Corbevax gets DCGI nod as heterologous COVID-19 booster dose
It is the first vaccine in India to get DCGI approval for a heterologous COVID-19 booster shot
Biological E recently announced that its Corbevax COVID-19 vaccine 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 six months of administration of primary vaccination (two doses) of Covaxin or Covishield vaccines for restricted use in emergency situation. BE’s Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster, the company said in a statement.
Recently, BE has furnished its clinical trials data to the DCGI, who, after a detailed evaluation and deliberations with Subject Experts Committee (SEC), 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. The clinical trial data showed that Corbevax booster dose provided significant enhancement in immune response and safety profile required for an effective booster.
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 six months prior to the administration of Corbevax as a booster dose, the statement notified.
It further said that the booster dose of Corbevax increased the neutralising antibody titers in the Covishield and Covaxin groups significantly when compared to placebo. 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. After the booster dose of Corbevax, Omicron nAbs were observed in 91 per cent and 75 per cent of subjects who had received primary vaccination by Covishield and Covaxin, respectively.
The Corbevax booster dose also resulted in significant Th1 skewed cellular immune response as indicated by cytokine expression analysis post stimulation of the T-cells. It 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 mentioned.