Comments to the Advisory Committee on Immunization Practices (ACIP)

March 12, 2026

The Partnership to Fight Infectious Disease (PFID) appreciates the opportunity to comment on the agenda for the Advisory Committee on Immunization Practices (ACIP) meeting on March 18-19, 2026.

The deliberations of ACIP in 2025 and subsequent federal actions have already resulted in sweeping changes to the childhood immunization schedule, cutting the number of routinely recommended vaccines and shifting several long‑standing recommendations to “shared clinical decision‑making” or high‑risk categories. CDC’s most recent changes to reduce the number of vaccines routinely recommended for children were announced without transparency into the deliberations, with no scientific evidence of new safety signals, and with no opportunity for external expert input or public comment.

As ACIP now turns to high‑profile questions about Covid‑19, long Covid, and mRNA vaccines, this recent experience raises serious concerns about whether the committee will maintain the stability, independence, and evidence‑based standards that have long underpinned the nation’s immunization policy infrastructure.

Respecting the evidence evaluation and recommendation processes foundational to evidence-based ACIP recommendations traditionally

Prior to changes over the last year, the immunization schedules reflected decades of experience with a rigorous, stepwise vaccine development and policy process. Vaccines are first evaluated in preclinical studies, then in phased human trials that assess safety, dosing, and efficacy, followed by independent review and licensure by the U.S. Food and Drug Administration (FDA), and ongoing safety surveillance through systems such as VAERS, the Vaccine Safety Datalink, and dedicated pregnancy registries. Only after FDA review does ACIP conduct its own systematic evidence assessment – using the GRADE and Evidence‑to‑Recommendations frameworks – to decide whether a vaccine should be routinely recommended for adults, children, or pregnant women, or reserved for specific risk groups, or left to individualized decision‑making. Importantly, every vaccination administered, including vaccines recommended as routine, involves informed consent from the person being vaccinated, or in the case of children, their parent.

For more than a decade, ACIP has grounded its work in a formal evidence‑based methodology built around the GRADE approach and the Evidence‑to‑Recommendations (EtR) framework. In 2010, ACIP adopted GRADE to ensure that every new or substantially revised recommendation includes a systematic assessment of evidence quality, the balance of benefits and harms, patient values and preferences, and health economic considerations, all summarized in standardized evidence tables. The GRADE evidence evaluation process is used by more than 110 organizations globally. In 2018, ACIP unanimously adopted an EtR framework that makes explicit how these factors are weighed when moving from evidence to decisions, with detailed handbooks, users’ guides, and vaccine‑specific EtR frameworks now posted publicly for Covid‑19 and other vaccines. Moreover, the ACIP has published their EtR evaluations as part of its tradition of transparency. Abandoning or sidelining these long‑standing tools – without a transparent, methodologically grounded replacement – would represent an arbitrary departure from ACIP’s own stated standards and from widely accepted norms for vaccine policy deliberations

The current adult immunization schedule showcases just how this transparent, methodical process can yield clear, stable recommendations that clinicians trust and patients understand. Over time, that process has delivered major reductions in vaccine‑preventable diseases in adults – such as invasive pneumococcal disease, shingles, HPV‑related cancers, and severe influenza – while maintaining a strong safety record under continuous post‑marketing monitoring. We implore ACIP to treat any updates to vaccine recommendations with the same level of rigor and transparency.

mRNA's proven effectiveness and life-saving potential

In 2020, President Trump led Operation Warp Speed, leveraging decades of publicly and privately funded research in mRNA technology to deliver one of the most significant achievements in the history of public health, a vaccine that helped end the Covid-19 pandemic. In doing so, American leadership demonstrated the extraordinary potential of mRNA technology.

mRNA vaccines train the immune system against a pathogen without relying on a live or inactivated virus, delivering targeted instructions for the body’s own cells to produce a harmless viral protein. Both the mRNA and resulting protein are broken down and cleared from the body shortly after the immune response is triggered. The platform works with remarkable efficiency and does not alter DNA. These facts are well established in peer-reviewed literature and confirmed by extensive real-world safety monitoring involving hundreds of millions of doses administered in the U.S. and billions globally.

mRNA research spans more than three decades of foundational scientific work across multiple laboratories and institutions. The Covid-19 vaccine represented the culmination of this broad scientific enterprise – not the product of any single individual. Development, authorization, and ongoing monitoring have been subject to rigorous review by FDA, CDC, and independent advisory bodies.

Clinical trials are now testing mRNA-based approaches for a wide range of diseases, including melanoma, and pancreatic, breast, colorectal, and non-small cell lung cancers, with early findings demonstrating reduced recurrence and improved disease-free survival in certain settings. The platform’s adaptability positions it as a critical tool for responding to emerging infectious diseases and other serious health threats.

Additionally, a recently published narrative review synthesized nonclinical studies, large randomized clinical trials, national surveillance systems, and regulatory assessments to address mechanistic safety questions regarding mRNA COVID‑19 vaccines, including claims about residual DNA, biodistribution, immune modulation, malignancy, autoimmune disease, and all‑cause mortality. Across this body of evidence, the authors found no support for increased long‑term mortality, cancer, autoimmune disease, genotoxicity, or other long‑term safety issues attributable to mRNA COVID‑19 vaccination and confirmed that residual DNA levels fall within established FDA and WHO limits when measured with validated methods. Importantly, the review underscores that vaccine safety concerns should be evaluated using transparent, structured frameworks that systematically weigh benefits, harms, evidence quality, and feasibility—precisely the role of ACIP’s GRADE and Evidence‑to‑Recommendations processes that should be fully applied in upcoming deliberations on Covid‑19, a long Covid, and mRNA vaccines.

Given the visibility and public interest surrounding mRNA technology, ACIP discussions must remain firmly grounded in the totality of high-quality evidence. Assertions that contradict established molecular biology, immunology, or safety surveillance findings should be addressed directly and transparently on the record, with citations to peer-reviewed data and federal safety monitoring systems.

Any departure from existing guidance should meet the same rigorous standard that defines credible vaccine policy.

Need for increased transparency, greater engagement with CDC and liaison experts in ACIP deliberations, and additional opportunity for stakeholder engagement

The recent changes in ACIP membership, workgroup structure, and meeting procedures over the last year have raised questions about conflict‑of‑interest safeguards, transparency, and the role of independent scientific voices. To restore trust, we encourage ACIP, the CDC, and HHS to ensure relevant workgroups on maternal, perinatal, adult, and childhood immunization include CDC subject‑matter experts, liaison organizations, frontline clinicians, and community representatives. Agendas and supporting materials must be shared with sufficient lead time for meaningful public comment.

ACIP’s credibility rests not only on its final recommendations, but on a process that is independent, methodologically sound, and open to public scrutiny. Therefore, we urge the committee to fully apply and publicly document the GRADE and Evidence-to-Recommendations frameworks for any proposed changes, including clear description of evidence quality, value judgments, and how benefits, risks, and equity considerations are weighed.

Immunization remains the best single protection against highly infectious diseases and is central to safeguarding pregnant people, infants, and families in every community. For decades, ACIP has been recognized as a global gold standard for evidence‑based, transparent vaccine recommendations. We respectfully urge the committee to reaffirm that role by preserving rigorous, open processes and by maintaining strong, evidence‑based protections for America’s health.