Just days before the Food and Drug Administration (FDA) is set to come to a decision on whether to approve booster shots for the coronavirus vaccine, dissent both within the agency and the scientific community is threatening to upend these efforts, according to the New York Times.
The FDA’s Peter Marks, who is in charge of all agency policies concerning the vaccine, pointed to an article recently published by the medical journal Lancet, which saw a group of international scientists argue against implementing booster shots for the general public. Two of the scientists who argued against boosters are top FDA officials working under Marks: Marion Gruber, director of the Office of Vaccines Research and Review, and Philip Krause, Gruber’s deputy.
Marks said he was informed of the article by a friend who simply texted him “Oh my God, it never stops.” Marks himself largely rejected the findings of the Lancet article, claiming that the article did not cite enough evidence from Israel, which has the highest rate of vaccinations per capita in the world, primarily with the Pfizer vaccine.
“I’m fully confident,” Marks said on Monday, “that when people come to the advisory committee meeting, and they witness the Israelis presenting their data, and they witness other data being presented, that there will be a good rationale for why boosters might be necessary.”
The FDA is scheduled to hold a meeting with its vaccine advisory committee on Friday to discuss the possible approval of a booster shot for the Pfizer-BioTech vaccine, the only one of the three vaccines that has previously been approved for wider use by the FDA.
With such outspoken dissent from directly inside the agency, the future of the planned booster shots remains in doubt. Such a proposal already faces opposition from the general public, which remains overwhelmingly opposed to the forced use of experimental vaccines or corresponding booster shots.
The coming decision on boosters, according to former FDA official Jeff Nesbit, will be among “the top five” most important decisions in the history of the agency. Eric Topol, a professor of molecular medicine at Scripps Research in La Jolla, said that “we have got a real problem here,” and “the last thing we need right now is all this infighting.”
Although the FDA does not have to follow the recommendations of the advisory committee, the optics of a split board, or even one in opposition to possible booster shots, would create even more chaos in the messaging front and solidify external opposition to any future mandates or restrictions.