Bharat Biotech and Ocugen to bring Covaxin in US and Canada

Written by MD Bureau Published On 2022-03-09T15:36:08+05:30 | Updated On 9 March 2022 3:36 PM IST

Bharat Biotech and Ocugen to bring Covaxin in US and Canada

Ocugen intends to continue working with FDA to evaluate regulatory pathways for the pediatric use of Covaxin.

New Delhi: Bharat Biotech a pioneering biotechnology company, on Monday said it, along with its partner Ocugen, is fully committed to bringing 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 2/3 Investigational Drug Application for Covaxin has been recently cleared by the US Food and Drug Administration(USFDA) 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 March 4, Ocugen Inc had announced that the USFDA has declined to issue a EUA for Covaxin for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals -- 2 to 18 years of age.

Last month, Bharat Biotech had announced that Covaxin would be assessed in the United States 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Ocugen Inc, the company's US and Canadian partner for Covaxin, had stated earlier that the US health regulator has withdrawn its clinical hold to study the COVID-19 vaccine candidate BBV152, known as Covaxin outside the US.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. PTI MSS BAL.

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Bharat Biotech is a pioneering biotechnology company. The company is known for its R&D and manufacturing capabilities. The company's mission is to deliver affordable, safe and high-quality vaccines and bio-therapeutics that help people prevail over diseases. The company seeks to lead innovation in biotechnology in order to lead the fight against disease with a focus on emerging markets.

bharat biotechocugencovaxinuscanadacoronaviruscovid19 vaccine

Source : PTI

MD Bureau

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