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New Zealand’s North Island braces for Cyclone Vaianu with thousands ordered to evacuate Artemis II splashdown – in pictures Swalwell denies allegations of sexual assault as calls grow for him to withdraw from California governor race Trump news at a glance: Epstein survivors have words for Melania Trump after surprise statement Multiple people face charges, including murder, in California fireworks blast Rory McIlroy surges into six-shot Masters lead with stunning second-round flourish Roberto De Zerbi targets ‘Ange-ball’ revival to save Spurs from relegation Bath hit back to reach semi-final after stunning Northampton in 11-try epic Australia crash out of BJK Cup after Britain secure upset with doubles win Zebras, wealth and power: Hungary’s election tests Orbán’s grip on power ‘TikTok effect’ brings sellout crowds and younger fans to Grand National meeting King signs up David Beckham to his Chelsea flower show team The war over Omagh’s gold: the £21bn mine plan tearing a community apart Britain’s shadow workforce is paid as little as 65p an hour. 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US government studies into vaccine safety are being suppressed
Robert B Shp · 2026-05-12 · via The Guardian

Last week, the New York Times and the Washington Post reported yet another troubling case of data suppression at the Food and Drug Administration (FDA). Studies of millions of vaccine recipients were completed by career scientists, peer-reviewed and accepted by working pharmacovigilance journals; after political appointees declined to sign off, they were withdrawn. The agency commissioned the work and received the answer, but is not releasing it.

In October, FDA scientists were directed to withdraw two Covid-19 vaccine safety studies that had already been accepted by the journals Drug Safety and Vaccine. In February, top officials declined to sign off on submitting Shingrix safety abstracts to a major drug-safety conference. The Covid studies were not small. One examined the records of 7.5 million Medicare beneficiaries for 14 pre-specified adverse outcomes after 2023–2024 Covid-19 vaccination, using a self-controlled case-series design with follow-up of up to 90 days. Only one signal – anaphylaxis at roughly one per million Pfizer-BioNTech doses – exceeded statistical noise. A second examined 4.2 million recipients aged six months to 64 years for more than a dozen outcomes; it identified the rare febrile-seizure and myocarditis signals already on the label. The Shingrix safety analysis confirmed the elevated but low Guillain-Barré risk that has been on the package insert for years.

The agency’s stated objection – that the authors “drew broad conclusions that were not supported by the underlying data” – describes, in any functioning scientific system, the ordinary work of peer review. Reviewers ask for narrower language; editors ask for revised discussion sections; manuscripts appear with more carefully bounded claims. What does not happen is for political appointees to instruct staff scientists to withdraw an accepted manuscript. The procedural anomaly is the story.

The asymmetry compounds it. In late November, a memo from the same FDA center linked the deaths of 10 children to Covid-19 vaccination, a claim the agency has not substantiated. That memo was released and widely covered. Two studies showing serious adverse effects to be very rare across nearly 12m doses were not. Vaccine-critical claims have moved through the agency at low evidentiary thresholds, while reassuring safety findings have been held to standards no peer-reviewed paper could realistically meet. The selectivity is the grammar of capture, and it does not stop at vaccine safety. It now shapes which surveillance signals reach physicians.

That architecture meets its first operational test in 32 days. On 11 June, the Fifa World Cup opens across North America: 48 teams, 11 United States host cities, more than 6 million attenders over 39 days. The tournament arrives during a regional measles resurgence: more than 9,000 confirmed cases in Mexico since the outbreak began in February 2025, Canada’s loss of measles elimination status in November, and United States vaccination coverage below the 95% threshold required for population immunity. In ordinary times, that combination would be a reason for heightened transparency. Instead, the Centers for Disease Control and Prevention has lost approximately a quarter of its workforce in the past year, has been editing its weekly journal under directive, and sits inside the same Department of Health and Human Services that has directed FDA scientists to withdraw vaccine-safety analyses already accepted by independent peer review.

I practice in Los Angeles, where the United States opens its World Cup tournament on 12 June at SoFi Stadium. A respiratory cluster appearing in a Westwood emergency room in early July would, in the system I trained in, reach me through three independent channels: local public health, the Morbidity and Mortality Weekly Report (MMWR) and the CDC’s pathogen-specific dashboards. Each of those channels has been edited or paused or captured this year. If the cluster turns out to be measles, or H5N1, the question every ICU attending in this city will be asking is the one we asked here in June 1981, when a short MMWR report described five cases of pneumocystis pneumonia in Los Angeles: is the surveillance system still telling us the truth? The system’s virtue then was not that it understood what was unfolding; it did not. Its virtue was that it was still permitted to publish what it saw.

Last week, a patient asked me whether the shingles vaccine was safe. I told her what I knew: the trials were clean, her risk of zoster was real, the most common side effect a sore arm. What I could not tell her, because I did not yet know it myself, was that FDA scientists had completed a safety analysis of that vaccine using agency-held records, written it up and submitted abstracts the agency would not clear.

When she comes back next month and asks again, the World Cup will already have begun. I will tell her what I told her last week. I will not tell her that the agency’s own scientists have studied the shingles vaccine on a population of millions, and that what they found has been kept from the medical literature. I will not be able to assure her that the federal public health system we will rely on, in the weeks that follow, to detect what the World Cup brings, is still free to tell clinicians what it sees.

  • Robert B Shpiner is a clinical professor of medicine (pulmonary and critical care) and associate professor of neurosurgery (neurocritical care) at the David Geffen School of Medicine at UCLA, where he has practiced critical care for more than 40 years