New Delhi: Ocugen, Bharat Biotech’s US partner, has announced that it had asked the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of 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.
There was a tweet posted from Ocugen’s social media handle as well.
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.
Bharat Biotech’s Covaxin and AstraZeneca and Serum Institute’s Covishield are the two widely used vaccines in India. Union Health Minister Mansukh Mandaviya expressed his joy as Covaxin got the WHO nod. He had said then, “WHO today granted for Emergency Use Listing (EUL) of Made-in-India Covaxin. On this occasion, I congratulate scientists of ICMR and Bharat Biotech (the manufacturer of Covaxin).”
Meanwhile, in the United States, Pfizer’s shot is the only one approved for children under the age of 18. “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,” Shankar Musunuri, chairman of the board, CEO and co-founder of Ocugen was quoted as saying by the Hindustan Times. But whether this will get the FDA nod, only time will tell.