New Delhi, Aug 24: The fight against the ongoing epidemic of COVID-19 is all set to get stronger. The office of the Drug Controller General of India has approved a proposal of the Pune-based Gennova Biopharmaceuticals Ltd., to go in for phase II / III trial of the country’s first mRNA-based vaccine for COVID-19 called HGCO19.
The company had submitted the 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 data and found that the vaccine was safe, tolerable, and immunogenic in the participants of the study.
Consequently, the proposal for Phase II and Phase III study for “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” was submitted that has now been approved.
The study will be conducted within India in 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.
The vaccine development program was partly funded by the Department of Biotechnology (DBT), Govt. of India under Ind CEPI, in June 2020. Later on, the DBT further supported the program under the Mission COVID Suraksha – The Indian COVID-19 Vaccine Development Mission, implemented by BIRAC.
“It is a matter of great pride that Nation’s first mRNA-based vaccine is found to be safe and the Drugs Controller General of India DCG(I) has approved Phase II/III trial. We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the Global Map for Novel Vaccine Development,” said Dr. Renu Swarup, Secretary, DBT, and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC)
Dr Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd., said that “After establishing the safety of our mRNA-based COVID-19 vaccine candidate HGCO19 in Phase I clinical trial, Gennova’s focus is to start Phase II/III pivotal clinical trial. In parallel, Gennova is investing in scaling up its manufacturing capacity to cater to the nation’s vaccine requirement”.
(India Science Wire)
Topics: Drug Controller General of India, DCG (I), Pune, Gennova Biopharmaceuticals Ltd., mRNA, vaccine, Central Drugs Standard Control Organisation, CDSCO, safety, tolerability, immunogenicity, Department of Biotechnology, DBT, Ind CEPI, COVID Suraksha, India’s first mRNA-based vaccine for COVID-19,
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