Bharat Biotech’s Covaxin rejected ‘Emergency Use Authorization’ by FDA

Phase 3 clinical trial data is crucial as only with it can the company seek emergency approval from World Health Organisation and to be considered a part of ‘vaccine passport’.

The US Food and Drug Administration (USFDA) has rejected a proposal for ‘an emergency use authorization’ (EUA) of Bharat Biotech for Covaxin. This will further delay the company’s vaccine launch in USA through its partner Ocugen.

The company now plans to seek a full approval for its Covid-19 vaccine. This is subsequent to US FDA asking the company to launch an additional trial so prior to filing for a Biologics Licence Application (BLA), which is a full approval.

In a statement to NYSE, Ocugen says, “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."

This development comes at a time when even after six months of Covaxin being included in India’s immunization programme, Bharat Biotech is not sharing data from its phase 3 clinical trials.

Shankar Musuniri, chief executive of Ocugen, indicating that there are ongoing discussions with the FDA on the additional documents required to clear its application, said, “While this will extend our timelines, we are committed to bringing Covaxin to the US."

This hinders the company’s plans to introduce its vaccine in regulated markets as it will require WHO or a regulator such as USFDA or the European Union’s validation to cross borders. Several countries do not recognize Covaxin yet, and those who have even received two doses of the vaccine are considered “unvaccinated".

Supposedly, FDA’s rejection for emergency authorization is because the company had submitted partial data from the Covaxin trial as late as March this year. USFDA had issued revised guidelines for covid vaccine approval last month stating it will no longer grant emergency authorization to new applications.

Ocugen in a statement to investors on 26 May says despite these new guidelines 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."

Bharat Bio has also delayed its timeline in India too of releasing the phase 3 data. In a statement the company said that it will release results in July (the earlier timeline was June). This data is crucial as only with it can the company seek emergency approval from World Health Organisation, which further will open the company to export its vaccines. Apart from exporting, this will also provide the much-needed validation for the vaccine to be considered as part of a ‘vaccine passport’.

As countries are about to open their borders to fully vaccinated individuals for non-essential travel, ‘Vaccine passports’ or immunity passports will soon become a reality.