In a statement, the company said, “BE’s clinical trial data showed that CORBEVAX® booster dose provided significant enhancement in immune response and excellent safety profile required for an effective booster.”
New Delhi: Corbevax, a Covid-19 vaccine by Biological E, was cleared for booster doses of those 18 and above, Biological E said on Saturday. The vaccine can be administered six months after a person has taken the first and second doses of either Covishield or Covaxin for restricted use in emergency situations. This makes Corbevax India’s first heterologous Covid booster.
Biological E’s managing director Mahima Datla said, “We are very happy with this approval, which will address the need for COVID-19 booster doses in India. We have crossed yet another milestone in our COVID-19 vaccination journey. This approval reflects once again the sustained world class safety standards and high immunogenicity of Corbevax.”
In a statement, the company said, “BE’s clinical trial data showed that CORBEVAX® booster dose provided significant enhancement in immune response and excellent safety profile required for an effective booster.”
According to reports, the approval came after a trial was conducted in 416 persons who were administered Corbevax or placebo (an agent with no therapeutic value) six months after having received two doses of either Covaxin or Covishield. The company, in its release, said, “The levels of neutralising antibodies – antibodies that specifically attack or block the Sars-CoV-2 virus – increased significantly in those who had taken Corbevax as compared to the placebo.”
The booster dose of Corbevax increased the neutralising antibody titers — or a measurement of the amount or concentration of a substance in a solution — in the Covishield and Covaxin groups significantly when compared to placebo, the company said.
The company said it found cell-mediated immunity to be higher in those who had received the Corbevax shot as compared to the placebo. “The 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 company said.
Biological E had earlier reduced the price of Corbevax to Rs 250 from Rs 840 a dose for private vaccination centres.