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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Can be stored in ordinary refrigerators
The company said it was equipped to make an updated vaccine within 60-100 days, should a new variant different from the Omicron types were to emerge. The unique selling point of GEMCOVAC-OM was that it was stable in a 2-8 degree Celsius range and could therefore be stored in “ordinary” refrigerators. The vaccines could be administered into the skin via a “needle-free” PharmaJet system. The company said it had also perfected the technology to ensure that multiple components of the vaccine could be separately produced and integrated in different parts of the world aiding rapid deployment if the need arose. “The persistent threat from long-COVID and global guidelines (from the WHO) recommend having a vaccine effective against the Omicron variant. We have also tested our vaccine at the National Institute of Virology (NIV) against the newest ( Omicron subvariant), XBB 1.16, and it is shown to be effective,” he added.
Data from clinical trials, which aren’t public yet but submitted to the DCGI for review, suggested that GENCOVAC-OM had a “greater” safety profile than Covishield and generated more neutralising antibodies, said Mr. Singh. “Much like flu vaccines need to be updated annually, we need to have an arsenal for the future and the DBT and the government have been so supportive because they know that this is the fastest way [to make future vaccines],” he told The Hindu. Neutralising antibodies are the specific class of antibodies that prevent the coronavirus from proliferating within the body.
The DBT part-funded Gennova’s technology development from proof of concept till Phase I clinical trial of the prototype mRNA-based vaccine developed against the Wuhan strain. “The project was further supported under the ’Mission COVID Suraksha…for further clinical development and scale up of the prototype vaccine, which received EUA on 29th June 2022. The platform technology developed was used to develop an Omicron-specific booster vaccine for COVID-19,” the DBT said in a statement.
DBT Secretary Rajesh S. Gokhale said “strategic infusion” of funds is essential to drive and create an ecosystem for technological innovation, and Gennova’s technology platform was “disease-agnostic” and could be used to make other vaccines relatively quickly.
