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A peer-reviewed study of over one million healthy children and teens set out to assess the safety and effectiveness of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine – and found that “myocarditis and pericarditis were documented only in the vaccinated groups, with rates of 27 and 10 cases/million after the first and second doses, respectively.”
Published in January at Epidemiology, the study, from researchers Colm, Andrews et al, from the Universities of Oxford and Bristol, and Harvard’s School of Public Health, examined the safety and effectiveness of Pfizer’s COVID shot in healthy children aged 5-15 as the vaccine launch began in late 2021.
The observational study used National Health Service (NHS) England’s OpenSAFELY-TPP database, comparing children and teens receiving “(1) the first vaccination to unvaccinated controls and (2) the second vaccination to single-vaccinated controls.”
Investigators specifically compared 141,711 children between the ages of 5 and 11, and 410,463 between the ages of 12 and 15. These children and young teens were given a first dose of the Pfizer shot while equal numbers of same-age children remained unvaccinated.
“We matched vaccinated individuals with controls on age, sex, and other important characteristics,” the researchers noted.
Outcome measures used were:
… positive SARS-CoV-2 tests (adolescents only), COVID-19 accident and emergency (A&E) attendance, COVID-19 hospitalization, COVID-19 critical care admission, and COVID-19 death; with safety outcomes, A&E attendance, unplanned hospitalization, pericarditis, and myocarditis.
“Across all analyses, there were no COVID-19-related deaths, and fewer than seven COVID-19-related critical care admissions,” the researchers observed, citing their results. “Myocarditis and pericarditis [heart inflammation] were documented only in the vaccinated groups, with rates of 27 and 10 cases/million after the first and second doses, respectively.”
While the investigators found that vaccination in adolescents reduced COVID-19 emergency room visits and hospitalization, they acknowledged nevertheless that “these outcomes were rare.”
The shot’s ability to protect against positive SARS-CoV-2 tests was also found to be “transient.”
“We estimated an initial protective effect against a positive SARS-CoV-2 test in adolescents that waned by 14 weeks,” Colm et al noted.
“While rare, all myocarditis and pericarditis events during the study period occurred in vaccinated individuals: there were no deaths after myocarditis or pericarditis,” they observed. “The rate of fractures was similar across vaccine groups in both adolescents and children. None of the child cohort required hospitalization or critical care after a pericarditis event. In the adolescents, the maximum length of hospital admission was 1 day for critical care and 2 days for hospitalization.”
“That there were no cases of myocarditis or pericarditis in the unvaccinated group does not mean that such events cannot occur without COVID-19 vaccination, only that these events were not observed in the unvaccinated groups in our specific matched analyses,” the researchers stated.
Meredith Evans, writing at Evie Magazine, reported the study last week, noting that “parents who hesitated or refused the shots for their children may feel their caution was justified,” and that “[h]ealthcare workers who raised concerns and faced professional consequences may feel similarly vindicated.”
The large study is highlighted in the wake of a ruling by a Boston-based U.S. District Court judge who blocked the Trump Department of Health and Human Services’ (HHS) actions to revise the Advisory Committee on Immunization Practices (ACIP).
Biden-appointed Judge Brian Murphy drew a firestorm previously for his attempts to overturn the Trump administration’s immigration policies.
Law professor and legal analyst Jonathan Turley wrote last week that Murphy’s string of seemingly anti-Trump judicial decisions brings to mind the adage of “Murphy’s Law,” i.e., “Anything that can go wrong will go wrong.”
“As with his earlier immigration order, the court seems to take the view that anything that can go wrong for the Trump Administration will go wrong for the Administration,” Turley observed. “At virtually every critical point, the court seems to adopt the harshest possible interpretation against the Administration.”
“Murphy effectively halted, for now, the meeting of Kennedy’s new Advisory Committee on Immunization,” he explained. “Kennedy had replaced many members of the ACIP, including some accused of conflicts of interest.”
“However, Murphy found that Kennedy had made arbitrary and capricious decisions in changing vaccine policies and changing the committee membership … Judge Murphy basically lambasts Kennedy for attacking good science and scientific methods,” Turley added. “His criticism is laden with assumptions about the ‘correct’ answers to questions governing vaccines.”
In a podcast last week, Dr. Kirk Milhoan, who has been the chairman of the new ACIP, lamented Murphy’s ruling.
“We were hoping to be able to discuss the real harms that have happened to people post-vaccine … not just harmed in a temporary way, but in a chronic way,” he said.
In June 2025, the Food and Drug Administration (FDA) released a “safety communication,” announcing its requirement that the prescribing information for Pfizer’s mRNA COVID-19 shot Comirnaty, and for Moderna’s mRNA COVID shot Spikevax, “include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines.”
The safety notice came following results of a long-term study in 2024 that focused on cardiac problems and outcomes of vaccine-associated myocarditis in American young people.
Despite these results and actions, nevertheless, Evans wrote at Evie that “[t]he larger question remains: for the children who did develop heart inflammation following vaccination, what recourse do their families have?”
“Will there be compensation, acknowledgment, or accountability for those whose hearts were affected by a vaccine they were assured was safe?,” she asked.
Following Murphy’s ruling, Sen. Rand Paul (R-KY) posted to social media once more about his bill, titled the End the Vaccine Carveout Act, that would serve to eliminate the “sweeping liability shields” of vaccine manufacturers who, Paul noted, “still enjoy special legal protections,”
“[P]eople injured by their products deserve a chance to seek justice,” he said.
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