The US Food and Drug Administration (FDA) has denied Bharat Biotech's request for an emergency use authorisation (EUA) for its covid vaccine, postponing the company's launch in the United States.
Bharat Biotech's US partner, Ocugen, announced on Thursday that the business will now pursue full approval for Covaxin, reports the Live Mint.
This is the result of the US FDA requesting that the company do another trial in order to file for a Biologics Licence Application (BLA), which is a full approval.
According to an Ocugen statement to NYSE, the FDA notified Ocugen with input on the Master File it had previously filed, advising the company to pursue a BLA filing rather than an EUA application for its vaccine candidate and asking further information and data.
Adding that the company is in discussions with the FDA on the additional documents required to clear its application. Shankar Musuniri, chief executive of Ocugen said, "While this will extend our timelines, we are committed to bringing Covaxin to the US."
This news comes as Bharat Biotech faces criticism in India for failing to share data from its phase 3 clinical trials nearly six months after the company's vaccine was approved for use in the country's vaccination program.
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 authorisation 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.