Express Pharma

Bharat Biotech and Ocugen committed to bring Covaxin in US and Canada

On 4th March, Ocugen Inc had announced that the US FDA has declined to issue a EUA for Covaxin for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals—two to 18 years of age.

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Bharat Biotech today said it, along with its partner Ocugen, is committed to bring COVID-19 vaccine Covaxin in the US and Canada for all age groups.

In a statement issued on Twitter, the Hyderabad-based vaccine major said Ocugen’s phase-II/III Investigational Drug Application for Covaxin has been recently cleared by the US Food and Drug Administration (FDA) for conducting clinical trials in adults.

“Ocugen intends to continue working with FDA to evaluate regulatory pathways for the pediatric use of Covaxin,” it added.

On 4th March, Ocugen Inc had announced that the US FDA has declined to issue a EUA for Covaxin for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals—two to 18 years of age.

Last month, Bharat Biotech had announced that Covaxin would be assessed in the US as a COVID-19 vaccine candidate.

Ocugen Inc, the company’s US and Canadian partner for Covaxin, had stated earlier that the US health regulator has withdrawn its clinical hold to study the COVID-19 vaccine candidate BBV152, known as Covaxin outside the US.

Covaxin (BBVI52), developed by Bharat Biotech in conjunction with the Indian Council of Medical Research (ICMR), is a vaccine candidate currently under evaluation in the US.

In the US and Canada, Ocugen Inc is co-developing the Covaxin vaccine candidate for COVID-19.

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