DCGI approves Corbevax as first heterologous COVID-19 booster shot for adults

Hyderabad: Hyderabad-based vaccine company Biological E Limited (BE) on Saturday announced that its Corbevax Covid-19 vaccine has been approved by the Drug Controller General of India (DCGI) as a heterologous booster dose to individuals aged 18 years and above. This can be used after six months of administration of primary vaccination (two doses) of Covaxin or Covishield vaccines for restricted use in emergency situations. BE’s Corbevax is the first such vaccine in India to be approved as a heterologous Covid-19 booster.

Recently, BE has furnished its clinical trials data to the DCGI. It granted approval for administering the Corbevax vaccine as a heterologous booster dose to people who have already taken two doses. BE’s clinical trial data showed that Corbevax booster dose provided enhancement in immune response and safety profile required for an effective booster.

“We are happy with this approval, which will address the need for Covid-19 booster doses in India. This approval reflects the world class safety standards and high immunogenicity of Corbevax,” said Mahima Datla, Managing Director, Biological E. BE has conducted a multicentre Phase III placebo controlled heterologous booster clinical trial in 416 subjects from 18 to 80 years of age. The booster vaccine was well tolerated and safe. There were no severe or adverse events of interest for three months of follow-up after the booster dose was administered.

The Corbevax vaccination slot can be booked through the Co-WIN app or Co-WIN portal. So far, 51.7 million doses of Corbevax have been administered to children across the country, including 17.4 million who have completed the two-dose regimen. BE has supplied 100 million doses to the Government of India, a release said. Corbevax is developed and manufactured by Biological E in association with Texas Children’s Hospital and Baylor College of Medicine as a recombinant protein sub-unit vaccine against Covid-19.

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