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Biological E. Limited (BE), a late entrant to Covid-19 vaccine space, has received nod for its Corbevax vaccine to be used as a heterologous Covid-19 booster dose by the Drug Controller General of India (DCGI).
The vaccine can be given as a booster dose to people over 18 years of age after six months of taking the two doses of primary vaccination (of Covaxin or Covishield) for restricted use in an emergency situation. “The clinical trial data showed that Corbevax booster dose provided significant enhancement in immune response and excellent safety profile required for an effective booster,” Mahima Datla, Managing Director, Biological E. Limited, said.
The company claims that Corbevax is the first vaccine in the country to be approved as a heterologous Covid-19 booster.
Recently, the Hyderabad-based pharmaceutical and vaccine company has submitted its clinical trials data to the DCGI. “After a detailed evaluation and deliberations with Subject Experts Committee, the regulator granted the approval,” BE has said in a statement on Saturday.
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 or Covaxin at least six months prior to the administration of Corbevax as a booster dose.
The booster dose increased the neutralising antibody titers in the Covishield and Covaxin groups significantly when compared to placebo.
“The Corbevax booster vaccine was well tolerated and safe. There were no severe or adverse events of interest for three months of follow-up after the booster dose was administered,” the statement said..
So far, 51.7 million doses of Corbevax have been administered to children across the country. Of these, 17.4 million have completed the two-dose regimen. The company supplied 100 million doses to the Union Government.
The vaccine 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 subunit vaccine against Covid-19.
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