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Pfizer’s COVID-19 vaccine under extra scrutiny after FDA finds serious safety concern in vaccinated children

Pfizer’s COVID-19 vaccine under extra scrutiny after FDA finds serious safety concern in vaccinated children

A new federally funded study reveals that children ages 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 US Food and Drug Administration (FDA), found that the number of cases among vaccinated children reached the threshold of a safety signal, raising concerns about the possible effects side effects of the vaccine.

These findings add to the growing body of evidence linking the vaccine to heart conditions in young individuals, prompting calls for more research and greater vigilance on 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 reached the threshold of a safety signal. The elevated risk was observed seven days after vaccination. The researchers reviewed commercial database records and found 89 cases of myocarditis among 12- to 15-year-olds and 64 cases among 16- to 17-year-olds.

The study looked at 20 different health problems to determine whether vaccinated people experienced them at higher rates. Only myocarditis and pericarditis met criteria for a safety signal, suggesting a potential link to vaccination.

US officials have already concluded that these heart conditions may be caused by the Pfizer and Moderna COVID-19 vaccines, although warnings were not issued until months after the approval. 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 people who lost their insurance within a certain time period.

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 years. Although more cases were identified among children aged 5 to 11 years, it was not enough to reach the safety signal threshold. The study confirmed 27 cases of myocarditis or pericarditis out of 37 cases for which medical records could be obtained. None of the other 19 health problems examined in the study met the signal criteria.

The researchers say these findings provide additional evidence of the safety of vaccines against COVID-19 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 Pfizer to withdraw the vaccine, believes the study underestimates the frequency and severity of vaccine-induced myocarditis. He cited more than 200 articles in the peer-reviewed literature and documented cases of fatal myocarditis associated with COVID-19 vaccines. Critics argue that the study did not adequately account for vaccine-healthy bias and raised concerns about the length of the risk windows used in the analysis.

Separately, a recent risk-benefit assessment by the US Centers for Disease Control and Prevention (CDC) for updated vaccines against COVID-19 has also been criticized. The assessment, presented by CDC chief Megan Wallace, said the vaccines would prevent hospitalizations and deaths in adolescents ages 12 to 17. However, experts have pointed to flaws in the analysis, including the use of outdated hospitalization rates and the exclusion of outpatient medical services. found in the research of cases of myocarditis. Some critics argue that the risk-benefit analysis does not take into account acquired immunity through a previous 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 persist about vaccines and their potential side effects, experts are calling for more research and clinical trials to assess the effectiveness and safety of vaccines, especially in specific populations such as children.

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