Biological E’s corbevax has become the first vaccine in India to get regulatory approval for a heterologous Covid-19 booster shot. 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.
Hyderabad-based pharmaceutical and vaccines company Biological E said on Saturday that the Drug Controller General of India (DCGI) had approved Corbevax as a heterologous Covid-19 booster dose to individuals aged 18 years and above. This can be administered after six months of administration of primary vaccination (two doses) of Covaxin or Covishield.
Mahima Datla, managing director, Biological E, said this approval would address the need for Covid-19 booster doses in India.
BE had furnished its clinical trials data to the DCGI. After a detailed evaluation and deliberations with Subject Experts Committee, it granted approval for administering the Corbevax vaccine. The clinical trial data showed that the Corbevax booster dose provided significant enhancement in immune response and the excellent safety profile required for an effective booster.
The company 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 and Covaxin. The booster dose of Corbevax increased the neutralising antibody titers in the Covishield and Covaxin groups significantly when compared to placebo. The booster shot also resulted in a significant increase in the nAb titers against the Omicron variant, the company said. There were no severe or adverse events of interest for three months of follow-up after the booster dose was administered.