Memos released in recent days by the Food and Drug Administration show that the agency’s vaccine chief overruled staff scientists who favored widespread access to Covid shots, setting off a firestorm of criticism from lawmakers, state officials and doctors.
Agency staff members had concluded that the F.D.A. should allow a wide range of age groups to receive the vaccines, citing high hospitalization rates among young children with Covid and saying that the virus’s evolution is “complex and remains unpredictable.”
But Dr. Vinay Prasad, the agency official in charge of vaccines and gene therapies at the F.D.A., disagreed, overriding those scientists and deciding to issue very narrow eligibility limits.
The F.D.A. last week said that no one under 65 was eligible to receive the Covid vaccines made by Moderna or Pfizer unless they had underlying medical conditions that put them at risk for severe disease.
The agency’s policy was the most restrictive to date for public access to the shots, intensifying opposition to the Trump administration’s retreat from longstanding vaccine standards and accepted childhood immunization schedules.
The fissure underscores the continuing clashes between Health Secretary Robert F. Kennedy Jr.’s decision-making on vaccine policy and the positions of long-serving federal officials and public health experts. The split was most recently exemplified by the mass exodus last week of top officials at the Centers for Disease Control and Prevention.
The divisions also have been playing out with some public distrust of the Covid shots that use mRNA technology, highlighted this weekend by President Trump in a social media post. The president, without mentioning Mr. Kennedy, demanded more data on the vaccines.
In one memo, Dr. Prasad seemed to echo those concerns by seeking further studies and data on the pandemic-era shots. He wrote: “No one knows if these products have harms that only materialize 10 or 20 years later, as such is a necessary limit of time. It is ignorant to claim that unknown long-term risks are not possible.”
On Wednesday, Pfizer responded to Mr. Trump’s concerns, saying it would release more data and heaping praise on the president’s leadership of Operation Warp Speed, the program that accelerated the development of Covid-19 vaccines. Dr. Albert Bourla, the company chief executive, said the federal effort “saved over $1 trillion in health care costs due to reductions in serious illness and avoidance of hospitalizations.”
“This American leadership also delivered a new platform that may drive significant innovation in cancer research,” Dr. Bourla said in a statement, referring to mRNA technology. “Such an accomplishment would typically be worthy of the Nobel Peace Prize, given its significant impact.”
In his memo, Dr. Prasad nodded to increasing public reluctance toward giving healthy children the shots. Rates of Covid vaccination among young people have declined as they are less likely to become severely ill from the virus.
“F.D.A. is ultimately accountable to the American people, and Americans have overwhelmingly stated that they feel the evidence to vaccinate a healthy child with a Covid-19 mRNA product is not enough to compel them to act,” Dr. Prasad’s memo stated.
He also requested studies that include a close look at whether the spike protein generated by the vaccines lingers in the body and contributed to long Covid symptoms. Dr. Prasad stated that many people had drawn a correlation between the two, although he said he had not.
Noel Brewer, a professor at the University of North Carolina who was among the 17 C.D.C. vaccine advisers fired by Mr. Kennedy, said some scientists would welcome efforts to examine a possible link.
But he said vaccine confidence among those without a science background tended to come from individual doctors and some health officials.
“Having people at the head of these government agencies cast doubt on vaccines has been very unhelpful,” Dr. Brewer said. “So the good work they’re trying to do by gathering new data will do only a little bit to help a nation recover from all the doubts that have been cast on vaccination by the leadership.”
It also remains to be seen whether the new studies will satisfy Mr. Kennedy, who once petitioned the F.D.A. to pull the Covid vaccines off the market during a deadly phase of the pandemic when he worked as an anti-vaccine activist. The health secretary also has espoused a discredited theory that the Covid vaccines were the deadliest ever made.
Mr. Kennedy, however, has been supportive of Dr. Prasad, helping to persuade the president that he should be hired back after being forced out of the F.D.A. earlier this summer.
The newest vaccine policies and other recent moves at the F.D.A. and the C.D.C. have unsettled outside public health experts and some states, leading to new coalitions that are distancing themselves from the latest federal shifts in immunization guidance.
Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia who has been harshly critical of Mr. Kennedy, was ousted from a key F.D.A. panel. Dr. Offit said a senior F.D.A. official asked him to stay on the committee, but his application was not approved at the Department of Health and Human Services late in August.
An H.H.S. spokesman said Dr. Offit’s removal was part of a routine decision against renewing members of several committees. Dr. Offit said he couldn’t speculate on whether the action was related to his calls for Mr. Kennedy to resign.
“He’s exactly the wrong person you want in this position,” Dr. Offit said on Tuesday. “He’s a science denialist, so he doesn’t have any interest in good science.”
Though the recent approvals made the Covid vaccines available to people who are 65 and older, the federal restrictions have already begun to raise concerns about access. CVS and Walgreens pharmacies have imposed limits on the shots in some states until further federal action is taken.
The drugstore chains and other providers are waiting on recommendations of the C.D.C.’s influential vaccine advisory committee, which is expected to meet on Sept. 18 and 19. It could further limit who can get the shots through recommendations that affect insurance coverage and whether pharmacy staff members can administer the shots.
The latest round of F.D.A. decisions approved Pfizer and Moderna vaccines for children, replacing emergency authorizations, including updated shots aimed at a more recent strain of the virus.
For the Moderna shot, F.D.A. records show that staff scientists carefully reviewed data presented by C.D.C. staff experts earlier this year. They showed that young children from 6 months to 23 months of age had high rates of hospitalization, with about 100 per 100,000 young children.
Those were similar rates to adults ages 50 to 64, who nearly unanimously had at least one underlying condition, compared with fewer than half of the young children, F.D.A. staff scientists stated in their recommendations to agency officials.
The American Academy of Pediatrics also pointed to that data in its recommendation that all children in that age group get the Covid vaccination.
Dr. Prasad outlined his reasoning for limiting the vaccine to children who had at least one medical condition that would put them at elevated risk of severe disease. (Those conditions, such as obesity, physical inactivity and asthma, are listed here.)
He wrote that many of the large studies were conducted during earlier phases of the pandemic, saying the trials were not large enough to detect meaningful numbers of hospitalizations and deaths, since they are rare in children. He also pointed out that European countries do not recommend giving to the shots to healthy children.
“The U.S. has been a global outlier with its push to vaccinate healthy children with a novel mRNA product,” Dr. Prasad wrote.
Among other initiatives, Dr. Prasad indicated that he wanted more questions answered about the practice of giving several vaccines, like those for the flu, RSV and Covid, at the same time.
He said Pfizer should study the effects of that practice and questioned whether receiving the shots together increased the rates of side effects, like Bell’s palsy.
“Such a trial may be able to ascertain even unexpected increases in safety signals,” he wrote. “In the absence of such studies, F.D.A. cannot affirm that concurrent administration is both safe and effective.”
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
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