This is a consequence of the US FDA asking the company to launch an additional trial so that the company can file for a Biologics Licence Application (BLA), which is a full approval. “The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data,” said a statement from Ocugen to NYSE. Adding that the company is in discussions with the FDA on the additional documents required to clear its application. “While this will extend our timelines, we are committed to bringing Covaxin to the US,” said Shankar Musuniri, chief executive of Ocugen.
This development comes at a time when Bharat Biotech is under criticism in India for not sharing data from its phase 3 clinical trials almost six months after the company’s vaccine was included in India’s immunization programme.
The company has been betting on being able to launch its vaccine in regulated markets as it looks to gain validation at a time where authorization of a covid vaccine from WHO or a regulator such as USFDA or the European Union is needed to cross borders. At present, several countries do not recognize the Bharat Biotech vaccine, and those who have received two doses of the vaccine are considered “unvaccinated” in some countries.
News Source : First Post
