SII had applied on Monday to DCGI seeking permission for conducting trials of Covovax on children in the age group of 2 to 17.
The SEC said that the vaccine has not been approved in any country, and SII must first submit data regarding the safety and efficacy of the vaccine.
Serum Institute of India (SII) had applied to the Drug Controller General of India (DCGI) on Monday seeking permission for clinical trials of Covovax on 2 to 17 year olds. The trial was to be conducted on 920 children on 10 sites.
A panel of experts on Wednesday recommended against granting permission for conducting the trials. The Subject Expert Committee (SEC) noted that the vaccine has not been approved in any country.
The SEC also recommended that SII should submit the safety and immunogenicity data of Covovax from the ongoing clinical trials in adults for considering the clinical trials in children.
The clinical trials of Covovax in adults began in India in March 2021 and the Pune based company expects to launch it by September for adults. Covishield was rolled out by SII in India in January. If approved, Covovax would become the 3rd vaccine to begin trials in children.
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