FDA earlier told that no new EUA will be approved for covid vaccines: Bharat Biotech – ET HealthWorld


Hyderabad-based Bharat Biotech today said that the USFDA had earlier communicated that no new Emergency Use Authorisation (EUA) will be approved for covid vaccines, a day after its US partner Ocugen hit a major bump after FDA rejected EUA for Covaxin.

The Pennsylvania-based eye disease company had to change its application from an Emergency Use Authorization to a full Biologics License Applications (BLA) approval.

Bharat Biotech said the biological license application process is the standard process for vaccines.

“No vaccine manufactured or developed in India has ever received Emergency Use Authorisation or full licensure from the USFDA,” it said in a statement.

So far, Covaxin has received EUA from 14 countries with more than 50 countries in the process.

The company said that an additional clinical trial will be required to support the marketing application submission for Covaxin.

“With good herd immunity and significant percentage of the population vaccinated, the pandemic is reducing in the United States,” it added.





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