As the US’s top vaccine officials come under pressure from lawmakers and former leaders, the US Food and Drug Administration (FDA) says it will release information “soon” about changes to regulations following unconfirmed claims of deaths after Covid vaccination.
It’s part of a sweeping effort, led by Robert F Kennedy Jr, secretary of the US Department of Health and Human services (HHS), to change the routine vaccines given in childhood, limiting access to and casting doubt upon safe and effective vaccines.
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), announced wide-ranging but vague changes to vaccine regulations in an email to staff where he also claimed, with no evidence, that Covid vaccination had killed 10 children.
The ongoing investigation is also focusing on deaths among adults after Covid vaccination, an HHS spokesperson confirmed.
“FDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to COVID vaccines,” HHS press secretary Emily Hilliard said in a statement. The agency will release more information “soon”, she said, claiming that “previous FDA leadership failed to properly investigate” the deaths.
The FDA was previously reported to be considering a total of 25 deaths pulled from the Vaccine Adverse Event Reporting System (VAERS) – a database to which anyone may submit reports.
“What I would want to know is, have these not been investigated before? What is different?” asked Debra Houry, former chief medical officer for the US Centers for Disease Control and Prevention (CDC). “I would want to see the data and have them verified.”
The announcement, and the lack of details in the weeks following, represents a major departure from previous FDA priorities to release information immediately about potential safety signals.
“It remains striking that even this much time has passed without details” or evidence to support the “bombshell” claim, said Jason L Schwartz, an associate professor of health policy and management at the Yale School of Public Health. “It’s so different than anything we would have typically expected if there had been a serious adverse event linked to a vaccine, let alone deaths, let alone deaths that a senior FDA official was saying were because of the vaccine.”
The longer the evidence is delayed, “the more it raises questions about what’s really under the hood regarding these allegations”, Schwartz said.
Democratic lawmakers on the US House committee on energy and commerce sent a scathing letter on Friday to commissioner Marty Makary, expressing “continued concern” over the FDA’s role in “undermining our nation’s vaccine infrastructure”. The letter decried a lack of transparency from federal officials and the inability for the public to comment on new regulatory approaches.
All 12 former heads of the FDA blasted Prasad’s moves as a “threat to evidence-based vaccine policy and public health security” last week in a commentary for the New England Journal of Medicine.
The senator Bill Cassidy, a Republican from Louisiana, requested a full Senate briefing on the claims, he said on X.
“Withholding this critical information is not radical transparency and will worsen confusion and fear among patients and parents,” Cassidy wrote. “We should not move forward on vaccine policy changes without further information.”
Yet Prasad’s memo indicated that changes were already underway – and Tracy Beth Høeg said the same before the Advisory Committee on Immunization Practices (ACIP) on Thursday. Høeg was tasked by CBER with looking for deaths after vaccination since the summer, and she was recently named acting director of the FDA’s Center for Drug Evaluation and Research (CDER).
The FDA is revising its framework for safety monitoring of vaccines, Høeg said at the meeting: “That’s in the works right now.”
Officials are “looking for more potential safety issues with vaccines”, Høeg said. That means “widening the net of potential outcomes that we’re looking at, and looking at different methodologies, so we’re sure to – we’re less likely to miss potential safety issues with vaccines.”
Some of the different methodologies for assessing risk are already being put in place, she added.
New vaccine regulations will “require better evidence for expanding indications of vaccines to populations, such as pregnant women [and] younger children”, including randomized controlled trials, Høeg said.
Pregnant people have not typically been included in initial clinical trials out of an abundance of caution; vaccines during pregnancy are often approved later, after safety and effectiveness are established. Children are typically included in clinical trials after trials with adults have proven safe and effective.
Flu vaccines specifically are undergoing new oversight, Prasad said in his email, though he offered no reason for why safety signals over Covid vaccines might prompt changes to flu vaccines, which use completely different processes. Flu vaccines are updated each year.
There was a “full investigation” conducted “a number of years ago” into certain deaths in an unspecified time period following Covid vaccination, Høeg said. CBER staff, who were not named by Høeg or by Prasad in his email, ree-xamined the data in recent months. More information “should be coming imminently soon”, she said.
There was no other discussion at ACIP about the child death rumors, an omission Schwartz called “striking”. Previously, before Kennedy dismissed all 17 of the highly experienced advisers, there were regular updates on Covid vaccine effectiveness and any safety signals were thoroughly examined by the advisers. A discussion on monitoring the risks of Covid vaccines was planned in the draft agenda, but did not appear in the final schedule for this meeting.
“Let’s see the details. Let’s see the evidence. Let’s see the reports,” Schwartz said. “At this point, all the public has to go on are leaked internal emails.”
Convincing evidence would include “an autopsy report done by a medical examiner”, Houry said.
Health agencies take reports of serious adverse events very seriously, and they always investigate reports of death, Houry said. She would like to see details on how the new investigation differed from the initial investigation.
“What is new? What different information was received?” she asked.
It is highly unusual for an official to make claims like these without published data or discussion by advisory groups, Houry said. “It makes no sense – this was not following gold-standard science, where it’s reviewed by outside experts before it’s presented.”
The departure is part of a broader trend from health agencies to crack down on safe and effective vaccines, including new limitations on vaccines to protect against hepatitis B; measles, mumps, rubella, and chickenpox; and Covid, as well as vaccines containing thimerosal (AKA thiomersal), a preservative with a demonstrated safety record.
“The goalposts clearly seem unreachable for some aspects of our vaccine development, especially flu vaccines,” Schwartz said. “It certainly seems like the scales are tipped against facilitating the introduction of new vaccines, even ones with long records of success.”
