ZyCoV-D

Last updated

ZyCoV-D
ZyCoV-D Logo.svg
Vaccine description
Target SARS-CoV-2
Vaccine type DNA
Clinical data
Routes of
administration 		Intradermal
ATC code
  • None
Legal status
Legal status
Identifiers
DrugBank

ZyCoV-D is a DNA plasmid-based COVID-19 vaccine developed by Indian pharmaceutical company Cadila Healthcare, with support from the Biotechnology Industry Research Assistance Council. It is approved for emergency use in India.

Contents

Technology

The vaccine contains a DNA plasmid vector that carries the gene encoding the spike protein of SARS-CoV-2. As with other DNA vaccines, the recipient's cells then produce the spike protein, eliciting a protective immune response. The plasmid also contains unmethylated CpG motifs to enhance its immunostimulatory properties. [1]

The plasmid is produced using E. coli cells. [1]

The vaccine is given as an intradermal injection using a spring-powered jet injector. [1] [2] This is because successful transfection of DNA vaccines requires traveling across both the cell plasma membrane and the nuclear membrane, [3] and using a conventional needle gives poor results and leads to low immunogenicity. [3] [4]

Clinical trials

Pre-clinical trials

In February 2020, Cadila Healthcare decided to develop a DNA plasmid based COVID-19 vaccine at their Vaccine Technology Centre (VTC) in Ahmedabad. [5] The vaccine candidate was able to pass the pre-clinical trials on animal models successfully. A report of the study was made available via bioRxiv and later published in the journal Vaccine . [1] [6] Thereafter, human trials for Phase I and II were approved by the regulator. [7]

Phase I and II trials

Phase I trials of the vaccine candidate started on 15 July 2020 and continued until October 2020. The vaccine candidate was tested on 48 healthy individuals in the 18–55 age range, with 28 days between each of the three doses. The trial found the vaccine to be "safe, well-tolerated and immunogenic". [8]

Cadila Healthcare began phase II trials of the vaccine candidate from 6 August 2021 with over 1,000 volunteers as part of the adaptive Phase I/II multi-centric, dose escalation, randomised, double-blind placebo controlled method. [9] [10] [11] The company reported that phase II trials were completed by November 2020. [12] [13]

Phase III trials

In November 2020, the company announced it would test the vaccine candidate on about 30,000 patients in Phase III trials. [13] In January 2021, the Drugs Controller General of India (DCGI) granted permission to conduct the Phase III clinical trials for 28,216 Indian participants in the 12–99 age group. [14] [15] Of this, about 1,000 individuals were in the 12–18 age group. [16] [17] Interim results from the phase III trials were made available in July 2021. [18]

On 1 July 2021, Cadila Healthcare reported the efficacy to be 66.6% against symptomatic COVID-19 and 100% against moderate or severe disease in its interim analysis of its phase 3 trial data. [19] [20] [21]

Authorizations

  Full authorization
  Emergency authorization

On 1 July 2021, Cadila Healthcare applied to the Drugs Controller General of India (DCGI), seeking approval for Restricted Use in Emergency Situation for the vaccine. [22] On 20 August 2021, the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) recommended that the DCGI grant the approval, [23] which the DCGI then granted on the same day. [24]

Deployment

On 23 April 2021, production of the ZyCoV-D vaccine was started, with a yearly capacity of 240 million doses. [25]

See also

Related Research Articles

<span class="mw-page-title-main">Zydus Lifesciences</span> Indian multinational pharmaceutical company

Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad, which is primarily engaged in the manufacturing of generic drugs. The company ranked 100th in the Fortune India 500 list in 2020.

Inovio Pharmaceuticals is an American biotechnology company focused on the discovery, development, and commercialization of synthetic DNA products for treating cancers and infectious diseases. In April 2020, Inovio was among some 100 companies, academic centers, or research organizations developing a vaccine candidate for treating people infected with COVID-19, with more than 170 total vaccine candidates in development.

<span class="mw-page-title-main">COVID-19 vaccine</span> Vaccine against SARS-CoV-2

A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID‑19).

<span class="mw-page-title-main">Convidecia</span> Vaccine against COVID-19

AD5-nCOV, trade-named Convidecia, is a single-dose viral vector vaccine for COVID-19 that is also used as an inhaled booster. It was developed by CanSino Biologics, with Phase III trials conducted in Argentina, Chile, Mexico, Pakistan, Russia, and Saudi Arabia with 40,000 participants.

<span class="mw-page-title-main">Covaxin</span> Vaccine against COVID-19

Covaxin is a whole inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology.

<span class="mw-page-title-main">COVID-19 vaccination in India</span> Immunisation programme against COVID-19 in India

India began administration of COVID-19 vaccines on 16 January 2021. As of 4 March 2023, India has administered over 2.2 billion doses overall, including first, second and precautionary (booster) doses of the currently approved vaccines. In India, 95% of the eligible population (12+) has received at least one shot, and 88% of the eligible population (12+) is fully vaccinated.

<span class="mw-page-title-main">COVIran Barekat</span> COVIran Barakat vaccine against COVID-19

COVIran Barekat is a COVID-19 vaccine developed in Iran by Shifa Pharmed Industrial Group, a subsidiary of the Barkat Pharmaceutical Group. It is an inactivated virus-based vaccine. Iranian authorities have authorized its emergency use. This makes it the first locally developed COVID-19 vaccine to be approved for emergency use in the Middle East.

<span class="mw-page-title-main">CureVac COVID-19 vaccine</span> Vaccine candidate against COVID-19

The CureVac COVID-19 vaccine was a COVID-19 vaccine candidate developed by CureVac N.V. and the Coalition for Epidemic Preparedness Innovations (CEPI). The vaccine showed inadequate results in its Phase III trials with only 47% efficacy. In October 2021 CureVac abandoned further development and production plans for CVnCoV and refocused efforts on a cooperation with GlaxoSmithKline.

<span class="mw-page-title-main">Inovio COVID-19 vaccine</span> COVID-19 vaccine candidate

Inovio COVID-19 vaccine is a COVID-19 vaccine candidate developed by Inovio Pharmaceuticals.

<span class="mw-page-title-main">SCB-2019</span> Vaccine candidate against COVID-19

SCB-2019 is a protein subunit COVID-19 vaccine developed by Clover Biopharmaceuticals using an adjuvant from Dynavax technologies. Positive results of Phase I trials for the vaccine were published in The Lancet and the vaccine completed enrollment of 29,000 participants in Phase II/III trials in July 2021. In September 2021, SCB-2019 announced Phase III results showing 67% efficacy against all cases of COVID-19 and 79% efficacy against all cases of the Delta variant. Additionally, the vaccine was 84% effective against moderate cases and 100% effective against hospitalization.

<span class="mw-page-title-main">Sanofi–GSK COVID-19 vaccine</span> Vaccine candidate against COVID-19

The Sanofi–GSK COVID-19 vaccine sold under the brand name VidPrevtyn Beta, is a COVID-19 vaccine developed by Sanofi Pasteur and GSK.

<span class="mw-page-title-main">BriLife</span> Vaccine candidate against COVID-19

BriLife, also known as IIBR-100, is a replication-competent recombinant VSV viral vectored COVID-19 vaccine candidate. It was developed by the Israel Institute for Biological Research (IIBR). The IIBR partnered with the US-based NRx Pharmaceuticals to complete clinical trials and commercialize the vaccine. A study conducted in hamsters suggested that one dose of the vaccine was safe and effective at protecting against COVID-19.

<span class="mw-page-title-main">Sinopharm WIBP COVID-19 vaccine</span> Vaccine against COVID-19

The Sinopharm WIBP COVID-19 vaccine, also known as WIBP-CorV, is one of two inactivated virus COVID-19 vaccines developed by Sinopharm. Peer-reviewed results show that the vaccine is 72.8% effective against symptomatic cases and 100% against severe cases. The other inactivated virus COVID-19 vaccine developed by Sinopharm is the BIBP vaccine (BBIBP-CorV) which is comparably more successful. 1 billion doses are expected to be produced per year.

<span class="mw-page-title-main">Corbevax</span> Vaccine against COVID-19

Corbevax is a protein subunit COVID-19 vaccine developed by Texas Children's Hospital Center for Vaccine Development and Baylor College of Medicine in Houston, Texas and Dynavax technologies based in Emeryville, California. It is licensed to Indian biopharmaceutical firm Biological E. Limited (BioE) for development and production.

<span class="mw-page-title-main">HGC019</span> Vaccine candidate against COVID-19

HGC019 is a mRNA and Self-amplifying mRNA (saRNA) based COVID-19 vaccine candidate being developed by Gennova Biopharmaceuticals and HDT Bio Corp. with active support from NIH under The Indo-US Vaccine Action Program (VAP) and Department of Biotechnology, India.

<span class="mw-page-title-main">V-01</span> Vaccine candidate against COVID-19

V-01 is a protein subunit COVID-19 vaccine candidate developed by a subsidiary of Livzon Pharmaceutical Group Inc.

<span class="mw-page-title-main">Razi Cov Pars</span> Vaccine candidate against COVID-19

Razi Cov Pars is a COVID-19 vaccine developed by the Iranian Razi Vaccine and Serum Research Institute Razi Cov Pars is a covid-19 vaccine based on recombinant protein, which is being produced by Razi Vaccine and Serum Research Institute, Iran. This vaccine is the first injectable-intranasal recombinant protein corona vaccine.It's the second Iranian COVID-19 vaccine reaching human trials and is currently in phase III of clinical research during which it's compared to the Sinopharm BIBP vaccine.

<span class="mw-page-title-main">COVAX-19</span> Vaccine candidate against COVID-19

COVAX-19 is a recombinant protein-based COVID-19 vaccine developed by South Australian-based biotech company Vaxine, in collaboration with CinnaGen, a private company with operations in the Middle East. It is under clinical trial in collaboration with the Iranian company CinnaGen.

<span class="mw-page-title-main">COVID-19 vaccine clinical research</span> Clinical research to establish the characteristics of COVID-19 vaccines

COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy, effectiveness, and safety. As of November 2022, 40 vaccines are authorized by at least one national regulatory authority for public use:

<span class="mw-page-title-main">S-268019</span> Vaccine candidate against COVID-19

S-268019-b is a protein subunit COVID-19 vaccine candidate developed by Shionogi.

References

  1. 1 2 3 4 Dey A, Chozhavel Rajanathan TM, Chandra H, Pericherla HP, Kumar S, Choonia HS, et al. (July 2021). "Immunogenic potential of DNA vaccine candidate, ZyCoV-D against SARS-CoV-2 in animal models". Vaccine. 39 (30): 4108–4116. doi:10.1016/j.vaccine.2021.05.098. ISSN   0264-410X. PMC   8166516 . PMID   34120764.
  2. ↑ Raghavan P (2 July 2021). "Explained: How ZyCov-D vaccine works, how it is different". The Indian Express . Archived from the original on 1 July 2021. Retrieved 2 July 2021.
  3. 1 2 Rauch S, Jasny E, Schmidt KE, Petsch B (2018). "New Vaccine Technologies to Combat Outbreak Situations". Frontiers in Immunology. 9: 1963. doi: 10.3389/fimmu.2018.01963 . PMC   6156540 . PMID   30283434.
  4. ↑ Jiang J, Ramos SJ, Bangalore P, Fisher P, Germar K, Lee BK, et al. (June 2019). "Integration of needle-free jet injection with advanced electroporation delivery enhances the magnitude, kinetics, and persistence of engineered DNA vaccine induced immune responses". Vaccine. 37 (29): 3832–3839. doi: 10.1016/j.vaccine.2019.05.054 . PMID   31174938.
  5. ↑ "Zydus Cadila launches a fast tracked programme to develop vaccine for the novel coronavirus, 2019-nCoV (COVID-19)" (PDF). www.zyduscadila.com. Cadila Healthcare. Archived from the original (PDF) on 3 February 2021. Retrieved 3 March 2021.
  6. ↑ Yadav PD, Kumar S, Agarwal K, Jain M, Patil DR, Maithal K, et al. (3 February 2021). "Assessment of immunogenicity and protective efficacy of ZyCoV-D DNA vaccine candidates in Rhesus macaques against SARS-CoV-2 infection". bioRxiv. doi:10.1101/2021.02.02.429480. S2CID   231885750.
  7. ↑ "A prospective, randomized, adaptive, phase I/II clinical study to evaluate the safety and immunogenicity of Novel Corona Virus −2019-nCov vaccine candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects". ctri.nic.in. Clinical Trials Registry India. 15 December 2020. CTRI/2020/07/026352. Archived from the original on 22 November 2020.
  8. ↑ Momin T, Kansagra K, Patel H, Sharma S, Sharma B, Patel J, et al. (August 2021). "Safety and Immunogenicity of a DNA SARS-CoV-2 vaccine (ZyCoV-D): Results of an open-label, non-randomized phase I part of phase I/II clinical study by intradermal route in healthy subjects in India". eClinicalMedicine . 38. Lancet Publishing Group: 101020. doi:10.1016/j.eclinm.2021.101020. ISSN   2589-5370. PMC   8285262 . PMID   34308319.
  9. ↑ "COVID-19 vaccine progress and FDA approvals for Zydus Cadila". Generics and Biosimilar Initiative . Pro Pharma Communications International. 13 November 2021. Archived from the original on 4 December 2020. Retrieved 20 August 2021.
  10. ↑ "Zydus Cadila's ZyCov-D vaccine found to be 'safe and immunogenic'". @businessline. The Hindu. 24 December 2020. Archived from the original on 25 January 2021. Retrieved 3 March 2021.
  11. ↑ Rawat K, Kumari P, Saha L (February 2021). "COVID-19 vaccine: A recent update in pipeline vaccines, their design and development strategies". European Journal of Pharmacology. 892: 173751. doi: 10.1016/j.ejphar.2020.173751 . PMC   7685956 . PMID   33245898.
  12. ↑ Pilla V (3 November 2020). "Covid Vaccine: Zydus Cadila completes phase-2 trial, to submit data in November". Moneycontrol . Network18 Group. Archived from the original on 3 November 2020. Retrieved 20 August 2021.
  13. 1 2 Thacker T (7 November 2020). "Zydus Cadila to test ZyCoV-D on 30,000 patients in Phase-3 trials". The Economic Times.
  14. ↑ "A phase III, randomized, multi-centre, double blind, placebo controlled, study to evaluate efficacy, safety and immunogenicity of Novel Corona Virus -2019-nCov vaccine candidate of M/s Cadila Healthcare Limited". ctri.nic.in. Clinical Trials Registry India. 1 June 2021. CTRI/2021/01/030416. Archived from the original on 10 April 2021.
  15. ↑ "DBT-BIRAC supported indigenously developed DNA Vaccine Candidate by Zydus Cadila, approved for Phase III clinical trials". pib.gov.in. Press Information Bureau. 3 January 2021. Archived from the original on 5 March 2021. Retrieved 3 March 2021.
  16. ↑ "Zydus seeks emergency-use nod for plasmid DNA vaccine". @businessline. The Hindu. 1 July 2021. Archived from the original on 2 July 2021. Retrieved 4 July 2021.
  17. ↑ Kaul R (18 August 2021). "Covid vaccine for children in India by September, says ICMR-NIV director". Hindustan Times . HT Media. Archived from the original on 18 August 2021. Retrieved 20 August 2021.
  18. ↑ "Zycov-D, India's first COVID-19 vaccine for those above 12, gets nod". The Hindu. The Hindu Group. 20 August 2021. Archived from the original on 20 August 2021. Retrieved 20 August 2021.
  19. ↑ "Zydus applies to the DCGI for EUA to launch ZyCoV-D, the world's first Plasmid DNA vaccine for COVID-19" (PDF). Cadila Healthcare (Press release). 1 July 2021. Archived from the original (PDF) on 2 July 2021. Retrieved 1 July 2021.
  20. ↑ "Zydus Cadila jab shows 66.6% efficacy, seeks regulatory nod". livemint. 2 July 2021. Archived from the original on 1 July 2021. Retrieved 2 July 2021.
  21. ↑ Khobragade A, Bhate S, Ramaiah V, Deshpande S, Giri K, Phophle H, et al. (April 2022). "Efficacy, safety, and immunogenicity of the DNA SARS-CoV-2 vaccine (ZyCoV-D): the interim efficacy results of a phase 3, randomised, double-blind, placebo-controlled study in India". Lancet. 399 (10332): 1313–1321. doi:10.1016/S0140-6736(22)00151-9. PMC   8970574 . PMID   35367003.
  22. ↑ "Emergency use nod sought for ZyCoV-D". The Hindu. 1 July 2021. Archived from the original on 1 July 2021. Retrieved 3 July 2021.
  23. ↑ Sharma M (20 August 2021). "Expert panel recommends Zydus Cadila's three-dose Covid vaccine ZyCoV-D for EUA". India Today . New Delhi: Living Media. Archived from the original on 20 August 2021. Retrieved 20 August 2021.
  24. ↑ "Zydus Cadila's 3-Dose Covid Vaccine ZyCoV-D Gets DCGI's Approval For EUA". Outlook India . 20 August 2021. Archived from the original on 20 August 2021. Retrieved 20 August 2021.
  25. ↑ Staff Writer (24 April 2021). "Cadila Healthcare starts production of Covid vaccine candidate". mint. Archived from the original on 17 May 2022. Retrieved 27 April 2021.

Further reading


This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.