Bharat Biotech’s partner seeks Covaxin nod in US for children between 2 & 18 years

New Delhi: Bharat Biotech’s partner in the United States for the Covid-19 vaccine-Ocugen has sought emergency use authorization (EUA) from US Food and Drug Administration (FDA) to use Covaxin in children aged 2 to 18 years.

The US-based firm has applied for the authorization 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.

The study was conducted in India from May to July this year to evaluate the safety, reactogenicity and immunogenicity of Covaxin in three age groups: 2-6 years, 6-12 years and 12-18 years, where all participants were given two doses of the vaccine 28 days apart.

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, including no events of special interest such as Guillain-Barre Syndrome, anaphylactic reactions, myocarditis, pericarditis, and vaccine-induced thrombotic thrombocytopenia, Ocugen 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.

“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,” said Shankar Musunuri, chairman of the board, CEO and co-founder of Ocugen.

“If cleared, Covaxin will offer another option to the parents who want to get their young ones inoculated against the disease which has killed more than five million people across the globe. The US has been among the worst-affected countries and one of the top contributors in the daily infection tally,” he added.

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.

Covaxin, developed in India by Bharat Biotech, gained emergency approval from the World Health Organization (WHO) and has already been cleared for use in 17 countries. It is one of the four vaccines being used in India in the nationwide inoculation programme. The other three vaccines are Covishield, Sputnik V and the one made by Zydus Cadilla.