America’s drug regulator Food and Drug Administration (FDA) has refused emergency use authorization (EUA) to India’s indigenous Covid vaccine Covaxin. American company Ocugen partnered with Bharat Biotech for the vaccine.
This may prove to be a big setback for Bharat Biotech as Covaxin has not yet received approval from WHO. In such a situation, the denial of approval of a reputed regulator like FDA can become bad news for the vaccine. At present, many countries do not recognize Bharat Biotech’s vaccine.
In India too, there have been constant questions about Covaxin. Bharat Biotech is yet to release the data of Phase 3 trial. This data is very important.
Why didn’t the FDA approve?
The FDA has stated that the information was not sufficient to make a decision on the EUA request. In its feedback, the FDA has asked for ‘additional information and data’.
According to Ocugen, the regulator has advised to take full authorization through Biologic License Application (BLA). For this the company will have to launch a trial.
Ocugen says it is in talks with the FDA to understand what additional information will be required for a BLA request. There is a possibility that the data of an additional trial will be required for this.
FDA changed guidelines
Ocugen’s EUA request was rejected because the company submitted incomplete data for the Covaxin trial in March this year.
But the FDA changed its guidelines regarding approval of the Covid vaccine only last month. The regulator had said that it will no longer give EUA to the new application.
