In a significant development, Hyderabad-based Biological E Limited’s Covid-19 vaccine Corbevax has emerged as the first vaccine to bag approval from the Drug Controller General of India (DCGI) for use as a heterologous booster dose, for those aged 18 years and above, after 6 months of administration of the second dose of either Covaxin or Covishield as primary vaccination for restricted use in emergency situation, Trend reports citing Times of India.
After BE recently furnished its clinical trials data to the DCGI, the drug regulator, after a detailed evaluation and deliberations with Subject Experts Committee, granted approval.
BE said it’s clinical trial data showed that the Corbevax
booster dose provided significant enhancement in immune response
and excellent safety profile required for an effective booster.
Corbevax is an RBD protein subunit vaccine.
Commenting on the development, 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-19 vaccination journey. This approval reflects once again the sustained world class safety standards and high immunogenicity of Corbevax.”
The Hyderabad-based vaccine maker 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 Corbevac 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,” it said.
The Corbevax booster dose also resulted in significant Th1 skewed cellular immune response as indicated by cytokine expression analysis post stimulation of the T-cells, Biological E added.
The company said the Corbevax heterologous booster vaccine was well tolerated and safe with no severe or adverse events of interest for three months of follow-up after the booster dose was administered.
Pointing out that the Corbevax vaccination slot can be booked through the Cowin app, it 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 so far.
The vaccine has been 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 Covid-19.