Covaxin to be evaluated as Covid vaccine candidate in the US: Bharat Biotech

With more than 200 million doses having been administered to adults outside the US, Covaxin is currently authorised under emergency use in 20 countries

PGurus Newsdesk

February 20, 2022

With more than 200 million doses having been administered to adults outside the US, Covaxin is currently authorised under emergency use in 20 countries

US FDA lifts clinical hold on Bharat Biotech’s Covid vaccine Covaxin

On Saturday Bharat Biotech said that its Covaxin will be evaluated as a COVID-19 vaccine candidate in the US. In a statement, Ocugen Inc, Bharat Biotech’s partner in the US and Canada for Covaxin, noted that the American health regulator — the US Food and Drug Administration (FDA) — has lifted its clinical hold to evaluate the COVID-19 vaccine candidate BBV152, known as Covaxin outside the US.

Covaxin is India’s indigenous COVID-19 vaccine manufactured by Bharat Biotech, which has been developed in collaboration with the Indian Council of Medical Research (ICMR)–National Institute of Virology (NIV).

Bharat Biotech said, “Covaxin will be evaluated as a COVID-19 vaccine candidate in the United States. US biotech company Ocugen announced that the US Food and Drug Administration (FDA) has lifted its clinical hold on the company’s Investigational New Drug Application (IND) to evaluate the COVID-19 vaccine candidate, BBV152, known as Covaxin outside the United States.”

Bharat Biotech tweeted, “COVAXIN will be evaluated as a COVID-19 vaccine candidate in the United States.”

COVAXINⓇ will be evaluated as a COVID-19 vaccine candidate in the United States. #COVID19 #COVAXIN #VaccineMandate #BharatBiotech #bbv152 #COVID #clinicaltrial #Pandemic pic.twitter.com/nIWWDUKhvW

— BharatBiotech (@BharatBiotech) February 19, 2022

Ocugen is co-developing Bharat Biotech’s Covaxin vaccine candidate for COVID-19 in the US and Canada. Covaxin is one of the two vaccines which is being administered mainly in India.

Covaxin has already been granted Emergency Use Listing (EUL) in 13 countries so far, according to the World Health Organization. With more than 200 million doses having been administered to adults outside the US, Covaxin is currently authorized under emergency use in 20 countries.

Ocugen CEO and co-founder Shankar Musunuri said in a statement. “We are pleased to be able to move our clinical program for Covaxin forward, which we hope will bring us closer to offering an alternative COVID-19 vaccine.”

He further said: “We firmly believe that managing this pandemic requires more than one approach to vaccines, so we are heartened to be able to continue developing our vaccine candidate.”

[With Inputs from IANS]

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