Confidential Report Urges Overhaul of COVID Vaccine Safety Monitoring

A leaked document prepared for the federal government's top vaccine advisory panel proposes the most significant changes to COVID vaccine safety monitoring in years — including a new diagnostic syndrome, a dedicated medical billing code, and a national research network. The recommendations land at a moment when the entire federal apparatus for tracking vaccine harms is being rebuilt from the ground up, raising urgent questions about scientific rigor, political influence, and the thousands of Americans who say they were injured by the shots.

The Report

A confidential report drafted for the Advisory Committee on Immunization Practices (ACIP) — the panel that advises the CDC on vaccine policy — calls for sweeping changes to how the medical establishment identifies, tracks, and treats injuries from COVID-19 vaccines [1]. The document, first obtained by The New York Times and published on March 15, 2026, was written "with a sense of urgency" by a COVID-19 work group operating under ACIP's reconstituted leadership.

The report details three planned votes for ACIP's March 18-19 meeting. The first would recommend that harms caused by COVID vaccines be awarded a distinct diagnostic code — specifically ICD-10 code T50.B25 — that could be used for insurance reimbursement [3]. The second proposes formal diagnostic guidelines for a new condition the report calls "post-acute-Covid-19-vaccination syndrome," or P.A.C.V.S., defined as symptoms persisting at least 12 weeks after vaccination that cannot be explained by another medical condition [1][3]. The third calls for a network of federally funded research centers to study the long-term effects of both COVID vaccines and the illness itself.

The work group cites a 2023 Rasmussen Reports survey finding that nearly one in four Americans reported knowing someone who died from a COVID vaccine [1] — though survey methodologists have noted that such self-reported data cannot establish causation and is subject to significant recall and attribution bias.

A Reconstituted Committee

The report did not emerge from the ACIP that existed during the pandemic. In June 2025, Health and Human Services Secretary Robert F. Kennedy Jr. retired all 17 sitting ACIP members and reconstituted the committee with eight new appointees [6]. The new chairman is Retsef Levi, an MIT operations research professor who has been publicly critical of COVID vaccine safety data. The vice chairman is Robert Malone, a biochemist who has become one of the most prominent voices questioning mRNA vaccine technology [1][6].

The COVID-19 work group assembled by Levi includes outside experts spanning a range of perspectives: Christine Stabell Benn, a global health professor at the University of Southern Denmark; Joe Fraiman, a New Orleans emergency physician; Wafik El-Deiry, an oncologist at Brown University; Mitchell Miglis, a Stanford neurologist specializing in autonomic dysfunction; and Stanley Perlman, a University of Iowa virologist [6]. Several members have published peer-reviewed research on vaccine adverse events, while others have been criticized for amplifying unverified claims.

The work group's mandate extends beyond diagnostic codes. It includes investigating DNA contamination in vaccine vials, the persistence of mRNA and spike protein in the body, immune system changes from repeated boosting, cardiovascular risks, reproductive safety, and the conditions reported by people who identify as vaccine-injured [6].

The Broader Overhaul: VAERS Is Dead, Long Live AEMS

The ACIP report arrives in the middle of a parallel transformation at the FDA. On March 11, 2026, the agency announced the launch of the Adverse Event Monitoring System (AEMS), a unified platform replacing three legacy databases: VAERS (the Vaccine Adverse Event Reporting System), FAERS (for drugs and biologics), and AERS (for animal products) [4][5].

The old VAERS system, jointly managed by the CDC and FDA since 1990, had long been criticized from multiple directions. Public health officials noted it was a passive surveillance system — anyone could submit a report, and submission of a report did not establish causation. Vaccine safety advocates, including Kennedy, called it a "template of regulatory malpractice" that captured fewer than 1% of actual vaccine-related injuries [5]. During the pandemic, VAERS became a flashpoint: its raw data was frequently cited out of context on social media, while its structural limitations made it genuinely difficult to detect real safety signals quickly.

AEMS promises to address some of these shortcomings. The system will process approximately 6 million adverse event reports annually in real time, replacing the old quarterly data release schedule [4]. It incorporates AI-powered analysis for pattern detection, such as identifying spikes in myocarditis reports, and enables comparison between vaccinated and unvaccinated cohorts [5]. FDA Commissioner Marty Makary said the modernization fixes "outdated and fragmented" systems, projecting $120 million in savings over five years [4].

But critical questions remain. It is unclear how the new system will assess the credibility of individual reports or verify claims — the same fundamental challenge that plagued VAERS [4]. And some public health experts worry that the emphasis on real-time transparency, while valuable, could amplify unverified signals before they can be properly investigated.

Source: GDELT Project

Data as of Mar 16, 2026CSV

The Compensation Gap

The push for better tracking exists against a stark backdrop: the federal government's COVID vaccine injury compensation program has denied the vast majority of claims. As of April 2025, the Countermeasures Injury Compensation Program (CICP) had reached decisions on 4,111 out of 13,764 COVID-19 countermeasure claims — denying 4,044 of them, a rejection rate of 98.4% [7]. Only 72 COVID vaccine injury claimants had been awarded any compensation as of December 2025, with most receiving only a few thousand dollars out of a total $6 million paid [7].

The CICP, administered by the Health Resources and Services Administration, operates under different rules than the better-known National Vaccine Injury Compensation Program (VICP) that covers childhood vaccines. CICP claimants have no right to a hearing, no right to appeal, and a one-year filing deadline that many injured individuals say they missed because they did not initially connect their symptoms to vaccination [7]. A 2025 review by CIDRAP found that less than 3% of filed claims were deemed eligible for compensation [7].

Advocates for vaccine-injured patients argue that the absence of a recognized diagnostic category has created a vicious cycle: without a formal diagnosis, patients cannot document their condition for compensation claims, and without compensation data, the government lacks a clear picture of the scope of injuries.

Source: HRSA / CIDRAP

Data as of Mar 16, 2026CSV

The Scientific Debate

Not everyone views the ACIP work group's proposals as a step forward. In a March 2026 op-ed, CIDRAP's Dr. Jake Scott argued that the reconstituted ACIP is "rehashing outdated pandemic concerns rather than addressing current public health priorities" [8]. Scott noted that the myocarditis signal from early mRNA vaccines — approximately 38 cases per million doses after the second dose in 2021-22 — was real, was properly detected by the Vaccine Safety Datalink, and has since resolved. Current vaccine formulations show myocarditis rates at or below background population levels, approximately 2 per million doses [8].

Scott raised deeper methodological concerns about the ACIP process. He noted that the committee has abandoned the systematic GRADE (Grading of Recommendations Assessment, Development and Evaluation) and Evidence-to-Recommendations frameworks that previously guided its work [8]. He criticized the bundling of unverified VAERS reports — passive surveillance data that anyone can submit — with rigorous data from the Vaccine Safety Datalink, which tracks confirmed diagnoses in defined populations.

The American College of Obstetricians and Gynecologists has withdrawn from ACIP participation, citing scientific integrity concerns [8]. Meanwhile, the U.S. faces over 1,300 measles cases in 2026, a crisis some public health officials attribute partly to declining vaccine confidence.

On the other side, researchers like Christine Stabell Benn — a work group member — have published peer-reviewed studies documenting non-specific effects of vaccines that go beyond their targeted diseases, arguing that the current framework for evaluating vaccine safety is too narrow. Emergency physician Joe Fraiman co-authored a reanalysis of Pfizer and Moderna trial data that found a higher rate of serious adverse events in vaccine recipients than previously reported, though the study's methodology was disputed by other researchers.

Political Crosscurrents

The timing of the report reflects delicate political calculations within the Trump administration. ACIP had initially considered holding separate votes on whether to rescind recommendations for certain COVID vaccines entirely — a move that would have been unprecedented. That proposal was dropped in early March, with the Washington Post reporting that Kennedy's advisers pulled back amid concerns about the political fallout ahead of the 2026 midterm elections [9].

The result is a middle path: the work group's proposals acknowledge vaccine injuries without directly challenging the vaccines' authorization status. Creating a diagnostic code and research infrastructure validates the experiences of people who believe they were harmed, while stopping short of the dramatic step of withdrawing vaccine recommendations.

HHS Deputy Chief of Staff Stefanie Spear, a longtime Kennedy adviser, has been closely involved in shaping the committee's direction [1]. The interplay between political appointees and the work group's scientific agenda has drawn scrutiny from both sides — vaccine safety advocates who want more aggressive action and public health officials who fear the process is being driven by ideology rather than evidence.

What Happens Next

The ACIP meeting on March 18-19, 2026, will be the first concrete test of whether the work group's proposals move from paper to policy. If the committee votes to recommend a diagnostic code for P.A.C.V.S., it would mark the first formal federal recognition of a chronic post-COVID-vaccination syndrome — a development that could reshape insurance coverage, clinical practice, and the legal landscape for injury claims.

The simultaneous rollout of AEMS means that whatever ACIP decides will play out within a fundamentally different surveillance infrastructure than existed during the pandemic. Whether that infrastructure proves more effective at detecting real safety signals — or more susceptible to amplifying noise — may determine public trust in vaccines for a generation.

Thousands of Americans who report debilitating symptoms after COVID vaccination have waited years for institutional acknowledgment. The question now is whether the federal government's response will be guided by the weight of evidence or the winds of politics — and whether, in a polarized landscape, it is still possible to tell the difference.