New Delhi: The Centre has approved Biological E’s Corbevax for restricted use in an emergency as a heterologous booster dose, official sources confirmed on Wednesday.
On Tuesday, media had reported that Corbevax booster for heterologous first has been approved by the Centre.
Last month the National Technical Advisory Group on Immunisation (NTAGI) recommended Biological E’s CORBEVAX as a heterologous booster for adults above 18 yrs old.
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On June 4, this year Biological E. Limited (BE), a Hyderabad-based pharmaceutical and vaccines company announced that its CORBEVAX COVID-19 vaccine has been approved by the Drug Controller General of India (DCGI) as a heterologous booster dose after 6 months of administration of primary jabs of Covaxin or Covishield vaccines for restricted use in the emergency situation for the individuals aged 18 years and above.
“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 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,” an official statement from BE read.
“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.
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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.
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