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.
Found something really interesting while reading the briefing documents for Pfizer vax for kids under 12 years old. So hard to find this document on FDA website. They really bury this information.https://t.co/AC7MN09uJc pic.twitter.com/l4OUj1WQUr
— ⚠️Gerard Delaney⚠️ (@Gerard39delaney) November 9, 2021
“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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