RFK Jr. Proposes Overhaul of Vaccine Injury Compensation Program
Background: The 1986 No-Fault System
In 1986, Congress created the Vaccine Injury Compensation Program (VICP) under the National Childhood Vaccine Injury Act to stabilize the U.S. childhood immunization market. A special excise tax—currently $0.75 per disease covered per dose—feeds a Treasury trust fund that has disbursed $4.8 billion to date. The VICP’s no-fault design shields manufacturers from most civil verdicts, while providing streamlined adjudication by up to eight special masters in the U.S. Court of Federal Claims.
How the VICP Works Today
- Injury Table & Timeframes: Defines ~20 recognized adverse events (e.g., anaphylaxis, Guillain-Barré syndrome) with specific post-vaccination windows (e.g., 0–72 hours for anaphylaxis).
- Claims Process: Petitioners file Form 3624, pay a $400 filing fee, and submit medical records. The Department of Health and Human Services (HHS) and Department of Justice (DOJ) litigate before a special master.
- Funding & Payout: Awards cover medical expenses, lost wages, and capped pain-and-suffering ($250,000), plus attorneys’ fees. No punitive damages are allowed.
- Appeals: Unresolved petitioners may exit to federal district court, but the Bruesewitz v. Wyeth (2011) Supreme Court ruling limits negligence claims.
Proposed Changes by Secretary Kennedy
Since his May 2025 confirmation, HHS Secretary Robert F. Kennedy Jr. has signaled multiple interventions:
- Expand Compensable Conditions: Kennedy has publicly questioned the exclusion of autism, diabetes, narcolepsy, and other chronic ailments from the Injury Table.
- Extend Statute of Limitations: Current law imposes a 3-year limit from symptom onset; Kennedy aims to double or remove this cap, citing late-manifesting autoimmune diseases.
- Deregister Vaccines: He may delist shots from the VICP’s covered schedule, reopening manufacturers to civil suits and potential jury awards.
- Administrative Overhaul: Appointing Andrew Downing—an attorney with hundreds of VICP filings—to guide revisions, and potentially streamline evidentiary standards to favor petitioners.
Financial and Actuarial Analysis
Trust Fund Solvency: The Department of the Treasury projects VICP assets at $4.3 billion as of June 2025, yielding annual investment income of ~1.2%. Under a base caseload (≈300 new petitions/year), the fund remains solvent through 2045.
Stress Scenario: If autism and other high-prevalence conditions were added—with an estimated 1.1 million U.S. children diagnosed annually—the actuarial liability could swell by $50–$100 billion. Even a conservative 1% claim rate on total vaccine doses (≈300 million pediatric doses/year) would exhaust the fund in 5–7 years, absent a tax hike.
“Expanding the Injury Table to include conditions with baseline incidence rates in the thousands could be financially catastrophic,” says Dr. Mark Baer, actuary at HealthTrust Analytics. “We’d see a compound annual growth in claims exceeding 20%. Congress would need to triple the excise tax or cap awards drastically.”
Legal and Regulatory Pathways
Adjusting the VICP involves:
- Rulemaking: HHS must publish Notice of Proposed Rulemaking in the Federal Register, allow 60 days for public comment, and finalize within 180 days.
- Statutory Amendments: To alter the 3-year statute or redefine table injuries, Congress must pass enabling legislation—unlikely in the current polarized environment.
- Judicial Review: Special masters’ decisions can be appealed to the Court of Federal Claims and then to the Federal Circuit, introducing potential case law on new injury categories.
Impact on Vaccine Manufacturing and Public Health
Industry Response
PhRMA Statement: “Upending the VICP threatens patient access to FDA-approved vaccines,” said Andrew Powaleny, PhRMA spokesperson, pointing to a fragility where only 2–3 companies produce MMR and IPV (inactivated polio vaccine).
If legal exposure rises, manufacturers may deprioritize U.S. supply, as occurred in the early 1980s when 50+ lawsuits forced Merck, Wyeth, and others to exit the pertussis vaccine market. Today, U.S. measles cases have surged to 1,400 in 2025—the highest in 33 years.
Public Health Risks
- Herd Immunity Erosion: A projected 15% drop in pediatric immunization rates could trigger outbreaks of measles, pertussis, and polio.
- Economic Costs: CDC analysis estimates each measles case costs $14,000 in containment. A 10,000-case outbreak could exceed $140 million in public-sector spending.
- Global Impact: The U.S. underwrites Gavi and COVAX contributions; Kennedy’s 2025 refusal to fund low-income country vaccinations drew criticism from WHO Director-General Tedros Adhanom Ghebreyesus.
Expert Perspectives
Scientific Community Insights
“The VICP’s no-fault structure has enabled unprecedented vaccine innovation—20+ new vaccines since 1986,” notes Dr. Paul Offit, co-inventor of the rotavirus vaccine. “Undermining it risks public trust and supply.”
In 2009, the Institute of Medicine reviewed VICP’s evidence base and found no causal link between thimerosal or MMR and autism. Expanding to conditions without strong epidemiological support contradicts global pharmacovigilance standards (e.g., EMA, WHO).
Policy and Legal Commentary
“Kennedy’s moves could provoke litigation, gridlock, and ultimately a Congressional reset,” warns Dorit Reiss, University of California Law professor. “We may see either a massive tax increase or a return to full civil liability.”
Recommendations & Next Steps
- HHS should publish a clear timeline for the VICP review and open a stakeholder consultation, including manufacturers, public health experts, and patient advocates.
- Congressional committees (HELP, Energy & Commerce) might hold hearings with independent actuaries to model financial impacts.
- A bipartisan working group could propose targeted amendments—e.g., creating an “Adult Vaccine Injury Program” separate from childhood immunizations.
Conclusion
RFK Jr.’s agenda to reshape the Vaccine Injury Compensation Program introduces complex technical, financial, and legal challenges. While his goal of enhanced patient safety resonates with some advocates, the potential for fund insolvency, supply disruption, and legislative battles looms large. Stakeholders across public health, industry, and government will need to collaborate to ensure that any reforms preserve the delicate balance that has supported U.S. immunization success for nearly four decades.