Gennova Biopharma submits final vaccine trial data to regulator

Gennova Biopharmaceuticals has presented data from human trials of its mRNA Covid-19 vaccine to India's drug regulatory authority for evaluation, people in the know said.

Pune-based Gennova is developing the country's first indigenously developed mRNA vaccine for Covid-19. The subject expert committee under the drug regulator will take up its application in its next meeting. "The date of the meeting is yet to be decided," one of the people said.

If all goes well, the vaccine can be rolled out next month. The company has conducted phase-2/3 trials of the vaccine candidate to evaluate its safety, immunogenicity and tolerability on 4,000 participants.