DGCI Approves Indian mRNA Booster Vaccine for Omicron Variant of COVID-19
The Wire Staff
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New Delhi: The Drug Controller General of India on Monday approved India’s first indigenous mRNA booster vaccine for the omicron variant of COVID-19, GEMCOVAC-OM, for emergency use. The vaccine was developed by Pune-based Gennova Biopharmaceuticals Ltd, The Hindu reported.
“A booster dose against SARS-CoV2 is still required in the country. Original vaccines have shown limited efficacy against the Omicron lineage. An updated vaccine is required and yes, we anticipate enough demand in the market for the precautionary dose,” Dr Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd, said.
According to The Indian Express, the vaccine is likely to be launched in New Delhi in two-three weeks. It has not been announced yet how much it will cost.
A year ago, the same company had got emergency use approval for GEMCOVAC-19, the country’s first m-RNA vaccine against COVID-19. However, this vaccine too has not yet been made commercially available and is likely to be launched at the same time as GEMCOVAC-OM.
Since many Indians have opted not to take even the 'precautionary' third dose of the COVID-19 vaccine, it is unclear what the demand for these vaccines will be like.
GEMCOVAC-OM is unique in that it can be stored in an "ordinary refrigerator", The Hindu reported. The vaccines may also be administered into the skin via a “needle-free” PharmaJet system.
“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,” Singh said.
Data from the clinical trials of this vaccine is not public but has been submitted to the DCGI. According to Singh, data suggested that GENCOVAC-OM had a “greater” safety profile than Covishield and generated more neutralising antibodies.
“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],” Singh told The Hindu.
The vaccine can be given as a booster to anyone who has taken the Covishied or Covaxin doses in the past, according to The Indian Express.
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