Bharat Biotech's Covaxin Approval Requested In US For Children Below 18
NDTV
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.
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.
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