Two of the Food and Drug Administration’s top vaccine regulators are set to leave the agency this fall, a development that could disrupt the FDA’s work deciding whether to recommend coronavirus vaccines for children under 12 and booster shots for the general population.
dr. Marion Gruber, the director of the FDA’s vaccine agency, will retire in late October, and her deputy, Dr. Philip Krause, will be leaving in November, according to an email Dr. Peter Marks, the agency’s chief vaccine regulator, sent to staff on Tuesday. One reason for their departure was that Dr. Gruber and Dr. Krause were upset about the recent announcement by the Biden administration that American adults should receive a booster vaccination against the coronavirus eight months after receiving their second shot, according to people familiar with their thinking.
Neither believed there was enough data to defend such a decision, the people said, and both saw the announcement, reinforced by President Biden, as putting pressure on the FDA, the people said.
dr. Marks said he would serve as the vaccine agency’s acting director as the agency searched for its next leader. Stephanie Caccomo, a spokeswoman for the agency, said it was “confident in the expertise and ability of our staff to continue our critical public health work.”
Some public health experts have said the announcement of the government’s booster shot, which contained a warning that the FDA would first have to clear such shots, predated the agency and undermined its responsibility to make that assessment alone. by career scientists.
Some have also challenged the booster injection plan as premature, saying the available data shows that the Pfizer-BioNTech and Moderna vaccines hold up well against serious illness and hospitalization, including against the Delta variant. Additional injections would only be justified if the vaccines didn’t meet that standard, some said.
White House officials have emphasized that the plan for Americans to receive boosters next month was uniformly endorsed by top federal health officials, including Dr. Janet Woodcock, the acting FDA Commissioner. And they’ve described the need to develop a booster plan as urgent in the face of growing evidence that the vaccines lose potency against infection over time — a trend they fear will increase their protection against serious illness and hospitalization as well. could quickly weaken.
The officials have specifically cited data from Israel, which has vaccinated more of its population before than the United States, as a particularly worrying sign of what lies ahead. Data from other countries “have made us even more concerned about the increased risk of declining vaccine effectiveness against hospitalization, serious illness and death,” said Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention, attended a White House briefing on the pandemic on Tuesday.
When asked about reports that Dr. Gruber and Dr. Krause were unhappy with the pressure on the agency, Jeffrey D. Zients, the White House’s Covid-19 response coordinator, reiterated that the booster strategy is dependent on FDA review.
“As our medical experts have pointed out, after reviewing all of the available data, in their clinical judgment it is time to prepare Americans for a booster injection,” he said at the briefing. “We have announced our approach to stay ahead of the virus, give states and pharmacies time to plan and be transparent with the American people.”
But some critics have said the explanation falls short as FDA regulators are now trying to determine whether booster shots are safe and effective after the White House — and their own bureau chief, Dr. Woodcock – have already approved it to administer them.
“This process is the reverse of what we would normally expect in vaccine policy,” with the government announcing plans based on a certain outcome before regulators can complete their assessment, said Jason L. Schwartz, an associate professor of health policy at the Yale School of Public Health. . “That has made it even more complicated and confusing for the public.”