Bharat Biotech’s US partner, Ocugen, has applied to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for Covaxin in children under the age of 18. Dr Raches Ella, Bharat Biotech’s clinical lead for Covid-19 vaccines, tweeted, “We are glad to announce our EUA file to the US-Food and Drug Administration (FDA) through our collaborators – Ocugen.”
There was also a tweet from Ocugen’s social media account.
We’ve filed an EUA application with the @US_FDA to seek emergency use authorization of our investigational #COVID-19 vaccine candidate for children ages 2-18 in the US. It is being administered under emergency use authorization in 17 countries. Learn more: https://t.co/DjM7ORsppc pic.twitter.com/DOMKQ2P2YH
— Ocugen (@Ocugen) November 5, 2021
Diwali came early to India as on Wednesday (November 3), the World Health Organisation (WHO) granted approval for Emergency Use Listing (EUL) for Bharat Biotech’s COVID-19 vaccine, Covaxin.The approval was done on the recommendation of the Technical Advisory Group (TAG) for Emergency Use Listing (TAG-EUL), an independent advisory panel that provides recommendations to WHO on whether a COVID-19 vaccine can be listed for emergency use under the EUL procedure.
Covaxin by Bharat Biotech and Covishield by AstraZeneca and Serum Institute are the two most extensively used vaccines in India. Mansukh Mandaviya, the Union Health Minister, expressed his delight at the WHO’s approval of Covaxin. He had remarked at the time, “Made-in-India Covaxin has been given Emergency Use Listing (EUL) by the World Health Organization (WHO). On this occasion, I salute ICMR scientists and Bharat Biotech (the Covaxin maker).”
Meanwhile, Pfizer’s vaccine is the only one approved for children under the age of 18 in the United States. The Hindustan Times quoted Shankar Musunuri, chairman of the board, CEO, and co-founder of Ocugen, as saying, “Filing for Emergency Use Authorization in the US for paediatric use is a significant step toward our hope to make our vaccine candidate available here and help combat the Covid-19 pandemic.” Only time will tell whether this receives FDA approval.
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