Aiming to streamline the compensation process for people claiming harm from COVID-19 vaccines, Robert F. Kennedy Jr.’s Department of Health and Human Services is gearing up to draft a list of injuries believed to be linked to the shots.
In a proposed rule uploaded to the site of the Office of Information and Regulatory Affairs, HHS said that the anticipated table will “list and explain injuries that, based on compelling, reliable, valid, medical, and scientific evidence, are presumed to be caused by covered COVID-19 countermeasures" recommended under the Public Readiness and Emergency Preparedness Act.
The posting did not specify what types of vaccine injuries HHS currently has in mind, and the Department did not immediately respond to Fierce’s request for comment on its plans for the table.
While rare, certain injuries associated with mRNA COVID vaccines, such as myocarditis, have been recognized by medical literature. Nevertheless, COVID-19 vaccines are also a popular bugbear among the anti-vaccine movement, making this latest development not all that surprising given Kennedy’s well-documented history of vaccine skepticism.
The table is also expected to clarify the timeframe in which those injuries must have occurred after the use of a COVID-19 countermeasure to make a claim.
The list of injuries would ultimately support the United States’ Countermeasures Injury Compensation Program (CICP), under which the HHS secretary has the authority to provide benefits to people “who sustain serious physical injury or death as a direct result of the administration or use of covered countermeasures,” per the text of the proposed rule.
The rule responsible for the table is slated to be proposed in November, and a public comment period will subsequently wrap up in January 2027, according to the rule notice.
The language on the standards for including an injury in the table could be cause for concern given that, if read broadly, it may give Kennedy the power to make a “scientifically unsound table decision and then argue that no court can review it,” Richard Hughes IV, of the law firm Epstein Becker Green, told Stat News this week.
At the same time, Hughes acknowledged the benefit in drafting an injury list specifically for COVID vaccines, which could help implement federal compensation programs as originally envisioned.
A fixation on vaccine policy and safety has been a hallmark of Kennedy’s tenure as HHS secretary.
In one high-profile example, last year’s shock exit of former FDA Center for Biologics Evaluation and Research (CBER) chief Peter Marks, M.D., Ph.D., was allegedly driven in part by the ex-director’s attempts to prevent Kennedy’s unfettered access to the federal vaccine safety database VAERS, in Marks’ own telling of the events.
Marks stressed that he’d tried to compromise with Kennedy, and was willing to make the adverse event reporting system more transparent, but he had concerns about what the Health secretary’s team would do with broad access to the database, according to an interview he gave to the Associated Press last April.
Earlier this year, former FDA commissioner Marty Makary, M.D., unveiled a new, unified adverse event monitoring system, known as the FDA Adverse Event Monitoring System (AEMS), which has brought vaccine and drug and biologic event reports under a single umbrella.