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CORBEVAX gets DCGI nod as a heterologous COVID-19 booster dose

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People who are 18 years and above and have already taken two doses of either covishield or covaxin can now receive a dose of corbevax as a heterologous COVID-19 booster

Biological E. (BE) has 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 to 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 to the DCGI who after a detailed evaluation and deliberations with Subject Experts Committee, 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. 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.

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 booster dose of corbevax increased the neutralising antibody titers in the covishield and covaxin groups significantly when compared to placebo.

  

 

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