According to sources, the government panel has asked the institute to complete trials on adults first. The SII hopes to introduce US firm Novavax’s Indian version of the Covid-19 vaccine – ‘Covavax’ by September this year and start trials on children from July.
The SII applied to the Drugs Controller General of India (DCGI) on Monday seeking permission to conduct a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups 10 sites.
“The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application, noted that the vaccine has not been approved in any country,” a source said. “It also recommended that the Pune-based company should 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 source said.