Margaret A. Hamburg and Harvey V. Fineberg , 2025-04-24 15:00:00
Vaccines don’t save lives. Vaccinations do. And every dollar spent on routine immunization in the U.S. is estimated to save $11, not to mention that vaccinations have prevented countless deaths and suffering.
Yet U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. has spent decades spreading false warnings about the danger of vaccines, including their purported association with autism, a thoroughly debunked claim. The administration has also taken a series of deeply worrisome actions to halt vaccine research, cancel vaccine clinics, and remove vaccine information from government websites.
The stakes are too high for us to sit back and watch. We cannot allow vaccine-preventable conditions, such as measles and whooping cough, to become regularly occurring outbreaks here in the U.S. again, causing needless suffering and death.
And that is why we are co-chairing a new effort, the Vaccine Integrity Project, organized by the University of Minnesota’s Center for Infectious Disease Research and Policy and supported by a grant from Alumbra, a foundation established by philanthropist Christy Walton.
Our goal is to safeguard vaccine policy, information, and utilization in the U.S. and to ensure that the best available evidence determines how we use vaccines to protect individuals, families and communities against vaccine-preventable diseases. Judgments about the benefits, risks, and uses of vaccines must be grounded in the most up-to-date science rather than anecdotes. The information that is the basis for how and why vaccines are used must be free from vested interests, unsubstantiated beliefs, or political influence.
The Vaccine Integrity Project responds to a reality that confronts our country.
Even in the face of a measles outbreak that has affected hundreds of people in more than two dozen states and has already taken the lives of two unvaccinated children and one adult, Kennedy continues to offer half-hearted and cautionary support for vaccination, often framing it as a risky individual choice. Given his history as the leader of an anti-vaccine organization, it is only prudent to anticipate ways the secretary could in the future exert his authority to reduce vaccine accessibility and discourage lifesaving immunizations.
For decades, the Centers for Disease Control and Prevention has advanced guidance for immunizations to protect the public’s health based on recommendations of its Advisory Committee on Immunization Practices (ACIP). After cancellation of an ACIP meeting earlier this year, the committee convened last week for the first time in the new administration. We cannot know whether HHS will continue to appoint unbiased experts with no conflicting interests, or even continue to seek informed, expert advice, as Kennedy has already falsely claimed that “97% of the people on [ACIP] had conflicts.”
Nor can we take comfort in the abrupt departure earlier this month of Peter Marks as director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. After four decades of distinguished public service, Marks explained in his letter of resignation, “It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”
We take up the Vaccine Integrity Project as a precautionary step. Should ACIP or FDA processes or scientific evaluation become compromised, America cannot afford to be left without any organized systems to ensure that evidence grounded in science continues to guide decisions about the use of vaccines.
Over the coming months, a steering committee — led by us and composed of leaders in medicine, public health, and health policy — will engage health professionals, organizations, and the public to gather ideas on how nongovernmental entities can help safeguard sound vaccine policy in the U.S. Potential mechanisms may include vaccine evaluations, the development of clinical guidelines, and the identification of critical knowledge gaps where further research would be valuable.
The Vaccine Integrity Project will be able, if needed, to develop thoughtful, evidence-based recommendations to ensure that both the American public and health care providers continue to have access to reliable information on the safety, effectiveness, availability, and use of vaccines.
As with any form of insurance, we hope there will never be a need to activate such an alternative system. But hoping for the best is not a strategy. We have a responsibility to prepare for the worst.
Margaret A. Hamburg is former commissioner of the Food and Drug Administration and co-president of the InterAcademy Partnership. Harvey V. Fineberg is president of the Gordon and Betty Moore Foundation and past president of the Institute of Medicine, now National Academy of Medicine.
