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trials carried out earlier. Both the phases I/II and III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).
Vaccine Technology Centre (VTC), a vaccine research centre of the Zydus group, Translational Health Science and Technology Institute (THSTI), an autonomous institute of DBT, Interactive Research School for Health Affairs (IRSHA), Pune, and GCLP lab set-up under DBT-National Biopharma Mission (NBM) also played a vital role in this success story.
Website link:
https://pib.gov.in/PressReleseDetail.aspx?PRID=1747669
DBT-BIRAC supported nation’s first mRNA-based vaccine found to
be safe gets a nod from DCGI to move into phase II/III trial
Gennova Biopharmaceuticals Ltd., the Pune-based biotechnology company, working on the nation’s first mRNA-based COVID-19 vaccine, submitted an interim clinical data of the phase I study to the Central Drugs Standard Control Organisation (CDSCO), the Government of India’s National Regulatory Authority (NRA).
The Vaccine Subject Expert Committee (SEC) reviewed the interim phase I data and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study.
Gennova submitted the proposed phase II and phase III study titled ‘A Prospective, Multicentre, Randomized, Active-controlled, Observer-blind, Phase II Study Seamlessly Followed by a Phase III Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Candidate HGCO19 (COVID-19 Vaccine) in Healthy Subjects’, which was approved by the office of the DCGI, CDSCO.
The study will be conducted in India at approximately 10-15 sites in phase II and 22-27 sites in phase III. Gennova plans to use the DBT-ICMR clinical trial network sites for this study.
Gennova’s mRNA-based COVID-19 vaccine development programme was partly funded by DBT under Ind CEPI in June 2020. Later on, the DBT further supported the programme under the Mission COVID Suraksha, the Indian COVID-19 vaccine development mission, implemented by BIRAC.
Website link:
https://dbtindia.gov.in/pressrelease/dbt-birac-supported-nation%E2%80%99s-first- mrna-based-vaccine-found-be-safe-gets-nod-drugs
National Institute of Animal Biotechnology, Hyderabad notified as Central Drugs Laboratory for testing and batch release of vaccines
In public interest, it is necessary to establish more facilities to regulate the testing of COVID-19 vaccines for quick release of vaccine batches for prevention and treatment of COVID-19 infection. For this, the Government of India has identified two autonomous institutes of DBT, viz., National Institute of Animal Biotechnology (NIAB), Hyderabad and National Centre for Cell Science (NCCS), Pune, for upgradation as Central Drug Laboratories (CDLs). The funding support for the same was provided under the PM-CARES funds.
VOL. IV ISSUE 10
VIGYAN PRASAR 7
COVID-19 SCIENCE & TECHNOLOGY EFFORTS IN INDIA