Ocugen Inc, Bharat Biotech’s partner for the US and Canada for Covid-19 vaccine Covaxin, has submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the jab for paediatric use.
The submission is based on results of a Phase 2/3 paediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large.
“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.
Munsuniri said 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.
However, the data presented by Ocugen may not be enough for the FDA to grant the request, news agency reported.
The study was conducted in India from May to July this year to evaluate the safety, reactogenicity and immunogenicity of the vaccine in the 2-18 age group. Covaxin was evaluated in three age groups: 2-6 years, 6-12 years and 12-18 years and all participants were given two doses of the vaccine 28 days apart.
In the clinical trial with 526 children, no serious adverse events or hospitalisations were observed.
Pfizer’s shot is the only one approved in the United States for children under the age of 18.
Covaxin, developed in India by Bharat Biotech, gained emergency approval from the World Health Organization (WHO) on Wednesday 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.