Serum Institute shakes as government panel says no to Covovax trial on children | Latest India News
A group of experts from the country’s central pharmaceutical authority on Wednesday recommended not to allow the Serum Institute of India (SII) to conduct the phase 2/3 trial of the Covid-19 Covovax vaccine on children aged two at 17, the PTI news agency reported.
The SII had asked the Comptroller General of Drugs of India (DCGI) on Monday for permission to conduct a trial of Covovax on 920 children, 460 each in the age groups 12-17 and 2-11, at 10 sites.
But the Central Pharmaceutical Standards Supervisory Organization’s Committee of Experts on the matter refused the authorization, saying Covovax has not been approved in any country, according to PTI. The IBS was asked to submit safety and immunogenicity data (of Covovax) from the ongoing clinical trial in adults before proceeding with the trials in children, PTI reported.
Novavax announced last month that NVX-CoV2373 demonstrated 100% protection against moderate and severe disease, and overall efficacy of 90.4%, 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 ZyCov-D from Zydus Cadilla.
The Pune-based company has partnered with US biotech company Novavax to locally manufacture NVX-CoV2373 under the brand name Covovax.
Clinical trials of Covovax began in India in March and SII CEO Adar Poonawalla previously said the vaccine could be launched in India by September for adults.
“I am delighted to witness the manufacturing of the first batch of Covovax (developed by @Novavax) this week at our factory in Pune. The vaccine has great potential to protect our future generations under the age of 18. The tests are in progress. Well done to the @seruminstindia team! He later said in a Twitter post.
So far, four vaccines – Bharat Biotech’s Covaxin, IBS Covishield, Russia’s Sputnik V, and one manufactured by Moderna (sold under the brand name “Spikevax” in the United States) – have been licensed by the Indian government.
The IBS had deployed the Covishield vaccine in the country in January. He had entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.