In setback to Serum Institute of India, a panel of the central drug authority has denied permission for the phase 2/3 trial of Covid-19 vaccine Covovax on children aged two to 17 years, PTI has reported quoting sources.
The SII applied to the Drugs Controller General of India on Monday seeking permission for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.
"The Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation noted that the vaccine has not been approved in any country," the report said.
The panel has also asked Serum to submit the safety and immunogenicity data of Covovax from the ongoing clinical trial in adults for considering the conduct of a clinical trial in children.
The clinical trials of Covovax began in India in March and the SII hopes to launch it by September for adults.