A young boy between the age of 5 and 11 died after receiving his first dose of the Pfizer-BioNTech COVID-19 vaccine, according to the Centers for Disease Control and Prevention (CDC).
Yet, the CDC’s vaccine advisory panel on May 19 still recommended a third dose for the age group despite the boy’s death, the fact that 70% of children already have natural immunity and based on data from a small subset of only 30 children.
CDC director Rochelle Walensky approved the CDC’s recommendation allowing kids aged 5 to 11 to receive a booster five months after their second Pfizer dose.
“Vaccination with a primary series among this age group has lagged behind other age groups, leaving them vulnerable to serious illness,” Walensky said.
“With over 18 million doses administered in this age group, we know that these vaccines are safe, and we must continue to increase the number of children who are protected.”
Dr. Tom Shimabukuro, a member of the agency’s vaccine safety team said during a virtual meeting held by the Advisory Committee on Immunization and Practices (ACIP) a young male died 13 days after receiving his first dose of Pfizer’s COVID vaccine.
The boy experienced a fever 12 days after his first dose. A day later, he experienced abdominal pain and vomiting. He passed away the same day. Evidence showed the boy suffered from heart inflammation known as myocarditis.
Myocarditis, or inflammation of the heart, is a severe and potentially fatal condition. It was virtually unknown in young people until it became a recognized side effect of mRNA COVID vaccines.
Pericarditis is inflammation of the pericardium, a sac-like structure with two layers of tissue that surrounds the heart to hold it in place and help it work.
“This patient had a rapid clinical course. From the time they started experiencing their abdominal pain day 13 after dose one until the time they were brought into the [emergency department] and subsequently died was on the order of a couple of hours,” Shimabukuro said.
“Histopathological evidence of myocarditis was present on autopsy, and that was resolved to be the cause of death,” he added.
The date and location of the boy’s death were not disclosed, although it had to have occurred this year.
The death was reported to the Vaccine Adverse Events Reporting System (VAERS), which is co-managed by the CDC and U.S. Food and Drug Administration, and was verified by the CDC through an interview with the healthcare provider.
Tests conducted on the boy by the CDC’s infectious disease pathology branch, “did not find evidence of viral infection at the time of death,” Shimabukuro said.
The ACIP did not ask questions or discuss the death, but instead, determined the benefits of Pfizer’s COVID vaccine — whose perceived protection wanes rapidly — outweigh the risks.
Shimabukuro said the CDC verified 19 other reports of myocarditis following Pfizer’s COVID vaccine in the 5 to 11 age group, with 16 patients requiring hospital care. Fourteen patients had recovered by the time symptoms were reported to VAERS.
According to the latest data from VAERS, between Dec. 14 and May 13, 2022, 4,194 cases of myocarditis and pericarditis reported — 2,570 cases attributed to Pfizer’s, 1,427 cases to Moderna’s and 183 cases to Johnson & Johnson’s COVID vaccines.
In the 5 to 11 age group, 22 reports of myocarditis and pericarditis have been reported, although the number has decreased in previous weeks as the agency has “deleted” reports from the system without explanation.
According to the CDC website, the agency only investigates reports of heart inflammation if the individual meets the agency’s case definition for myocarditis following mRNA COVID vaccination and submitted a report to VAERS.
To meet the case definition, the individual must have had “symptoms such as chest pain, shortness of breath and feelings of having a fast-beating, fluttering or pounding heart, and medical tests to support the diagnosis of myocarditis and rule out other causes.”
So if an individual receives a COVID vaccine and subsequently dies from a heart condition that they didn’t seek medical attention for, their death is not counted in the statistics or investigated by the CDC.
Two young teenage boys were previously determined to have died shortly after getting the Pfizer vaccine from heart complications, but the agency has refused to acknowledge that their deaths could be linked to the vaccine.
Joseph Keating, 26, died four days after receiving the Pfizer-BioNTech vaccine from myocarditis. His autopsy confirmed he died from the heart inflammation he experienced after receiving the vaccine and his death certificate lists “Pfizer’s COVID-19 vaccine” as the cause of death.
Keating’s only warning signs were fatigue, muscle soreness and an increased heart rate. The CDC also did not investigate his death, nor did they include his death in their myocarditis statistics.
Data is inadequate to determine safety and efficacy of Pfizer’s COVID vaccine
According to the data presented during the ACIP meeting, to justify its request for authorization of a booster in the 5 to 11 age group, Pfizer presented data from a small group of 30 children showing a third dose boosted antibody levels against the omicron COVID variant 22 fold one month after administration compared to two doses.
The problem? Omicron is not the dominant COVID variant circulating in the U.S., data from 30 children is insufficient to justify authorizing a third dose for millions of children and the children were only followed for 28 days.
In a broader group of only 401 kids, Dr. Charu Sabharwal, Pfizer’s director of vaccine clinical research said most adverse reactions to the third dose were mild to moderate, with fatigue and headache most commonly reported. Some children reported fevers as high as 104 degrees, but there were no cases of heart inflammation.
However, a subset of 401 children is not large enough to detect serious and rare adverse events like blood clots or heart inflammation.
The FDA is currently reviewing an application from Moderna to authorize it’s COVID vaccine for children ages 6 months to 5 years.
ACIP committee member Dr. James Loehr, a family physician from New York, urged regulators to expedite the COVID vaccine review for the youngest age group. Dr. Doran Fink, a deputy director of the FDA’s division of vaccines, told committee regulators the agency is working quickly to review the data. A final decision on that vaccine is expected in June.