FDA to update regulations after unconfirmed claims of Covid vaccine-linked death | Trump administration

As top US vaccine officials face pressure from lawmakers and former executives, the US Food and Drug Administration (FDA) said it will “soon” release information on changes to regulations following unconfirmed claims of deaths after Covid vaccination.

It is part of a broader effort led by Robert F Kennedy Jr, secretary of the US Department of Health and Human Services (HHS), to change routine childhood vaccines, limiting access to and casting doubt on safe and effective vaccines.

Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, announced broad but vague changes to vaccine regulations in an email to staff in which he also claimed, without any 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.

“The FDA is conducting a thorough investigation, across multiple age groups, into deaths potentially linked to COVID vaccines,” Health and Human Services 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.

It was previously reported that the FDA was considering a total of 25 deaths taken from the Vaccine Adverse Event Reporting System – a database that anyone can submit reports to.

“What I would like to know is, have these issues not been investigated before? What is different?” asked Debra Houry, former chief medical officer of the U.S. Centers for Disease Control and Prevention. “I would like to see the data and have it verified.”

The announcement, and the lack of details in the weeks since, represents a major departure from the FDA’s previous priorities of immediately disclosing information about potential safety signals.

“It remains striking that even this much time has passed without details” or evidence to support this “bombshell” claim, said Jason L Schwartz, associate professor of health policy and management at the Yale School of Public Health. “This is so different from anything we would typically expect if there had been a serious adverse event related to a vaccine, let alone deaths, let alone deaths that a senior FDA official said were due to the vaccine.”

The longer the evidence is delayed, “the more it raises questions about what’s really behind these allegations,” Schwartz said.

Democratic lawmakers on the House Energy and Commerce Committee sent a scathing letter to Commissioner Marty Makary on Friday, expressing “continuing concern” about the FDA’s role in “weakening our nation’s vaccine infrastructure.” The letter decried a lack of transparency on the part of federal officials and the public’s inability to comment on new regulatory approaches.

Last week, the 12 former FDA officials called Prasad’s actions “a threat to evidence-based vaccine policy and public health safety” in a commentary for the New England Journal of Medicine.

Bill Cassidy, a Republican senator from Louisiana, requested a full Senate briefing on these claims, he said on X.

“Withholding this critical information does not constitute radical transparency and will increase confusion and fear among patients and parents,” Cassidy wrote. “We should not move forward on vaccine policy changes without more information. »

Still, Prasad’s memo indicated that changes were already underway — and Tracy Beth Høeg said the same thing before the Advisory Committee on Immunization Practices (ACIP) on Thursday. Høeg has been tasked by the Center for Biologics Evaluation and Research with researching 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 vaccine safety monitoring framework, Høeg said at the meeting: “That is in progress right now. »

Officials are “looking for more potential safety issues with vaccines,” Høeg said. This means “widening the net of potential outcomes that we look at, and looking at different methodologies, so that we can be sure to do so – we are less likely to miss potential safety issues with vaccines.” »

Some of the different risk assessment methodologies are already in place, she added.

New vaccine regulations “will require better evidence to expand vaccine indications to populations, such as pregnant women.” [and] young children,” including randomized controlled trials, Høeg said.

Pregnant people were generally not included in initial clinical trials as a precaution; Vaccines during pregnancy are often approved later, once their safety and effectiveness have been established. Children are usually included in clinical trials after trials with adults have been shown to be safe and effective.

Flu vaccines in particular are under new scrutiny, Prasad said in his email, although he gave no reason why safety signals regarding Covid vaccines might lead to changes in flu vaccines, which use completely different processes. Flu vaccines are updated every year.

A “full investigation” was carried out “several years ago” into some deaths that occurred over an unspecified period after Covid vaccination, Høeg said. Staff at the Center for Biologics Evaluation and Research, who were not named by Høeg or Prasad in his email, have been re-examining the data in recent months. More information “should be coming shortly,” she said.

There was no further discussion at ACIP about the child death rumors, an omission Schwartz called “striking.” Previously, before Kennedy fired the 17 highly experienced advisers, there were regular updates on the effectiveness of the Covid vaccine and all safety signals were thoroughly reviewed by the advisers. A discussion on monitoring the risks of anti-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 needs to say are leaked internal emails. »

Compelling evidence would include “an autopsy report performed by a medical examiner,” Houry said.

Health agencies take reports of serious adverse events very seriously and always investigate reports of deaths, Houry said. She would like to have details on the differences between the new investigation and the initial investigation.

“What’s new ? What different information was received? she asked.

It’s highly unusual for an official to make such claims without published data or discussion by advisory groups, Houry said. “This makes no sense – it does not respect gold standard science, where data is reviewed by outside experts before being presented.

The departure is part of a broader trend by 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 that has been shown to be safe.

“The targets seem clearly unattainable for some aspects of our vaccine development, particularly flu vaccines,” Schwartz said. “It certainly appears that the balance is tipped against facilitating the introduction of new vaccines, even those with a long track record of success. »