Comments to the Advisory Committee on Immunization Practices

 September 12, 2025 

The Partnership to Fight Infectious Disease (PFID) remains deeply concerned that the abrupt dismissal of Centers for Disease Control and Prevention Director Susan Monarez, alongside the wholesale removal of ACIP’s membership earlier this year, has undermined long-standing practices of scientific integrity, transparency, and independence in the immunization policy process. The ACIP and working groups rely extensively on the expertise of CDC medical and scientific professionals. The significant loss of CDC staff and leadership further undermines the scientific capabilities of the ACIP and its ability to make evidence-based recommendations. For more than six decades, ACIP has been recognized across the world as the gold standard for evidence review, ensuring that millions of Americans receive reliable guidance and protection from vaccine-preventable diseases. That legacy is now at risk.

The public reporting surrounding Dr. Monarez’s removal highlights precisely why transparency in ACIP’s structure and leadership matters. By law, the CDC director is charged with reviewing and approving ACIP recommendations. Dr. Monarez’s dismissal because, she said, she refused to simply rubber stamp committee actions without proper review calls into question whether the current ACIP operates with the independence required to maintain trust in our immunization infrastructure. Adding to this uncertainty, recent Senate testimony disparaged her credibility despite her qualifications and confirmation just one month earlier, sending contradictory and troubling messages about the value of expertise in this process.

The credibility of vaccine policy rests on process and transparency as much as outcomes. ACIP recommendations are made after a thorough working group process that include specific terms of reference. Working groups have traditionally included ACIP members as well medical and scientific experts representing a variety of fields and working within government, academic, and private organizations. The working groups review and analyze the science and clinical data, including adverse events, in detail over multiple meetings before developing evidence summaries and preparing recommendation options for the ACIP to consider.

To organizations like ours and the general public, there has been no transparency or evidence that seems to be informing the agenda for the September 18-19, 2025 scheduled ACIP meeting. The addition of multiple new ACIP members who may be called upon to make decisions at this meeting without the benefit of any exposure to the working group deliberations or process raise serious additional concerns.

In fact, it is unclear if the working groups are actually providing information on the agenda items for this meeting. We strongly urge that the ACIP leaves the current recommendations in place for these reasons. Additionally, the current recommendations for the MMRV and hepatitis B vaccines and the RSV monoclonal antibody treatments were based on the rigorous, evidence-driven process traditionally used to guide ACIP recommendations. ACIP’s historical strength lies in its rigorous vetting process of its members: Professional qualifications are reviewed carefully, conflicts of interest are disclosed and managed, and committee balance is maintained across clinical, academic and public health expertise. That process typically requires more than a year of careful vetting before appointing ACIP members. Moreover, most former ACIP members started as members of working groups which provided significant expertise into the analysis and considerations behind the working groups processes and findings for ACIP member consideration.

The recent appointment of new ACIP members outside of these procedures undermines confidence in any recommendations the current committee makes. Without reinstating a transparent, merit-based vetting process, ACIP will erode decades of public trust during a time of rising hesitancy.

The U.S. has seen the highest measles cases in three decades and remains vulnerable to losing its elimination status. In 2024-2025, we had one of the most severe flu seasons in recent memory and have seen surging cases of whooping cough across the U.S. At such a moment, any proposals to weaken the well-established childhood schedule, including changes to recommendations for hepatitis B, MMR and RSV vaccines, endanger public health. These vaccines have prevented millions of hospitalizations and deaths and remain foundational to protecting children, families and communities. We strongly urge ACIP to keep current recommendations in place and avoid fueling confusion or validating misinformation.

We are also concerned that the upcoming meeting may involve discussion that could fuel misinformation about aluminum salts as vaccine adjuvants, despite decades of clinical research and safety data. The FDA — not ACIP — has statutory responsibility for reviewing safety and e icacy of vaccine ingredients, and aluminum as an adjuvant has been repeatedly and rigorously assessed as safe. Most recently, a Danish population study spanning two decades and more than 50 chronic diseases found no association between accumulating aluminum exposure through vaccines and adverse long-term health outcomes. PFID and our peers will be watching any discussion of adjuvants closely for the inclusion of extensive research involving the safety profile of aluminum-containing vaccines, not just “studies” which have been retracted for errors in evidence and analysis, in the event this discussion becomes more prominent. Reopening this settled science will disrupt vaccine supply and create barriers to access at a time when more, not fewer, tools are needed to protect against infectious disease.

Traditionally, ACIP has served as a source of stability and fact-based guidance. Its recommendations have carried the weight of both expertise and public confidence. Today, that legacy is under threat. We urge the U.S. Department of Health & Human Services and the CDC to restore ACIP’s credibility by recommitting to a transparent, independent and evidence-based structure; reinstating a rigorous nomination and vetting process; and, resisting efforts to weaken established vaccine protections or to reopen scientific matters long resolved.

The health of millions of Americans — and faith in the public health institutions charged with protecting them — depend on taking these steps without delay.