In a minor setback to Hyderabad based pharma giant Bharat Biotech, the FDA has rejected the Emergency Approval for Covaxin, the company’s COVID-19 vaccine. The company in its statement added that it will pursue the full license path. How is Emergency Usage Approval different from full license path, and why did the FDA rejected the EUA for Covaxin, let’s find out.
Details
Bharat Biotech’s Covaxin was rejected by the US Food and Drug Administration (FDA) for the EUA (Emergency Usage Approval). The FDA asked the US partner of Bharat Biotech – Ocugen Inc – to go for a Biologics License Application or Full License route. This crushes all hopes of Bharat Biotech for having its vaccine be approved for emergency use.
After the development, Ocugen Inc released a statement saying the company won’t further pursue EUA and will go on the route as suggested and recommended by the FDA.
“The company will no longer pursue an Emergency Use Authorization (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the Master File. The company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data,”
-Ocugen’s statement read.
Why did FDA reject Bharat Biotech’s Covaxin for EUA?
According to the Ocugen, the US based drug and food regulatory body did not give approval due to insufficient data required to make the decision. Ocugen’s CEO and co-founder, Dr. Shankar Musunuri claimed that the company was close to finalizing its EUA application, but the FDA suggested the company to go down the BLA path. “While this will extend our timelines, we are committed to bringing Covaxin to the US,” Dr. Musunuri said.
What is the difference between full FDA approval and EUA?
According to FDA’s own website-
“Emergency Use Authorization (EUA) is a regulatory mechanism to allow the use of vaccines and medicines to prevent and/or reduce the impact of life-threatening diseases or conditions as caused by COVID-19.”
An EUA approved vaccine can be used in a situation when there are no other adequate & approved treatment options. An EUA is in place till the time a public health emergency has not ended.
Meanwhile, fully approved FDA vaccines can remain in the market even when the public health emergency is declared to have ended.
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Has any vaccine so far received an EUA or complete license from the FDA?
According to Ocugen, so far not a single Indian vaccine manufacturer has received the EUA or a BLA (biologics license application). The company states that if the Covaxin gets an approval by the United Nations, it will be a great leap forward for vaccine manufacturing in the country. It should also be noted that FDA has also announced that no new vaccine will be given an EUA.
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Does this FDA’s suggestion to Bharat Biotech mean that Covaxin is unsafe?
No. Earlier, the chairman of Bharat Biotech cleared that Covaxin has in fact showed high efficacy in the human clinical trials and it has even showed excellent record in trials related to emergency use.
“Our goal for all vaccines developed at Bharat Biotech is to provide global access. With its potential effectiveness against multiple existing and emerging variants, we believe that Covaxin is an important vaccine for everyone, including children, based on its unique yet traditional vaccine platform. We are diligently working with Ocugen to bring Covaxin to the US market and now to the Canadian market,”
-the chairman of Bharat Biotech, Dr. Krishna Ella said.
Although the FDA has not approved Covaxin for emergency usage approval, it has used the EUA from 13 countries across the world and the company is awaiting the confirmation of such EUA from 50 other countries.
