US Pharma Company Asks FDA for Emergency Use of Covaxin Among Children

The approval has been sought on the basis of a study conducted on 526 kids outside the US.

1 min read
<div class="paragraphs"><p>The approval has been sought on the basis of a study conducted on 526 kids outside the US. </p></div>

United States (US)-based bio-pharmaceutical company Ocugen on Friday, 5 November, said that it had approached the Food and Drug Administration (FDA) for emergency use of Covaxin – a COVID-19 vaccine developed by Ocugen partner Bharat Biotech in India – for those aged between 18 and 20, reported news agency AFP.

However, Ocugen's data may not be enough for an FDA approval as it has been been gathered from clinical trials conducted outside the US on a "small group of children."

After a long delay, Bharat Biotech's Covaxin received approval from the World Health Organization for emergency use on 3 November and has already been cleared for use in 17 countries.

Millions of Covaxin doses have been administered outside the US – most notably in India, where over 12 crore have been jabbed with Bharat Biotech's vaccine.

What Covaxin's Study Found 

  • The request for approval is based on a study conducted on 526 individuals aged between 2 and 18 years, who received two doses of Covaxin with a gap of 28 days.

  • The findings from this study were then compared with those of a study conducted on 25,800 adults in India. According to the company, the comparison found "similar protection in children, ages 2-18, to that demonstrated in adults older than 18 years."

  • The trial conducted on 526 children did not lead to any case of adverse events or hospitalisation.

At present, Pfizer is the only vaccine in the US for children below 18 and recently, it was cleared by authorities for use among those aged 5 to 11 years.

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