Government panel recommends against allowing Serum Institute of India to conduct phase 2 & 3 clinical trials of Covavax #COVID19 vaccine on children of age 2-17 years: Sources pic.twitter.com/loOhzpjyFe
— ANI (@ANI) July 1, 2021
The government panel has asked Serum Institute to complete trials of Covavax COVID-19 vaccine on adults first, ANI reported citing sources.
Serum Institute of India (SII) had applied to DCGI seeking permission to conduct a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.
As per a PTI report, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) also noted that the vaccine has not been approved in any country.
In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.
Explained: What Novavax data means to India, approval timelines, volumes and price
The vaccine candidate 'NVX-CoV2373' demonstrated 100 percent protection against moderate and severe disease, 90.4 percent efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial, Novavax said in a statement on June 14.
The clinical trials of Covovax on adults began in India in March and the SII hopes to launch it by September.