News Desk, Press24 News, New Delhi
Published by: Jeet Kumar
Updated Thu, 01 Jul 2021 12:47 AM IST
Serum Institute has applied to the Drugs Controller General of India seeking permission to test Kovovax on 920 children, 460 each, aged 12-17 and 2-11.
Serum Institute of India
– Photo: PTI (File)
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According to sources, the government committee has recommended against allowing Serum Institute to conduct Phase II or III clinical trials of Kovovax vaccine on children in the age group of 2-17 years.
Serum Institute on Monday applied to the Drugs Controller General of India seeking permission to test Kovovax on 920 children aged 12-17 and 2-11, 460 each, at 10 sites.
A source said the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on COVID-19 discussed the application and noted that the vaccine has not been approved in any country.
In August 2020, Novavax and SII announced an agreement under which the US biotechnology company licensed SII to manufacture and supply the vaccine in low- and middle-income countries. In March 2021, CEO Poonawalla said that Kovovax would be launched by September this year.
Hyderabad-based Bharat Biotech also has two vaccines that are being tested on children, Covaxin and BBV154, a shot-in-the-nose vaccine. Zaydz has also started testing children in the age group of 12-18 years.
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