The Pennsylvania-based eye illness firm needed to change its utility from an Emergency Use Authorization to a full Biologics License Applications (BLA) approval.
Bharat Biotech mentioned the organic license utility course of is the usual course of 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.