update 1-FDA staff says Nvax vaccine lowers COVID risk(ZT)

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.

 

所有跟帖： 

• yahoo nvax 論壇上有人說核酸和蛋白疫苗引起心肌炎的數據是這樣的 -5181- ♂ (1399 bytes) () 06/03/2022 postreply 18:52:04

• 你要是真有興趣，別去看這些亂七八糟不知來曆的數據。去看FDA VRBPAC briefing package -GoGym- ♀ (297 bytes) () 06/03/2022 postreply 19:11:37

• 0.007%和0.005%區別很大？mRNA疫苗臨床沒心肌炎,那實際打出來心肌炎是怎麽回事？30多國家開打至少2個多月了 -5181- ♂ (106 bytes) () 06/03/2022 postreply 19:29:53

• 說的是心肌炎的比例啊，NVX 臨床兩萬不到就有五個心肌炎，而mRNA三四萬臨床沒有心肌炎，你自己算算比例 -GoGym- ♀ (281 bytes) () 06/03/2022 postreply 21:10:21

• FDA對MRNA是扶持對NVAX是打壓.是的.澳洲打4種疫苗,副作用有報道.mrna臨床不報道不等於實際心肌炎少. -5181- ♂ (5712 bytes) () 06/04/2022 postreply 09:41:58

• 是這樣的，我讀了FDA的分析 .... -va168- ♀ (6078 bytes) () 06/04/2022 postreply 07:59:43

• 不必過分迷信FDA,是人都有私心.fda"嚴格” 審批後下架的藥也不少,質疑FDA很正常. -5181- ♂ (134 bytes) () 06/04/2022 postreply 10:04:56