This week, two of the FDA’s top vaccine regulators announced they would be leaving the agency this fall, apparently in part due to frustration with the administration’s booster plan. dr. Marion Gruber, who heads the agency’s vaccine office, and her deputy, Dr. Philip Krause, people have been telling people there was not nearly enough data to justify offering additional injections to the general population starting in just weeks.
There could be more friction ahead. On September 17, the FDA’s external advisory committee will publicly review Pfizer’s data in support of a booster shot. Although Pfizer has asked the FDA to approve booster doses for people ages 16 and older, the agency could decide to limit who gets a booster. The CDC and its external advisory panel should also weigh in.
A key member of the FDA’s advisory panel, Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital in 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 administration seemed to expect the FDA and CDC to stamp their booster timeline. “Bypassing and marginalizing those agencies has resulted in veterans you need in this pandemic leaving the FDA,” he said, referring to Dr. Gruber and Dr. Krause.
Several studies have shown that the potency of the Pfizer-BioNTech and Moderna vaccines decreases over time against infection, but suggest that the vaccines continue to provide robust protection against severe illness and hospitalization.
But dr. Surgeon general Vivek Murthy said in an interview on Thursday that a few studies have suggested a decline in protection against serious diseases over time. “We felt that if we waited a few more months, we would see protections against hospitalizations and deaths diminish,” he said.
In an interview published Thursday on WebMD.com, Dr. Woodcock expressed that opinion, saying the trend of breakthrough infections has led health officials at some point to believe that “we will see hospitalizations and more serious illnesses” among fully vaccinated people. When that happens, she said “we want to be done” with the booster plan.
Some Americans are already getting booster shots ahead of FDA approval: More than a million fully vaccinated people have received an extra dose since mid-August.