NEW DELHI — An expert panel of the country’s central drug authority on Wednesday 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, News agency PTI reported.
The SII had applied to the Drugs Controller General of India (DCGI) on Monday seeking permission for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.
But the the Subject Expert Committee of the Central Drugs Standard Control Organisation denied the permission saying Covovax has not been approved in any country, according to PTI.
The SII has been asked to submit the safety and immunogenicity data (of Covovax) from the ongoing clinical trial in adults before proceeding with the trials on children, PTI reported.
Novavax had announced last month that NVX-CoV2373 demonstrated 100% protection against moderate and severe disease, and 90.4% overall efficacy, in its Phase 3 trial.
If approved, Covovax would have been the third vaccine to be tested on children in the country after Bharat Biotech’s Covaxin and Zydus Cadilla’s ZyCov-D.
The Pune-based company has tied up with US biotechnology company Novavax to locally manufacture NVX-CoV2373 under the brand name Covovax.
The clinical trials of Covovax began in India in March and SII chief executive officer (CEO) Adar Poonawalla had earlier said the vaccine could be launched in India by September for adults.
“Excited to witness the first batch of Covovax (developed by @Novavax) being manufactured this week at our facility in Pune. The vaccine has great potential to protect our future generations below the age of 18. Trials are ongoing. Well done team @seruminstindia!” he later said in a post on Twitter.
So far, four vaccines – Bharat Biotech’s Covaxin, the SII’s Covishield, Russia’s Sputnik V and the one manufactured by Moderna (sold unde the brand name ‘Spikevax’ int he US) – have been cleared by the Indian government.
The SII had rolled out Covishield vaccine in the country in January. It had entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.