The US Food and Drug Administration (FDA) has rejected the proposal for Covaxin’s emergency use in America. Henceforth, the emergency authorization of Covaxin is now delayed in the US. Ocugen, Bharat Biotech’s US partner said that; the company will now seek a full Covaxin approval. The US health authority has asked Bharat Biotech and Ocugen; to launch an additional trial. Moreover, the company needs to file for a Biologics License Application (BLA), which is a full approval.
FDA Rejects Application for Covaxin’s Use in America
Ocugen had earlier submitted a master file copy to the FDA. The health authority provided feedback; on the master file and recommended it pursue a BLA. Moreover, they have demanded additional data; on the information. India’s Covaxin approval; is currently rejected in the US. Ocugen is constantly working with the Food and Drug Administration; on additional documents required for approval. Currently, Bharat Biotech is also facing criticism in India; for not sharing its phase 3 clinical trials data. Their vaccine is in use for over 6 months now in the country. Covaxin is proven highly effective against COVID-19.
Covaxin Needs to Get Approval to Attain Global Recognition
Presently, Covaxin has not gained approval; in the global markets. A vaccine is needed to get approval; from either WHO or the FDA to cross borders. Many countries around the world; do not recognize Bharat Biotech’s COVID-19 vaccine. Those who have received both the Covaxin doses; are even considered unvaccinated in many countries. However, this has impacted mainly students who study overseas. Therefore, it is really important for Covaxin; to get approval as soon as possible.
Ocugen will Submit Additional Data to FDA Soon
Earlier this year, FDA said that it will not accept any applications for vaccine approval. Even after this announcement, Ocugen managed to get eligible; for submitting its application in June. The company’s application was rejected; because they had submitted only one trial’s result in March this year. Ocugen needs to submit more data to gain approval in the US. However, Covaxin’s rejection in the US; will not affect India’s vaccination drive. The central government hopes; that the company will soon complete the formalities; and gain approval in the US.