ZyCoV-D
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| File:ZyCoV-D vial.jpg A vial of ZyCoV-D | |
| Vaccine description | |
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| 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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.svg){kind=small} COVID-19 portal |
ZyCoV-D is a DNA plasmid based COVID-19 vaccine being developed by Cadila Healthcare with support from the Biotechnology Industry Research Assistance Council.
Efficacy
On 1 July 2021, Cadila Healthcare reported the efficacy to be 66.6% against symptomatic Covid and 100% against moderate or severe disease in its interim analysis of its phase 3 trial data.[1][2][3][4][unreliable medical source?]
Manufacturing
On 23 April 2021, production of the ZyCoV-D vaccine was started, with a yearly capacity of 240 million doses.[5]
Technology
The plasmids here are coded with the instructions to make the spike protein of SARS-CoV-2. Vaccination gives the code to cells in the recipient’s body, that begin making the spike protein of the virus. The immune system of the recipient recognize this and develop antibodies in response. The vaccine is administered intradermally using a spring-powered device commonly referred as jet injector that delivers the shot as a narrow, precise stream of fluid penetrating the skin.[6][unreliable medical source?]
Clinical trials
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.[7] 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.[8][9] Thereafter, human trials for Phase I and II were approved by the regulator.[10]
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.[11][12]
Phase III trials
In November 2020, the company announced it would test the vaccine candidate on 30,000 patients in Phase III trials.[13] The vaccine would be given out in three doses at five sites across four cities of India.[14] In January 2021, the Drugs Controller General of India (DCGI) granted permission to conduct the Phase III clinical trials for 28,216 Indian participants.[15][16]
In April 2021, the company reported that they expected to have initial data for the Phase III trials by May 2021.[17]
A parallel trial was conducted alongside phase-III, on 20 participants of age group (12–18) years in Karnataka.[18] In total, 1000 children participated for trails of (12–18) age group.[19]
Authorizations
On 1 July 2021, Cadila Healthcare applied to the Drugs Controller General of India (DCGI), seeking emergency use authorization.[20]
See also
References
- ^ "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.
- ^ Neetu Chandra Sharma (2 July 2021). "Zydus Cadila jab shows 66.6% efficacy, seeks regulatory nod". livemint.com.
- ^ Sohini Das (2 July 2021). "Zydus' Covid-19 vaccine shows 66.6% efficacy, seeks DCGI approval". Business Standard.
- ^ Zydus Cadila plans to roll out COVID vaccine 45-60 days after EUA nod; key points on needle-free, plasmid DNA shot : FirstPost
- ^ Staff Writer (24 April 2021). "Cadila Healthcare starts production of Covid vaccine candidate". mint. Retrieved 27 April 2021.
- ^ Raghavan, Prabha (2 July 2021). "Explained: How ZyCov-D vaccine works, how it is different". The Indian Express.
- ^ "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.
- ^ 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.
- ^ "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.
- ^ "Zydus seeks emergency-use nod for plasmid DNA vaccine". @businessline. The Hindu. 1 July 2021.
- ^ "Emergency use nod sought for ZyCoV-D". The Hindu. 1 July 2021.
External links
- "Explained: How ZyCov-D vaccine works, how it is different". The Indian Express.
- "What is ZyCov-D, world's first DNA vaccine for Covid?". Hindustan Times.
Further reading
- Kutzler, MA; Weiner, DB (October 2008). "DNA vaccines: ready for prime time?". Nature reviews. Genetics. 9 (10): 776–88. doi:10.1038/nrg2432. PMC 4317294. PMID 18781156.
- Liu, MA (24 April 2019). "A Comparison of Plasmid DNA and mRNA as Vaccine Technologies". Vaccines. 7 (2). doi:10.3390/vaccines7020037. PMC 6631684. PMID 31022829.
