India's First mRNA-Based Covid Vaccine Gets DCGI Approval For Phase 2-3 Trials

The Pune-based biotechnology company had submitted the interim clinical data of the Phase-I study to the Central Drugs Standard Control Organisation (CDSCO).

New Delhi: India's first mRNA-based Covid-19 vaccine on Tuesday got the Drugs Controller General of India (DCGI) nod to move into Phase 2 and 3 trials. According to reports, the Centre informed that the vaccine developed by Gennova Biopharmaceuticals Ltd. was found to be safe, and was given go-ahead for Phase II/III trials. 

The Pune-based biotechnology company had submitted the interim clinical data of the Phase-I study to the Central Drugs Standard Control Organisation (CDSCO), the government's National Regulatory Authority (NRA).

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, the Ministry of Science & Technology said in a statement.

Gennova submitted the proposed Phase II and Phase III study entitled "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 and CDSCO.

As per the information shared by the Centre, Phase 2 study will be conducted in India at approximately 10-15 sites whereas Phase 3 study will be done in 22-27 sites. 

Gennova plans to use the DBT-ICMR clinical trial network sites for this study.

"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," Dr. Sanjay Singh, CEO of Gennova Biopharmaceuticals said.

"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," Dr. Renu Swarup, Secretary, DBT and Chairperson, BIRAC said.

Gennova's mRNA-based Coronavirus vaccine development program was partly funded by the Department of Biotechnology (DBT), Government of India under Ind CEPI in Jun 2020. Later on, the DBT further supported the program under the Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission, implemented by BIRAC.