Biological E's Corbevax gets DCGI nod as a heterologous Covid booster dose

The Hyderabad-based company claimed that the booster dose of Corbevax increased the neutralising antibody titers in the Covishield and Covaxin groups significantly when compared to placebo

Biological E’s Corbevax becomes the first vaccine to get the Drug Controller General of India’s (DCGI) nod to be used as a heterologous booster for adults who have either received two shots of Covaxin or Covishield.

India’s vaccine policy think tank National Technical Advisory Group on Immunisation (NTAGI) is also studying data on vaccine dose mixing, but has not yet come out with a decision. So far, India was using a homologous booster shot for all precaution doses. However, Biological E claimed that now a Corbevax shot can be booked through the Co-WIN portal by anyone who wished to take a shot.

On Saturday, the Hyderabad-headquartered company said that its protein sub-unit vaccine Corbevax has been approved by the DCGI as a heterologous Covid booster dose for individuals aged 18 years and above after 6 months of administration of primary vaccination (two doses) of Covaxin or Covishield.

“Recently, BE has furnished its clinical trials data to the DCGI who after a detailed evaluation and deliberations with Subject Experts Committee, granted their approval for administering Corbevax vaccine as a heterologous booster dose to people who have already taken two doses of either Covishield or Covaxin. BE's clinical trial data showed that Corbevax booster dose provided significant enhancement in immune response and excellent safety profile required for an effective booster,” the company said.

Mahima Datla, Managing Director, Biological E. Limited, said: "We are very happy with this approval, which will address the need for COVID-19 booster doses in India. We have crossed yet another milestone in our Covid vaccination journey. This approval reflects once again the sustained world class safety standards and high immunogenicity of Corbevax.”

BE has conducted a multicentre Phase III placebo controlled heterologous booster clinical trial in 416 subjects from 18 to 80 years of age who were previously vaccinated with two doses of either Covishield or Covaxin at least 6 months prior to the administration of Corbevax as a booster dose.

The company claimed that the booster dose of Corbevax increased the neutralising antibody titers in the Covishield and Covaxin groups significantly when compared to placebo. There were no severe or adverse events of interest for 3 months of follow-up after the booster dose was administered, it added. 

It added that a subset of subjects evaluated for neutralizing antibodies (nAb) against the Omicron variant, the Corbevax booster shot resulted in a significant increase in the nAb titers against the Omicron variant. “After the booster dose of Corbevax, Omicron nAbs were observed in 91 percent and 75 percent of subjects who had received primary vaccination by Covishield and Covaxin respectively,” Biological E said, adding that the Corbevax booster also resulted in enhanced cellular immune response.

The Corbevax vaccination slot can be booked through the Co-WIN app or Co-WIN portal, Biological E said.

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 of Corbevax to the Government of India.