India Approves First Heterologous COVID-19 Booster Shot for Adults

India-based Biological E. Limited announced yesterday that its CorbeVax® COVID-19 vaccine was approved by the Drug Controller General of India (DCGI) as a heterologous COVID-19 booster dose for certain adults.

Initially developed in Houston, Texas, the recombinant protein sub-unit CorbeVax is the first vaccine approved as a heterologous COVID-19 booster in India.

The DCGI, after a detailed evaluation and deliberations with Subject Experts Committee, granted their approval for administering the CorbeVax vaccine as a heterologous booster dose to people who have already taken two doses of either COVISHIELD or COVAXIN vaccines.

Ms. Mahima Datla, Managing Director, Biological E. Limited (BE), said in a press release issued on June 4, 2022, "This approval reflects once again the sustained world-class safety standards and high immunogenicity of CorbeVax."

BE had conducted a multicentre Phase III placebo-controlled heterologous booster clinical trial in 416 subjects from 18 to 80 years of age. The booster dose of CorbeVax increased the neutralizing antibody titers in the COVISHIELD and COVAXIN groups significantly compared to placebo.

In a subset of subjects evaluated for nAb against the Omicron variant, the CorbeVax booster shot significantly increased 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.

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

So far, 51.7 million doses of CorbeVax have been administered to children across India, 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.

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