HYDERABAD: Biological E Limited's Corbevax has emerged as India's first Covid-19 vaccine to receive approval as a heterologous booster dose for those aged 18 years and above, after six months of receiving the second dose of either Covaxin or Covishield.
Drug Controller General of India (DCGI) gave the emergency use authorisation (EUA) after evaluating the clinical trial data and following deliberations with the subject experts committee (SEC).
Biological E said its clinical trial data showed that the Corbevax booster dose provided significant enhancement in immune response and safety profile. Corbevax as a heterologous booster was well tolerated and safe with no severe or adverse events for three months of follow-up.
The vaccine-maker conducted a multi-centre phase III placebo-controlled clinical trial on 416 subjects from 18 to 80 years of age, who were previously vaccinated with two doses of either Covishield or Covaxin. "The booster dose of Corbevax increased the neutralizing antibody (nAb) titers in the Covishield and Covaxin groups significantly when compared to placebo," BE said.
Booster effective against Omicron
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," BE added.
"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 added.
Mahima Datla, managing director of Biological E, said the approval 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."
Corbevax, which is an RBD protein subunit vaccine, had so far been approved for emergency use only in children. While EUA for the 12-14 years age group was granted in mid-March, it got the nod for use in kids in the 5-11 years age bracket in April.
Till June 4, a little over 52 million doses of Corbevax were administered to children across the country, including over 17.4 million who have completed the two-dose regimen.
BE, which bagged an advance order from the Indian government for the supply of 300 million doses of Corbevax in June 2021, has so far delivered 100 million doses.
In mid-May, BE also slashed prices of the vaccine from Rs 840 per dose (with GST) to Rs 250 a dose, including GST, for private vaccination centres.
Corbevax has been developed and manufactured by Biological E Limited in association with Texas Children's Hospital and Baylor College of Medicine.
