Guwahati: The Center had approved the restricted emergency usage of Biological E’s Corbevax as a heterologous booster dose, sources confirmed on Wednesday.
The National Technical Advisory Group on Immunization (NTAGI) endorsed Biological E’s CORBEVAX last month as a heterologous booster for individuals older than 18 years old.
The Drug Controller General of India (DCGI) has approved the CORBEVAX COVID-19 vaccine by Biological E. Limited (BE), a Hyderabad-based pharmaceutical and vaccines company, as a heterologous booster dose after 6 months of administration of primary Covaxin or Covishield vaccines for restricted use in emergency situations for people aged 18 and over.
According to an official statement of Biological E, “CORBEVAX is the first such vaccine in India to be approved as a heterologous COVID-19 booster. Recently, BE has furnished its clinical trials data to the DCGI who after a detailed evaluation and deliberations with the Subject Experts Committee, granted their approval for administering the Corbevax vaccine as a heterologous booster dose to people who have already taken two doses of either Covishield or Covaxin,” ANI reported.
“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,” it added.
Mahima Datla, Managing Director, Biological E. Limited, 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 that once again sustained world-class safety standards and high immunogenicity of Corbevax.”
“BE has 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 6 months prior to the administration of Corbevax as a booster dose,” the statement read further.
“The booster dose of Corbevax increased the neutralizing antibody titers in the Covishield and Covaxin groups significantly when compared to the placebo,” it added.
India’s cumulative COVID-19 immunisation coverage crossed 207.03 Crore (2,07,03,71,204) till 7 am on August 10.