Kennedy Launches Federal Initiative to Study Vaccine Injuries

On October 8, U.S. Health Secretary Robert F. Kennedy Jr. announced a department-wide effort to study health problems reported after vaccination. The centerpiece is a clinic at the National Institutes of Health (NIH) opened that Monday to treat and observe patients who claim vaccine-related injuries. The initiative also proposes a new billing code to reimburse physicians for reporting suspected injuries to the Vaccine Adverse Event Reporting System (VAERS), updates to VAERS, and electronic-health-record requirements to capture vaccine-related adverse events.

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Kennedy, founder of Children’s Health Defense, has long questioned vaccine safety. In his first year he dismissed all 17 independent members of the CDC’s Advisory Committee on Immunization Practices and appointed new panelists. Earlier this year the CDC released a revised childhood-vaccine schedule; a federal court issued a preliminary injunction in March blocking key parts of those changes, finding that Kennedy and HHS had violated federal law.

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The United States already monitors vaccine safety through VAERS, the Vaccine Safety Datalink, and the Vaccine Injury Compensation Program (VICP), which has awarded roughly $5 billion across about 12,300 claims since 1988.

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• The CDC describes the chance of a serious vaccine reaction as “very remote.” During the COVID-19 pandemic, VAERS identified myocarditis in young men at about 1 in 20,000 doses and blood-clot events with the Johnson & Johnson vaccine at about 1 in 500,000 doses.

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• Pennsylvania is experiencing the nation’s worst measles outbreak in decades, with more than 1,000 cases and five measles-related deaths among unvaccinated individuals.

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HHS framed the measures as a way to “encourage” health-care workers to report suspected injuries and to give families a dedicated research clinic. Kennedy said the effort responds to families who feel their concerns have been ignored, noting that “for many years, you’ve asked questions from outside the government, as I did.” He previously raised the issue in a September 17 speech to supporters of Children’s Health Defense.

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Dr. Peter Hotez, co-director of Texas Children’s Hospital Center for Vaccine Development, argued that the current system already works well and that the new initiative appears aimed at sowing doubt as vaccination rates fall. Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania, warned that Kennedy’s bias could shape studies to confirm his pre-existing views.

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• “The US already has the most advanced sophisticated system of vaccine monitoring the world has ever seen, with multiple redundant systems in place,” — Dr. Peter Hotez

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• “For many years, you've asked questions from outside the government, as I did,” — Kennedy

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Bloomberg and MedicalDaily reported that the clinic’s budget, enrollment numbers, and review procedures have not been released, and HHS officials declined comment. Sources differ on the extent of Kennedy’s influence over the CDC advisory committee.

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HHS plans to formalize the physician-reimbursement proposal through rulemaking, though no deadline has been announced. The agency also intends to issue guidance on electronic-health-record reporting requirements for vaccine adverse events.

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