US FDA red flags emergency use nod for Covaxin; Bharat Biotech to seek full approval now

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The US Food and Drug Administration (FDA) has rejected Bharat Biotech’s proposal for an emergency use authorization (EUA) of Covaxin, its COVID-19 vaccine.

US FDA red flags emergency use nod for Covaxin; Bharat Biotech to seek full approval now

The US Food and Drug Administration (FDA) has decided against giving an emergency use authorization (EUA) to Bharat Biotech's COVID-19 vaccine, Covaxin.

The Hyderabad-based pharma company will now seek full approval of Covaxin after the US federal regulatory agency asked its partner firm, Ocugen, to go for Biologics Licence Application (BLA) with additional data.

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.

It added that the company is in discussions with the FDA on the additional documents required to clear its application.

The development may delay the launch of Covaxin in the US.

“While this will extend our timelines, we are committed to bringing Covaxin to the US," Mint quoted Shankar Musuniri, chief executive of Ocugen, as saying.

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.

Despite this revised guideline, Ocugen told investors on May 26 that the company would be eligible to submit its EUA in June.

“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.

In India, too, Bharat Biotech delayed its timeline to release the phase-3 data. The company recently told news agency ANI that it would release results from its phase-3 trial in July, instead of June that was the earlier timeline.
The phase-3 trial data is crucial for the company to seek emergency approval from the World Health Organization (WHO), which will in turn allow the company to export its vaccines. Besides, it will also grant the company’s vaccine the much-needed validation required to be considered a part of “vaccine passport".

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.

At present, many countries do not recognise the Bharat Biotech COVID-19 vaccine, and those who have received two doses of the vaccine are considered “unvaccinated" in some countries, Mint reported.

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.

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