Corbevax gets approval from DGCI as asymptomatic COVID-19 booster

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Biologics E’s Corbevax has become the first vaccine in India to receive regulatory approval for a heterogeneous COVID-19 booster shot. People who are 18 years of age and older and have already taken two doses of Covishield or Covaxin can now receive a single dose of Corbevax as a contrasting COVID-19 booster.

Hyderabad-based drug and vaccine company Biological E said on Saturday that the Drug Controller General of India (DCGI) had approved Corbevax as an asymptomatic COVID-19 booster dose for persons aged 18 years and above. It can be administered after six months of administration of either Covaxin or Covishield’s primary vaccination (two doses).

Mahima Datla, Managing Director, Biologicals E said that this approval will meet the requirement of Kovid-19 booster dose in India.

BE had submitted data from its clinical trials to DCGI. After detailed evaluation and deliberations with the subject expert committee, it approved the administration of Corbevax vaccine. Clinical trial data demonstrated that the Corbevax booster dose provided a significant increase in immune response and the excellent safety profile required for an effective booster.

The company conducted a multicenter Phase III placebo-controlled heterologous booster clinical trial in 416 subjects 18 to 80 years of age who had previously been vaccinated with Covishield and two doses of Covaxin. The booster dose of Corbevax significantly increased neutralizing antibody titers in the Covashield and Covaxin groups compared with placebo. The company said the booster shot resulted in a significant increase in NAB titers compared to the Omron version. No serious or adverse events occurred for three months of follow-up after the booster dose was given.



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