Amid criticism in India for not sharing data from its phase 3 clinical trials almost six months after the vaccine was included in India’s immunization programme, Ocugen, the US partner of Bharat Biotech, on Thursday claimed the company will now be seeking full approval of Covaxin. 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 a 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.
A group of public health experts, including doctors from AIIMS and members from the national task force on Covid-19, has recommended that there is no need to vaccinate people who had documented Covid-19 infection and underlined that mass, indiscriminate, and incomplete vaccination can also trigger the emergence of mutant strains.