'Submit data of adults first': Govt expert panel rejects SII's application for Covovax trials on children
New Delhi | Jagran News Desk: An expert panel of India's central drug authority on Wednesday (June 30), denied the Serum Institute of India's application seeking permission for conducting Covovax trials on children from ages 2-17, news agency PTI reported.
The SII had submitted the application to the Drugs Controller General of India (DCGI) on June 28, 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.
As per the report by news agency PTI, the Subject Expert Committee (SEC) has stated that the vaccine has not been approved in any country. "The 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 was quoted as saying.
"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," they further added.
In June, Novavax reported efficacy of 90.4% in the interim analysis from its phase 3 trial on 29,960 participants in the US and Mexico. It also showed that the vaccine had an efficacy of 100% in preventing people from getting moderate and severe diseases.
The clinical trials of Covovax began in India in March. SII CEO Adar Poonawalla had earlier said that it hopes to start clinical trials of Covovax on children by July and introduce the vaccine for adults in India by September.
“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!” read his post on Twitter.
Posted By: Talibuddin Khan