As fall respiratory virus season ramps up, major changes to the vaccine policy landscape in the U.S. are coming. Some states, such as Florida, have announced an effort to end all vaccine requirements for children to attend school. Federally, changes promulgated by the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr., have caused issues with the fall COVID-19 vaccine rollout and resulted in a major shakeup of leadership within the Centers for Disease Control and Prevention (CDC). This follows months of subtle US vaccine policy changes that will have great effect globally. This summer, Secretary Kennedy sent a video message stating the United States would no longer be funding Gavi, a leading international vaccine organization who is responsible for vaccinating more than one billion children since its inception. Without U.S. support, Gavi will not be able to immunize as many children against preventable disease, causing unnecessary death and global disease spread.
While Secretary Kennedy’s stances on vaccines have been known for years, he testified during his January confirmation hearing that he would not allow his personal views shape national policy. However, in early June, Secretary Kennedy announced the removal of all 17 experts that sit on the CDC’s Advisory Committee on Immunization Practices (ACIP). While this is under his purview as the Secretary of HHS, this unprecedented move shook the confidence of many, some of whom trusted him to not make drastic changes to U.S. vaccine policy.
As Secretary Kennedy announced new members of the vaccine panel, Congressional leaders and others began to speak in dissent to the changes. Sen. Ron Wyden (D-OR), Ranking Member on the Senate Finance Committee, sent a letter voicing his concerns and listed over a dozen questions for the Secretary to answer. On the other side of the aisle, Sen. Bill Cassidy (R-LA), urged him to cancel the scheduled ACIP meeting due to the lack of experience of the new panelists.
The first meeting that included the new members of this committee took place on June 25 – 26, 2025. The meeting, which was rescheduled from February 2025, included discussions on the annual influenza vaccine recommendations as well as vaccines to protect against RSV for young children. Advisors also controversially discussed thimerosal, a rarely-used preservative used in trace amounts in some multi-dose vaccines for adults. Claims that this chemical causes autism have been debunked. Ultimately, the newly-appointed panel of seven, less than half of the number that usually comprises the panel, voted to recommend single-dose, thimerosal-free flu vaccinations for those aged 6 months and older. The panel also voted 5-2 to recommend clesrovimab, a vaccination against RSV, to infants less than 8 months old entering their first RSV season.
Since June, Secretary Kennedy and his top advisors have changed the vaccine landscape further, increasing barriers to access and eliminating vaccine research. In early August, HHS announced that it would stop all mRNA vaccine development under the Biomedical Advanced Research and Development Authority (BARDA). The announcement included a quote from Secretary Kennedy that claimed mRNA vaccines are ineffective and shifting nearly $500 million in funding to “safer, broader vaccine platforms.” These vaccines previously in development were working to protect against diseases such as the influenza strain H5N1, commonly referred to as bird flu.
Multiple changes have also been made to COVID-19 vaccinations for both children and pregnant people. On August 27, 2025, the FDA revoked the Emergency Use Authorization (EUA) that the current COVID-19 vaccines were operating under, citing the end to the public health emergency. When the FDA issued approval for updated shots, it came with new restrictions. As of the writing of this blog, the Pfizer, Moderna and Novavax products are approved for all individuals aged 65+, and those aged 5-64 with at least one underlying health condition. Children under 5 years old will only be allowed to access Moderna’s vaccine, and only if they have at least one comorbidity. If parents want their healthy child to receive an updated dose of the vaccine, they will need to find a provider willing to write a prescription for it. This “off-label” use comes with additional legal risk for providers causing many providers to be uncomfortable with the practice. This major barrier to access is an evolving situation that we anticipate will change in the near future.
Despite multiple assurances that he would not drastically change vaccine policy, Secretary Kennedy has already taken drastic steps that will directly impact the ability of children and pregnant women to receive vaccines. As respiratory illness season starts up and kids go back to school, the progression of federal vaccine policy changes and how states respond will be of high interest. Looking forward, we anticipate the President’s “Make America Healthy Again” (MAHA) agenda will take center stage, as one of Secretary Kennedy’s main priorities is to “restore trust in vaccine safety.” In the short term, we plan to watch along as the new members of ACIP meet on September 18-19, 2025 to discuss the childhood vaccine schedule and vaccine coadministration, among other topics.
Editors Note: This topic is rapidly evolving and this blog should be treated as a point in time.
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