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A report by Senator Ron Johnson alleges that the Biden Administration knew about the potential myocarditis risks of the COVID-19 vaccine and delayed warnings

The document claims that since February 2021, federal health agencies were informed of dozens of cases of myocarditis and other cardiac complications in young people who received the vaccine from Pfizer and Moderna.

Johnson in the Senate / Andrew Caballero- Reynolds

Johnson in the Senate / Andrew Caballero- ReynoldsAFP

Agustina Blanco
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A 54-page interim report from the office of Sen. Ron Johnson (R-Wis.), chairman of the Senate Permanent Subcommittee on Investigations, alleges that top U.S. federal health officials delayed for months in 2021 issuing public warnings about the potential risks of myocarditis and pericarditis associated with COVID-19 mRNA vaccines, despite early warnings received.

According to the report, as of February 2021, federal health agencies, including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), were informed by the Israel Ministry of Health of 40 cases of myocarditis and other cardiac complications in young people who received the Pfizer vaccine.

At the time, Israel had a significantly higher vaccination rate than the United States, which allowed these cases to be detected earlier. However, the initial response from an FDA official approximately ten days later highlighted the limitations of passive surveillance and incomplete data, requesting more information from Israeli authorities.

The report details that, in mid-April 2021, a Department of Defense contractor presented the COVID-19 vaccine safety technical working group (VaST) with evidence suggesting a "high likelihood" that post-vaccination cardiac symptoms were eosinophilic hypersensitivity myocarditis.

By that time, the Vaccine Adverse Event Reporting System (VAERS) had recorded more than 158 cases of myocarditis, pericarditis, and myopericarditis.

Despite these signals, licensure of the adolescent vaccine was approved in May 2021. Although VaST members recommended informing providers about myocarditis risks, top health officials debated issuing a formal warning through the national Health Alert Network (HAN).

CDC's Dr. Sara Oliver wrote on May 25, 2021, to Moderna that the pros and cons of issuing a HAN were being evaluated, as CDC wanted to avoid appearing as "alarmist."

The next day, then FDA commissioner Dr. Janet Woodcock expressed opposition to the proposed wording of the warning, while Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, noted that myocarditis and pericarditis “have not actually signaled” clearly as side effects.

Another official expressed concerns about ineffective communication with providers, according to New York Post reports.

Instead of issuing the HAN warning, the CDC posted a notice on its website on May 28, 2021, acknowledging an increase in cases of myocarditis and pericarditis following the Pfizer and Moderna mRNA vaccines, but maintaining the vaccination recommendation for people 12 years of age and older.

By that time, reports in VAERS had increased to 752 cases.

Internal Biden Administration talking points described myocarditis as "rare," although Johnson's report notes that it is unclear whether this influenced the decision not to issue the HAN.

It was not until June 25, 2021, that the FDA updated Pfizer and Moderna vaccine labels to include warnings about the risk of myocarditis and related complications.

Johnson's report, released a day after the FDA announced measures to tighten requirements for booster doses, criticizes the delay in informing the public and suggests that this decision put the health of young Americans at risk.

The report concludes by demanding a thorough investigation into the government's response to adverse events from COVID-19 vaccines, arguing that the information generated by federal agencies, funded by citizen tax dollars, belongs to the American people.

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