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Pfizer Admits Myocarditis Risk for 5-12 Year-Olds Requires 5-Year Study

by Adan Salazar
November 15th 2021, 5:48 pm
Drug giant admits clinical trials were too short to determine long-term myocarditis risks in children who take Covid-19 vaccine.
'The number of participants in the current clinical development program is too small to detect any potential risks...'
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Clinical trials conducted by drug giant Pfizer were too short to determine long-term myocarditis risks in children who take the Covid-19 vaccine, the company admitted in documents submitted to the FDA.

The information appears on page 11 of an FDA advisory committee briefing from late last month, where Pfizer even admits its sample size of clinical trial volunteers was also too small to detect myocarditis risks in children aged 5 to 12.

“The number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination,” Pfizer states in its Overall Risk-Benefit Conclusions.

Long-term safety of COVID-19 vaccine in participants 5 to <12 years of age will be studied in 5 post-authorization safety studies, including a 5-year follow-up study to evaluate long term sequelae of post-vaccination myocarditis/pericarditis.

Despite this, the FDA last month issued emergency use authorization for Pfizer-BioNTech’s COVID-19 vaccine to be given to children between the ages of five and 11. 

Meanwhile, the FDA has delayed a similar EUA for Moderna citing a need to conduct a more thorough examination into myocarditis risks.

The company’s vaccine formulation for youngsters contains tromethamine, a drug added with little fanfare that’s “used to treat metabolic acidosis, which often “occurs after heart bypass surgery or cardiac arrest,” according to Kaiser Permanente.

Read the Pfizer doc:


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