Don't allow Serum Institute to Conduct Phase 2-3 Trials of Covavax on Children, Says Govt's Expert Panel

Centre’s panel has recommended not to allow Serum Institute of India to conduct phase two and three clinical trials of Covavax Covid-19 vaccine on children in 2-17 years age group, reported sources as saying.

The Serum Institute (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 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 (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.

Earlier, the Centre said that recently declared Novavax Covid vaccine efficacy data in a large trial are promising and that clinical trials are being conducted and are in an advanced stage of completion in India.

“What we’re learning from data available in the public domain that this vaccine is very safe and highly effective. It’ll be produced in India," said Dr VK Paul, Member-Health, Niti Aayog said in a routine briefing by the Union Health Ministry on the Covid-19 situation in India.

Novavax’s vaccine exhibited a 90.4 per cent overall efficacy in Phase-3 clinical trials. That puts it in the same bracket as two of the frontline vaccines being used in the US and European countries, the ones produced by Pfizer-BioNTech and Moderna, which had efficacy rates of 91.3 per cent and 90 per cent in Phase 3 trials, respectively.