A new US initiative to investigate reported vaccine injuries and overhaul adverse-event reporting is drawing criticism from experts who say existing safety systems are being overlooked.
The Department of Health and Human Services has unveiled a broad new push to investigate reported vaccine injuries, opening a dedicated clinic at the National Institutes of Health, proposing payment for doctors who file suspected cases and ordering electronic health records to capture vaccine-related adverse events. According to the department’s announcement on 8 October, the package also includes plans to modernise the Vaccine Adverse Event Reporting System, or VAERS, so that reporting is easier for clinicians and the database is more useful for researchers and medical staff.
The initiative has drawn sharp criticism from vaccine experts, who say the federal government already has multiple layers of vaccine safety monitoring in place. Paul A. Offit, director of the Vaccine Education Centre at Children’s Hospital of Philadelphia, told Healio that the new effort risks giving undue weight to weak claims and could be used to promote the idea that vaccines cause chronic illness. He pointed to the timing of the move, saying it comes as the United States is dealing with a large measles outbreak.
VAERS sits at the centre of the controversy. The CDC says the system records unverified reports and cannot, on its own, prove that a vaccine caused a medical problem. Kevin A. Ault, a professor of obstetrics and gynaecology at Penn State College of Medicine, told Healio that reporting to VAERS is already familiar to many physicians and is not especially burdensome. Ault, who served on the CDC’s Advisory Committee on Immunization Practices from 2018 to 2022, also said existing federal surveillance tools already track vaccine safety through VAERS, V-safe, the Vaccine Safety Datalink and the Clinical Immunization Safety Assessment Project.
The HHS announcement framed the changes as an attempt to restore confidence in public health institutions. In a statement cited by the department, Robert F. Kennedy Jr. said the administration wanted to listen to patients and families who say they have suffered vaccine injuries rather than dismiss them, and argued that the new steps would help make vaccines safer. The department did not answer Healio’s detailed questions about the policy, instead pointing to the same statement.
Medical groups warned that the messaging could have the opposite effect. The American Medical Association said investigating possible adverse events is important for patient safety and public trust, but cautioned that continued attacks on established vaccination practices could further depress immunisation rates and revive preventable diseases. The move is the latest in a series of vaccine-related actions from the Trump administration this year, following executive orders aimed at revisiting childhood vaccine schedules and reducing the number of vaccines recommended for children.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
