Govt Panel Rejects SII”s Application for Covovax Trial on Children
NEW DELHI, July 1: The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) has not approved the Serum Institute of India’s (SII) request to allow clinical trials of its second Coronavirus vaccine “Covovax” on children, official sources said.
“The expert panel was of the opinion that more data needs to be examined on the vaccine’s safety results in adults before it is allowed to be tested in children,” officials said.
Covovax is the brand name of US biotechnology company Novavax’s protein-based Covid-19 vaccine, NVX-CoV2373, which is being locally manufactured by SII.
The company applied to the national drugs controller, Drugs Controller General of India, seeking approval to conduct adaptive phase 2/3 clinical trials of Covovax on children aged between 2 and 17 years in the country.
The application was moved on Monday seeking approval to conduct a trial on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 selected sites across the country.
The vaccine, however, has not received regulatory approvals in any of the countries so far, including USA.
If approved by the expert panel, Covovax will be the third Covid-19 vaccine to be tested in children in the country after Bharat Biotech’s Covaxin, and Zydus Cadila’s ZyCov-D.
Serum Institute had hoped to start clinical trials of Covovax in children by July. In the past, SII chief executive officer Adar Poonawalla had said the vaccine could be launched in India by September subject to grant of the necessary regulatory clearances.
SII has already begun at risk manufacturing and stockpiling of Covovax last month in India.
The company is locally producing the Covishield vaccine developed by Oxford University and AstraZeneca, which is one of the two vaccines currently being used under the national Covid-19 immunisation programme.
Besides Covishield, SII is also committed to sharing Covovax doses with the COVAX facility to be distributed among low and middle income countries.
(Manas Dasgupta)
