Medicine:ZyCoV-D

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Short description: Vaccine candidate against COVID-19

ZyCoV-D
ZyCoV-D Logo.svg
Vaccine description
Target diseaseSARS-CoV-2
TypeDNA vaccination
Clinical data
Routes of
administration		Intradermal
ATC code
  • None
Legal status
Legal status
  • Full list of ZyCoV-D authorizations
Identifiers
DrugBank

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.

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

External links





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