Pfizer Pushes Deadline for Study of Myocarditis in Kids and Adults Under 21
Pfizer launched the study in November 2022, but has not publicly released interim data and now says the study won’t be complete until November 2030.
Pfizer is drawing criticism for delaying — until November 2030 — completion of its myocarditis safety study in children and young adults under 21.
Pfizer launched the study in November 2022, but has not publicly released interim data. Some experts said Pfizer may be attempting to delay disclosure of data that could raise questions about the vaccine’s safety.
Last month, the U.S. Food and Drug Administration (FDA) approved updated versions of package inserts for the Pfizer and Moderna COVID-19 vaccines to include stronger warnings about the risks of myocarditis and pericarditis.
Pfizer originally planned to complete its study later this year, but pushed it back to 2030, nearly a decade after Pfizer-BioNTech’s first COVID-19 vaccine was released.
According to TrialSite News, the delay has “raised public concern about whether Pfizer is delivering on its post-marketing surveillance obligations in a timely and transparent manner.”
Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense (CHD), said, “It is possible the clinical study results are worse than what independent researchers already know to be true. Pfizer’s delay — while the most vulnerable are still exposed to the hazards of their product — will exacerbate the atrocity.”
The study, performed in collaboration with the U.S. government’s National Heart, Lung, and Blood Institute, assesses the long-term health outcomes of 300 patients ages 21 and younger who developed myocarditis or pericarditis after receiving Pfizer’s COVID-19 vaccine.
The study also includes a control group of 100 patients who developed those conditions following COVID-19 infection or after contracting multisystem inflammatory syndrome associated with COVID-19.
Internal medicine doctor Clayton J. Baker said Pfizer likely would have published the interim data if it had been positive. He said:
“If their findings to date were reassuring for their product, there would be a strong incentive for them to simply publish those reassuring findings this year, as originally promised.
“The ethical and scientifically sound course would be to publish the data they have gathered to date now, continue to follow the subjects and publish another update in 2030.”
Pfizer study limits myocarditis diagnoses to within 7 days of vaccination
In an op-ed for TrialSite News, Dr. Robert W. Malone, a physician-scientist known for his early contributions to mRNA technology, said there is “no sign of anything nefarious” with Pfizer’s study or its move to extend it. Malone is a newly appointed member of the Centers for Disease Control and Prevention’s (CDC) vaccine advisory panel.
Noting that Pfizer is conducting its study at 32 pediatric hospitals across the U.S. and Canada, Malone wrote that “establishing and operating a clinical research site is both expensive and time-consuming” and that by operating 32 sites, Pfizer likely believes it is “going to be wicked hard to enroll enough patients into this study.”
Malone said the FDA could request and publicize interim data from the study. “Could the FDA have insisted on interim study reports? Yes, and maybe they did (although I do not see that on the clinicaltrials.gov website description),” Malone wrote.
Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons, said Pfizer is likely “having difficulty” enrolling 300 participants in its study. She said the study likely does not have enough participants to “find rare side effects,” and is vulnerable to participant dropouts.
“The sample size of 300 is very small, rendering any results to be statistically meaningless,” said investigative journalist Sonia Elijah, who has written extensively on clinical studies for the COVID-19 vaccines.
Elijah said the study’s design will likely limit the number of myocarditis and pericarditis cases that are identified.
The study’s definition of Pfizer Comirnaty vaccine-associated myocarditis and pericarditis as occurring within seven days of vaccination is “very narrow,” Elijah said, and may “underestimate the true incidence” of myocarditis.
Guidelines used by the CDC and the Brighton Collaboration recognize the onset of post-vaccination myocarditis for 40 days and six weeks, respectively. According to a 2022 report by the U.S. government-run Vaccine Adverse Event Reporting System (VAERS), myocarditis may appear up to 120 days after vaccination.
Elijah said the study also lacks “a control group of unvaccinated and uninfected individuals.” This makes it “harder to establish” the causality between COVID-19 vaccination or infection and the development of myocarditis and other heart conditions.
Myocarditis safety signal first identified in 2021
In 2023, the CDC identified myocarditis and pericarditis as adverse events related to the mRNA COVID-19 vaccines produced by Pfizer and Moderna, based on evidence of “a causal association between mRNA COVID-19 vaccines” and these conditions.
In April, the FDA informed Pfizer and Moderna that they must update their COVID-19 vaccine labels to include stronger warnings about the risks of heart damage. Those updates were made last month.
Both COVID-19 vaccines’ labels previously warned that the shots posed a risk of post-vaccination myocarditis and pericarditis for young men. The new labels state that the known rate of myocarditis and pericarditis is about 8 cases per million doses for children and adults under 65 years old.
The updated labels also warn that the “highest estimated incidence was in males 16 through 25 years of age,” among whom the rate was 38 cases per million.
The FDA issued the letters on the same day the U.S. Senate released a 55-page report finding that public health officials under the Biden administration failed to warn the public of the myocarditis risk associated with COVID-19 shots.
During a congressional hearing in May, several witnesses, including cardiologist Dr. Peter McCullough, vaccine-injured orthopedic surgeon Dr. Joel Wallskog and attorney Aaron Siri, presented evidence connecting the COVID-19 vaccines to several cardiac conditions, including myocarditis and sudden cardiac death.
Documents previously uncovered by CHD through Freedom of Information Act (FOIA) requests show the Israeli Ministry of Health informed U.S. public health agencies about a myocarditis safety signal connected to the mRNA COVID-19 vaccines in February 2021. Pfizer and the CDC withheld this information from the public.
In March 2024, the CDC responded to a FOIA request submitted by The Epoch Times requesting information about the frequency of myocarditis in people who received the COVID-19 vaccines by producing a 148-page document. However, it was almost fully redacted.
Growing number of studies link COVID shots to myocarditis
A study published last year in JAMA, the Journal of the American Medical Association, downplayed the risk of myocarditis following COVID-19 vaccination.
However, a letter by two Canadian researchers published in JAMA in January said that the study arbitrarily reduced the number of myocarditis cases by limiting the diagnosis window to seven days.
A peer-reviewed South Korean study published in July 2024 found a 620% higher risk of myocarditis and 175% increased risk of pericarditis in people who received the vaccine compared to historical controls.
A preprint study published in May 2024 of 1.7 million children in England found cases of myocarditis and pericarditis only in children who received the COVID-19 shots. No cases were identified in children who didn’t receive the vaccine.
And a study of 23.1 million residents of four Nordic countries published in JAMA Cardiology in 2022 found that both doses of the primary series of mRNA COVID-19 vaccines “were associated with increased risk of myocarditis and pericarditis” — with the risk highest among males between the ages of 16 and 24.
VAERS data show 27,491 reported cases of myocarditis or pericarditis connected with the COVID-19 vaccines as of June 27. However, this figure may underestimate the true prevalence of myocarditis, as a 2011 Harvard report found that less than 1% of all adverse events are reported to VAERS.
Orient questioned the need for Pfizer to continue its post-marketing study, when a connection between the COVID shots and myocarditis has already been identified. “Now that there is a safety signal, why not halt use?” Orient asked.
A growing number of scientists and physicians have recommended a moratorium on COVID-19 mRNA vaccines, while others have called for an outright ban. Some U.S. states and communities, including Idaho, Kentucky and Montana, are pursuing legislative initiatives and resolutions to ban mRNA products.
Last year, Florida Surgeon General Joseph Ladapo called for a “halt in the use of COVID-19 mRNA vaccines.” In October 2024, Idaho’s Southwest District Health board voted to pull COVID-19 vaccines from the 30 locations where it provides healthcare services, becoming the first health agency in the U.S. to remove the shots.
Related articles in The Defender
Pfizer, Moderna Must Add Stronger Warnings About Possible Heart Damage From COVID Vaccines, FDA Says
JAMA Study Downplayed COVID Vaccine-related Myocarditis Risk, Researchers Say
‘Stunning’ 620% Higher Risk of Myocarditis After mRNA COVID Vaccines
Pfizer, CDC Withheld Evidence of Myocarditis After COVID Shots, New Documents Reveal
Such a clown show; they keep tossing bones
Saddens me what Dr Malone wrote in his article. He is defending them in a way. Saying the study needs to be done. Before he was placed on ACIP he spoke differently. He is on the defense now as well in his writing. Just like voting yes on the new RSV due to the positive results from Beyfortus. Tell that to the parents that have lost their babies to Beyfortus that are in VAERs. That is no longer a safety signal it would appear for any shot.