This week, two of the FDA’s top vaccine regulators announced that they will be leaving the agency this fall. apparently partially because of frustration with management’s support plan. Heading the agency’s vaccine office, Dr. Marion Gruber and her assistant Dr. Philip Krause said there isn’t nearly enough data to justify extra vaccinations to the general population starting in just weeks.
There may be more friction ahead. On September 17, the FDA’s external advisory committee is scheduled to publicly review Pfizer’s data supporting a booster shot. Although Pfizer has requested the FDA to approve supplemental doses for people 16 years of age and older, the agency may decide to restrict who receives support. The CDC and its external advisory panel would also have to weigh in.
One of the key members of the FDA’s advisory board is Dr. Paul Offit argues that boosters are premature. “There is no longer a compelling reason to take a third dose,” he said in an interview Thursday.
He said management expects the FDA and CDC to rubber-stamp the booster timeline. Dr. Gruber and Dr. “Bypassing and marginalizing these agencies has driven the veterans you need in this pandemic to leave the FDA,” he said, referring to Krause’s departures.
Various studies have shown that the efficacy of Pfizer-BioNTech and Moderna vaccines diminishes over time against infection, but suggests that the vaccines continue to provide strong protection against severe illness and hospitalizations.
However, general surgeon Dr. Vivek Murthy said in an interview on Thursday that several studies have suggested a decline in protection against serious diseases over time. “Our feeling was that if we wait a few more months, we’ll see the protection against hospitalizations and deaths deteriorate,” he said.
a Interview published on Thursday At WebMD.com, Dr. Woodcock echoed this view, saying that the breakthrough infection trend had led medics to believe that at some point, “we would see hospitalizations and more serious illness” among fully vaccinated people. When that happens, he said, “we want to be ready” with the empowering plan.
Some Americans are already taking booster shots before FDA approval: more than a million Since mid-August, fully vaccinated persons have received an additional dose.