Gennova To Get Additional Govt Funding For India's First mRNA Covid-19 Vaccine Candidate

In a boost to India's fight against Covid-19 pandemic, the Centre has approved additional funding for conducting clinical trials of country's first messenger RNA (mRNA) based Covid-19 vaccine candidate.

The mRNA based Covid-19 vaccine, HGC019, has been developed by Pune-based biotechnology company Gennova Biopharmaceuticals Limited.

The company is expected to get up to Rs 100 crore under Mission COVID Suraksha, after it successfully completes the first phase of vaccine's clinical trials.

The Department of Biotechnology (DBT) under the Ministry of Science and Technology announced that it has approved additional funding towards clinical studies of India's'first of its kind' mRNA-based COVID-19 vaccine - HGC019, an official release said on Monday (12 April).

This funding has been awarded under the 'Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission' by DBT's dedicated Mission Implementation Unit at Biotechnology Industry Research Assistance Council (BIRAC) after multiple rounds of evaluation of all the applications that were submitted in response to the 'Request for Expression of Interest (REOI)' under Mission COVID Suraksha for the 'Development of COVID-19 vaccine candidate(s)', the release said.

According to the release, DBT has been hand-holding Gennova right from the start and has facilitated establishing Gennova's mRNA-based next-generation vaccine manufacturing platform by providing seed funding for the development of HGC019.

The mRNA Covid-19 vaccine has been developed by Gennova in collaboration with USA's HDT Biotech Corporation.

HGC019 has already demonstrated safety, immunogenicity, neutralization antibody activityin the rodent and non-human primate models. The neutralizing antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of COVID-19.

Gennova has completed two preclinical toxicity studies as per the Drugs and Cosmetics (Ninth Amendment) Rules - 2019, to establish the safety of the vaccine candidate and got regulatory clearance from the Review Committee on Genetic Manipulation (RCGM) and office of the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO), Government of India, to conduct clinical trials.

The company has also initiated the process to enroll healthy volunteers from the Phase I/II clinical trials.