Muristek
New Delhi, June 4
The Drug Controller General of India (DCGI) on Saturday approved Hyderabad-based firm Biological E's Corbevax as India's first heterologous booster to individuals aged 18 years and above after six months of administration of primary vaccination (two doses) of Covaxin and Covishield.
Different from primary doses
Trials showed Corbevax booster provided better immune response To be given after 6 months of Covaxin or Covishield (twin doses) It's first booster to be cleared that's different from primary doseBiological E said the clearance was the first for any heterologous (different from primary dose) booster dose, with only Covaxin and Covishield cleared for homologous (same as primary dose) booster doses, at a gap of nine months after the first two doses. The company had recently furnished its clinical trial data to the DCGI.
Biological E's data showed that Corbevax booster provided significant enhancement in immune response and excellent safety profile required for an effective booster. Mahima Datla, Biological E Managing Director, said, "We have crossed yet another milestone in our Covid vaccination journey."
Biological E conducted a multicentre Phase III placebo-controlled heterologous booster clinical trial in 416 participants aged 18 to 80 years who were previously vaccinated with two doses of either Covishield or Covaxin at least six months prior to the administration of Corbevax booster.
The booster dose of Corbevax increased the neutralising antibodies in the vaccinated groups significantly when compared to placebo (the group which was not vaccinated with Corbevax booster). "Corbevax booster shot also resulted in a significant increase in antibodies against the Omicron variant. After the booster dose of Corbevax, Omicron antibodies were observed in 91 per cent and 75 per cent of subjects who had received primary vaccination by Covishield and Covaxin, respectively," the company said.
Corbevax heterologous booster vaccine was also well tolerated and safe. There were no severe or adverse events for three months of follow-up after the booster dose was administered. Corbevax was earlier approved for children aged 5-12 years.
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. Biological E has supplied 100 million doses of Corbevax to the government. It is entirely developed and manufactured by Biological E in association with Texas Children's Hospital and Baylor College of Medicine as a recombinant protein sub-unit vaccine against Covid.