The United States FDA to evaluate India's Covaxin as CoVid vaccine candidate

Source : Hindustan Times

American Biotech company Ocugen is developing Covaxin in partnership with Bharat Biotech in the US and Canada. (Ocugen Twitter )

Covaxin will be evaluated as a coronavirus vaccine candidate in the United States, Bharat Biotech on Saturday. The US Food and Drug Administration (FDA), the country’s top health regulator, has lifted its clinical hold to evaluate the COVID-19 vaccine candidate BBV152, known as Covaxin outside the US, Ocugen, the vaccine maker’s partner further elaborated. Occugen is developing the vaccine in partnership with Bharat Biotech in the US and Canada.  

"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," Ocugen CEO and co-founder Shankar Musunuri said in a statement.

We’re pleased to share that the @US_FDA lifted the clinical hold on our Investigational New Drug (IND) application for our #COVID19 #vaccine candidate. We are eager to move forward! Read more: https://t.co/ipiCRe3UzS pic.twitter.com/hCj8wMKV10

— Ocugen (@Ocugen) February 18, 2022

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."   Over 200 million doses of Covaxin have so far been given to adults under emergency use authorization, the pharma giant further explained.   

Covaxin “is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). It is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades,” Ocugen further underlined. 

The vaccine was recently added by the WHO to its list of vaccines authorized for emergency use.  

In India, it’s one of the two major vaccines (apart from Covishield) that are being given to the country’s population.  It was the first homegrown vaccine in the country against coronavirus.