Pfizer Quietly Studied Myocarditis in Children a Month Before FDA Authorized COVID Shots for Kids Ages 5-11
While the Centers for Disease Control and Prevention was promoting the COVID-19 vaccine as “safe and effective” for children and teens, Pfizer was studying whether and how much it damaged their hearts, according to a DailyClout report on internal Pfizer documents.
While the Centers for Disease Control and Prevention (CDC) was promoting the COVID-19 vaccine as “safe and effective” for children and teens, Pfizer was studying whether and how much it damaged their hearts, according to a DailyClout report on internal Pfizer documents.
The documents show that Pfizer conducted a “Phase 2/3 Study” in Europe, during which it vaccinated and collected blood samples from children ages 5-11 and 12-15 and tested them for troponin I.
Troponin I, a protein released into the bloodstream when the heart is damaged, is an indicator of subclinical myocarditis.
Pfizer began the study in September 2021, the month before the U.S. Food and Drug Administration (FDA) granted Pfizer emergency use authorization (EUA) for its COVID-19 vaccine for children ages 5-11.
The FDA said it based the EUA on the agency’s “thorough and transparent evaluation of the data” that found “no serious side effects.”
However, Pfizer’s ongoing active surveillance and testing for troponin 1 was an acknowledgment of the undisclosed risk of vaccine-induced myocarditis and pericarditis, according to Dr. Christopher Flowers, who wrote the report on the Pfizer documents for DailyClout.