- On Monday, the SII applied to Drugs Controller General of India (DCGI).
- Serum Institute of India had applied for the approval to test Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at ten locations.
- The vaccine has not been authorized in any country, said the Subject Expert Committee (SEC).
According to the news agency PTI, an expert panel of the country’s central drug authority recommended against providing approval to the Serum Institute of India (SII) to perform a phase 2/3 trial of the Covid-19 vaccine Covovax on children aged two to seventeen years.
The Serum Institute of India (SII) applied to the Drugs Controller General of India (DCGI) on Monday for permission to conduct a Covovax trial on 920 children at ten sites, 460 each in the 12-17 and 2-11 age groups.
According to PTI, the Central Drugs Standard Control Organisation’s Subject Expert Committee declined the request, citing the fact that Covovax has not been licenced in any country.
Before moving further with the trials on children, the SII has been asked to provide the safety and immunogenicity data (of Covovax) from the ongoing clinical trial in adults.
In a Phase 3 trial, Novavax announced that NVX-CoV2373 provided 100 percent protection against moderate and severe illness, as well as 90.4 percent overall efficacy.
After Bharat Biotech’s Covaxin and Zydus Cadilla’s ZyCov-D, Covovax would have been the third vaccine to be tested on children in India.
The Pune-based company has partnered with Novavax, a US biotechnology firm, to manufacture NVX-CoV2373 under the Covovax brand.
Covovax clinical trials began in India in March, and SII CEO Adar Poonawalla had stated that the vaccine could be available in India by September for adults.
“Excited to witness the first batch of Covovax (developed by @Novavax) being manufactured at our Pune facility this week. The vaccine offers a lot of promise in terms of protecting future generations under the age of 18. The trials are still going on. “Well done team @seruminstindia!” he later said on Twitter.
The Indian government has approved four vaccinations so far: Bharat Biotech’s Covaxin, the SII’s Covishield, Russia’s Sputnik V, and Moderna’s Spikevax (sold under the brand name “Spikevax” in the US).
In January, the SII started rolling out the Covishield vaccine throughout the country. To manufacture the vaccine, it has formed a partnership with the University of Oxford and AstraZeneca.