The US FDA (Food and Drug Administration) has rejected Bharat Biotech’s proposal for an emergency use authorization (EUA) of its covid vaccine (Covaxin), delaying the company’s vaccine launch in that country.
Ocugen, the US partner of Bharat Biotech, on Thursday said the company will now be seeking a 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 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.
Ocugen’s rejection of emergency authorization is because the company submitted partial data from the Covaxin trial only in March this year, but the USFDA last month came out with a revised guideline for covid vaccine approval that said it will no longer grant emergency authorization to new applications. Despite this revised guideline from FDA, Ocugen in a statement to investors on 26 May said that the company will be eligible to submit its EUA in June.
“Since we have been in discussions with the FDA since late last year, we do not believe that the FDA’s recently revised guidance regarding EUAs raises any concerns about our ability to submit the EUA for Covaxin as planned, which is currently in process and which we expect to submit to the FDA in June. We believe that the FDA’s new guidance confirms that Ocugen continues to meet all criteria for submission of an EUA,” the company’s statement from 26 May said.
Bharat Biotech did not immediately respond to an email seeking comment. In India, too, the company delayed its timeline to release the phase 3 data. In a statement to wire agency ANI, the company said that it will release results from its phase 3 data in July (the earlier timeline was June). The phase 3 data is crucial for the company, as only with those results can the company seek emergency approval from the World Health Organisation. An emergency approval from the WHO will allow the company to export its vaccines, besides granting the much-needed validation that is required for the vaccine to be considered as part of a “vaccine passport”.
Vaccine passport or immunity passports are becoming a reality as countries open their borders for non-essential travel to fully vaccinated individuals.