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Home National & International

Bharat Biotech’s US partner Ocugen seeks approval for Covaxin in US for children below 18 years

Lagatar News by Lagatar News
November 6, 2021
in National & International
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Lagatar24 Desk

Washington, Nov 6: Bharat Biotech’s US partner Ocugen has announced that it had asked the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA)  for COVID-19 vaccine Covaxin, for children below 18.

“We are pleased to announce our EUA filing to the US-Food and Drug Administration (FDA) through our partners-Ocugen,” tweeted Dr Raches Ella, Bharat Biotech’s clinical lead for COVID-19 vaccines.

Due to a tolerable safety profile, COVAXIN is ideally placed for children. We are pleased to announce our EUA filing to the US-FDA through our partners- Ocugen. https://t.co/xu6CyLds8H

— Dr. Raches Ella (@RachesElla) November 5, 2021

Notably, The World Health Organization (WHO) on Wednesday granted approval for Emergency Use Listing (EUL) for Bharat Biotech’s COVID-19 vaccine, Covaxin.

Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen called the move a significant step toward our hope to make our vaccine candidate available here and help combat the Covid-19 pandemic.

The FDA asked Pfizer and Moderna, whose COVID vaccines have already been given approval in the United States, to conduct trials with thousands of children to have a better insight into any side effects.

Notably, Pfizer’s shot is the only one approved in the United States for children under the age of 18.

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