Federal health officials reported to plan presentation linking dozens of pediatric deaths to COVID-19 vaccines

Federal health officials are preparing to present information to a panel of Centers for Disease Control and Prevention advisers that reportedly links the COVID-19 vaccines to the deaths of more than two dozen children, according to reporting that cites anonymous sources.

The Washington Post reported that officials under the Trump administration plan to include claims about pediatric deaths in a presentation next week to the Advisory Committee on Immunization Practices, the panel that reviews vaccine recommendations. The report said the findings appear to be based on reports submitted to the Vaccine Adverse Event Reporting System, or VAERS, a voluntary database that officials and public health experts caution is not designed to determine causality.

The Food and Drug Administration said Friday it is examining the rare deaths of 25 young people who received Pfizer or Moderna COVID-19 vaccines and is seeking additional data on vaccine safety for pregnant women. FDA Commissioner Marty Makary told CNN that staff were reviewing autopsy reports and interviewing families in connection with those investigations.

Officials emphasize that VAERS accepts reports from patients, clinicians, pharmacists and members of the public and that reports are not verified. The CDC has repeatedly cautioned that VAERS data alone cannot show whether a vaccine caused an adverse event and that further clinical and epidemiologic investigation is necessary to establish a causal link.

In an emailed statement to The Washington Post, HHS spokesperson Andrew Nixon said, "FDA and CDC staff routinely analyze VAERS and other safety monitoring data, and those reviews are being shared publicly through the established ACIP process. Any recommendations on updated COVID-19 vaccines will be based on gold standard science and deliberated transparently at ACIP next week."

The planned presentation comes amid heightened debate over U.S. vaccine policy. Department of Health and Human Services Secretary Robert F. Kennedy Jr., a longtime critic of routine vaccine recommendations, has instructed health officials to stop recommending COVID-19 vaccines for healthy children, according to previous reports. The American Academy of Pediatrics continues to recommend annual COVID-19 vaccination for children 6 to 23 months and says older children may be vaccinated based on parental choice.

Public health agencies acknowledge myocarditis and pericarditis — inflammation of the heart muscle and surrounding tissue — as rare adverse events associated with mRNA COVID-19 vaccines. An FDA analysis cited by officials estimated those conditions occur at a rate of about one in 125,000 doses for 2023–2024 shots among people younger than 65. The analysis also reported a higher observed rate in younger males, noting 19 cases per 500,000 doses in that group.

Most cases of vaccine-associated myocarditis have been reported as mild and patients generally recover, public health officials say. Myocarditis and pericarditis can also be caused by viral infections, including SARS-CoV-2, and prior studies have estimated a range of occurrence for vaccine-associated cases. To date, federal health officials say there is no conclusive evidence in the United States that myocarditis or other vaccine-associated conditions have directly caused deaths.

The ACIP process is expected to include presentation of safety-monitoring findings to aid deliberation on updated vaccine recommendations. The committee's work has drawn scrutiny after members were removed and new appointees were named to the panel earlier this year; reporting has said some of the new appointees have expressed skepticism about routine COVID-19 vaccination.

Health agency reviews typically involve multiple data sources beyond VAERS, including active surveillance systems, electronic health records, and medical record reviews, to assess whether reported events are plausibly linked to vaccination. Public health experts say establishing causality requires careful case review, comparison with expected background death rates, and investigation of other possible causes.

The agency reviews and the ACIP meeting come as states continue to vary in their vaccine guidance — with some limiting mandates and others promoting wider access — and as parents, clinicians and public health authorities weigh the relative risks of vaccination against the risks posed by COVID-19 infection. The FDA and CDC have said they will publicly share findings and deliberations through the ACIP process.

The Washington Post and CNN reported the initial details of the planned presentation and the ongoing FDA review. The FDA and HHS provided statements saying routine safety monitoring is underway and that any policy recommendations will be based on scientific review.

Officials with the CDC did not immediately provide additional comment beyond prior guidance on myocarditis and the use of VAERS data. The agencies have said they will continue to investigate reported adverse events and update their guidance as warranted by evidence.