ZyCoV D
Alternative Names: Coronavirus DNA vaccine - Zydus Cadila; Novel corona virus-2019-nCov vaccine; Plasmid DNA vaccine - Zydus CadilaLatest Information Update: 07 Jan 2022
At a glance
- Originator Zydus Cadila
- Class COVID-19 vaccines; DNA vaccines; Viral vaccines
- Mechanism of Action Immunostimulants
-
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
- Available For Licensing Yes
Highest Development Phases
- Registered COVID 2019 infections
Most Recent Events
- 05 Jan 2022 ZyCoV D receives Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) for COVID-2019 infections (Prevention, In adolescents) in India, prior to January 2022
- 23 Aug 2021 Registered for COVID-2019 infections (Prevention, In adults, In adolescents, In the elderly) in India (Intradermal)
- 23 Aug 2021 ZyCoV D receives Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) for COVID-2019 infections (Prevention) in India
Development Overview
Introduction
ZyCoV D is a DNA vaccine being developd by Zydus Cadila for the prevention of COVID-2019 infections. The vaccine is delivered intradermally using the PharmaJet's Tropis® needle-free injection technology to enhance its effectiveness. The vaccine acts against major viral membrane protein responsible for the cell entry of the coronavirus known as COVID-19. The plasmid DNA would be introduced into the host cells, where it would be translated into the viral protein to generate an immune response mediated by the cellular and humoral arms of the immune system. The vaccine candidate has received emergency use authorisation approval in India.
PharmaJet's Tropis® needle-free injection technology reduces the local side effects typically associated with needle use including injection site pain.
Zydus Cadila is looking for partners for development of vaccine for COVID-2019 infections (Zydus Cadila website, February 2020).
Company Agreements
In November 2021, Enzychem Lifesciences and Zydus Cadila entered in to manufacturing license and technology transfer agreement for ZyCoV-D® in prevention of COVID-2019 infections. Under the terms of this agreement, Zydus shall transfer its manufacturing technology and provide technical assistance to Enzychem. Both CHL and Enzychem believe that this partnership will lead to estimated manufacturing of 80 million or more doses of the plasmid DNA vaccine in 2022. Accordingly, Enzychem shall pay Zydus license fees and royalties for the commercialization of the Plasmid DNA-based COVID-19 vaccine made in South Korea and exported to a number of countries, including low-medium income countries (LMICs) in Latin America and Asian New Southern Policy member countries. [1]
Key Development Milestones
In November 2021, Zydus Cadila has received an order to supply one crore doses of ZyCoV D, to the Government of India at Rs. 265 per dose and the needle-free applicator being offered at Rs. 93 per dose, excluding GST. The pricing has been decided in consultation with the Government of India [2] .
In August 2021, Zydus Cadila received the Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV D plasmid DNA vaccine for COVID-2019 [3] . The DCGI decision was based on the data from a pivotal phase III clinical trial. In July 2021, the company had applied for the EUA to the DCGI [4] [5] . Prior to January 2021, India’s national regulatory agency approved ZyCoV D in 12 years and older population [3] .
In January 2021, Zydus Cadila initiated phase III trial to evaluate efficacy, safety and immunogenicity of ZyCoV D (CTRI/2021/01/030416). The randomised, multi-centre, double blind, placebo controlled trial intends to recruit approximately 28216 volunteers in India. In the same month, Zydus received approval from the Drug Controller General of India (DCGI) to initiate a phase III trial for prevention of COVID-19 infections. In the July 2021, Company released efficacy and safety data from the trial. ZyCoV D was tested in adolescent population in the 12-18 years age group in India and found to be safe and very well tolerated. The tolerability profile was similar to that seen in the adult population [6] [5] [7] .
In December 2020, Zydus completed the phase II portion of the trial and announced that the vaccine was safe and immunogenic [8] . Earlier, in July 2020, Zydus Cadila announced initiation of adaptive phase I/II trial to assess safety, tolerability and immunogenicity of the vaccine. First patient was dosed in the trial and company enrolled 1000 participants across multiple clinical sites in India. As of August 2020, phase I portion of the trial was complete and the company is initiating phase II portion of the trial [9] [10] . Earlier in same month, Zydus received approval from Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO) to initiate phase I/II human clinical trials in India. In January 2021, Zydus released safety and immunogenicity results from a phase I/II trial [6] [11] [12] .
In July 2020, Zydus Cadila released results from the preclinical studies demonstrating strong immunogenicity, safety and neutralising the wild type virus in virus neutralisation assay in multiple animal species [11] . No safety concerns were observed in repeat dose toxicology by both intramuscular and intradermal route of administration. In rabbits, up to three times the intended human dose was found to be safe, well tolerated and immunogenic [10] .
Drug Properties & Chemical Synopsis
- Route of administration Intradermal
- Formulation unspecified
- Class COVID-19 vaccines, DNA vaccines, Viral vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J05A-X (Other antivirals)
-
EPhMRA code
J5B9 (Antivirals, others)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | Under Emergency Use Authorisation | In adolescents, In adults, In the elderly, Prevention | Registered | India | Intradermal / unspecified | Zydus Cadila | 23 Aug 2021 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Zydus Cadila | Originator | India |
| Zydus Cadila | Owner | India |
| PharmaJet | Technology Provider | USA |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| Zydus Cadila | - | Unspecified | - | 24 Feb 2020 |
Scientific Summary
Adverse Events
Interim results from phase III clinical trials did not show severe cases or deaths due to COVID-19 in the vaccine arm after administration of the second dose of the vaccine [5] .
Results from a phase I/II trial showed that ZyCoV-D was safe and well tolerated [6] [12] .
In preclinical studies ZyCoV-D showed no safety concerns in repeat dose toxicology studies by both intramuscular and intradermal routes of administration. The vaccine was well tolerated and safe. The trial also showed that ZyCoV-D is safe for children in the age group of 12 to 18 years [11] .
Immunogenicity
Summary
Results from a phase I/II trial showed that ZyCoV-D elicited a strong immunogenic response [6]
In preclinical studies ZyCoV-D elicited a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralize the wild type virus in virus neutralization assay [11] .
Therapeutic Trials
Interim results from phase III clinical trials showed primary efficacy of 66.6% for symptomatic RT-PCR positive cases. No moderate case of COVID-19 disease was observed in the vaccine arm post administration of the third dose which suggested 100% efficacy for moderate disease. [5] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Jul 2020 | Trial Update | Zydus Cadila plans a phase I/II trial in COVID-2019 infections (Prevention) in India (Intradermal) in July 2020 [11] | 06 Jul 2021 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 05 Jan 2022 | Regulatory Status | ZyCoV D receives Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) for COVID-2019 infections (Prevention, In adolescents) in India, prior to January 2022 [3] Updated 07 Jan 2022 |
| 23 Aug 2021 | Phase Change - Registered | Registered for COVID-2019 infections (Prevention, In adults, In adolescents, In the elderly) in India (Intradermal) [4] Updated 25 Aug 2021 |
| 23 Aug 2021 | Regulatory Status | ZyCoV D receives Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) for COVID-2019 infections (Prevention) in India [4] Updated 25 Aug 2021 |
| 01 Jul 2021 | Regulatory Status | Zydus Cadila files an Emergency Use Authorization application with the Drug Controller General of India (DCGI) in India for COVID-2019 infections [5] Updated 06 Jul 2021 |
| 01 Jul 2021 | Scientific Update | Efficacy and adverse events data from a phase III trial in COVID-2019 infections released by Zydus Cadila [5] Updated 06 Jul 2021 |
| 20 Jan 2021 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections (Prevention) in India (Intradermal) (CTRI/2021/01/030416) Updated 06 Jul 2021 |
| 03 Jan 2021 | Regulatory Status | Zydus Cadila receives approval from the DCGI to initiate phase III trials in COVID-2019 infections [6] Updated 06 Jan 2021 |
| 03 Jan 2021 | Scientific Update | Safety and immunogenicity data from a phase I/II trial in COVID-2019 infections released by Zydus Cadila [6] Updated 06 Jan 2021 |
| 24 Dec 2020 | Trial Update | Zydus Cadila completes a phase I/II trial in COVID-2019 infections (Prevention) in India (Intradermal) [8] Updated 29 Dec 2020 |
| 24 Dec 2020 | Trial Update | Zydus Cadila plans a phase III trial for COVID-2019 infections (Prevention) [8] [6] Updated 29 Dec 2020 |
| 06 Aug 2020 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (Prevention) in India (Intradermal) [9] Updated 10 Aug 2020 |
| 15 Jul 2020 | Phase Change - I/II | Phase-I/II clinical trials in COVID-2019 infections (Prevention) in India (Intradermal) [10] Updated 16 Jul 2020 |
| 15 Jul 2020 | Scientific Update | Adverse events data from a preclinical trial in COVID-19 infections released by Zydus Cadila [10] Updated 16 Jul 2020 |
| 03 Jul 2020 | Trial Update | Zydus Cadila plans a phase I/II trial in COVID-2019 infections (Prevention) in India (Intradermal) in July 2020 [11] Updated 06 Jul 2021 |
| 03 Jul 2020 | Scientific Update | Safety and immunogenicity data from preclinical trial in COVID-2019 infections released by Zydus Cadila [11] Updated 14 Jul 2020 |
| 03 Jul 2020 | Regulatory Status | Zydus Cadila receives approval from the CDSCO to initiate phase I/II trial for ZyCoV-D in COVID-2019 infections [11] Updated 07 Jul 2020 |
| 20 Apr 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in India (Intradermal) [13] Updated 24 Apr 2020 |
| 24 Feb 2020 | Licensing Status | Coronavirus vaccine - Zydus Cadila is available for licensing as of 24 Feb 2020. https://www.zyduscadila.com/ (Zydus Cadila pipeline, February 2019) Updated 24 Feb 2020 |
| 15 Feb 2020 | Phase Change | Early research in COVID-2019-infections (Prevention) in India (Intradermal) Updated 24 Feb 2020 |
References
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Enzychem to Partner with Zydus Cadila to Manufacture COVID-19 Plasmid DNA Vaccine in Korea.
Media Release -
Cadila Healthcare Ltd., to supply 1 crore doses of ZyCoV-D, the world's first Plasmid DNA vaccine to the Government of India.
Media Release -
PharmaJet partner Zydus Cadila Announces COVID-19 Vaccine Expansion Plan to Multiple Countries With Korean Firm.
Media Release -
PharmaJet Partner Zydus Cadila Announces Emergency Use Authorization Approval for Worlds First Plasmid DNA COVID-19 Vaccine.
Media Release -
Zydus applies to the DCGI for EUA to launch ZyCoV-D, the world's first Plasmid DNA vaccine for COVID-19.
Media Release -
Zydus Cadila receives approvals from the DCGI to start Phase III Clinical Trial of ZyCoV-D - fully indigenously developed vaccine.
Media Release -
A Phase III Clinical Trial to Evaluate ZyCoV-D in Volunteers
ctiprofile -
Zydus Cadila submits Phase I/II clinical trial data of ZyCoV-D, seeks nod to start Phase III Clinical Trials.
Media Release -
Zydus Cadila Announces Completion of Dosing in Phase I Clinical Trial of ZyCoV-D.
Media Release -
Zydus starts human dosing of its vaccine 'ZyCoV-D'.
Media Release -
Zydus' vaccine for COVID-19 (ZyCoV-D) successfully completes preclinical development and receives permission to initiate human clinical trials.
Media Release -
An Adaptive Phase I/II, Dose-Escalation, Multi-centric, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of ZyCoV-D in Healthy Adult Volunteers
ctiprofile -
Zydus explores the biologicals route to treat novel Coronavirus with long-acting Interferon alpha-2b.
Media Release
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