PDF of this Expression of Concern:

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U.S. Vaccine/Immunization Science & Policy: Interruption of Expert Advisory Committees & Public Comment Processes
08 Mar 2025

For decades, every person in the United States has benefitted from scientifically-sound, evidence-based recommendations on vaccines and immunization developed by independent, volunteer, expert advisory committees and supporting public comment mechanisms.

These recommendations are further reviewed and in most cases then approved by relevant U.S. government agencies [HHS, FDA, CDC] and then become part of immunization schedules and programs across the country.

In turn, these recommendations, decisions and their supporting processes have had global impact, with many country ministries of health factoring U.S. actions into their decision-making about national immunization investments and programs.

There are three independent expert advisory committees – with supporting public comment mechanisms – driving these vaccines/immunization recommendations and which operate under the U.S. Federal Advisory Committee Act [1].

FDA – Vaccines and Related Biological Products Advisory Committee [VRBPAC]
The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility. The Committee also considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.
The Committee shall consist of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of immunology, molecular biology, rDNA, virology; bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry. [accessed 07 March 2025]

CDC – Advisory Committee on Immunization Practices (ACIP)
The Advisory Committee on Immunization Practices (ACIP) is a federal advisory committee that develops recommendations on the use of vaccines in the civilian population of the United States. CDC sets the U.S. adult and childhood immunization schedules based on recommendations from ACIP.
…ACIP consists of 15 experts who are voting members and are responsible for making vaccine recommendations. The Secretary of the U.S. Department of Health and Human Services (DHHS) selects these members after an application and nomination process. Fourteen of these members have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, or preventive medicine. One member is a consumer representative who provides perspectives on the social and community aspects of vaccination.
In addition to the voting members, there are 30 non-voting representatives from professional organizations that are highly regarded in the health field. These members comment on ACIP’s recommendations and offer the perspectives of groups that will implement the recommendations…. [accessed 07 March 2025]

HHS – National Vaccine Advisory Committee (NVAC)
Established in 1987, the National Vaccine Advisory Committee (NVAC) recommends ways to achieve optimal prevention of human infectious diseases through vaccine development and provides direction to prevent adverse reactions to vaccines. This advice is presented to the Assistant Secretary for Health who serves as the Director of National Vaccine Program on matters related to program responsibilities.
Functions of NVAC:

• Studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the States.
• Recommends research priorities and other measures the Director of the National Vaccine Program should take to enhance the safety and efficacy of vaccines.
• Advises the Director of the Program in implementation of sections 2102 and 2103 of the Public Health Service Act.
• Identifies the most important areas of government and non-government cooperation that should be considered in implementing sections 2102 and 2103 of the Public Health Service Act.
  [accessed 07 March 2025]

This expression of concern is triggered by the U.S. government’s cancellation or postponement of, or failure to announce the 2025 schedules for, meetings of these three expert advisory committee and their supporting public comment processes.

For example:
:: An FDA – VRBPAC regular meeting should have already considered and recommended the most effective composition of the Fall flu vaccine. There is no indication whether or when this meeting might be scheduled.

:: The scheduled Feb 26-27, 2025 CDC – ACIP meeting has been postponed with no indication of when it will be re-scheduled. It was to conduct scientific reviews and vote on vaccine recommendations including Meningococcal Vaccines, Chikungunya Vaccines; Influenza Vaccines; RSV Vaccines; HPV Vaccines; and Mpox Vaccine. We understand that “There is currently no information for a rescheduled meeting.”

:: Posting of the 2025 schedule for the HHS – National Vaccine Advisory Committee (NVAC) has not occurred on its normal annual cycle. We understand that “Currently NVAC is under a pause as the new Administration considers its plans for managing federal policy and advisory committee meetings.”

:: In parallel, the public comment mechanisms on the matters before these expert advisory committees have been suspended or cancelled in turn.

The integrity of the work of these expert advisory committees depends on many factors, but importantly on the regularity and continuity of their respective meetings, the competent support of agency staffs, and the confidence that these processes are free from political influence or interference of any kind.

We strongly urge HHS [U.S. Department of Health and Human Services] to immediately resume all scheduling and support processes associated with these expert committees and their supporting public comment cycles. Full stop.

[1] Federal Advisory Committee Act at 5 U.S.C. sec. 1009:
Sec. 1009. Advisory committee procedures
(a) COMMITTEE MEETINGS.—
(1) OPEN TO PUBLIC.—Each advisory committee meeting shall be open to the public.
(2) NOTICE OF MEETINGS.—Except when the President determines otherwise for reasons of national security, timely notice of each meeting shall be published in the Federal Register, and the Administrator shall prescribe regulations to provide for other types of public notice to insure that all interested persons are notified of each meeting in advance.
(3) PARTICIPATION.—Interested persons shall be permitted to attend, appear before, or file statements with any advisory committee, subject to such reasonable rules or regulations as the Administrator may prescribe.

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GE2P2 Global Foundation
…advancing scientific rigor, ethical resilience and research integrity…

GE2P2 Global’s purpose is to advance scientific rigor, ethical resilience, and integrity in research and evidence generation. We engage this purpose across the sciences and the humanities, and across sectors including health, human rights, humanitarian action, education-literacy-heritage, development, climate, and peace. We strive to respond to growing challenges to the foundational role of and trust in scientifically-rigorous and ethically-generated evidence in global governance, policy, and practice. We act through our community of practice operating in more than 30 countries. GE2P2 Global was founded in 2016 and operates as a non-profit foundation [501[c]3] with a public benefit corporation affiliate.

The Foundation’s Center for Vaccine Ethics & Policy was established in 2005 to respond to the ethical imperative to accelerate the development and delivery of needed vaccines — producing sustained immunity and therapeutic benefit for all people at risk – assuring effective, affordable, and equitable access regardless of circumstance or geography. The Center publishes an open-access weekly digest – Vaccines and Global Health: The Week in Review.

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Contact: David R Curry, david.r.curry@ge2p2global.org