Questions surrounding two Pennsylvania deaths labeled “measles-associated,” along with the FDA’s approval of updated COVID-19 vaccines without direct randomized human efficacy trials of the new formulations, have intensified debate over how public health agencies communicate uncertainty and evaluate vaccine evidence.
By yourNEWS Media Newsroom
Questions over how Pennsylvania officials characterized two deaths involving measles and how federal regulators evaluated the latest mRNA vaccines are fueling a broader debate over transparency, evidence and the level of certainty conveyed by public health authorities.
A detailed report by Just the News examined both controversies, focusing on whether officials have provided sufficient evidence to support claims surrounding the deaths and whether updated vaccine approvals were backed by adequate human data.
The disputes come as health officials confront record-low COVID-19 vaccination rates, a gradual decline in seasonal influenza vaccination since the first year COVID vaccines became available and a slight drop in measles vaccination among kindergartners.
In Pennsylvania, Democratic Gov. Josh Shapiro and state health officials have said two people who were not vaccinated against measles died in cases associated with the virus.
The deaths were initially reported as involving two unvaccinated Pennsylvania residents, but questions emerged over whether measles caused either death or merely occurred alongside other medical circumstances.
The state has used the phrase “measles-associated,” terminology that does not necessarily mean measles was the direct cause of death.
Critics have compared the distinction to debates during the COVID-19 pandemic over whether fatalities were caused by the virus or involved patients who happened to test positive, an issue that generated questions about COVID death classifications and how underlying causes were recorded.
Coroner Disputes Measles Role in Newborn’s Death
One of the Pennsylvania cases involved a newborn in Lancaster County.
Lancaster County Coroner Stephen Diamantoni concluded that the infant died from a traumatic rupture of the spleen rather than measles.
Diamantoni defended his conclusion after The Atlantic visited an Amish family believed to be connected to the case.
“I’ve had several discussions with our forensic pathologist, and he feels adamantly that this was not a measles death and that it was a traumatic rupture of his spleen,” Diamantoni told The Atlantic.
He separately told Lancaster Online that “there was no swelling or enlargement whatsoever,” which he said would have been expected if measles had contributed significantly to the death.
Instead, he described “massive blood loss” caused by a “traumatic laceration of the spleen”.
Measles was nevertheless reportedly listed as a contributing condition on the infant’s death certificate.
The infant’s mother had recovered from what The Atlantic described as a severe case of measles.
Maternal-fetal medicine physician Adam Urato criticized the state’s handling of the case, saying officials and media outlets “misled the public & did a grave disservice to the mother” by portraying the death as measles-related without adequately explaining the conflicting evidence.
An X post containing Urato’s comments circulated as criticism of the state intensified.
Urato speculated that if the infant had experienced a difficult breech delivery requiring extensive maneuvers, a traumatic spleen injury could provide an explanation unrelated to measles.
That possibility has not been established publicly as the cause of the injury.
Officials Have Released Little About Second Death
Questions also remain over the second Pennsylvania death.
State officials have released little information about that individual, including age, underlying medical conditions or the specific evidence used to classify the case as measles-associated.
Lancaster County Commissioner Josh Parsons, a Republican, challenged Shapiro’s claim that state law prevented the administration from releasing even basic demographic information.
Diamantoni said Monday that his office was investigating another death involving someone with measles but that he was uncertain whether it was the same case referenced by state officials.
Pennsylvania’s Department of Health has publicly described the two cases as “measles-associated” deaths, leaving unresolved the question of whether the infection directly caused either death.
The Centers for Disease Control and Prevention has taken a more cautious approach.
The CDC’s measles surveillance page does not count either Pennsylvania case as a confirmed measles death.
According to the agency, the “available information” does not yet establish whether the individuals died from measles or died while infected with the virus.
As a result, the CDC has not confirmed a measles death in the United States this year.
Physicians and Pathologists Criticize Communication
The dispute has drawn criticism from medical professionals who say public confidence can be damaged when officials convey more certainty than the evidence supports.
Writing in The Atlantic, pathologist Benjamin Mazer said Shapiro and state officials “may indeed have committed a catastrophic communication blunder” if they either overstated the available evidence or selectively released information for political purposes.
“Think of the consequences” if officials concealed “genuine uncertainty” about measles’ role in the newborn’s death, Mazer wrote.
“A grieving parent would hear her governor announce that the tragedy was in some way her fault. And anti-vaccine activists would have the opportunity to pounce on the mistake to continue downplaying the lethality of infections,” he continued.
Vaccine litigation attorney Aaron Siri also criticized the state’s handling.
“This is not the first time that a purposeful release of limited, misleading, and/or false information by health authorities is used to fear monger [sic] and cast blame and judgement on those who decline one or more vaccine products,” Siri wrote.
He cited his firm’s analysis of deaths involving Texas children, which challenged prior characterizations that measles was responsible for those fatalities.
Those conclusions represent Siri’s interpretation of the records and have been contested within the broader debate over measles complications and mortality.
Shapiro has dismissed what he called “online conspiracy theories” surrounding the Pennsylvania cases rather than publicly releasing additional medical details.
The controversy is occurring as his Department of Health pursues a significant expansion of gubernatorial authority involving communicable and noncommunicable diseases.
The proposal has drawn objections from state and local Republican officials and was compared by The Daily Wire to powers exercised during the COVID-19 pandemic.
A separate X post discussing the controversy highlighted criticism of the administration’s statements.
Urato has separately disputed reporting about his relationship with FDA officials, including claims that the agency offered him full-time employment and that he was close to former FDA drug evaluation official Tracy Beth Hoeg.
Hoeg’s departure from the agency this spring has not been publicly explained.
Updated COVID Vaccines Approved Without New Placebo-Controlled Human Efficacy Trials
A separate controversy concerns the FDA’s Thursday approval of updated COVID-19 vaccines from Pfizer-BioNTech and Moderna.
Critics say the agency approved the reformulated vaccines without requiring direct placebo-controlled human efficacy trials specifically testing the new formulations before authorization.
That does not mean the vaccines were approved without evidence. Regulators also consider prior clinical experience with the vaccine platform, immune-response data, animal studies and evidence involving earlier formulations when evaluating updated vaccines.
Critics, however, argue that the absence of new randomized controlled trials leaves unanswered questions about the precise benefit-risk profile of each updated formulation.
The approach has also been compared with the FDA’s evaluation of Moderna’s first mRNA influenza vaccine, which critics said showed only modestly improved efficacy compared with a conventional flu vaccine while producing a higher rate of reported adverse events.
At the FDA Vaccine and Related Biological Products Advisory Committee’s spring meeting on the 2026-27 COVID vaccine formulation, members reviewed human immune-response data from existing vaccines against circulating variants, the antigenic characteristics of newer variants and animal immune-response data involving candidate formulations.
The committee did not have completed human efficacy data for the new formulations themselves.
When members asked for COVID vaccine safety data, CDC representative Natalie Thornburg said the official responsible for those data was unavailable and had not presented before the committee “in years past.”
Critics Point to Small Animal Studies
Epidemiologist and McCullough Foundation administrator Nicolas Hulscher criticized the approvals, saying preclinical testing cited during the regulatory process involved only eight to 10 mice per group.
He pointed to presentations provided by Moderna and Pfizer to the advisory committee.
Critics drew parallels to the Biden administration’s 2022 authorization of updated COVID boosters, which also generated controversy because animal data involving eight mice formed part of the evidence considered before widespread rollout.
According to Hulscher, Pfizer’s prospective human study for the newest formulation did not begin until Monday, while Moderna’s Phase 3b/4 human study was not scheduled to begin until mid-November.
Former Senate pharmaceutical corruption investigator Paul Thacker criticized the process on X.
“These updated COVID vaccines haven’t gone through a randomised controlled trial (RCT) but were pushed through by politicos in the White House, because, despite RFK Jr., Big Pharma controls the Trump WH as it has controlled all White Houses in my professional life time,” Thacker wrote.
“Reporters at major outlets talk about this with their sources (who then talk to me) but these journalists won’t report this” because of concerns about encouraging vaccine hesitancy, he added.
Thacker’s characterization represents his own assessment of the regulatory process.
The debate echoes earlier controversy in which critics said the Biden administration overruled or pressured FDA vaccine regulators over COVID booster policy.
FDA Changes Pfizer’s Post-Approval Research Requirements
Former FDA regulatory review officer Jessica Adams has separately raised questions about changes to Pfizer’s post-approval commitments.
Adams said the FDA released Pfizer from a previous research commitment attached to last year’s vaccine approval.
That earlier requirement involved prospectively examining “circulating SARS-COV-2 spike antigen” and self-reported symptoms among people reporting possible COVID vaccine injuries and symptoms associated with long COVID.
An X post discussing the FDA decision highlighted the change.
The FDA replaced the prior commitment with two different requirements.
One calls for a nonclinical study examining the biodistribution and persistence of vaccine-derived spike protein following vaccination.
The other calls for a retrospective analysis of existing vaccine trial data for symptom clusters potentially consistent with long-term vaccine injury, sometimes described as post-COVID vaccine syndrome.
Adams argued that the change substitutes weaker retrospective and nonclinical methods for evidence that would have been collected prospectively.
“One could even argue this is a bigger deal than the two measles-associated deaths reported this week,” Adams said.
While “significant questions about efficacy and long-term safety remain unresolved,” she said, the FDA is replacing “prospective, randomized evidence […] with weaker study designs that are now likely to become the standard going forward.”
The FDA’s decision to modify a post-approval requirement does not itself establish that a vaccine is unsafe or ineffective, but the change has prompted criticism from researchers and former regulators who argue that prospective human evidence should remain a central part of evaluating unresolved safety questions.
Financial markets have meanwhile continued to react strongly to announcements involving new mRNA products even before complete clinical data become publicly available.
Moderna shares rose 177% after the company announced preliminary claims involving an experimental mRNA cancer vaccine without releasing the underlying trial dataset, according to Just the News.
Taken together, the Pennsylvania measles dispute and the debate over updated mRNA vaccine approvals center on different scientific questions but share a common concern raised by critics: how much certainty public officials and regulators should communicate when important evidence remains incomplete.
In Pennsylvania, the CDC has not yet confirmed that measles caused either reported death, while the Lancaster County coroner has explicitly rejected measles as the cause of the newborn’s death.
At the federal level, updated COVID vaccines continue to be evaluated through an established regulatory framework that relies partly on prior platform experience, immunogenicity studies and preclinical data, while critics are calling for more prospective, randomized human evidence specific to each new formulation.
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