New Delhi: A panel of experts, constituted by the government, recommended against giving permission to the Serum Institute of India (SII) to conduct phase two and three clinical trials of Covavax coronavirus vaccine on children aged between 2-17 years, sources said on Thursday.
As per latest developments, the government panel has also asked ISS to complete trials on adults first.
Adar Poonawalla, CEO of Pune-based SII, in March this year had said that the trials for ‘Covavax’, the coronavirus vaccine developed by US-based manufacturer Novavax, have started in India. Poonawalla had also added that he is hoping the launch of the vaccine will take place by September this year.
The SII had applied to the Drugs Controller General of India (DCGI) on June 28 seeking permission for conducting a full trial of Covovax on 920 children, 460 of them being in the 12-17 and 2-11 age groups, 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.