CORBEVAX gets DCGI nod as heterologous COVID-19 booster dose

People who are 18 years and above and have already taken two doses of either COVISHIELD or COVAXIN can now receive a dose of CORBEVAX as a heterologous COVID-19 booster 

Biological E (BE), a Hyderabad-based pharmaceutical and vaccines company, announced that its CORBEVAX COVID-19 vaccine has been approved by the Drug Controller General of India (DCGI) as a heterologous COVID-19 booster dose for individuals aged 18 years and above after six months of administration of primary vaccination (two doses) of COVAXIN or COVISHIELD vaccines for restricted use in an emergency. 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 who after a detailed evaluation and deliberations with the 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 the excellent safety profile required for an effective booster. 

Mahima Datla, MD, Biological E, said, “We are 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-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 six months before the administration of CORBEVAX as a booster dose.

The booster dose of CORBEVAX increased the neutralising antibody titers in the COVISHIELD and COVAXIN groups significantly when compared to the 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 per cent and 75 per cent of subjects who had received primary vaccination by COVISHIELD and COVAXIN respectively.   

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 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 of CORBEVAX to the Government of India. 

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

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