This week, two of the FDA’s top vaccine regulators announced that they would be leaving the agency this fall, apparently in part out of frustration with the government’s booster plan. Dr. Marion Gruber, who heads the agency’s vaccine office, and her deputy Dr. Philip Krause have told people that there isn’t nearly enough data to justify offering the general population additional vaccinations starting at just a few weeks.
More friction may be imminent. On September 17, the FDA’s external advisory committee is due to publicly review Pfizer’s data supporting a booster vaccination. Although Pfizer has asked the FDA to approve booster doses for people aged 16 and over, the agency may decide who can get a booster vaccination restricted. The CDC and its external advisory body would also have to weigh up.
A key member of the FDA advisory board, Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, argues that boosters are premature. “There is no compelling reason to get a third dose now,” he said in an interview on Thursday.
He said the government apparently expected the FDA and CDC to approve their booster schedule. “The bypassing and marginalization of these agencies has resulted in veterans who need you in this pandemic leaving the FDA,” he said, referring to the departures of Dr. Gruber and Dr. Frill.
Various studies have shown that the Pfizer-BioNTech and Moderna vaccines decrease in effectiveness against infection over time, but suggest that the vaccines continue to provide robust protection against serious illness and hospitalization.
But dr. Vivek Murthy, the surgeon general, said in an interview Thursday that some studies suggest a decrease in protection from serious illnesses over time. “Our feeling was that if we waited several more months, the protection against hospitalizations and deaths would break down,” he said.
In an interview posted on WebMD.com Thursday, Dr. Woodcock shared this view, saying that the trend towards breakthrough infections has at some point led health officials to believe that “we will experience hospitalizations and more serious illnesses in fully vaccinated people”. . When that happens, she said, “let’s be ready with the booster plan”.
Some Americans are given a booster vaccination even before FDA approval: more than a million fully vaccinated people have received an extra dose since mid-August.