Covid-19: DCGI gives nod to phase 2/3 trials of India’s first mRNA vaccine

The Director Controller General of India (DCGI) has found the nation’s first mRNA-based Covid-19 vaccine, developed by Gennova Biopharmaceuticals, to be safe and approved it for phase 2/3 trials.

The Pune-based biotechnology submitted interim clinical data from the Phase I study to the National Regulatory Authority and the Central Drugs Standard Control Organisation (CDSCO).

Gennova Biopharmaceuticals CEO Dr. Sanjay Singh told The Indian Express that the company had enrolled 82 volunteers in three trial sites for the Phase I trial. He added that the safety data was good enough and the company had received approval for phase 2/3 trials, which are likely to begin in two weeks.

The interim Phase I trial data was reviewed by the vaccine Subject Expert Committee, which found the HGCO19 (Covid-19 vaccine) to be safe, immunogenic, and tolerable in the participants.

The Phase II trial will be conducted at 10-15 sites, while the Phase III study will take place across 22-27 sites. Gennova Biopharmaceuticals plans to use the clinical trial network sites of the Indian Council of Medical Research (ICMR)’s Department of Biotechnology (DBT) for the study. Dr. Singh said the company hoped to enrol 4,400 volunteers.

The vaccine development was funded by the DBT and the Centre’s Ind CEPI in June 2020. The programme received further support from the DBT as part of its Mission Covid Suraksha — The Indian Covid-19 Vaccine Development Mission, which is being implemented by BIRAC.

Dr. Singh said the company aimed to roll out the vaccine by the year-end. Initially, the vaccine would be limited to adults. The company is also scaling up manufacturing capacity to meet India’s vaccine needs.

DBT Secretary and BIRAC Chairperson Dr. Renu Swarup said it was a matter of pride that India’s first mRNA-based vaccine was safe and approved by the DCGI for phase 2/3 trial.

She expressed confidence that it would become an important vaccine, not just for India but the world. She said it was a significant milestone in the country’s indigenous vaccine development mission and put it on the map for novel vaccine development.