The U.S. health department announced new steps to collect and examine reports of health problems following shots. The plan includes an NIH clinic, changes to VAERS and vaccine-event entries in electronic health records.
A National Institutes of Health clinic opened on Oct. 5 to evaluate patients who report health problems after vaccination and study their cases, HHS said. The department also proposed reimbursing physicians for reports to the Vaccine Adverse Event Reporting System, or VAERS. It said the CDC would update the system and that electronic health records would capture reported events.
VAERS accepts reports from patients, clinicians and others about events that occur after vaccination. The CDC says a report by itself does not show that a vaccine caused the problem. The data can flag possible safety signals for further investigation.
The United States has a separate no-fault compensation program for vaccine injuries. Reuters reported that it has paid about $5 billion on roughly 12,300 injury and death claims since 1988. Claims are filed with the government rather than vaccine makers.
The initiative comes amid legal challenges to changes in the childhood vaccination schedule. The CDC revised several universal recommendations in January. A federal court blocked key parts of the changes in March, finding that HHS had violated federal law in restructuring the agency’s vaccine advisory committee. The injunction also stopped the committee from holding meetings to issue recommendations often needed for insurance coverage.
Kennedy has long questioned vaccine safety and is reshaping federal immunization policy. Public health experts have raised concerns about falling vaccination rates and a resurgence of measles. HHS says the new effort is intended to improve patient care and build better evidence. Reports of events after a shot, on their own, do not establish that the vaccine caused them.