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Why Was Bharat Biotech’s Covaxin Not Approved In US?

New Delhi: Bharat Biotech’s Made in India COVID vaccine Covaxin has not been approved for emergency use in the United States. Rejecting Covaxin’s application for emergency use authorisation in the US, the Food and Drug Administration (FDA) sought more data on the clinical trials for the vaccine.

Why did FDA reject Covaxin?

The reason behind FDA’s rejection is because Bharat Biotech submitted partial trial data from March this year. According to an official statement, the FDA has asked Ocugen to submit additional trial data so that it can file for a Biologics Licence Application (BLA), which is a full approval, instead of the emergency use approval.

Covaxin has been facing criticism in India for not sharing its Phase-3 trial data, despite being approved by India’s top drug regulator, the Drugs Controller General of India (DCGI) six months ago.

Covaxin’s lack of Phase-3 trial data

Bharat Biotech, which is currently carrying out the Phase-3 clinical trials for Covaxin, informed news agency ANI on Wednesday that it will make the data public in July, following which the company will be applying for full licensure of the Covid-19 vaccine. “Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for Covaxin,” Bharat Biotech told the news agency.

Bharat Biotech added that Phase-4 trials are also being done to check the “real-world effectiveness” of the vaccines” and to meet scientifically approved standards for safety and efficacy.

Phase 3 trial data of Bharat Biotech’s Covaxin is essential for validation from the World Health Organisation (WHO), which will allow the Hyderabad-based pharmaceutical company to export its Covid-19 vaccine and make it a part of the much-coveted “vaccine passport”.

However, without the Phase 3 trial data, Covaxin remains unapproved in several countries. Some foreign countries are even considering Indian students vaccinated with Covaxin as “unvaccinated”.