FDA Finally Grants Full Approval to Pfizer Vaccine

Jeffrey A. SingerAftercalls from members of the scientific, public health, and medical community —myself included —the Food and Drug Administration finally overcame bureaucratic inertia and granted full approval to the Pfizer‐​BioNTech mRNA COVID-19 vaccine—ahead of its self‐​imposed deadline of January 2022. This is good news. Pfizer will now market the vaccine under the brand nameComirnaty.Hundreds of millions of doses have been administered over the course of nearly a year and the safety profiles of these vaccines have been remarkably good. Now the FDA should move quickly on the other mRNA vaccine made by Moderna. The company submitted its application for full approval in June, a month after Pfizer ’s application. Johnson and Johnson, makers of the one‐​dose adenovirus‐​based vaccine has not yet applied for full approval.It is important to stress that, while the vaccine does not prevent 100 percent of infection, it is highly effective against severe disease —severe enough to require hospitalization and/​or death. The health care news site MedPage Todayreported that Peter Marks, MD, PhD, Director of the FDA ’s Center for Biologics and Research issued the following statement:Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty ’s safety and effe...
Source: Cato-at-liberty - Category: American Health Authors: Source Type: blogs