关于心肌炎，这是Novavax的回复： 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. 5例心肌炎包括了打安慰剂后接种了疫苗(post-crossover) 的人。1例是发生在28天后，似乎不能算是疫苗引起的；1例似乎是心包炎；所以只有3例。考虑到5万人的参加临床的人，比例是6／10万人。而正常情况下，心肌炎是6.57／10万人，在安全范围内。 至于mRNA疫苗的3期临床为何没有，就要问他们了（比如辉瑞的个别数据点有问题，网上有报道），理论上3万正常人会有2例。
Novavax 获得EUA后，会递交booster和12－17岁的EUA申请。
https://www.cnbc.com/2022/06/07/novavax-covid-vaccine-clears-key-step-on-path-to-fda-authorization-after-committee-endorses-the-shot.html
去年底Novavax上交的就是EUA的申请材料，BLA需要更多的数据和材料，批准的标准更严格。
目前Novavax在日本和韩国是拿到了BLA。
我也觉得很奇怪，Novavax大规模接种之后的副作用数据到目前还没看到。
一个需要关注的事情是心肌炎，Novavax clinical trial里面发现了6个心肌炎，5疫苗1安慰剂，这个比例好像有点高，不知道是真的心肌炎概率更高还是只是运气不好。
作为对比，两个mRNA疫苗的心肌炎都是在推广到了年轻男性的时候才被发现，clinical trial里面没有
理论上讲Novavax是细胞外抗原，炎性反应要小很多。clinical trial里面发烧的概率也比前面几个疫苗低得多，第一针0.4%，第二针6.2%
不过我个人觉得作为疫苗，短时间的发烧头疼什么的其实都不是很大的事情，主要要看ITP，心肌炎、血栓这样非常严重的副作用到底有多少。
再就是目前知道有少数人打了疫苗以后由于炎性反应的影响，会出现类似long covid的症状，比如头疼、心悸、brain fog等等，可以持续好几个月。理论上讲novavax类似的问题要小一些，不知道实际上怎么样。
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.
5例心肌炎包括了打安慰剂后接种了疫苗(post-crossover) 的人。1例是发生在28天后，似乎不能算是疫苗引起的；1例似乎是心包炎；所以只有3例。考虑到5万人的参加临床的人，比例是6／10万人。而正常情况下，心肌炎是6.57／10万人，在安全范围内。
至于mRNA疫苗的3期临床为何没有，就要问他们了（比如辉瑞的个别数据点有问题，网上有报道），理论上3万正常人会有2例。
请问，细胞外抗原疫苗有本不应该发生的心肌炎问题，目前厂商或官方没有解释吗？