Approval for mRNA-based Covid-19 booster vaccine

Pune: Gennova Biopharmaceuticals Ltd, a Pune-based company, announced on Tuesday that its mRNA Covid-19 booster vaccine — Gemcovac — against Omicron variant of SARS-CoV-2 has received emergency use authorisation (EUA) from the office of the Drugs Controller General of India (DCGI).Gemcovac is the first booster Covid-19 vaccine developed in India against the highly transmissible Omicron variant. The vaccine has demonstrated robust immune responses in the phase III clinical trials conducted at 20 centres across 13 cities in India.The currently approved vaccines used as precautionary/ booster doses are designed against the ancestral strain of SARS-CoV-2. Their ability to neutralise the circulating Omicron variant of SARS-CoV-2 is limited. Developing antibodies and memory immune responses specific to the Omicron variant would reduce the probability of infection and hospitalisation and prevent future waves of the pandemic. The Made-in-India Gemcovac specifically addresses this gap.Gemcovac is a lyophilized (freeze dried) vaccine, stable at 2- 8 °C and is available for adults. The booster vaccine can be administered safely to individuals who have received two doses of either Covaxin or Covishield.It is delivered intradermally using a device called Tropis, developed by PharmaJet, USA. This is a needle-free device that obviates the disadvantages of using a needle, such as a needle phobia, sharps disposal, and needle-stick injuries, to name a few.Dr. Sanjay Singh, CEO, Gennova Biopharmaceuticals Limited, said, “There is a realisation that the Covid-19 will remain and keep mutating, and therefore we need to be prepared with vaccines to deal with emerging variants. The mRNA platform, that was developed in association with the Department of Biotechnology, Government of India, provides an opportunity for a quick turnaround for vaccine development for any variants of concern in future.”
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