Govt panel recommends against allowing SII to conduct Covovax trial on children aged 2-17 yrs
SII had applied to the DCGI, seeking permission to conduct a trial of Covovax on 920 children, 460 each in the 12-17 and two-11 age groups, at 10 sites.
On Wednesday, an expert panel of India's central drug authority recommended against granting permission to the Serum Institute of India (SII) to conduct the phase 2/3 trial of COVID-19 vaccine Covovax on children aged two to 17 years, sources said.
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 two-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.
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The recommendations are learnt to have been approved by the DCGI.
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.
The clinical trials of Covovax began in India in March, and the SII hopes to launch it by September for adults.
In January, the SII had rolled out the Covishield vaccine in the country. It had entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
In another development, Canada had suspended the use of the Oxford-AstraZeneca coronavirus vaccine for people under age 55, following concerns it might be linked to rare blood clots.
The National Advisory Committee on Immunisation had recommended the pause for safety reasons, and the Canadian provinces, which administer health in the country, announced the suspension in March 2021.
(Disclaimer: Additional background information has been added to this PTI copy for context)
Edited by Suman Singh