India’s first mRNA vaccine against coronavirus – Developed by Pune-based Genova Biopharmaceuticals Ltd (part of Emcure group of companies) – has been found safe and has been given permission from Drugs Controller General of India (DCGI) in Phase II and III. of clinical trials.
The firm had submitted interim clinical data of its Phase I trial to the Central Drugs Standard Control Organization (CDSCO), the national regulatory authority of the Government of India.
“We had enrolled 82 participants at three trial sites (two in Pune and one in Kolhapur) in the Phase 1 trial (vaccine, HGCO190), which has been completed. The safety data was quite good and has been approved for Phase II and III trials which are now expected to start in the next two weeks,” said Dr Sanjay Singh, CEO, Genoa Biopharmaceuticals Ltd. Indian Express.
The Vaccine Subject Expert Committee reviewed interim phase I data and found that HGCO19 was safe, tolerable and immunogenic in study participants.
Genoa submits proposed Phase II and Phase III studies titled ‘A prospective, multi-centre, randomized, active-controlled, observer-blind, phase II study to evaluate the safety, tolerability and immunogenicity of candidate HGCO19 in healthy subjects, originally followed by the Phase III study.‘, which was approved by the office of DCG (I), CDSCO.
The study will be conducted at approximately 10-15 sites in Phase II and 22-27 sites in Phase III. Genova plans to use the Department of Biotechnology-Indian Council of Medical Research clinical trials network sites for this study. “We expect to enroll 4,400 participants,” Dr Singh said.
“Our goal is to roll out the vaccine as soon as possible by the end of the year and initially it will be for adults, before we work on one for children,” Dr Singh said. He said Genoa is investing in scaling up its manufacturing capacity to meet the country’s vaccine requirement.
Genova’s mRNA-based COVID-19 vaccine development program was partly funded by DBT under the Ind CEPI mission, back in June 2020. DBT supported the program under Mission COVID Suraksha – Indian COVID-19 Vaccine Development Mission, which was implemented by Biotechnology Industry Research Assistance Council (BIRAC).
Dr. Renu Swarup, Secretary, DBT and Chairperson, BIRAC, said in a statement, “It is a matter of great pride that the country’s first mRNA-based vaccine was found to be safe and the Drugs Controller General of India has approved Phase II and III. The trial. We are confident that this will be an important vaccine for both India and the world. It is an important milestone in our indigenous vaccine development mission and puts India on the global map for new vaccine development.
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