Drug panel may review Gennova’s mRNA Omicron booster vaccine

Drug panel may review Gennova’s mRNA Omicron booster vaccine

New Delhi: The subject experts committee (SEC) under the drug regulatory authority is likely to review India’s first mRNA-based Omicron specific Covid-19 booster shot for authorisation this week, people in the know told ET.

Pune-based Gennova Biopharmaceuticals had submitted data to the drug regulator this month, amid an increase in the number of Covid-19 cases. Gennova, a subsidiary of Pune-based drugmaker Emcure, has developed an Omicron-specific vaccine GEMCOVAC-OM which has been assessed for its safety and immunogenicity when administered as a booster in participants who have received two doses of either Covishield or Covaxin, the two main Covid-19 vaccines used in the immunisation drive. The company has conducted phase II/III trials and results have been submitted to the drugs controller general of India (DCGI). The trial was conducted on 3,200 participants.

“The SEC is likely to take up its application this week,” a person told ET. Once approved this will be the first Omicron specific booster shot to be approved in India. “The trial results show that GEMCOVAC®-OM was found to be safe and well tolerated and no vaccine related adverse events were observed. Moreover, the vaccine demonstrated superior immune response,” the same people said.

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

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(With inputs from health)