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February 21, 2022

FDA lifts clinical hold on Ocugen’s IND application for Covid-19 vaccine

The regulatory authority placed a clinical hold on the IND application for the vaccine in November last year.

The US Food and Drug Administration (FDA) has lifted the clinical hold on Ocugen’s Investigational New Drug application (IND) to assess the Covid-19 vaccine candidate, BBV152.

Called Covaxin outside the US, it is a whole-virion inactivated Covid-19 investigational vaccine candidate.

Ocugen’s partner Bharat Biotech developed the vaccine in partnership with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).

The highly purified vaccine leverages the same vero cell manufacturing platform utilised in producing polio vaccines.

The latest move comes after the FDA placed a clinical hold on the IND application for the vaccine in November last year. 

Ocugen CEO, co-founder and board chairman Dr Shankar Musunuri said: “We are pleased to be able to move our clinical programme for Covaxin forward, which we hope will bring us closer to offering an alternative Covid-19 vaccine. 

“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.”

At present, Covaxin obtained emergency use authorizations (EUA) in 20 countries with EUA applications pending in more than 60 countries. 

In November last year, the World Health Organization (WHO) has granted Emergency Use Listing (EUL) to Covaxin for usage in people of the age 18 years and above.

Earlier this year, Ocugen reported data from a study where sera collected from individuals who received a booster vaccine dose six months following the initial two-dose regimen showed to neutralise the Omicron and Delta variants of the SARS-CoV-2 virus.

Furthermore, prior studies showed the vaccine’s neutralising potential against various other variants, including Alpha, Beta and Delta.

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