Drug panel may review Gennova’s mRNA Omicron booster vaccine

New Delhi: The topic consultants committee (SEC) beneath the drug regulatory authority is prone to assessment India’s first mRNA-based Omicron particular Covid-19 booster shot for authorisation this week, individuals within the know advised ET.

Pune-based Gennova Biopharmaceuticals had submitted knowledge to the drug regulator this month, amid a rise within the variety of Covid-19 circumstances. Gennova, a subsidiary of Pune-based drugmaker Emcure, has developed an Omicron-specific vaccine GEMCOVAC-OM which has been assessed for its security and immunogenicity when administered as a booster in contributors who’ve acquired two doses of both Covishield or Covaxin, the 2 predominant Covid-19 vaccines used within the immunisation drive. The corporate has performed part II/III trials and outcomes have been submitted to the medicine controller normal of India (DCGI). The trial was performed on 3,200 contributors.

“The SEC is prone to take up its software this week,” an individual advised ET. As soon as authorized this would be the first Omicron particular booster shot to be authorized in India. “The trial outcomes present that GEMCOVAC®-OM was discovered to be protected and effectively tolerated and no vaccine associated antagonistic occasions had been noticed. Furthermore, the vaccine demonstrated superior immune response,” the identical individuals stated.

Gennova’s vaccine shall be a needle-free shot.