HHS Secretary Robert F. Kennedy Jr. is leading a broad vaccine safety research effort across federal health agencies, The New York Times reported May 12.
The effort comes as Mr. Kennedy has scaled back public remarks on vaccines ahead of the midterm elections.
Five things to know:
1. The effort, not previously disclosed publicly, is being overseen by Martin Kulldorff, PhD, a biostatistician known for vaccine safety research and chief science and data officer of HHS’ Office of the Assistant Secretary for Planning. Scientists at the FDA and CDC are conducting the work alongside federal data contractors with access to millions of patient records, according to six sources who wished to remain anonymous. Mr. Kennedy has long questioned whether vaccines are a “potential culprit” for neurological and autoimmune disorders, and a driver of what he describes as an epidemic of chronic disease. He did not respond to a request for comment from the Times.
2. In late February, industry officials gathered with leaders from major health systems to discuss the research initiative. The inquiry will focus on health outcomes of vaccinated versus unvaccinated children, a potential link between vaccines and autism, and the safety of thimerosal, a mercury-based preservative used in some flu vaccines.
3. Critics of the effort, including former CDC vaccine safety officials, have raised concerns that the effort will invest resources into an already highly researched area rather than open scientific inquiries into the causes of chronic disease. The CDC and FDA already conduct extensive vaccine safety surveillance through a number of established databases and research methods. Some researchers also warn that vaccinated-versus-unvaccinated comparison studies carry significant methodological limitations, as vaccinated children tend to receive more medical care and may receive more diagnoses.
4. An HHS spokesperson said in a statement to the Times that the effort reflects the administration’s commitment to “gold-standard vaccine research” and will “inform vaccine recommendations, address critical gaps identified by scientific and medical organizations, including the Institute of Medicine, and strengthen public trust in public health.”
5. The CDC’s portion of the research effort is projected to cost up to $50 million, one source told the Times, though the overall federal cost is unclear. The initiative also involves the National Institutes of Health and universities, according to the HHS spokesperson. It is unclear whether the effort will replace other routine federal vaccine surveillance.
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