51812022-06-03 20:33:23

https://www.yahoo.com/lifestyle/1-u-fda-staff-says-125219179.html

Novavax Statement on US FDA Briefing Document Related to Myocarditis/Pericarditis

https://ir.novavax.com/Novavax-Statement-on-US-FDA-Briefing-Document-Related-to-Myocarditis-Pericarditis

Jun 3, 2022 Throughout the pandemic, as publicly available vaccines have been administered, there have been numerous investigations into findings related to myocarditis. We have learned that we can expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk. Myocarditis is most often caused by nonspecific viral infections. The data from our placebo-controlled studies show that overall, in our clinical development program, the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%). Furthermore, in the post-crossover portions of our studies, the cases we have seen are all within the expected rate. Based on our interpretation of all the clinical data supporting NVX-CoV2373, including over 50,000 participants in clinical trials, we believe there is insufficient evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis.

 

51812022-06-04 02:52:04
yahoo nvax 论坛上有人说核酸和蛋白疫苗引起心肌炎的数据是这样的
GoGym2022-06-04 03:11:37
你要是真有兴趣,别去看这些乱七八糟不知来历的数据。去看FDA VRBPAC briefing package
51812022-06-04 03:29:53
0.007%和0.005%区别很大?mRNA疫苗临床没心肌炎,那实际打出来心肌炎是怎么回事?30多国家开打至少2个多月了
GoGym2022-06-04 05:10:21
说的是心肌炎的比例啊,NVX 临床两万不到就有五个心肌炎,而mRNA三四万临床没有心肌炎,你自己算算比例
va1682022-06-04 15:59:43
是这样的,我读了FDA的分析 ....
51812022-06-04 17:41:58
FDA对MRNA是扶持对NVAX是打压.是的.澳洲打4种疫苗,副作用有报道.mrna临床不报道不等于实际心肌炎少.
51812022-06-04 18:04:56
不必过分迷信FDA,是人都有私心.fda"严格” 审批后下架的药也不少,质疑FDA很正常.