US company Ocugen announced Friday that it had asked authorities for emergency use authorization for Covid-19 vaccine Covaxin, which was developed in India, for ages 2 to 18.
Ocugen's data, gathered from clinical trials conducted outside of the United States with only a small group of children, may not be enough for the Food and Drug Administration (FDA) to grant the request.
Covaxin, developed in India by Ocugen's partner, Bharat Biotech, gained emergency approval from the World Health Organization on Wednesday and has already been cleared for use in 17 countries.
Tens of millions of doses have been administered to adults outside of the United States, notably in India.
The immunization uses inactivated virus technology, common in other childhood vaccines including polio shots.
The approval request is based on results from a study of 526 kids between ages 2 and 18 who received two doses of Covaxin 28 days apart.
The findings were compared with those from a group of 25,800 adults in India, which suggested "similar protection in children, ages 2-18, to that demonstrated in adults older than 18 years," the company said.
Ocugen co-founder Shankar Musunuri in a press release called the move "a significant step toward our hope to make our vaccine candidate available here."
In the clinical trial with 526 children, no serious adverse events or hospitalizations were observed, but the study's sample size may not have been large enough to detect rare side effects.
The FDA asked Pfizer and Moderna, whose Covid-19 vaccines have already been authorized in the United States, to conduct trials with thousands of children to have a better insight into any side effects.
Pfizer's shot is the only one approved in the United States for children under the age of 18, and health authorities cleared the way this week for 5 to 11-year-olds to receive the vaccine.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
Top Medical Body Slams Study On Covaxin Safety, Side-Effects, Wants Apology Fact Check: Can Covaxin Lead To Death After 2 Years Of Vaccination? Covaxin Has Excellent Safety Record: Bharat Biotech On Study Citing Risks 11 Dead, Many Critical In Jaipur Fire As 2 Trucks Collide Outside Petrol Pump Atul Subhash's Mother Goes To Top Court For 4-Year-Old Grandson's Custody Gas Leak, Then Blast: CCTV Shows Moments After Jaipur Crash That Killed 11 BJP To Not Name Chief Ministerial Candidate For Delhi Polls: Source BPSC To Hold CCE 70th Prelims Re-exam On This Date, Check Details Indian Stocks Witness Another Day Of Bloodbath As Sensex, Nifty Shed 1.5% Each Track Latest News Live on NDTV.com and get news updates from India and around the world.