辉瑞给FDA的文件里说5-11岁试验人数太少没法观察出疫苗是否有心肌炎副作用

C
CoolTeeth
楼主 (北美华人网)
The Pfizer briefing document for vaccination in kids age 5 to 11 admits that their clinical trial was too underpowered to detect myocarditis.
"The number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination."
The clinical trial had 2,268 participants (1518 vaccine recipients and 750 placebo recipients), but many physicians are warning that the rate of myocarditis in children is around 1 out of 5,000, and that this underpowered clinical trial is being used to justify vaccinating 26 million children in this age group.
这个文件的第11页第三段 https://www.fda.gov/media/153409/download
C
CoolTeeth
用FDA雇佣的某位专家的逻辑,不要紧,给大量孩子们打了就可以知道了,不给大量孩子注射永远都不知道会不会有这个副作用。
r
ruguomei
至少上面也说(page 9): No cases of myocarditis/pericarditis were observed during the vaccination period through approximately 3 months of follow-up post-Dose 2 in the 5 to <12 years of age group in Study C4591007.
C
CoolTeeth
回复 3楼的帖子
观察了三个月就够了?而且他们自己也说了人数太少。还有,之前有12岁以上去参加试验的在参议员听证会上揭发说她第一针出现副作用后就被辉瑞直接淘汰了也不记录在案,那么对5-12岁辉瑞就不会这样干了?