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The Hindu
The Hindu
National
Jacob Koshy

Regulator approves first Omicron-specific mRNA vaccine from India

India’s first indigenous mRNA vaccine for the Omicron variant, GEMCOVAC-OM, developed by Pune-based Gennova Biopharmaceuticals Ltd, was approved under emergency use guidelines by the Drug Controller General of India late Monday. This comes a year after the company got approval for GEMCOVAC-19, the country’s first m-RNA vaccine against COVID-19.

Both the vaccines are yet to be commercially available, though Gennova officials said at a press conference on Tuesday that the vaccines were likely to be formally “launched and rolled out” within the next “two to three weeks”. With a surfeit of COVID vaccines, about 95 crore second doses already administered and slackening demand for ‘precautionary’ or ‘booster’ doses, the market prospects for GEMCOVAC-OM are unclear. The company has released little information on the expected demand, cost of the vaccines, prospects for export and its availability in hospitals and health centres.

Gennova CEO Sanjay Singh said that by the time his company got regulatory approvals for GEMCOVAC-19, the demand for primary doses was largely met by other vaccines, however there was still a “huge demand for vaccines specific to the Omicron variant”. Following the approval last year of its vaccine effective against the Wuhan strain, the company manufactured 70 million doses, 12 million of which were approved by the Central Research Institute, Kasauli – a prerequisite for every batch of vaccine or drug to be sold.

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