Bharat Biotech's partner seeks Covaxin approval in US for children below 18 years
Nov 06, 2021
New Delhi [India], November 6 : Bharat Biotech's US partner Ocugen has announced that it had asked the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of Covaxin for children below 18.
"We are pleased to announce our EUA filing to the US-Food and Drug Administration (FDA) through our partners- Ocugen," tweeted Dr Raches Ella, Bharat Biotech's clinical lead for Covid-19 vaccines.
The World Health Organisation (WHO) on Wednesday granted approval for Emergency Use Listing (EUL) for Bharat Biotech's COVID-19 vaccine, Covaxin.
The approval was done on the recommendation of the Technical Advisory Group (TAG) for Emergency Use Listing (TAG-EUL), an independent advisory panel that provides recommendations to WHO on whether a COVID-19 vaccine can be listed for emergency use under the EUL procedure.
Bharat Biotech's Covaxin and AstraZeneca and Serum Institute's Covishield are the two widely used vaccines in India.
