Did the FDA Understaff Its Review of the Pfizer/BioNTech Vaccine?
COVID-19, Vaccine, Food and Drug Administration
In what is arguably the most important decision the Food and Drug Administration has made this year — its emergency use authorization of the Pfizer/BioNTech Covid-19 vaccine — the agency apparently assigned only a single reviewer in each of two key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes months to do.
The FDA’s authorization last week followed similar authorizations in the United Kingdom and Canada. But the FDA’s decision is particularly important because of its reputation for being the international “gold standard” in regulatory rigor.
Peter Doshi & Matthew Herder, "Did the FDA Understaff Its Review of the Pfizer/BioNTech Vaccine?", Opinion Editorial, STAT (17 December 2020) online: < www.statnews.com > [perma.cc/4PFX-CRR4].