Ahmedabad-based Zydus Cadila, which has created India’s second home-made coronavirus vaccine (Covid-19), has reportedly submitted more data related to the vaccine’s immunogenicity and safety to the country’s pharma regulator, the Drugs Controller General of India (DCGI).
Previously, the DCGI had asked the firm to return with more data on this front. However, as per phase 1 trial results, the DNA plasmid-based vaccine, ZyCoV-D, was found to be immunogenic and safe. The result of the 48-participant trial was published by Lancet.
“Immunogenicity” is defined as the ability of a foreign substance to trigger an immune response in the body of a human being or an animal.
An emergency use authorisation (EUA) by the DCGI will be granted after it reviews data recommended in the meeting of its Subject Expert Committee (SEC). If satisfied, the regulator is expected to approve the vaccine in August.
On July 1, Zydus Cadila submitted an application, seeking EUA for its three-dose vaccine for citizens above the age of 12. It mentioned in its application that the vaccine showed an efficacy of 66.6% in an interim analysis of phase 3 trials. ZyCoV-D is one of two vaccines which, experts believe, will soon be granted approval to be administered to children; Hyderabad-based Bharat Biotech’s Covaxin, the country’s first indigenous anti-Covid jab is the other. Currently, those aged 18 and above are eligible for vaccination against Covid-19.
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