FDA先批准辉瑞然后要求其2025年做完关于已知严重副作用的研究

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CoolTeeth
楼主 (北美华人网)
这不是草菅人命啥才是?
Aren't these the main areas people are having trouble with inflammation? Back, chest, heart
Those tests will be done by 2025
If they don't lose them.....like the trial study


”We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis. Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks. Therefore, based on appropriate scientific data, we have determined that you are required to conduct the following studies: 4. StudyC4591009,entitled“ANon-InterventionalPost-ApprovalSafetyStudyof the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY. We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule: Final Protocol Submission: August 31, 2021 Monitoring Report Submission: October 31, 2022 Interim Report Submission: October 31, 2023 Study Completion: June 30, 2025 Final Report Submission: October 31, 2025 5. StudyC4591021,entitled“PostConditionalApprovalAct ” https://www.fda.gov/media/151710/download Hat Tip: Bmac
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CoolTeeth
TMD还给疫苗改了名字,现在辉瑞疫苗名字是COMIRNATY,呵呵呵
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yuanxue
Modena 的有消息吗
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CoolTeeth
回复 3楼yuanxue的帖子
目前没有
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CoolTeeth
They make up numbers, silence opposite voices, hide a lot of info about the vaccine and force mandates in the name of doing it for our good? Yeah right...
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Purple_car
回复 2楼CoolTeeth的帖子
full approval以后 很多大学跟进mandate了 白等还在push各个leader, business owner去mandate
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CoolTeeth
回复 6楼Purple_car的帖子
很多大学是哪些?新闻链接please
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CoolTeeth
“The government can’t force you to get a vaccine or any medical treatment. It is unconstitutional and it will never pass in Congress. The only thing the gov’t can do is convince private businesses to require a vaccine passport for employment or access to their stores.”
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dingdang8467
给楼上的无脑儿做些科普,每个药都要做已上市批准后的药物警戒风险评估。有些药还需要做四期临床。根据药物不同风险不同要求不同。如果无脑儿要零风险的药,只有你们党/你们川造的出来。
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CoolTeeth
回复 9楼的帖子
哦,看来你是行内人非常懂。所以以前的药也都是实验没做完对照组都没了然后已知严重副作用一大把并且还不知道原因的情况下FDA也给批的是吧?
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dingdang8467
回复 11楼CoolTeeth的帖子
实验没做完是什么概念?实验都是一直在做一直在完善的,所有药都是这样的。你害怕别吃,别用。吃用那些“实验做完了”的。
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CoolTeeth
回复 12楼的帖子
你去看看clinicaltrial.gov 上摩德纳和辉瑞的前2针实验啥时候结束就知道我说的实验没做完是什么意思了,他们第三期这个月结束整个primary 2023年才结束结果他们的对照组今年二月就没了。你觉得这很正常觉得其他的药都是这种情况?你喜欢当小白鼠没人拦着,但是请别强迫别人也去当小白鼠。
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dingdang8467
回复 13楼CoolTeeth的帖子
没人强迫你。我强迫你对我也没好处。你单位学校强迫你你可以不去。都是个人选择。你觉得祖国好,祖国疫苗好也可以回去打。
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vitd120
TMD还给疫苗改了名字,现在辉瑞疫苗名字是COMIRNATY,呵呵呵
CoolTeeth 发表于 2021-08-24 08:26

本来就叫这个。另一个更难听,spikevax
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dingdang8467
你们的智商不足以说服这里的人不打疫苗,死心吧。公司学校一召唤屁颠屁颠的。如果你们打了蛊惑其他人不打,用个半生不熟的临床数据,那看看你们敢不敢报真id,坐牢不是开玩笑的。我话放在这里。还是那句话,川普在的时候我就说了,谁政治化病毒谁政治化疫苗祝你死全家!
普罗旺斯的淡紫
回复 7楼的帖子
University of Michigan 在full approval以前就要求所有学生教职员工必须打疫苗戴口罩。目前91%的学生都打了。https://campusblueprint.umich.edu/vaccine/ 会有越来越多学校要求的。美国政府又不会上门抓你打针,总有不强制你的地方。