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. Â 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.
