Hyderabad-based Biological E. Limited (BE)’s COVID-19 vaccine Corbevax has been approved by the Drug Controller General of India (DCGI) as a heterologous COVID-19 booster dose to individuals aged 18 years and above after 6 months of administration of primary vaccination (two doses) of Covaxin or Covishield vaccines for restricted use in emergency situations.
In a release issued on Saturday, the company said that Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster. 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 their 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 BE’s 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 Corbevax increased 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. 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,’’ the company stated.
Biological E hasn’t received World Health Organisation’s emergency use listing for the jab. WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
Also BE has supplied 100 million doses of Corbevax to the Government of India. Corbevax is entirely 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.