Pfizer’s COVID-19 Vaccine Under Further Scrutiny After FDA Detects Serious Safety Concern in Vaccinated Children

A new federally funded study reveals that children aged 12 to 17 who received Pfizer’s COVID-19 vaccine face an increased risk of heart inflammation, specifically myocarditis and pericarditis. The study, conducted by researchers from the U.S. Food and Drug Administration (FDA), found that the number of cases among vaccinated children met the threshold for a safety signal, raising concerns about the vaccine’s potential side effects.

These findings add to the growing body of evidence linking the vaccine to heart conditions in young individuals, sparking calls for further research and heightened vigilance regarding the safety of COVID-19 vaccines for pediatric populations.

The study, published in the Journal of the American Medical Association, reported that the number of cases met the threshold for a safety signal. The elevated risk was observed within seven days of vaccination. The researchers reviewed records from commercial databases and found 89 cases of myocarditis among 12- to 15-year-olds and 64 cases among 16- and 17-year-olds.

The study examined 20 different health problems to determine if any were experienced at higher rates by vaccinated individuals. Only myocarditis and pericarditis met the criteria for a safety signal, suggesting a potential link to vaccination.

U.S. officials have already concluded that these heart conditions can be caused by the Pfizer and Moderna COVID-19 vaccines, although warnings were not issued until months after authorization. Excessive immune responses triggered by lipid nanoparticles are considered a possible mechanism for the development of these heart conditions. The study, which analyzed data from December 2020 to mid-2022, excluded individuals who lost their insurance within a specified time frame.

Out of the 3 million children who received at least one dose of the vaccine, 153 cases of myocarditis or pericarditis were identified among those aged 12 to 17. While more cases were identified among children aged 5 to 11, it was not enough to reach the safety signal threshold. The study confirmed 27 cases of myocarditis or pericarditis out of the 37 cases for which medical records were obtainable. None of the other 19 health problems examined in the study met the signal criteria.

The researchers claim that these findings provide additional evidence for the safety of COVID-19 vaccines in the pediatric population. However, some experts have raised concerns about the study’s methodology and interpretation. Dr. Peter McCullough, a cardiologist who has called for the withdrawal of the Pfizer vaccine, believes that the study underestimates the frequency and severity of vaccine-induced myocarditis. He cited over 200 papers in the peer-reviewed literature and documented cases of fatal myocarditis associated with the COVID-19 vaccines. Critics argue that the study did not adequately account for the healthy vaccine bias and raised concerns about the duration of the risk windows used in the analysis.

Separately, a recent risk-benefit assessment by the U.S. Centers for Disease Control and Prevention (CDC) for the updated COVID-19 vaccines has also faced criticism. The assessment, presented by CDC official Megan Wallace, claimed that the vaccines would prevent hospitalizations and deaths in adolescents aged 12 to 17. However, experts have pointed out flaws in the analysis, including the use of outdated hospitalization rates and the exclusion of outpatient medical encounters in the search for myocarditis cases. Some critics argue that the risk-benefit analysis fails to consider the immunity acquired through prior infection.

The time period for the study took place during the administration of the old Pfizer vaccine, which is no longer available in the United States.

As concerns about the vaccines and their potential side effects persist, experts are calling for further research and clinical trials to assess the vaccines’ effectiveness and safety, particularly in specific populations like children.