Official sources stated on Wednesday that the Central Government has authorised Biological E’s Corbevax for limited usage in an emergency as a heterologous booster dosage. On Tuesday, ANI reported that the Centre has authorised Corbevax booster for heterologous first.
The National Technical Advisory Group on Immunisation (NTAGI) recently recommended Biological E’s CORBEVAX as a heterologous booster for people over the age of 18.
On June 4, this year, Biological E. Limited (BE), a Hyderabad-based pharmaceutical and vaccines company, announced that its CORBEVAX COVID-19 vaccine had been approved by the Drug Controller General of India (DCGI) as a heterologous booster dose after 6 months of administration of primary Covaxin or Covishield vaccines for restricted use in emergency situations for individuals aged 18 and above.
“BE’s CORBEVAX is the first such vaccine in India to be licenced as a heterologous COVID-19 booster.” BE recently provided its clinical trial data to the DCGI, who 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 after a detailed evaluation and deliberations with the Subject Experts Committee,” according to an official statement from BE.
“BE’s clinical trial results demonstrated that Corbevax booster dosage delivered considerable augmentation in immune response and outstanding safety profile necessary for a successful booster,” it stated.
Biological E. Limited’s Managing Director, Mahima Datla, stated, “We are delighted with this clearance, which will fulfil India’s requirement for COVID-19 booster dosages. Another milestone in our COVID-19 immunisation journey has been reached. This clearance supports Corbevax’s continued world-class safety standards and high immunogenicity.”
“BE conducted a multicenter Phase III placebo-controlled heterologous booster clinical trial in 416 subjects ranging in age from 18 to 80 years old who had previously received two doses of either COVISHIELD or COVAXIN at least 6 months prior to the administration of Corbevax as a booster dose,” the statement continued.
“The Corbevax booster dosage significantly enhanced neutralising antibody titers in the Covishield and Covaxin groups as compared to the placebo,” it noted.
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Till 7 a.m. on August 10, India’s cumulative COVID-19 vaccine coverage had surpassed 207.03 Crore (2,07,03,71,204).
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