UNKNOWN RISK: Pfizer admits more studies are needed on myocarditis risk linked to COVID vaccines for kids
11/17/2021 / By Mary Villareal
Pharmaceutical giant Pfizer admits in documents submitted to the Food and Drug Administration (FDA) that clinical trials conducted to determine long-term myocarditis risks in children are too short.
This information, which has not been made public by the company or the FDA, appears on page 11 of an FDA advisory committee briefing last October, in which Pfizer admitted its sample size of clinical trial volunteers was too small to detect myocarditis risks in children 5 to 12 years old.
The statement was buried in the briefing documents for Pfizer’s vaccine for kids under 12 years old. It reads: “The number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination. 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 or pericarditis.”
https://www.science.news/2021-11-17-pfizer-admits-more-studies-needed-covid-vaccine.html#
