Industry

DCGI nod for Corbevax as heterologous C-19 Booster Dose

Biological E's CORBEVAX is the first such vaccine in India to be approved as a heterologous C-19 booster.

June 6, 2022

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Last Updated on December 31, 2023 by The Health Master

Hyderabad: Biological E. Limited (BE), a Hyderabad-based pharmaceutical and vaccines company, has announced that its CORBEVAX C-19 vaccine has been approved by the Drug Controller General of India (DCGI).

This has been approved as heterologous C-19 booster dose to individuals aged 18 years and above after 6 months of administration of primary vaccination (two doses) of COVAXIN or COVISHIELD vaccines for restricted use in emergency situation.

Biological E’s CORBEVAX is the first such vaccine in India to be approved as a heterologous C-19 booster.

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.

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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.

Ms. Mahima Datla, Managing Director, Biological E. Limited, said, “We are very happy with this approval, which will address the need for C-19 booster doses in India.

We have crossed yet another milestone in our C-19 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 booster dose of CORBEVAX increased the neutralizing antibody titers in the COVISHIELD and COVAXIN groups significantly when compared to placebo.

In a subset of subjects evaluated for 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% and 75% of subjects who had received primary vaccination by COVISHIELD and COVAXIN respectively.

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CORBEVAX booster dose also resulted in significant Th1 skewed cellular immune response as indicated by cytokine expression analysis post stimulation of the T-cells.

The CORBEVAX heterologous booster vaccine was well tolerated and safe. There were no severe or adverse events of interest for 3 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 of CORBEVAX to the Government of India.

CORBEVAX is entirely developed and manufactured by Biological E. Limited in association with Texas Children’s Hospital and Baylor College of Medicine as a recombinant protein sub-unit vaccine against C-19.

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