FDA Rejected Covaxin’s Emergency Use Authorization: Here’s Why

Why the US rejects Covaxin 2021? The US Food and Drug Administration(FDA) rejected Bharat Biotech’s proposal for an emergency use authorization(EUA). So working people, students and people who want to travel abroad to meet their families need to wait longer if they have been vaccinated by Covaxin.

Here’s Why the USA Rejects Covaxin

Bharat Biotech’s US partner Ocugen stated that Covaxin no longer requires emergency approval. According to the FDA’s suggestion, it should rather propose for full approval of the anti-COVID shot.

The biopharmaceutical company, Ocugen further said that the decision was made because of the recommendation put forth by the FDA asking the company to file an additional clinical trial so that it can apply for a Biologics License Application (BLA), which is known as a full approval.

According to a statement from Ocugen to NYSE, the FDA offered feedback to Ocugen related to the Master File the Company had submitted earlier and recommended that Ocugen should prepare for a BLA submission instead of a EUA application for its vaccine candidate and demanded adequate information and data.

The Company said that it expects the data of additional clinical trials should support the marketing application submission for the vaccine.

Ocugen Chief Executive Officer Dr Shankar Musunuri stated that this will extend the company’s timelines, they are committed to providing Covaxin to the United States.

The USA-Based biopharma player is co-developing the vaccine along with Hyderabad Biotech for the US market.

Ocugen successfully secured rights to market the Covaxin in Canada and has started discussion for regulatory approval from Health Canada.

Indian Government Response

The Government said on Friday it respects the FDA’s decision. Following FDA’s rejection, the US biopharmaceutical company declared that it will work for the submission of a biologics license application(BLA) for its Coronavirus vaccine candidate and that it won’t pursue EUA for Covaxin.

Everything you need to know about Covaxin

Covaxin is known as India’s indigenous COVID-19 vaccine developed by Bharat Biotech in collaboration with the ICMR.

In July 2020, the Covaxin got approval for Phase I and II Human Clinical Trials. 

Presently, Covaxin has emergency use approvals in more than 10 countries.

The Covaxin vaccine is produced using Whole-Virion Inactivated Vero Cell-derived platform technology.

Currently, several countries do not recognise Covaxin. But some countries approved Covaxin including Mauritius, the Philippines, Iran, Mexico, Nepal, Guyana, Zimbabwe and Paraguay.

Covaxin is added along with immune-potentiators. It is called vaccine adjuvants that are included in the vaccine to boost its immunogenicity.