Health and Human Services Agency Opens First Clinic to Study Vaccine Injuries
WASHINGTON — The Department of Health and Human Services opened a new National Institutes of Health clinic this week to evaluate and study patients who report health problems after vaccination, the centerpiece of a broader push by Secretary Robert F. Kennedy Jr. to document, investigate, and treat what the department calls potential vaccine-related injuries.
The clinic opened Oct. 5 on the NIH campus in Bethesda, Maryland. HHS and NIH leaders marked the opening with a ribbon-cutting. The department announced the clinic and three related actions on Oct. 8.
“We must listen to patients and families who report vaccine injuries — not dismiss or gaslight them,” Kennedy said in the department’s statement. “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.”
At the Bethesda event, Kennedy went further, according to footage released by HHS. “Vaccine injury is an invisible disease, and it is purposely invisible,” he said. “We have not done the studies that need to be done to understand who’s vulnerable to those kind of injuries.”
What the clinic will do
HHS said the clinic pairs specialized patient care with research. NIH clinicians and researchers will evaluate patients, study their experiences, investigate possible causes, and look for better approaches to care. The department said the goal is to expand access to evaluation while building evidence on health problems reported after vaccination.
An internal NIH memo obtained by NPR and Inside Health Policy describes the work as an observational study of people who say they were injured by vaccines, with findings that could inform changes to recommended vaccine schedules. The public HHS announcement does not mention schedule changes. NIH Director Jay Bhattacharya’s office declined comment to The New York Times on the initiative.
Reporting, records, and reimbursement
The clinic is one of four steps HHS listed:
A new NIH clinic for patients reporting health problems after vaccination.
A Centers for Medicare & Medicaid Services proposal to reimburse physicians, for the first time, for time spent filing suspected vaccine-injury reports to the Vaccine Adverse Event Reporting System. HHS said the change would align vaccine reporting with ordinary Medicare payment rules and reduce barriers to reporting.
A requirement, through federal health-information technology standards, that electronic health records capture vaccine-related adverse events so the information follows patients between providers.
Modernization of VAERS so reporting is simpler and more useful to researchers. On Sept. 28, the Centers for Disease Control and Prevention awarded a contract of about $992,000 to SPN Solutions to build a modernized reporting application, including mobile access. CDC also added a VAERS QR code to Vaccine Information Statements earlier this year.
VAERS is a passive system. Patients, doctors, manufacturers, and others can file reports. A report is not proof that a vaccine caused the event. Federal officials have long used it as an early-warning tool that can flag patterns for further study. Kennedy has repeatedly called the system inadequate. In a Sept. 17 speech to Children’s Health Defense, the group he formerly led, he said injuries could be “very rare” but that the current system does not show how rare.
Existing compensation program
The United States already has a no-fault system for certain vaccine injuries. Congress created the National Vaccine Injury Compensation Program in 1986 after lawsuits over the whole-cell pertussis vaccine threatened the vaccine supply. The program, run through the Health Resources and Services Administration, began accepting claims in 1988 and is funded by an excise tax on covered vaccines.
HRSA states that compensation does not necessarily mean the vaccine caused the injury. About 60 percent of awards come from settlements in which HHS has not concluded that the vaccine caused the claimed harm. The agency also says serious side effects are rare. CNN reported that Kennedy has separately outlined plans to reform the compensation program.
