华人网上MM有高人， 指出现在大家能打到的P家疫苗不是FDA正式批准的Comirnaty， 还只是当时紧急授权的疫苗。 FDA 正式批准的瑞辉(P家)疫苗是Comirnaty，跟EUA紧急授权的P家疫苗法律上不同。 如果我理解有误， 立马删！ 多谢！ ------------------------------------------------------- https://www.nebraskamed.com/COVID/you-asked-we-answered-are-pfizers-comirnaty-and-biontech-covid-19-vaccines-the-same-or-different "[1] The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness." The FDA's approval letter [ 链接：www.fda.gov/media/151710/download ] outlines rules Pfizer and BioNTech must follow to maintain full approval for people ages 16 and older. It also explains how the companies can earn full FDA approval for people 16 and under. These rules include completing a series of studies focusing on people under age 16 to obtain full approval in this population. These studies are already underway. The companies must also maintain post-approval studies for those over 16 to monitor the vaccine's safety and efficacy. These studies are a standard part of the post-approval process that most drugs must go through to maintain full FDA approval. This list of required studies does not mean the vaccine is not fully approved.
回复 1楼San1ba4的帖子 转华人MM相关帖子： 辉瑞之前的是紧急使用 （EUA）后来批准的是那个加了商标的版本 但是美国你根本打不到 能打到的还是之前EUA的 就是玩了个文字游戏 让大家觉得批准了 之前很多人是说批准了就去打 这一波又骗了不少人去 但是实际上打出问题因为打的是EUA所有没有人会负责 官方文件在这里 https://www.fda.gov/media/150386/download 第三页，下面footnote 10. 10 The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness. 这里讨论的有两种，一种是FDAapprove的COMIRNATY，一种是仍然EUA的Pfizer-BioNTech COVID-19 Vaccine。前面一句话说两种可以替换使用，但是下面一句话才是关键，这两种是legally不同的。法律意义上不同的。 FDA approved产品打出问题是可以告要求赔偿的，EUA状态的是紧急使用，自愿使用，是不能赔偿的。 法律意义不同就是这个意思。 宣传上说Pfizer疫苗已经FDA批准，但是美国是找不到这个标牌COMIRNATY产品的。不信自己去找找看。 wk，还真是FDA只approve了Comirnaty，而Pfizer-BioNTech COVID-19只是EUA 既然FDA说这俩疫苗内容一模一样，那为什么不approve美国人打的Pfizer-BioNTech COVID-19？完全说不通，除非为了免责，太猫腻了 https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna [ 链接：www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna ] How is Comirnaty (COVID-19 Vaccine, mRNA) related to the Pfizer-BioNTech COVID-19 Vaccine? The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA), made by Pfizer for BioNTech and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses.
华人网上MM有高人， 指出现在大家能打到的P家疫苗不是FDA正式批准的Comirnaty， 还只是当时紧急授权的疫苗。 FDA 正式批准的瑞辉(P家)疫苗是Comirnaty，跟EUA紧急授权的P家疫苗法律上不同。 如果我理解有误， 立马删！ 多谢！ ------------------------------------------------------- https://www.nebraskamed.com/COVID/you-asked-we-answered-are-pfizers-comirnaty-and-biontech-covid-19-vaccines-the-same-or-different "[1] The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness." The FDA's approval letter [ 链接：www.fda.gov/media/151710/download ] outlines rules Pfizer and BioNTech must follow to maintain full approval for people ages 16 and older. It also explains how the companies can earn full FDA approval for people 16 and under. These rules include completing a series of studies focusing on people under age 16 to obtain full approval in this population. These studies are already underway. The companies must also maintain post-approval studies for those over 16 to monitor the vaccine's safety and efficacy. These studies are a standard part of the post-approval process that most drugs must go through to maintain full FDA approval. This list of required studies does not mean the vaccine is not fully approved. San1ba4 发表于 2021-10-17 12:30
如果我理解有误， 立马删！ 多谢！ ------------------------------------------------------- https://www.nebraskamed.com/COVID/you-asked-we-answered-are-pfizers-comirnaty-and-biontech-covid-19-vaccines-the-same-or-different
"[1] The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness."
The FDA's approval letter [ 链接：www.fda.gov/media/151710/download ] outlines rules Pfizer and BioNTech must follow to maintain full approval for people ages 16 and older. It also explains how the companies can earn full FDA approval for people 16 and under. These rules include completing a series of studies focusing on people under age 16 to obtain full approval in this population. These studies are already underway. The companies must also maintain post-approval studies for those over 16 to monitor the vaccine's safety and efficacy. These studies are a standard part of the post-approval process that most drugs must go through to maintain full FDA approval. This list of required studies does not mean the vaccine is not fully approved.
转华人MM相关帖子：
辉瑞之前的是紧急使用 （EUA）后来批准的是那个加了商标的版本 但是美国你根本打不到 能打到的还是之前EUA的 就是玩了个文字游戏 让大家觉得批准了 之前很多人是说批准了就去打 这一波又骗了不少人去 但是实际上打出问题因为打的是EUA所有没有人会负责
官方文件在这里 https://www.fda.gov/media/150386/download 第三页，下面footnote 10.
10 The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
这里讨论的有两种，一种是FDAapprove的COMIRNATY，一种是仍然EUA的Pfizer-BioNTech COVID-19 Vaccine。前面一句话说两种可以替换使用，但是下面一句话才是关键，这两种是legally不同的。法律意义上不同的。
FDA approved产品打出问题是可以告要求赔偿的，EUA状态的是紧急使用，自愿使用，是不能赔偿的。
法律意义不同就是这个意思。
宣传上说Pfizer疫苗已经FDA批准，但是美国是找不到这个标牌COMIRNATY产品的。不信自己去找找看。
wk，还真是FDA只approve了Comirnaty，而Pfizer-BioNTech COVID-19只是EUA 既然FDA说这俩疫苗内容一模一样，那为什么不approve美国人打的Pfizer-BioNTech COVID-19？完全说不通，除非为了免责，太猫腻了
https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna [ 链接：www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna ]
How is Comirnaty (COVID-19 Vaccine, mRNA) related to the Pfizer-BioNTech COVID-19 Vaccine? The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA), made by Pfizer for BioNTech and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses.
删了吧，这种低级谣言就不要一遍遍在板上发了。 一个是brand name, 一个是批准前的nickname. 没有任何被批准的疫苗没有brand name的
美国打了疫苗的人一半以上，华人比一半还多。
你突然说疫苗有问题，会造成心肌炎，心梗，脑梗，眼梗，你想象一下打了疫苗的人什么感受？
人最不能接受的是被否定, 而且这么大的一个事。给一点时间让人自己得出结论。不要劝人打疫苗，等一下也好。
什么感受? 打了没事的人连庆幸的感受都没有，因为对疫苗有强烈不良反应出现心肌炎或紫癫的人比例本来就不高，没事的算普通。不幸有强烈副作用的人我很同情，打了没事儿的不是该干嘛干嘛，感受个啥?
热烈祝贺你没感受！！
楼主妹妹总结的没问题。 这个EUA和参加临床试验是一样的。你事先要签免责声明，说明你是自愿参加，一切后果自负。服用approved的药不用签署任何免责声明。即使approved的药和EUA的药成分是一样的，如果你服用approved药出了问题，是可以告药厂的。当然你不一定能告赢，但总是有可能赢的。 但如果你签过免责声明，你当然也可以去告药厂，但只要所有签署的文件有法律效力，我没见过告赢的。
这年头 说人家是谣言也真是毫不费力了 诋毁事实为谣言 这黑白颠倒的世界啊
换个角度 既然都是一样的 那为啥打不到真实批准的有品牌的那个版本呢？你们谁在美国打到这个版本的请务必上来汇报一下坐标 也给算是给被强制的各位同胞行个好 实在被逼着要打 好歹打这个批准的版本 法律上至少万一打出问题还能找政府。不会像现在这样叫天天不应 唤地地不灵
你也是张口就喷啊，你有什么证据也拿出来给大家看看好了。