The US Food and Drug Administration (FDA) has decided against giving an emergency use authorization (EUA) to Bharat Biotech's COVID-19 vaccine, Covaxin.
Biologics Licence Application or BLA, is a "full approval" mechanism by the FDA for drugs and vaccines.
“Ocugen had submitted a master file previously, following which the FDA recommended that the company pursue a BLA submission instead of an EUA for its vaccine candidate and requested additional information and data," Ocugen said.
The development may delay the launch of Covaxin in the US.
Meanwhile, Bharat Biotech said that “data from an additional clinical trial will be required to support the marketing application submission for Covaxin.”
The US FDA rejected Ocugen’s EUA because the company submitted partial data from the Covaxin trial in March this year. Last month, the US FDA came out with a revised guideline for the COVID vaccine approval that said it would no longer grant emergency authorisation to new applications.
This could be the fallout of reduction in the pandemic in the United States with good herd immunity and vaccination of a significant percentage of the population.
“As we have been in discussions with the FDA since late last year, we do not believe that the recently revised guidance regarding EUAs raises any concerns about our ability to submit the EUA application for Covaxin as planned… we expect to submit this to the FDA in June…," the company’s statement said.
The development comes at a time when Bharat Biotech is under heat in India for not sharing data from its phase-3 clinical trials, even after almost six months of its vaccine being included in the country’s immunisation programme.
Meanwhile, Covaxin has received EUAs from 14 countries, with more than 50 others in the process to grant approval, it said in a statement.
The company also said that no vaccine manufactured or developed in India has ever received EUA or full licensure from USFDA.
If approved, it will be a great leap forward for vaccines innovation and manufacturing from India, the company statement added.