Cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) have been reported after Pfizer-BioNTech COVID-19 vaccination of children ages 12–17 years. These reactions are rare; in one study, the risk of myocarditis after the second dose of Pfizer-BioNTech in the week following vaccination was around 54 cases per million doses administered to males ages 12–17 years.
首先第一段,这是说我们pandemic,所以才有EUA的基础。下一段给了具体的解释,仍然是在EUA框架下。再看下面每一个section,都是emergency use。最后一段就是conclusion,这里写的很清楚了,首先, 使用EUA的标准满足了(pandemic),明确写到了emergency use 。第二句话,additionally,12-15岁,第三针等等。这句话专门用了 under this EUA -- 说明这份法律文件就是延长的以前的 EUA。 这次 BioTech 公司给他家的疫苗起了个品牌名,叫COMIRNATY。FDA 批准的是这个。但是这个产品在美国市场上没有。 第3页倒数第2段: "The Pfizer-BioNTech COVID-19 Vaccine that uses PBS buffer and COMIRNATY (COVID-19 Vaccine, mRNA) have the same formulation. The products are legally distinct with certain differences that do not impact safety or effectiveness. Accordingly, under this EUA, the PfizerBioNTech COVID-19 Vaccine that uses PBS buffer and COMIRNATY (COVID-19 Vaccine, mRNA) can be used interchangeably to provide doses for primary vaccination in individuals 12 years of age and older, or to provide a single booster dose in the adult populations described in Section II of this letter of authorization, without presenting any safety or effectiveness concerns". 划重点,美国市场上的 Pfizer-BioTech 疫苗在法律意义上,不是Comirnaty,所以你接受的是 medically 跟批准的 COMIRNATY 疫苗一样有效的东西,但是没有正式批准的产品的那些 legal 的责任。
TOKYO--(BUSINESS WIRE)--Cytokine storm and coagulopathy, the major life-threatening complications of COVID-19, whose biomarkers Interleukin-6 and D-Dimer were under control with consumption of two variants of Nichi Glucan food supplements from Japan in a pilot study. Immune parameters like ratios of neutrophil to lymphocyte (NLR), lymphocyte to c-reactive protein (LCR) and leucocyte to c-reactive protein (LeCR) were advantageous, along with CD4 and CD8 levels, in those who consumed Nichi Glucans than, those who didn’t, as published in Biomedicine and Pharmacotherapy, a peer reviewed journal (https://www.sciencedirect.com/science/article/pii/S0753332221010271).
Indeed, not all yeast glucans act the same because of the growth conditions and this might be also a key factor in the immunomodulation process. Besides the strain, brewery yeast β -glucan has a different pattern than those found in baker’s yeast and it seems to be well tolerated [36]. Nor such combinations between yeast glucan, vitamin C and resveratrol are neglected so a significant synergistic effect exists in order to boost the antibody production [37].…………… Taking together, bioactive compound exerts a great antiviral activity and previous studies clearly demonstrate its effectiveness in viral infections at the stage of viral entry, thus, it is necessary to perform further clinical trials and find the best combination which is suitable in the treatment of COVID-19.
如果孩子们没有肥胖,及免疫缺陷,或身体因某些疾病特别虚弱,不推荐打新冠疫苗。从已有疫情看,孩子得病很少,更鲜有重症,极少死亡。及时治疗比打疫苗更重要
以前说打了疫苗可以防止传播保护家人,在目前看来,这只是一厢情愿。连打疫苗者自己都避免不了被突破传染,怎么能阻止传染给别人。
关键在于,孩子们打疫苗的安全性,尚有待进一步观察。如果引起心脏等方面的问题,将得不偿失。
下面是CDC近两年的数据,列举了按年龄段划分的新冠、肺炎、流感死亡数。注意17岁以下组的数字,跟流感没啥差别,远低于死于肺炎的人数。
https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm
这个是更详细的美国孩子们疫情数据资料
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11-2-3/03-COVID-Jefferson-508.pdf
其中值得细读的是这张表,因新冠死亡的,与自杀相同,低于流感。
尽管在5-11岁儿童只用了成人疫苗剂量的1/3,引起普遍关注的心肌炎问题,並没有解决。对孩子的长期影响,有待追踪观察。
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html
Cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) have been reported after Pfizer-BioNTech COVID-19 vaccination of children ages 12–17 years. These reactions are rare; in one study, the risk of myocarditis after the second dose of Pfizer-BioNTech in the week following vaccination was around 54 cases per million doses administered to males ages 12–17 years.
更多我的博客文章>>>
真正的朋友亲人没有一个躲我的,反而被我的健康状态所感染。
副作用药厂没责任,医院诊所没责任,政府没责任。
Fuz 我给你这篇文章点赞。
不过上次你回复我的,虽然是来自FDA网站,但是依然是新闻稿。是FDA的新闻。LOL
真正的FDA批准文件在这里:
https://www.fda.gov/media/150386/download
既然有正式批准的 COMIRNATY了,这个品牌就可以在市场上做推广了。
可是你看看产品的网站,在医护人员的下拉菜单中,你根本找不到美国。在非医护人员的下拉菜单中,点击美国,你将看到下面的声明:
不多说了。大家自己阅读,检验,判断吧。
看看这次拍马屁能不能翻车
为啥文学城没有抠鼻子的表情,难道不知道抠鼻子有多爽吗?
老祖宗的话,还是要听一听的。不是有说:不听老人言,吃亏在眼前。祝福大家!
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孩子一起睡,没事。邻居大人都疫苗过了,孩子阳性,妈妈咳嗽很厉害。不知是否阳性。如果政策不考虑实际情况,就是误导
疫苗或感染获得的抗体。用于国际旅行证明。
那孩子大概可以不打了。
目前打和不打都是有利有弊,说不清楚哪个害处更大。
新加坡刚公布了四例包括幼儿在内的儿童感染新冠造成多器官水肿。当然有人会说这是为向孩子推广疫苗做宣传。
多少岁以上的孩子可用维生素C加上β-葡聚糖(Beta Glucan 1,3/1,6)早期干预新冠?
停用,以避免过度激活各种细胞因子所造成的非将异性器官损伤。
比如这种VC,口味适合孩子。
https://www.walmart.com/ip/Emergen-C-Kidz-250mg-Vitamin-C-Powder-Caffeine-Free-Vitamin-C-for-Kids-Immune-Support-Drink-Mix-Fruit-Punch-Flavor-30-Count-1-Month-Supply/28932351?wmlspartner=wlpa&selectedSellerId=0&&adid=22222222227020554269&wl0=&wl1=g&wl2=c&wl3=537158968308&wl4=pla-475853241345&wl5=9025857&wl6=&wl7=&wl8=&wl9=pla&wl10=8175035&wl11=online&wl12=28932351&veh=sem&gclid=Cj0KCQjw8p2MBhCiARIsADDUFVFIxdJVRscl4jURHTknpvj5ZCz8p8Dfp-syceCU_3n7NhWweaF4cQwaAvCnEALw_wcB&gclsrc=aw.ds
说是在感染期间服用,能减轻症状。
https://gutpathogens.biomedcentral.com/articles/10.1186/s13099-020-00385-2
How to boost the immune defence prior to respiratory virus infections with the special focus on coronavirus infections只看题目便知,是在感染病毒之前用的
有几篇日本研究文章,用的是特殊途径合成的beta-glucan, 不是市面常见的1,3或1,6-键。 这类由厂家直接赞助的研究,其目的性不言而寓
https://www.nutraingredients-asia.com/Article/2021/09/21/COVID-19-and-beta-glucans-Pilot-study-shows-two-strains-can-help-control-biomarkers-of-clinical-severity
https://www.businesswire.com/news/home/20211011005726/en/COVID-19-Cytokine-Storm-and-Coagulopathy-Markers-Controlled-With-Nichi-Glucan-Variants-The-First-of-Its-Kind-Report-in-a-Clinical-Study
Nichi Glucan and Nichi Glucan REFIX Beta 1,3-1,6 glucans, produced by AFO-202 and N-163 strains of Black Yeast Aureobasidium Pullulans are unique from other Beta glucans, being produced as an exo-polysaccharide with higher purity and unique structure, which are considered as reasons for their multiple benefits to human health, including the one reported in this clinical study in Covid-19 patients. (Graphic: Business Wire)
TOKYO--(BUSINESS WIRE)--Cytokine storm and coagulopathy, the major life-threatening complications of COVID-19, whose biomarkers Interleukin-6 and D-Dimer were under control with consumption of two variants of Nichi Glucan food supplements from Japan in a pilot study. Immune parameters like ratios of neutrophil to lymphocyte (NLR), lymphocyte to c-reactive protein (LCR) and leucocyte to c-reactive protein (LeCR) were advantageous, along with CD4 and CD8 levels, in those who consumed Nichi Glucans than, those who didn’t, as published in Biomedicine and Pharmacotherapy, a peer reviewed journal (https://www.sciencedirect.com/science/article/pii/S0753332221010271).
你所提到的VC和葡聚糖治新冠的提法,可能源于这篇小综述。目前为止,没看到任何临床数据支持这个假设。
https://biomedres.us/pdfs/BJSTR.MS.ID.005431.pdf
Indeed, not all yeast glucans act the same because of the growth conditions and this might be also a key factor in the immunomodulation process. Besides the strain, brewery yeast β -glucan has a different pattern than those found in baker’s yeast and it seems to be well tolerated [36]. Nor such combinations between yeast glucan, vitamin C and resveratrol are neglected so a significant synergistic effect exists in order to boost the antibody production [37].……………
Taking together, bioactive compound exerts a great antiviral activity and previous studies clearly demonstrate its effectiveness in viral infections at the stage of viral entry, thus, it is necessary to perform further clinical trials and find the best combination which is suitable in the treatment of COVID-19.
挺绕