The Federal Drug Administration (FDA) has caused concern among medical professionals after approving a fourth dose of the COVID vaccine for Americans 50 and over.
Dr. Marty Makary, a medical commentator and public policy expert from Johns Hopkins University, wrote an op-ed for The Wall Street Journal criticizing the FDA’s decision to approve a fourth vaccine dose. He cited how some of the agency’s experts did not even agree with the decision.
The New England Journal of Medicine’s editor-in-chief, Eric Rubin, sits on the FDA’s advisory committee. Last month, Rubin told CNN that he had not seen enough data to suggest anyone needs a fourth dose unless their immune system is seriously deficient.
“The only data that I’ve seen has been for participants followed for just a few weeks,” Rubin told CNN. “The most important information is going to be how well a fourth dose protects highly vulnerable people against serious disease and death, and I don’t know when that will be available.”
Another FDA committee member, Cody Meissner, chief of pediatric infectious diseases at Tufts Children’s Hospital, told Makary that the idea of a fourth dose is “an unanswered scientific question for people with a normal immune system.”
Paul Offit of the Children’s Hospital of Philadelphia, a member of the FDA’s Vaccines and Related Biological Products Committee, previously told the Atlantic in January that he advised his 20-something son not to get the third shot. The FDA recommends that everyone ages 12 and over receives the third booster. Offit told CNN he did not agree with recommending the fourth shot either.
“Where’s the evidence that somebody over 50 benefits from a fourth dose? Because the evidence to date appears to support the possibility for those over 65, although I haven’t, we haven’t, seen all the data… but where’s the evidence for a 50 to 64-year-old? Where’s that evidence? Because absent that evidence, then there shouldn’t be this recommendation,” he told CNN.
Makary says the FDA broke standard practice when it decided to approve the fourth vaccine dose by not taking the advice of independent experts on their committees.
The agency granted Pfizer a wide-ranging mandate to create the booster for Americans 50 and older. That was a bizarre move as the pharmaceutical company had only asked for emergency use approval of the fourth dose for Americans aged 65 and older.
Additionally, the FDA approved Pfizer’s application for emergency use just days after it was submitted for review, without convening its external vaccine experts.
The experts will have a chance to voice their opinion against the recommendation of a fourth booster shot in a meeting to discuss the future rollout of COVID-19 vaccines and boosters going forward.
Makary does not see much use for that meeting, as the FDA has already approved the fourth shot for Americans 50 years and older.
“That’s like having lawyers present arguments to a judge who’s already issued a verdict,” he said of the meeting in his WSJ column.
Still, officials from the FDA expect to roll out even more shots for Americans soon.
In a news briefing last week, Dr. Peter Marks, leader of the FDA’s Center for Biologics Evaluation and Research (thereby the top vaccine regulator in the agency), said he believes all Americans will need a fourth shot as early as this fall.
“It would not be surprising if there is a potential need for people to get an additional booster in the fall along with a more general booster campaign if that takes place,” Marks told reporters after the FDA authorized the fourth shot.
“It may be that a decision is made that rather than the vaccines we currently have, which are called vaccines against the prototype virus, that we will move to a vaccine that is either against one of the variants or something else.”
FDA Director Rochelle Walensky has asserted that additional doses of the COVID-19 vaccine are safe.
