Covaxin to be evaluated as Covid-19 vaccine candidate in US: Bharat Biotech

Hyderabad: Covaxin will be evaluated as a COVID-19 vaccine candidate in the United States, said Hyderabad-based Bharat Biotech on Saturday.

“Ocugen, Inc (NASDAQ: OCGN) 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. Ocugen, Inc is co-developing Bharat Biotech’s Covaxin vaccine candidate for Covid-19 in USA and Canada,” reads Bharat Biotech’s statement.

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

According to the WHO, Covaxin has already been granted Emergency Use Listing (EUL) in 13 countries as on January 31.  Covaxin was granted EUL by the national regulator, Drugs Controller General of India (DCGI), in the age group 12 to 18 years on December 24, 2021.

The COVID-19 Working Group of NTAGI recommended Covid vaccination in adolescents between 15 years to 18 years. India’s drug regulator has earlier granted regular market approval for the COVID-19 vaccine as well.