HHS Touts New Vaccine-Injury Initiatives

HHS announced a series of initiatives to further study vaccine industries, but public health advocates and vaccine experts say they will sow more mistrust in vaccines.

Health Secretary Robert F. Kennedy Jr. “has once again created a solution to a problem that doesn’t exist. It’s more window dressing to advance his anti-vaccine agenda and will only serve to create more confusion and doubt in public health,” said Elizabeth Jacobs, PhD, professor emerita of epidemiology and biostatistics at the University of Arizona in Tucson. “None of the proposed changes is likely to have an impact in providing reliable data regarding vaccine adverse events or risk factors. They do not even address studying potential cause-effect associations.”

The initiatives announced Thursday by HHS — some of which had been previously announced individually — include:

• A new NIH clinic dedicated to studying and caring for patients experiencing health problems following vaccination
• A proposal to pay physicians for reporting suspected vaccine-related injuries to the Vaccine Adverse Event Reporting System (VAERS) through a new CMS policy
• A proposal to require electronic health records to capture vaccine-related adverse events
• Modernizing VAERS to make reporting simpler and improve the tools available to researchers and medical professionals

“We must listen to patients and families who report vaccine injuries — not dismiss or gaslight them,” Kennedy said in a press release. “President Trump and I are building a health system that takes them seriously, follows the evidence, and uses what we learn to make vaccines safer. This is how we earn back trust in our public health institutions.”

Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said in a phone interview that Kennedy was continuing his several-decade mission of being an anti-vaccine advocate rather than serving as HHS secretary for all the people. “He’s on a mission to shred vaccine infrastructure. That’s what he’s going to do here,” Offit said.

“He’s about to put forward a series of poorly performed, confounded studies that show that vaccines are causing any number of chronic diseases,” Offit continued. “I think he’s hopeful that he’ll be able then to get the Vaccine Injury Compensation Program [VICP] to include those harms, including autism, which will make both him and his personal injury lawyer friends wealthier because it would destroy the VICP and now open up vaccines to the slings and arrows of civil litigation.”

Not everyone disapproved of the administration’s announcement. “For years, vaccine injury was relegated to the backseat, VAERS data was regarded as unreliable, and doctors who viewed vaccine injury as a serious concern were marginalized,” Joseph Varon, MD, president and chief medical officer of the Independent Medical Alliance, formerly the Front Line COVID-19 Critical Care Alliance, said in a statement. “Secretary Kennedy and his team deserve real credit for prioritizing vaccine injury with the policy changes and tangible resources desperately needed to help those injured.”

The American Medical Association (AMA) put out a more cautious statement. “The AMA strongly supports legitimate, ongoing vaccine safety monitoring, as well as research grounded in sound science,” AMA President Willie Underwood III, MD, MPH, said in a statement. “Research is key to advancing our understanding of this issue, but it must be conducted objectively, transparently, and free from political influence.”

“We are already witnessing the rise in vaccine-preventable diseases due to declines in immunization rates across the U.S.,” Underwood concluded. “Continuing to undermine confidence in established vaccination practices will further lower immunization rates and fuel the return of preventable diseases.”

Daniel Salmon, PhD, MPH, director of the Institute for Vaccine Safety at Johns Hopkins University in Baltimore, said the idea of looking at cases of suspected vaccine adverse events is a good idea, but it’s “very hard to do, and it needs to be done well.”

While there are “lots of ways to make VAERS better,” Salmon said, there are still no data on unvaccinated people, and thus no control group, “so it will still have limited utility.”

As for clinicians determining and entering potential vaccine-related adverse events into electronic health records, Salmon noted it’s not clear how clinicians “would make such a determination” given a lack of clear-cut definitions.

“We want to see more science in this space,” he said, “but it’s got to be done well.”

Jacobs agreed. “VAERS is an early warning system, no more and no less,” said Jacobs, who is a founding member of Defend Public Health, a group that opposes many of the Trump administration’s changes to the public health system. “It’s an important component to vaccine safety efforts, but even with these changes it will not be able to provide any rigorous data regarding any potential relationship between vaccines and adverse events. No amount of modernization or reimbursement of healthcare professionals will change that fact. Frankly, if they were interested in improving the health of Americans, they would reimburse doctors for having to complete endless prior authorizations from insurance companies instead.”

Enterprise & Investigative Reporting Director Kristina Fiore contributed to this story.