New Delhi, Mar 7 (PTI) Bharat Biotech on Monday said it, along with its partner Ocugen, is fully committed to bringing COVID-19 vaccine Covaxin in the US and Canada for all age groups. In a statement issued on Twitter, the Hyderabad-based vaccine major said Ocugen’s Phase 2/3 Investigational Drug Application for Covaxin has been recently cleared by the US Food and Drug Administration(USFDA) for conducting clinical trials in adults.
“Ocugen intends to continue working with FDA to evaluate regulatory pathways for the pediatric use of Covaxin,” it added.
On March 4, Ocugen Inc had announced that the USFDA has declined to issue a EUA for Covaxin for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals — 2 to 18 years of age.
Last month, Bharat Biotech had announced that Covaxin would be assessed in the United States as a COVID-19 vaccine candidate.
Ocugen Inc, the company’s US and Canadian partner for Covaxin, had stated earlier that the US health regulator has withdrawn its clinical hold to study the COVID-19 vaccine candidate BBV152, known as Covaxin outside the US.
Covaxin (BBVI52), developed by Bharat Biotech in conjunction with the Indian Council of Medical Research (ICMR), is a vaccine candidate currently under evaluation in the US.
In the US and Canada, Ocugen Inc is co-developing the Covaxin vaccine candidate for COVID-19. PTI MSS BAL
