ZyCoV-D
| Vaccine description | |
|---|---|
| Target | SARS-CoV-2 |
| Vaccine type | DNA |
| Clinical data | |
| Routes of administration | Intradermal |
| ATC code |
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| Identifiers | |
| DrugBank | |
| Part of a series on the |
| COVID-19 pandemic |
|---|
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|
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ZyCoV-D is a DNA plasmid based COVID-19 vaccine being developed by Cadila Healthcare with support from the Biotechnology Industry Research Assistance Council.
Clinical research
Phase I and II trials
In February 2020, Cadila Healthcare decided to develop a DNA plasmid based COVID-19 vaccine at their Vaccine Technology Centre (VTC) in Ahmedabad.[1] 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.[2] Thereafter, human trials for Phase I and II were approved by the regulator.[3]
The Phase II trials of the vaccine candidate were conducted in over 1,000 volunteers as part of the adaptive Phase I/II multi-centric, dose escalation, randomised, double-blind placebo controlled method.[4][5]
Phase III trials
In November 2020, the company announced it would test the vaccine candidate on 30,000 patients in Phase III trials.[6] The vaccine would be given out in three doses at five sites across four cities of India.[7] In January 2021, the Drugs Controller General of India (DCGI) granted permission to conduct the Phase III clinical trials for 28,216 Indian participants.[8][9]
In April 2021, the company reported that they expected to have initial data for the Phase III trials by May 2021.[10]
Trials on minors
A parallel trial was conducted alongside phase-III, on 20 participants of age group (12–18) years in Karnataka.[11]
Status
On 23 June 2021, it was reported that the Cadila Healthcare may apply for approval of its ZyCov-D vaccine for emergency use in India by month end.[12] On 26 June 2021, the Central Government of India informed the Supreme Court that the ZyCov-D vaccine is likely to get nod for administration to children (12-18 years) very soon.[13]
Production
On 23 April 2021, production of the ZyCoV-D vaccine was started, with a yearly capacity of 240 million doses. It is expected to get emergency use authorization in June or July.[14]
References
- ^ "Zydus Cadila launches a fast tracked programme to develop vaccine for the novel coronavirus, 2019-nCoV (COVID-19)" (PDF). www.zyduscadila.com. Cadila Healthcare.
- ^ Dey A, Rajanathan C, Chandra H, Pericherla HP, Kumar S, Choonia HS, et al. (26 January 2021). "Immunogenic Potential of DNA Vaccine candidate, ZyCoV-D against SARS-CoV-2 in Animal Models". bioRxiv: 2021.01.26.428240. doi:10.1101/2021.01.26.428240. S2CID 231777527.
- ^ "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.
- ^ "Zydus Cadila's ZyCov-D vaccine found to be 'safe and immunogenic'". @businessline. The Hindu. 24 December 2020.
- ^ 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.
- ^ Thacker T (7 November 2020). "Zydus Cadila to test ZyCoV-D on 30,000 patients in Phase-3 trials". The Economic Times.
- ^ "Covid 19 vaccine in India: Zydus Cadila begins enrolment for Phase 3 trial of ZyCoV-D in 4 cities". The Financial Express. 22 January 2021.
- ^ "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.
- ^ "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.
- ^ Das, Sohini (22 April 2021). "Cadila Healthcare testing two-shot regimen for ZyCoV-D, data likely by May". Business Standard India.
- ^ Bijapur, Naushad (20 May 2021). "20 children successfully undergo trials of indigenous ZyCoV-D vaccine at Karnataka hospital". The New Indian Express.
- ^ https://www.hindustantimes.com/india-news/zydus-cadila-to-seek-emergency-approval-for-its-covid-vaccine-all-you-need-to-know-101624427514740.html
- ^ https://www.indiatoday.in/coronavirus-outbreak/story/zydus-cadila-vaccine-12-18-age-group-soon-centre-to-supreme-court-1819837-2021-06-27
- ^ Writer, Staff (24 April 2021). "Cadila Healthcare starts production of Covid vaccine candidate". mint. Retrieved 27 April 2021.
External links
