Bharat Biotech's US partner Ocugen seeks FDA nod for Covaxin use in children
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Washington: Ocugen Inc., Bharat Biotech's partner for USA for its Covid-19 vaccine, said that it has submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of Covaxin for children in the age group 2-18 years.
The approval request is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which demonstrated comparable neutralising antibody response as seen in a large adult Phase 3 clinical trial conducted in India.
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.
