FDA rejects EUA proposal for COVAXIN vaccine

RNS: The United States Food and Drug Administration (FDA) has rejected an emergency use authorization (EUA) of India’s indigenous manufactured COVAXIN jab.

COVAXIN is India’s indigenous developed COVID-19 vaccine, being manufactured in India by Bharat Biotech a Hyderabad-based company. Bharat Biotech inked an agreement with Ocugen Inc, a biopharmaceutical company headquartered in Pennsylvania, US on 2 February 2021 aiming to explore the market in the US and Canada.

Ocugen, the US partner of Bharat Biotech said that the US Food and Drug Administration (FDA) has refused an emergency use authorization (EUA) to COVAXIN on the basis of inadequate data from clinical trials.

According to media reports, the US FDA has asked Ocugen to launch an additional trial and file for a Biologics Licence Application (BLA), which is a full approval.

In a statement issued on Friday by Bharat Biotech stated that “USFDA had earlier communicated that no new EUA’s will be approved for COVID vaccines. All applications have to follow the biological license application process, with is the standard process for vaccines.”

Reacting to the FDA’s rejection of COVAXIN jab for emergency use authorization, the Union Health Ministry on Friday said that it respects the decision taken by the authority but it will not have any impact on India’s vaccine plan.

Dr VK Paul, Member-Health, Niti Aayog expressed hope that the vaccine maker will comply with what the FDA has wanted. “We expect that our manufacturers will be able to comply with it. It has no impact on our own program. Our regulator has approved it,” he added.

He also said that Covaxin’s phase-3 trials will be published in a week’s time.

Meanwhile, several countries do not recognize the COVAXIN vaccine at present; those who have received two doses of the vaccine are considered “unvaccinated” in some countries.

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