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Launch Delayed as FDA Red Flags Emergency Use Authorisation of Bharat Biotech's Covaxin: Report

Health Minister Harsh Vardhan holds a dose of Bharat Biotech's COVID-19 vaccine called COVAXIN. (Reuters/File)

Health Minister Harsh Vardhan holds a dose of Bharat Biotech's COVID-19 vaccine called COVAXIN. (Reuters/File)

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.

United States’ Food and Drug Administration (FDA) has turned down Bharat Biotech’s proposal for an emergency use authorisation (EUA) of covaxin, delaying the company’s vaccine launch in that country.

According to a report by Mint, Ocugen, the US partner of Bharat Biotech, on Thursday said the company will now be seeking a full approval of Covaxin.

“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.

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

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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.

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.

In a statement on Friday, Bharat Biotech said, “With good herd immunity and significant percentage of the population vaccinated, the pandemic is reducing in the United States. The USFDA had earlier communicated that no new EUA’s will be approved for covid vaccines. All applications have to follow the biological license application process, with is the standard process for vaccines. Data from an additional clinical trial will be required to support the marketing application submission for Covaxin. Covaxin has received EUA’s from 14 countries with more than 50 countries in process. No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA. When approved, it will be a Great Leap Forward for vaccines Innovation and manufacturing from India."

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first published:June 11, 2021, 08:34 IST