ZyCoV-D

Short description: Vaccine candidate against COVID-19

ZyCoV-D

Vaccine description
Target disease| SARS-CoV-2
Type| DNA vaccination
Clinical data
Routes of
administration| Intradermal
ATC code|

* None

Legal status
Legal status|

* Full list of ZyCoV-D authorizations

Identifiers
DrugBank|

* DB15892

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

## Contents

* 1 Technology
* 2 Clinical trials
* 2.1 Pre-clinical trials
* 2.2 Phase I and II trials
* 2.3 Phase III trials
* 2.4 Authorizations
* 3 Deployment
* 4 See also
* 5 References
* 6 Further reading
* 7 External links

## 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

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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

* COVID-19 vaccination in India

## References

1. ↑ 1.0 1.1 1.2 1.3 "Immunogenic potential of DNA vaccine candidate, ZyCoV-D against SARS-CoV-2 in animal models". Vaccine 39 (30): 4108–4116. July 2021. doi:10.1016/j.vaccine.2021.05.098. ISSN 0264-410X. PMID 34120764.
2. ↑ "Explained: How ZyCov-D vaccine works, how it is different" (in en). The Indian Express. 2 July 2021. https://indianexpress.com/article/explained/explained-how-zycov-d-works-how-it-is-different-7385000/.
3. ↑ 3.0 3.1 "New Vaccine Technologies to Combat Outbreak Situations" (in English). Frontiers in Immunology 9: 1963. 2018. doi:10.3389/fimmu.2018.01963. PMID 30283434.
4. ↑ "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. June 2019. 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)". Cadila Healthcare. https://zyduscadila.com/public/pdf/pressrelease/Zydus_Cadila_launches_a_fast_tracked_programme_to_develop_vaccine_for_the_novel_coronavirus_2019-nCoVCOVID-19).pdf.
6. ↑ "Assessment of immunogenicity and protective efficacy of ZyCoV-D DNA vaccine candidates in Rhesus macaques against SARS-CoV-2 infection". bioRxiv. 3 February 2021. doi:10.1101/2021.02.02.429480.
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". Clinical Trials Registry India. 15 December 2020. http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45306.
8. ↑ "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 (Lancet Publishing Group) 38: 101020. August 2021. doi:10.1016/j.eclinm.2021.101020. ISSN 2589-5370. PMID 34308319. PMC 8285262. https://doi.org/10.1016/j.eclinm.2021.101020.
9. ↑ "COVID-19 vaccine progress and FDA approvals for Zydus Cadila". Generics and Biosimilar Initiative. Pro Pharma Communications International. 2021-11-13. https://www.gabionline.net/generics/news/COVID-19-vaccine-progress-and-FDA-approvals-for-Zydus-Cadila.
10. ↑ "Zydus Cadila's ZyCov-D vaccine found to be 'safe and immunogenic'" (in en). @businessline. The Hindu. 24 December 2020. https://www.thehindubusinessline.com/news/zydus-cadilas-zycov-d-vaccine-found-to-be-safe-and-immunogenic/article33412776.ece.
11. ↑ "COVID-19 vaccine: A recent update in pipeline vaccines, their design and development strategies". European Journal of Pharmacology 892: 173751. February 2021. doi:10.1016/j.ejphar.2020.173751. PMID 33245898.
12. ↑ "Covid Vaccine: Zydus Cadila completes phase-2 trial, to submit data in November". Moneycontrol (Network18 Group). 2020-11-03. https://www.moneycontrol.com/news/business/companies/covid-vaccine-zydus-cadila-completes-phase-2-trial-to-submit-data-in-november-6058811.html.
13. ↑ 13.0 13.1 "Zydus Cadila to test ZyCoV-D on 30,000 patients in Phase-3 trials". The Economic Times. 7 November 2020. https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/zydus-cadila-to-test-zycov-d-on-30000-patients-in-phase-3-trials/articleshow/79088859.cms.
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.". Clinical Trials Registry India. 1 June 2021. http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=51254&EncHid=&userName=ZyCoV-D.
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. https://pib.gov.in/Pressreleaseshare.aspx?PRID=1685838.
16. ↑ "Zydus seeks emergency-use nod for plasmid DNA vaccine" (in en). @businessline (The Hindu). 1 July 2021. https://www.thehindubusinessline.com/companies/zydus-seeks-emergency-use-nod-for-plasmid-dna-vaccine/article35084124.ece.
17. ↑ "Covid vaccine for children in India by September, says ICMR-NIV director". Hindustan Times (HT Media). 2021-08-18. https://www.hindustantimes.com/india-news/covid-vaccine-for-children-in-india-by-september-says-icmr-niv-director-101629284019229.html.
18. ↑ "Zycov-D, India's first COVID-19 vaccine for those above 12, gets nod". The Hindu (The Hindu Group). 2021-08-20. https://www.thehindu.com/news/national/zycov-d-indias-first-covid-19-vaccine-for-those-above-12-gets-nod/article36021251.ece.
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. Retrieved 1 July 2021.
20. ↑ "Zydus Cadila jab shows 66.6% efficacy, seeks regulatory nod". 2 July 2021. https://www.livemint.com/companies/news/zydus-cadila-applies-for-eua-for-covid-19-vaccine-zycovd-11625152872531.html.
21. ↑ "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. April 2022. doi:10.1016/S0140-6736(22)00151-9. PMID 35367003.
22. ↑ "Emergency use nod sought for ZyCoV-D" (in en-IN). The Hindu. 1 July 2021. https://www.thehindu.com/news/national/emergency-use-nod-sought-for-zycov-d/article35086029.ece.
23. ↑ "Expert panel recommends Zydus Cadila's three-dose Covid vaccine ZyCoV-D for EUA". India Today (New Delhi: Living Media). 2021-08-20. https://www.indiatoday.in/coronavirus-outbreak/story/expert-panel-recommends-zydus-cadila-three-dose-covid-vaccine-zycov-d-for-eua-1843331-2021-08-20.
24. ↑ "Zydus Cadila's 3-Dose Covid Vaccine ZyCoV-D Gets DCGI's Approval For EUA". Outlook India. 2021-08-20. https://www.outlookindia.com/website/story/india-news-govt-panel-recommends-emergency-use-authorisation-to-zydus-cadilas-3-dose-covid-vaccine/392099.
25. ↑ Staff Writer (2021-04-24). "Cadila Healthcare starts production of Covid vaccine candidate" (in en). https://www.livemint.com/companies/news/cadila-healthcare-starts-production-of-covid-vaccine-candidate-11619244017749.html.

## Further reading

* "DNA vaccines: ready for prime time?". Nature Reviews. Genetics 9 (10): 776–88. October 2008. doi:10.1038/nrg2432. PMID 18781156.
* "A Comparison of Plasmid DNA and mRNA as Vaccine Technologies". Vaccines 7 (2): 37. April 2019. doi:10.3390/vaccines7020037. PMID 31022829.
* "DNA vaccines against COVID-19: Perspectives and challenges". Life Sciences 267: 118919. February 2021. doi:10.1016/j.lfs.2020.118919. PMID 33352173.

## External links

* "Explained: How ZyCov-D vaccine works, how it is different" (in en). The Indian Express. 8 July 2021. https://indianexpress.com/article/explained/explained-how-zycov-d-works-how-it-is-different-7385000/.
* "What is ZyCov-D, world's first DNA vaccine for Covid?" (in en). Hindustan Times. 2 July 2021. https://www.hindustantimes.com/india-news/what-is-zycov-d-world-s-first-dna-vaccine-for-covid-101625162617692.html.

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