Hyderabad-based Biological E. Limited (BE)’s COVID-19 vaccine Corbevax has been approved by the Drug Controller General of India (DCGI) as a COVID-19 booster dose.
The vaccine can be administered to adults six months after the administration of primary vaccination (two doses) of Covaxin or Covishield for restricted use in emergency situations.
BE’s Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster, the company said in a release. A heterologous booster is when the third dose is different from the earlier doses.
“Recently, BE furnished its clinical trials data to the DCGI, who after a detailed evaluation and deliberations with Subject Experts Committee, granted approval for administering Corbevax vaccine as a heterologous booster dose to people who have already taken two doses of either Covishield or Covaxin,” said the release.
It added that clinical trial data showed that Corbevax booster dose provided significant enhancement in immune response and good safety profile required for an effective booster.
Mahima Datla, managing director, Biological E. Limited, said: “BE has conducted a multi-centre 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 Corbevax as a booster dose.’’
The study indicated that the booster dose of Corbevaxincreased the neutralising antibody titers in the Covishield or Covaxin groups significantly when compared to placebo.
The company added that Corbevax heterologous booster vaccine was well tolerated and safe.
‘‘There were no severe or adverse events of interest for 3 months of follow-up after the booster dose was administered. The Corbevax vaccination slot can be booked through the Co-WIN app or Co-WIN portal,”. the company stated.