Govt panel refuses SII permission to conduct Phase 2, 3 trials of Covavax on children
SII had applied to the DCGI seeking permission to conduct clinical trials of Covavax on children at 10 sites
New Delhi: An expert panel constituted by the government has recommended against granting permission to the Serum Institute of India (SII) to conduct phase two and three clinical trials of Covavax COVID-19 vaccine on children aged between 2-17 years, said sources on Thursday.
According to the sources, the government panel has asked the Institute to complete trials on adults first.
The CEO of Pune-based SII, Adar Poonawalla, had in March this year said that the trials for 'Covavax', the COVID-19 vaccine developed by US-based vaccine manufacturer Novavax, have begun in India, and added that he is hoping the vaccine launch will take place by September this year.
The Serum Institute of India had applied to the Drugs Controller General of India (DCGI) on Monday seeking permission to conduct clinical trials of Covavax on children at 10 sites.
"The Subject Expert Committee (SEC) recommended that the Pune-based company should submit the safety and immunogenicity data of Covavax from the ongoing trials in adults for considering the trials in children," sources told ANI.
Novavax's vaccine candidate has partnered with Pune-based vaccine manufacturer Serum Institute of India to produce doses in India.
Last month, the All India Institute of Medical Sciences (AIIMS) in Delhi began the screening of children in the age group of 6 to 12 years for the clinical trials of Covaxin, the indigenously developed Covid-19 vaccine.
AIIMS Delhi has already completed the clinical trial for a single dose of Covaxin for children aged 12-18 age group.
Meanwhile the US had in May approved Pfizer's COVID-19 vaccine for use in children as young as 12. Pfizer's shot is the first to be cleared in the United States for children 12 to 15.