Covid-19 roundup: FDA formally hands Pfizer/BioNTech's vaccine a priority review; European regulators look to Kineret to treat at-risk patients
The FDA said last Friday that it would give an expedited look at the Pfizer-BioNTech vaccine for full approval in patients ages 16 and older, with a PDUFA date set in January. But if past reports hold true, the jab could get the go-ahead long before the start of 2022.
Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, told Endpoints News in an April interview that it typically takes eight months to gain full approval, with two months to review the filing and six months to review the actual application. Due to the public health emergency at hand, Marks said that the agency was looking to make a decision on a “notably earlier basis” than normal.
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