Pfizer used a comic book to gain consent from children under 12 to participate in a clinical trial to see if the COVID-19 vaccine damaged their hearts.
The document is one of many being scrutinized following a court-mandated release of documents the US Food and Drug Administration used to approve the Pfizer and Moderna COVID-19 mRNA vaccines.
Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing, a vaccine trial consent form for parents, said a Pfizer study would “collect blood samples for potential troponin I testing. The younger age group (5 to <12 years of age) will be placebo-controlled meaning you will receive either active vaccine or placebo. The older age group (12 to <16 years of age) will be open-label, meaning everyone will receive active vaccine.”
The 28-page document from September 10 2021 advised parents the study was designed to test for troponin 1, a protein that is released into the bloodstream when heart damage has occurred.
“Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received BNT162b2. Cases have mainly been reported in males under 30 years of age and following the second vaccination,” the consent form warned.
“Symptoms include: Chest pain, shortness of breath, or feelings of having a fast-beating, fluttering or pounding heart. As a precaution, you should seek medical attention right away if your child has any of those symptoms after receiving the vaccine. The chance of having this occur is very low.”
The form had another warning.
“Although not seen to date, it cannot yet be ruled out that the study vaccine could make a later COVID-19 illness more severe.”
The form said the request to have their child participate was because they were healthy and of the target age, and consent from the parents was required for Pfizer to take serum samples from children to test for troponin 1.
For children aged 5 to 11, some would receive the vaccine and others a placebo, while those aged 12 to 16 would get the vaccine.
“Depending on your child’s age, mental status and local laws, the study team may need to verify your child’s agreement (called ‘assent’) to participate in this study,” the document explained.
“Depending on local law and your child’s age, your child’s permission may be required for the study team to share some of their test results with you.”
While those 12 and up received a ten-page consent form, that included a detailed preamble, Pfizer made an eight-page comic book to gain consent for the 5-to-11-year-olds.
Just prior to the lines to sign one's consent, a cartoon doctor explained, “There is a chance that during the study you could feel pain, feel bad or uncomfortable.” He also warned of possible “redness, swelling or pain” at the point of injection, or “headache, tiredness, fever, chills, muscle pain, joint pains, feeling sick (nausea).”
The doctor character warned heart problems could ensue, though not that they could be permanent.
“It is possible that you might get chest pain, shortness of breath, or feelings of having a fast-beating, fluttering or pounding heart. You may need to come to the clinic/hospital (doctor’s office) if you have these symptoms,” the character said.
“This study will help us make better vaccines so that other children like you could benefit from information we learn in this study.”
Retired radiology professor and medical doctor Chris Flowers reviewed the documents for DailyClout and thought little of the comic book.
“The cynicism of a corporation’s employees handing children comic books in order to secure their agreement to a test of possibly life-threatening heart damage, needs no emphasis,” wrote Dr. Flowers in Report 94 on the Pfizer and Moderna docs.
“Pfizer…only conducted two months of follow-up, and there was a small number of vaccinated subjects (3,109). While myocarditis may present soon after vaccination, particularly after a second dose, it can take much longer than one to two months to become symptomatic to the point where the patient becomes aware there is a medical issue occurring.
“As a result of both the brevity of the study and the small sample, the absence of evidence of myocarditis in the study lacks significance.”
An FDA report from October 26 2021 said anaphylaxis, myocarditis and pericarditis were “important identified risks” for 5-to-11-year-old vaccine recipients, while vaccine-associated enhanced disease was an “important potential risk.”
The FDA report said the Pfizer study had been “discussed,” providing no details except that myocarditis was not found in studies on post-vaccinated children.
Flowers said these safety signals should have been acknowledged earlier. On March 25, 2021, The Journal of Pediatrics published the reports of Seattle doctors that 35 cases of myocarditis were noted in children within one week of receiving the second dose of the vaccine.
“As more information surfaces from the court-mandated release of Pfizer clinical trial documents by the FDA, and via FOIA’d emails, the CDC’s cover-up of evidence of COVID-19 mRNA vaccine-associated myocarditis in minors becomes increasingly serious," wrote Flowers.
