jun 2021 | Scientific Update | Immunogenicity data from the phase III ENSEMBLE trial in COVID-2019 infections released by Janssen Pharmaceuticals [57] Updated 16 Jun 2021 |
| 25 May 2021 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (Prevention) in Netherlands (IM) (NCT04894305) (EudraCT2021-001374-30) Updated 06 Jan 2022 |
| 21 May 2021 | Trial Update | Janssen Vaccines & Prevention initiates a phase I trial for COVID-2019 infections (Prevention) in the Netherlands (IM) (NCT04894305) (EudraCT2021-001374-30) Updated 15 Jun 2021 |
| 14 May 2021 | Trial Update | Janssen Vaccines & Prevention plans a phase I trial for COVID-2019 infections (Prevention) in the Netherlands (IM) in May 2021 (NCT04894305) (EudraCT2021-001374-30) Updated 24 May 2021 |
| 21 Apr 2021 | Scientific Update | Updated efficacy data from the phase III ENSEMBLE trial for COVID-2019 infections released by Johnson & Johnson [51] Updated 27 Apr 2021 |
| 20 Apr 2021 | Regulatory Status | the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) provides updated guidance and labelling instructions for use of Ad26 COV2 S COVID-19 vaccine and its overall benefit-risk profile [25] [24] Updated 22 Apr 2021 |
| 16 Apr 2021 | Trial Update | Janssen Vaccines & Prevention completes enrolment in ENSEMBLE 2 phase III trial in COVID-2019 infections (Prevention) in the US, the UK, Belgium, Brazil, Colombia, France, Germany, Phillipines, South Africa and Spain (IM, Injection) (NCT04614948) Updated 26 Sep 2021 |
| 09 Apr 2021 | Licensing Status | Janssen Pharmaceuticals and the African Vaccine Acquisition Trust agree to co-promote COVID-19 vaccine in Africa for COVID-2019 infections [5] Updated 09 Apr 2021 |
| 26 Mar 2021 | Trial Update | Janssen Research & Development completes an Pre-approval access (PAA) program of COVID-19 vaccine for COVID-19 infection (Prevention), prior to March 2021 (NCT04817657) Updated 05 Apr 2021 |
| 25 Mar 2021 | Trial Update | Janssen Research & Development initiates an Pre-approval access (PAA) program of COVID-19 vaccine for COVID-19 infection (Prevention), prior to March 2021 (NCT04817657) Updated 05 Apr 2021 |
| 22 Mar 2021 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Switzerland (IM) [37] Updated 31 Mar 2021 |
| 17 Mar 2021 | Regulatory Status | Strategic Advisory Group of Experts (SAGE) recommends use of COVID-19 vaccine through the COVAX facility [39] Updated 22 Mar 2021 |
| 12 Mar 2021 | Regulatory Status | World Health Organization (WHO) recommends Emergency Use Listing (EUL) for COVID 19 vaccine for COVID-19 infection (Prevention) [40] Updated 23 Mar 2021 |
| 12 Mar 2021 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in European Union (IM) Updated 16 Mar 2021 |
| 12 Mar 2021 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention) in Norway, Iceland, Liechtenstein (IM) Updated 16 Mar 2021 |
| 11 Mar 2021 | Regulatory Status | The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending conditional marketing authorisation for COVID-2019 infections (Prevention) [27] Updated 12 Mar 2021 |
| 05 Mar 2021 | Phase Change - Registered | Registered (Interim order for emergency use) for COVID-2019 infections (Prevention) in Canada (IM) [27] [35] Updated 12 Mar 2021 |
| 28 Feb 2021 | Regulatory Status | The US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) recommends approval of single-shot COVID-19 vaccine for COVID-2019 infections in USA [21] Updated 14 Jul 2021 |
| 27 Feb 2021 | Regulatory Status | Janssen Pharmaceuticals announces intention to submit BLA to the US FDA for COVID-2019 infections for single-shot COVID-19 vaccine in 2021 [18] Updated 14 Jul 2021 |
| 27 Feb 2021 | Phase Change - Registered | Registered (emergency use authorisation) for COVID-2019 infections (Prevention) in USA (IM) [18] [19] Updated 01 Mar 2021 |
| 27 Feb 2021 | Regulatory Status | Janssen Pharmaceuticals initiates rolling submissions for the COVID-19 vaccine candidate in several countries worldwide, before February 2021 [18] Updated 01 Mar 2021 |
| 25 Feb 2021 | Trial Update | Janssen Vaccines & Prevention B.V.plans a phase II trial for COVID-2019 infection (Prevention) in South Africa, Spain, United Kingdom and in US (IM) (NCT04765384) Updated 16 Feb 2024 |
| 19 Feb 2021 | Regulatory Status | Janssen submits for Emergency Use Listing (EUL) to the World Health Organization (WHO) for Ad26.COV2 S [41] Updated 23 Feb 2021 |
| 18 Feb 2021 | Trial Update | Janssen Vaccines and Prevention B.V. in collaboration with Wits Health Consortium initiates a phase III trial for COVID-2019 infections (prevention) (IM, Injection) in South Africa (NCT04838795) Updated 13 Apr 2021 |
| 16 Feb 2021 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention) in European Union (IM) [28] Updated 22 Feb 2021 |
| 16 Feb 2021 | Regulatory Status | Johnson & Johnson plans to launch Ad26.COV2 S vaccine within the European Union in the second quarter of 2021 [28] Updated 22 Feb 2021 |
| 08 Feb 2021 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (Prevention) in Poland (IM) (EudraCT2020-005801-14) Updated 05 Apr 2021 |
| 05 Feb 2021 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention) in USA (IM) [20] Updated 08 Feb 2021 |
| 04 Feb 2021 | Regulatory Status | Johnson & Johnson intends to submit a conditional marketing authorisation application to EMA in February 2021 [20] Updated 22 Feb 2021 |
| 29 Jan 2021 | Scientific Update | Efficacy and adverse events data from a phase III ENSEMBLE trial for COVID-2019 infections released by Johnson & Johnson [52] Updated 02 Feb 2021 |
| 31 Dec 2020 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention) in Switzerland (IM) [37] Updated 31 Mar 2021 |
| 17 Dec 2020 | Trial Update | Janssen Vaccines & Prevention completes enrollment in the phase III ENSEMBLE trial for COVID-2019 infections (Prevention, in Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, South Africa, Ukraine, USA (NCT04505722) Updated 27 Jan 2021 |
| 01 Dec 2020 | Regulatory Status | Preregistration for COVID-2019 infections (Prevention) in Australia (IM), before December 2020 [32] Updated 14 Jul 2021 |
| 01 Dec 2020 | Regulatory Status | Therapeutic Goods Administration accepts submission dossier for Ad26 COV2 S COVID-19 vaccine for COVID-2019 infections for review [32] Updated 14 Jul 2021 |
| 01 Dec 2020 | Phase Change - Preregistration | Preregistration for COVID-2019 infections (Prevention) in Canada (IM) [36] Updated 08 Dec 2020 |
| 01 Dec 2020 | Regulatory Status | Janssen Pharmaceuticals plans to submit regulatory applications for COVID-2019 infections (Prevention) in various countries worldwide [36] Updated 08 Dec 2020 |
| 15 Nov 2020 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (Prevention) in the US, the UK, Belgium, Brazil, Colombia, France, Germany, Phillipines, South Africa and Spain (IM, Injection) (EudraCT2020-003643-29; NCT04614948) Updated 01 Dec 2020 |
| 14 Nov 2020 | Licensing Status | Janssen Pharmaceuticals expands its collaboration with the Biomedical Advanced Research and Development Authority (BARDA) for the development of Ad26.COV2 S [10] Updated 24 Nov 2020 |
| 06 Nov 2020 | Trial Update | Janssen Pharmaceuticals plans a phase III trial for COVID-2019 infections (Prevention) in Belgium, Colombia, France, Germany, Philippines, South Africa, Spain, United Kingdom, USA (IM) (NCT04614948) Updated 10 Nov 2020 |
| 30 Oct 2020 | Trial Update | Johnson and Jonhson reinitiates enrolment in phase III ENSEMBLE trials in COVID-2019 infections (Prevention) USA (IM) [53] Updated 30 Oct 2020 |
| 23 Oct 2020 | Regulatory Status | The Independent Data Safety Monitoring Committee recommends to resume phase III ENSEMBLE trial in the US [53] Updated 30 Oct 2020 |
| 23 Oct 2020 | Trial Update | Johnson and Jonhson suspends phase III ENSEMBLE trials in COVID-2019 infections (Prevention) in Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, South Africa, Ukraine, USA (IM), before October 2020 [53] Updated 30 Oct 2020 |
| 30 Sep 2020 | Scientific Update | Immunogenicity and safety data from a phase I/IIa trial in COVID-19 infections released by Janssen Pharmaceuticals [67] Updated 05 Oct 2020 |
| 30 Sep 2020 | Trial Update | Janssen Pharmaceuticals plans a phase III trial (a two-dose regimen) for COVID-2019 infections later in 2020 (Parenteral) [67] Updated 05 Oct 2020 |
| 23 Sep 2020 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (Prevention) in Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, South Africa, Ukraine, USA (IM) (NCT04505722) [54] Updated 25 Sep 2020 |
| 08 Sep 2020 | Scientific Update | Pharmacodynamics data from preclinical trials in COVID-2019 infections released by Janssen Pharmaceuticals [76] Updated 08 Sep 2020 |
| 28 Aug 2020 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (Prevention) in Spain (IM) (NCT04535453) Updated 25 Apr 2022 |
| 28 Aug 2020 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (Prevention) in Netherlands, Germany (IM) (NCT04535453; EudraCT2020-002584-63) Updated 14 Sep 2020 |
| 20 Aug 2020 | Trial Update | Janssen Vaccines & Prevention plans the phase III ENSEMBLE trial for COVID-2019 infections (Prevention, In volunteers) in USA, Brazil, Chile, Colombia, Mexico, Peru, Philippines, South Africa and Ukraine, in September 2020 (NCT04505722) Updated 25 Sep 2020 |
| 12 Aug 2020 | Trial Update | Janssen Pharmaceutical plans a phase I trial in healthy volunteers in Japan (NCT04509947) Updated 03 Sep 2020 |
| 11 Aug 2020 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (In adults, In the elderly, In volunteers) in Japan (IM) (NCT04509947) Updated 03 Sep 2020 |
| 30 Jul 2020 | Phase Change - I/II | Phase-I/II clinical trials in COVID-2019 infections (Prevention) in USA and Belgium (IM) (NCT04436276; 9299078) Updated 04 Aug 2020 |
| 30 Jul 2020 | Scientific Update | Immunogenicity data from a preclinical trial in COVID-2019 infections released by Janssen Pharmaceuticals [64] Updated 04 Aug 2020 |
| 30 Jul 2020 | Trial Update | Janssen Pharmaceuticals plans a phase I trial for COVID-2019 infections (Prevention) (Parenteral) in Japan [64] Updated 04 Aug 2020 |
| 30 Jul 2020 | Trial Update | Janssen Pharmaceuticals plans a phase IIa trial for COVID-2019 infections (Prevention) in Germany, Netherlands, Spain (Parenteral) [64] Updated 04 Aug 2020 |
| 30 Jul 2020 | Trial Update | Janssen Pharmaceuticals plans a phase III trial (a two-dose regimen trial) for COVID-2019 infections (Prevention) (Parenteral) [64] Updated 04 Aug 2020 |
| 10 Jun 2020 | Trial Update | Janssen Pharmaceuticals plans phase I/IIa trial for COVID-2019-infections (In volunteers) in USA and Belgium, in late July 2020 [85] Updated 04 Aug 2020 |
| 30 Mar 2020 | Regulatory Status | Janssen Pharmaceuticals expects to submit an Emergency Use Authorization application to the USFDA in February 2021 [55] [77] Updated 08 Feb 2021 |
| 13 Mar 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in USA (IM) [78] Updated 19 Mar 2020 |
| 13 Mar 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in USA (IM) [78] Updated 19 Mar 2020 |
| 18 Feb 2020 | Licensing Status | Janssen Pharmaceuticals expands its collaboration with the Biomedical Advanced Research and Development Authority (BARDA) for the development of Coronavirus vaccine [9] Updated 24 Feb 2020 |
| 11 Feb 2020 | Company Involvement | Janssen Pharmaceuticals collaborates with the Biomedical Advanced Research and Development Authority (BARDA) for the development of Coronavirus vaccine [8] Updated 14 Feb 2020 |
| 11 Feb 2020 | Trial Update | Janssen Pharmaceuticals plans phase I trials for COVID-2019-infections in USA [8] Updated 14 Feb 2020 |
| 30 Jan 2020 | Phase Change | Early research in COVID-2019-infections (Prevention) in USA (IM) [79] Updated 04 Feb 2020 |
| 30 Jan 2020 | Phase Change | Early research in COVID-2019-infections in USA (IM) [79] Updated 31 Jan 2020 |
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World Health Organization Strategic Advisory Group of Experts (SAGE) Interim Recommendation Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster.
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Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate.
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Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine.
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BIOQUAL Announces Publication of an Investigational COVID-19 Vaccine Candidate That Prevents Severe Clinical Disease in Animals.
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Johnson & Johnson COVID-19 Booster, Administered Six Months After Two-Dose Regimen of BNT162b2, Shows Substantial Increase in Antibody and T-cell Responses.
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Johnson & Johnson Accelerates Development of New Vaccine Candidate for Coronavirus Infection: Plans to Start Phase 1/2a Clinical Trial in Late July.
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A Randomized, Double-blind, Phase 2 Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Ad26.COV2.S Administered as Booster Vaccination in Adults 18 Years of Age and Older Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2
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