New Delhi: Pune-based Gennova Biopharmaceuticals is developing India’s first homegrown mRNA vaccine that will start trials on humans in February.
Gennova submitted the phase 2 trial data to the Drugs Controller General of India (DCGI), and its Subject Expert Committee (SEC) is expected to review the data this week, official sources told news agency ANI.
According to news agency Reuters, the vaccine was found to be “safe, tolerable, and immunogenic” in the participants of an initial study.
Meanwhile, Gennova also developed an Omicron-specific vaccine that was developed using the same mRNA technology. On condition of anonymity, sources told Reuters that the vaccine might need a small trial in India before being rolled out as a booster dose or standalone vaccine.
In September 2021, Gennova Biopharmaceuticals had submitted a statement about its vaccine trials saying, “The Drug Controller General of India, had approved Phase II and Phase III study protocols for HGCO19, India's first mRNA-based COVID-19 vaccine, developed by Gennova Biopharmaceuticals Limited back in August.”
It had also specified the scale and standards of the trials, “The study is being conducted in India at approximately 10-15 sites in Phase II and 22-27 sites in Phase III. Gennova is using the DBT-ICMR clinical trial network sites for this study.”
If approved, it will be India’s first mRNA vaccine like the ones developed by Pfizer and Moderna.