Corbevax vaccine gets approval of the government for emergency use for COVID-19

Corbevax has been developed by the Hyderabad based Biological E. Limited

Corbevax has been given approval as heterologous booster dose

August 10, 2022

The central government has approved the usage of Corbevax of the Biological E. Limited (BE), for emergency use as a heterologous booster dose. Corbevax can be used as a precaution dose for those above 18 years fully vaccinated with either Covishield or Covaxin. The precaution dose can be given after the completion of six months or 26 weeks from the administration of the second dose of either Covisheild or Covaxin. As per reports, the approval of the Union Health Ministry is based on the recommendations made by the COVID-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI).

BE has said that the booster dose of Corbevax increased the neutralizing antibody titers in the Covishield and Covaxin groups significantly. As per the statement of the BE:

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 Drugs Controller General of India (DCCI) 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.

BE’S clinical trial data showed that the Corbevax booster dose provided significant enhancement in immune response and the excellent safety profile required for an effective booster.

The statement further reads:

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.

Corbevax is India’s first indigenously developed RBD protein subunit vaccine. It is currently being used to inoculate children in the age group of 12 to 14 years under the COVID-19 immunization programme.

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