Pfizer and partner BioNTech will request emergency approval for their coronavirus vaccine candidate on Friday. More specifically, the pair is submitting an application for emergency use authorization (EUA) from the U.S. Food and Drug Administration.
But what does EUA mean? And how could it begin to resolve the ongoing global health crisis?
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“Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible,” Dr Ugur Sahin, CEO and co-founder of BioNTech, said in a statement on Friday.
An emergency authorization expedites the usual approval process through the FDA. These authorizations are intended to address serious, threatening diseases where there are no other alternatives.
Earlier this week, Dr. Stephen Hahn, FDA commissioner, said these so-called EUAs have gotten more spotlight amid the coronavirus pandemic, though these emergency approvals are not new. Hahn said the agency will publicly post data relating to EUAs for vaccines and other products in an effort to gain the public’s confidence and for greater transparency.
“In considering EUA requests, the agency promptly and carefully evaluates the totality of the scientific evidence that is available on the product’s safety and effectiveness to determine whether the medical product may be effective for its proposed authorized uses,” Hahn wrote in a statement.
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To get to this point, Pfizer assessed its vaccine candidate through various stages of clinical trials, and ultimately found it was 95% effective. The FDA also required companies to submit two months worth of safety data before filing for an emergency authorization.
It is unclear exactly when the FDA will release a decision on Pfizer’s vaccine candidate, though reports surfaced of an advisory group meeting in early December to discuss coronavirus vaccines, per CNBC, though these dates are reportedly tentative. This progress upholds a previously anticipated timeframe of potentially having initial doses of the vaccine in December.
Pfizer has previously said it expects to produce up to 50 million doses in 2020, and up to 1.3 billion doses in 2021. It will be offered in a two-dose jab, not unlike other candidates currently in development. The vaccine’s two doses will be separated by a period of 21 days, with the first shot occurring on day zero.
Fox News’ Alexandria Hein contributed to this report.