The delay has prompted accusations from medical experts and public health advocates of potential data suppression, especially in light of increasing evidence linking mRNA COVID-19 vaccines to heart inflammation in young people.
- Pfizer has delayed completion of its myocarditis safety study in individuals under 21 to November 2030, sparking criticism over transparency and concern that interim findings — which have not been released — may reveal safety issues with its COVID-19 vaccine.
- The study, involving 300 vaccinated participants and 100 controls, defines myocarditis cases only within seven days of vaccination, a narrow window that experts say could underestimate the true incidence compared to broader definitions used by the CDC and other health authorities.
- Updated FDA vaccine labels now warn of increased myocarditis risk, especially among males aged 16–25, with Pfizer and Moderna both required to include stronger language after mounting evidence from international and U.S. sources linked mRNA shots to heart inflammation.
- Multiple studies and adverse event reports, including VAERS data and international research, continue to show elevated myocarditis risks post-vaccination, fueling calls for greater scrutiny, transparency, and even moratoriums or bans on mRNA vaccines in some U.S. states.
Pfizer pushes deadline for study of myocarditis in kids and adults under 21
Launched in November 2022, the study is a collaborative effort with the U.S. National Heart, Lung, and Blood Institute. It follows 300 participants under age 21 who developed myocarditis or pericarditis after receiving Pfizer’s vaccine, with a control group of 100 individuals who developed similar conditions after a COVID-19 infection or related complications. Despite ongoing data collection, no interim results have been publicly released.
Critics argue that if the findings were positive, Pfizer would likely have already published them. Dr. Clayton J. Baker stated, “If their findings were reassuring, there would be a strong incentive to release them now.” Delaying results until 2030 while continuing vaccine administration, he said, is scientifically irresponsible.
Study design flaws have also been highlighted. Investigative journalist Sonia Elijah criticized the narrow definition of vaccine-related myocarditis — only counting cases diagnosed within seven days of vaccination. This contradicts other health guidelines. The CDC allows a 40-day window, while the Brighton Collaboration recognizes up to six weeks. VAERS data suggests symptoms can emerge up to 120 days post-vaccination. Elijah and others also noted the lack of an unvaccinated control group, making it harder to clearly establish causality.
Enrollment difficulties are another issue. Experts suggest Pfizer may be struggling to recruit enough participants, as noted by Dr. Jane Orient. With only 300 participants, the study lacks sufficient power to detect rare but serious side effects. Additionally, participant dropout over time could further undermine the study’s credibility.
Despite Pfizer’s delay, independent studies continue to link COVID-19 mRNA vaccines to increased heart inflammation risks. A South Korean study published in July 2024 found a 620% higher risk of myocarditis in vaccinated individuals. A 2024 UK study of 1.7 million children found myocarditis and pericarditis occurred only in vaccinated children. Likewise, a 2022 Nordic study involving 23.1 million people confirmed elevated myocarditis risk, especially among males aged 16 to 24.
In response to these findings, the FDA recently required stronger warning labels for Pfizer and Moderna vaccines. Current data show myocarditis occurs in about 8 cases per million doses for people under 65, with the highest rate — 38 per million — seen in males aged 16–25.
The CDC has acknowledged a causal link between mRNA vaccines and myocarditis since 2021. However, critics allege key data were withheld from the public, including early warnings from the Israeli Ministry of Health and redacted U.S. government reports obtained via FOIA.
With growing calls for accountability, some states like Idaho and Florida have moved to ban or restrict mRNA vaccine use. Experts and lawmakers continue to debate whether ongoing vaccination is justified given the known risks—especially as Pfizer’s key safety study remains unfinished for another five years.
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