Millions of children who received the Pfizer-BioNTech COVID-19 vaccine now have irreversible and severe heart defects, according to a new preprint study.
Scientists investigating the safety and effectiveness of Pfizer’s vaccine in fully vaccinated, partially vaccinated, and unvaccinated children and teens, found cases of deadly myocarditis and pericarditis only in vaccinated children.
“This study clearly shows that Pfizer’s COVID vaccine provides almost no benefit to children and adolescents, but does increase their risk of myocarditis and pericarditis,” remarked Brian Hooker, Ph.D., chief scientific officer of Children’s Health Defense. “It begs the question: Why does the CDC continue to recommend these unlicensed shots for kids? Where is the data they use to support their statement that the benefits of these vaccines outweigh the risks?”
The Defender reports: The study found that vaccinated children required slightly fewer emergency room visits and hospital stays, but that those outcomes were extremely rare in children and teens across all groups.
There were no COVID-19 deaths among any of the study subjects.
Public health agencies in the United Kingdom (U.K.) and in the U.S. granted authorization to the Pfizer vaccines based on clinical trials that measured immunogenicity — or how well the vaccine elicited an immune response in the body — and efficacy against infection.
The trials didn’t test how well the vaccines protected against severe disease. They also didn’t assess particular safety endpoints, like myocarditis and pericarditis, which have been reported globally.
To address this lack of key data from the clinical trials, researchers from Oxford, Harvard, the London School of Hygiene and Tropical Medicine, the University of Bristol and TPP, a global digital health company, created a hypothetical trial based on real-world observational data.
Their research confirmed a large body of evidence showing links between the COVID-19 shots and myocarditis and pericarditis, particularly in adolescents.
The research also confirmed that even in 2021, when the vaccine was first authorized for children and teens, that age group did not face a high risk for COVID-19-related serious outcomes, including death or the need for emergency care, hospitalization or critical care.
Since then, that risk has become even lower.
The researchers conducted their investigation using data from the NHS’ OpenSAFELY-TPP database, part of the OpenSAFELY platform, a secure platform that allows researchers to access de-identified NHS data.
The database covers 40% of English primary care practices and is linked to national coronavirus surveillance, hospital episodes and death registry data. It is funded by grants from the Wellcome Trust, the largest funder of medical research in the U.K. and one of the largest in the world.
The study included all adolescents in the database ages 12-15 and all children ages 5-11 as of Aug. 31, 2021, when the vaccine was authorized for that age group — over 1.7 million children.
To be eligible for the study, the children also had to be registered with a participating general practitioner who used the database for 42 days, had to have no evidence of COVID-19 infection within 30 days of vaccination, and their data had to include complete demographic information.
Clinically vulnerable children were excluded.
The researchers tested the effectiveness of the first vaccine dose versus no vaccine, and of two doses versus a single dose.
To do this, they matched each vaccinated child with an unvaccinated one. Participants were matched by age, sex, region, prior COVID-19 testing and childhood vaccination status.
The researchers then repeated the same method to compare outcomes for a second dose versus a single dose.
They tested for five measures of effectiveness — a positive COVID-19 test, visits to the emergency department, COVID-19 hospitalization, COVID-19 critical care admission and death from COVID-19.
In total, 410,463 teenagers who received one dose of the vaccine were matched to unvaccinated controls, and 220,929 adolescents who received two shots were matched to single-vaccinated controls.
Of the 1,262,784 children in the adolescent part of the study — vaccinated and unvaccinated — there were only 72 emergency room visits, 90 COVID-19 hospitalizations — three of which were critical care for unvaccinated children — and no deaths.
There were nine cases of pericarditis and three cases of myocarditis, all in the vaccinated group.
Initially, positive COVID-19 tests were lower in the vaccinated group. However, by 15 weeks post-vaccination, the rates of positive tests in both groups were similar. The incidence of needing either emergency care or hospitalization was slightly lower in the vaccinated group.
Similarly in the two-dose to one-dose comparison, the incidence of positive tests was initially lower in the first group, but by 14 weeks post-vaccination was about the same in both groups.
The incidence of hospitalization was slightly higher in the one-dose group than in the two-dose group.
Hooker said that is likely attributable to the “healthy vaccinee effect,” where adverse events following a first dose of a vaccine increase hospitalizations. Then those people don’t get a follow-up dose.
As a result, the people who do get a second dose are less likely to be people who have negative reactions to vaccines that require hospitalization.
In the 5- to 12-year-old age group, 177,360 who received the first dose were matched with unvaccinated controls and 66,231 children who received two doses were matched with single-dose controls.
Among all of the children in the vaccinated versus unvaccinated group, there were no emergency visits, only six hospitalizations and no deaths related to COVID-19.
There were three cases of pericarditis, all in vaccinated children.
Among all of the children in the two-dose versus one-dose group, there were no emergency visits, no hospitalizations and no deaths related to COVID-19.
They concluded that in adolescents, the vaccine reduced the rate of hospitalization more than it increased the risk for myocarditis and pericarditis, but for children, the increased risk of pericarditis was higher than the reduction of risk for hospitalization.
