Why India's Homegrown Covaxin Faced Rejection From US FDA

India has been administering Covaxin since January 16, 2021 even though its phase 3 results have still not been declared

The US Food and Drug Administration (FDA) has rejected the Emergency Use Authorisation (EUA) application for Bharat Biotech's Covaxin and has asked Ocugen, Bharat Biotech's US partner for more data.

This comes at a time when the inactivated SARS-CoV-2 virus vaccine produced by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology is facing criticism for its delayed Phase -3 results. Despite the company not sharing its final results, it is actively being administered to people in India since January 16, 2021. According to the interim results shared by the pharmaceutical, the vaccine has an 81% efficacy against SARS-Cov-2.

Ocugen will now be filing for a Biologics License Application (BLA) which will grant it full approval. They will have to launch an additional trial for the US FDA to review it and then grant it approval.

Why Did The FDA Reject The Application?

The US FDA announced in May that it would not give emergency use authorisation to any new COVID-19 vaccine applications and that vaccines will now have to apply for full application.

Ocugen had approached the FDA with the interim efficacy data released by Bharat Biotech in March. Even after the FDA's announcement, Ocugen, in a statement to its investors, stated that they would apply for the emergency use authorisation.

"Since we have been in discussions with the FDA since late last year, we do not believe that the FDA's recently revised guidance regarding EUAs raises any concerns about our ability to submit the EUA for Covaxin as planned, which is currently in process and which we expect to submit to the FDA in June. We believe that the FDA's new guidance confirms that Ocugen continues to meet all criteria for submission of a EUA," read the company's May 26 statement.

The FDA has now asked Ocugen to apply for BLA and the company believes that it will be able to get the vaccine to the US after this additional trial.

Why Are Countries Not Accepting Covaxin?

Covaxin has not been approved by the WHO, the USFDA or the European Union, yet. For the vaccine to be accepted by several countries, the vaccine needs to be approved by one of these regulators.

The WHO has approved the Oxford-AstraZeneca vaccine produced by SK Bio in Korea and Serum Institute of India, the Pfizer-BioNTech vaccine, the Moderna vaccine, the Jannsen vaccine, and the Sinopharm vaccine as emergency use listings. This allows the vaccine manufacturers to distribute their vaccines across the world.

As the regulators of many countries have not accepted Covaxin so far, the countries do not consider a person vaccinated if they have received Covaxin. Some US universities even wrote to their students that they will have to be revaccinated if they had received Covaxin or Sputnik V shots.

When Will Bharat Biotech Share Results?

Covaxin has been approved in India before it shared even its interim results and is being administered to the people in the country since January 16, 2021.

Published on June 4 as a pre-print in Medxriv, a non-peer-reviewed pan-India study called "Antibody Response after Second-dose of ChAdOx1-nCOV (Covishield™®) and BBV-152 (Covaxin™®) among Health Care Workers in India" aimed to check the antibody reaction among fully vaccinated health workers. The study found that the seropositivity rate- that is the proportion of people with antibodies against the virus was higher among the workers who received Covishield over those who received Covaxin.

When asked for their comment, Bharat Biotech told news wire agency ANI that it would be sharing its final efficacy results in the month of July which would show that their vaccine is equally effective.

Bharat Biotech further said that this study had questionable methodology and that they would only believe the results the Indian drug regulator will approve of. This study they added was not approved by the drug regulator nor registered on the Clinical Trials Registry of India.


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