12-year old Maddie de Garay was enrolled in Pfizer’s COVID vaccine clinical trial for 12-15 year olds. Only 1,131 children were included, and Maddie suffered a severe reaction to her first dose. She was forced to use a wheelchair, and eat through tubes. Because the trial was so small, there’s no way to know if her reaction will occur at a rate of 1/1,000, or more, or less.
From the article: “For a virus that rarely harms children, the need to assure safety of the Covid-19 vaccine is high. A study with only 1,131 children is underpowered. It will not pick up anything but the most common adverse events. If what Maddie suffered will occur in 1/1,000 children, that would result in 75,000 children in this country suffering this serious injury. If it happens 1/10,000 children, that is 7,500 suffering this serious injury. It could be that the cure is worse than the disease. But that will only be known if there is a properly powered (a.k.a., sized) clinical trial with children.
International scientists have declared that “inadequately powered studies should themselves be considered a breach of ethical standards.” Without a clinical trial of sufficient size that reviews all potential adverse events, such as that experienced by Maddie, for a sufficient duration, this potentially catastrophic result will not be identified prior to authorization or licensure.”
