English
New Delhi: Biological E’s Corbevax booster shot has been approved by the Union government people above 18 years of age those who have been fully vaccinated with Covaxin and Covishield COVID-19 vaccine. This is for the first time that a booster dose that is different from the one used for primary vaccination against Covid has been allowed in the country.
Earlier last month, the National Technical Advisory Group on Immunisation (NTAGI) recommended Biological E’s Corbevax as a heterologous booster for adults. Earlier, on June 4, 2022, Biological E’s Corbevax received DCGI approval for a heterologous COVID-19 booster shot for Restricted Use in Emergency Situation. It is the first vaccine in India to get DCGI approval for a heterologous COVID-19 booster shot.
Biological E Limited (BE), a Hyderabad-based pharmaceutical and vaccine company, 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 for 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 situation.
“BE’s 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 and submitted it to the DCGI, which 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,” read the statement of Biological E.
“BE’s clinical trial data showed that Corbevax booster dose provided a significant enhancement in immune response and excellent safety profile required for an effective booster,” it said.
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 once again the 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,” stated Biological E in a statement.
“The booster dose of Corbevax increased the neutralizing antibody titers in the Covishield and Covaxin groups significantly when compared to placebo,” it said.
For breaking news and live news updates, like us on Facebook or follow us on Twitter and Instagram. Read more on Latest India News on India.com.
