"Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for COVAXIN This process will extend our timelines," it added.
In February, Ocugen and Bharat Biotech had entered into a definitive agreement to co-develop, supply, and commercialise Covacin for the US market.
FDA has asked Ocugen, the US partner of Bharat Bio, to launch an additional trial so that it can file for for a full approval
Pfizer made a strong pitch for its vaccine for “prevention of Covid-19 in individuals 16 years and older, with or without evidence of prior infection”.
December 12, 2020
The agency now believes that the suggested dosing regimens "are unlikely to produce an antiviral effect," FDA chief scientist Denise Hinton said in a letter.
June 16, 2020