Gennova's mRNA-based vaccine to be delayed

Gennova Biopharmaceuticals will take some more time to launch its mRNA-based Covid-19 vaccine, as the drug regulatory authority has sought additional information from the Pune-based company, sources said.

Gennova had last month submitted interim data on India's first indigenously developed mRNA Covid vaccine to the drug regulator. The Central Drug Standard Control Organisation (CDSCO) has sent some queries to the company on the data, the people said. The Subject Expert Committee (SEC) will take up the application for grant of emergency use authorisation only after the CDSCO reviews the data and is satisfied, they said. "The regulator will review the data and then it will go to the SEC," said a government official.

The company has conducted Phase-2/3 trials to evaluate its safety, immunogenicity and tolerability on 4,000 participants.

Gennova had said earlier that its vaccine would not require sub-zero temperature for storage, a feature that would make its rollout in India easy. The mRNA jabs of Pfizer and Moderna need sub-zero temperature.

While over 95% of India's eligible population has received the primary dose of the Covid-19 vaccines, Niti Aayog member VK Paul had said the mRNA platform continued to be "important in the medium term, near future and beyond".