Vaccine candidate against COVID-19
Pharmaceutical compound
ZyCoV-D is aDNA plasmid -basedCOVID-19 vaccine developed byIndian pharmaceutical companyCadila Healthcare , with support from theBiotechnology Industry Research Assistance Council . It isapproved for emergency use in India.
Technology The vaccine contains a DNAplasmid vector that carries the gene encoding thespike protein ofSARS-CoV-2 . As with otherDNA vaccines , the recipient's cells then produce the spike protein, eliciting a protective immune response. The plasmid also containsunmethylated CpG motifs to enhance its immunostimulatory properties.[ 2]
The plasmid is produced usingE. coli [ 2]
The vaccine is given as anintradermal injection using a spring-poweredjet injector .[ 2] [ 3] transfection of DNA vaccines requires traveling across both thecell plasma membrane and thenuclear membrane ,[ 4] [ 4] [ 5]
Clinical trials
Pre-clinical trials In February 2020,Cadila Healthcare decided to develop aDNA plasmid basedCOVID-19 vaccine at their Vaccine Technology Centre (VTC) in Ahmedabad.[ 6] bioRxiv Vaccine [ 2] [ 7] [ 8]
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".[ 9]
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.[ 10] [ 11] [ 12] [ 13] [ 14]
Phase III trials In November 2020, the company announced it would test the vaccine candidate on about 30,000 patients inPhase III trials.[ 14] 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.[ 15] [ 16] [ 17] [ 18] [ 19]
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.[ 20] [ 21] [ 22]
Authorizations Full authorization
Emergency authorization
On 1 July 2021,Cadila Healthcare applied to theDrugs Controller General of India (DCGI), seeking approval forRestricted Use in Emergency Situation for the vaccine.[ 23] Central Drugs Standard Control Organisation (CDSCO) recommended that the DCGI grant the approval,[ 24] [ 25]
Deployment On 23 April 2021, production of the ZyCoV-D vaccine was started, with a yearly capacity of 240 million doses.[ 26]
See also
References ^ "Patent Landscape Report COVID-19-related vaccines and therapeutics" (PDF) .^a b c d 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 . ^ 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. Retrieved2 July 2021 . ^a b 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 . ^ 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 . ^ "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 fromthe original (PDF) on 3 February 2021. Retrieved3 March 2021 .^ 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.^ 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 101020.Lancet Publishing Group .doi :10.1016/j.eclinm.2021.101020 .ISSN 2589-5370 .PMC 8285262 PMID 34308319 . ^ "COVID-19 vaccine progress and FDA approvals for Zydus Cadila" .Generics and Biosimilar Initiative Archived from the original on 4 December 2020. Retrieved20 August 2021 .^ "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. Retrieved3 March 2021 .^ 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 . ^ 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. Retrieved20 August 2021 . ^a b Thacker T (7 November 2020)."Zydus Cadila to test ZyCoV-D on 30,000 patients in Phase-3 trials" .The Economic Times . ^ "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.Archived from the original on 5 March 2021. Retrieved3 March 2021 .^ "Zydus seeks emergency-use nod for plasmid DNA vaccine" .@businessline .The Hindu . 1 July 2021.Archived from the original on 2 July 2021. Retrieved4 July 2021 .^ 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. Retrieved20 August 2021 . ^ "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. Retrieved20 August 2021 .^ "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 fromthe original (PDF) on 2 July 2021. Retrieved1 July 2021 .^ "Zydus Cadila jab shows 66.6% efficacy, seeks regulatory nod" .livemint . 2 July 2021.Archived from the original on 1 July 2021. Retrieved2 July 2021 .^ 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 . ^ "Emergency use nod sought for ZyCoV-D" .The Hindu . 1 July 2021.Archived from the original on 1 July 2021. Retrieved3 July 2021 .^ Sharma M (20 August 2021)."Expert panel recommends Zydus Cadila's three-dose Covid vaccine ZyCoV-D for EUA" .India Today Living Media .Archived from the original on 20 August 2021. Retrieved20 August 2021 . ^ "Zydus Cadila's 3-Dose Covid Vaccine ZyCoV-D Gets DCGI's Approval For EUA" .Outlook India the original on 20 August 2021. Retrieved20 August 2021 .^ Staff Writer (24 April 2021)."Cadila Healthcare starts production of Covid vaccine candidate" .mint .Archived from the original on 17 May 2022. Retrieved27 April 2021 .
Further reading
External links
Institutions
Hospitals and
Organizations
Health Pandemic Relief funds
Data (templates)
Global Africa Americas Asia Europe Oceania Others
Development Classes Administration Vaccines
Inventors/ Controversy Related
Topics
Incidents Locations
Legal framework Agencies and
Officials
Union government State governments Agency executives Sujeet Kumar Singh(Director,NCDC ) Balram Bhargava (Director General,ICMR ) Shanta Dutta (Director,NICED ) Manoj V. Murhekar(Director,NIE ) Priya Abraham(Director,NIV ) V. G. Somani(Drug Controller General ) Shekhar C. Mande (Director,CSIR ) Tapas Kumar Kundu (Director,CDRI ) Rakesh Mishra (Director,CCMB ) Samit Chattopadhyay(Director,IICB ) S. Chandrasekhar(Director,IICT ) Ram A. Vishwakarma(Director,IIIM ) Sanjeev Khosla(Director,IIMT ) Anurag Agrawal (Director,IGIB ) Ashwini Kumar Nangia(Director,NCL ) D. K. Aswal(Chairman,NABL ) G. V. K. Reddy (Chairman,GVK EMRI ) R. K. Jain(Secretary General,IRCS )
.svg)
COVID-19 portal
