It sought approval to administer Covaxin to children aged 2 to 18 years of age.
The US-based firm has applied for the authorisation based on the basis of the results of phase 2 and 3 clinical trials conducted on 526 children aged between 2 and 18 years of age in India.
“Filing for Emergency Use Authorization in the US for paediatric use is a significant step toward our hope to make our vaccine candidate available here and help combat the Covid-19 pandemic,” Shankar Musunuri, chairman of the board, CEO and co-founder of Ocugen said on Friday.
Raches Ella, the clinical lead for Covid-19 vaccines at Bharat Biotech, said on Twitter that Covaxin is ideally placed for children because of its “tolerable safety profile”.
“Due to a tolerable safety profile, Covaxin is ideally placed for children. We are pleased to announce our EUA filing to the US-FDA through our partners- Ocugen,” he tweeted.
The study had shown that the vaccine induced antibody responses equivalent to those seen in adults, and no adverse effects of the vaccine were reported.
“No serious adverse events or hospitalizations were observed in Phase 2/3 pediatric study of COVAXIN (BBV152), including no events of special interest such as Guillain-Barre Syndrome, anaphylactic reactions, myocarditis, pericarditis, and vaccine-induced thrombotic thrombocytopenia,” it said in a statement.
Ocugen noted that Covaxin uses the same vero cell manufacturing platform as other vaccines for children, including the inactivated polio vaccine.
On Wednesday Bharat Biotech was granted Emergency Use Listing (EUL) for Covaxin from the World Health Organisation (WHO).