FDA 真的批准了辉瑞公司的 COVID 疫苗吗?等等,什么?|乔恩•拉波波特

2021年8月27日10:15:44其他揭露FDA 真的批准了辉瑞公司的 COVID 疫苗吗?等等,什么?|乔恩•拉波波特已关闭评论2791字数 14196阅读47分19秒阅读模式
摘要

在8月23日,美国食品药品监督管理局并没有完全批准辉瑞公司的疫苗。因此,这些人可以拒绝接种疫苗,理由是它仍处于试验阶段,这意味着它只被授予紧急使用授权。

August 25,2021

2021825

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The pressure is building."Take the vaccine."

压力越来越大,"接种疫苗吧。"

Many people are looking for a successful way to refuse the COVID vaccine in situations where the shots are mandated.I fully support such efforts.

许多人正在寻找一种成功的方法,在强制注射的情况下拒绝接种 COVID 疫苗。我完全支持这些努力。

Some people believe they can make the argument that the FDA didn't actually give full approval to the Pfizer vaccine on August 23rd.Therefore,these people can refuse the vaccine on the grounds that it is still experimental,meaning it has only been granted Emergency Use Authorization.

有些人认为他们可以争辩说,在823日,美国食品药品监督管理局并没有完全批准辉瑞公司的疫苗。因此,这些人可以拒绝接种疫苗,理由是它仍处于试验阶段,这意味着它只被授予紧急使用授权。

I'll discuss that practical strategy later in this article.

我将在本文后面讨论这个实用策略。

But first,I need to analyze the claim that the FDA didn't truly approve(license)the Pfizer vaccine.

但是首先,我需要分析一下 FDA 没有真正批准辉瑞公司疫苗的说法。

OK.Here we go.

好了,开始吧。

The first FDA document I'll reference is"Comirnaty and Pfizer-BioNTech COVID-19 Vaccine,"dated August 23,2021.The document opens with this statement:

我要引用的第一份 FDA 文件是"Comirnaty and Pfizer-BioNTech 2019冠状病毒疾病疫苗",日期为2021823日。文件以下面的声明开头:

"On August 23,2021,the FDA approved the first COVID-19 vaccine.The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine,and will now be marketed as Comirnaty,for the prevention of COVID-19 disease in individuals 16 years of age and older.The vaccine also continues to be available under emergency use authorization(EUA),including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals."

2021823日,FDA 批准了第一个2019冠状病毒疾病疫苗。这种疫苗被称为辉瑞生物技术2019冠状病毒疾病疫苗,现在将作为混合疫苗销售,用于预防16岁及以上人群的2019冠状病毒疾病。根据紧急使用授权(EUA),该疫苗也继续可供使用,包括1215岁的个人和某些免疫力低下的个人使用第三剂疫苗。"

"The FDA approved"means full approval.The FDA has fully approved the Pfizer-BioNTech COVID vaccine.

"FDA 批准"意味着完全批准。FDA 已经完全批准了辉瑞公司生物技术公司生产的 ovid 疫苗。

And this vaccine"will now be marketed"as the Comirnaty vaccine.

这种疫苗"现在将作为联合疫苗销售"

They are the same vaccine,medically speaking.The ingredients are the same.

从医学上讲,它们是同一种疫苗,成分是相同的。

The FDA document ALSO says the vaccine will continue to be available under the prior Emergency Use Authorization(EUA),for uses that are not yet fully approved.For example,injecting children 12-15,and as a third dose for certain immunocompromised people.

美国食品药品监督管理局的文件还说,该疫苗将继续根据之前的紧急使用授权(EUA),用于尚未完全批准的用途。例如,给12-15岁的儿童注射,对某些免疫功能低下的人注射第三剂。

The full approval and the EUA status are riding together,side by side.The EUA status covers uses of the vaccine not covered under full approval.

完全的批准和 EUA 的地位是一起骑,肩并肩。EUA 的地位涵盖了未经完全批准的疫苗的使用。

The rest of this FDA document offers links.One of the links leads to an FDA news release,dated August 23,titled,"FDA Approves First COVID-19 Vaccine."The release states:

这份文件的其余部分提供了链接。其中一个链接指向了 FDA 823日的新闻稿,标题是"FDA 批准第一批2019冠状病毒疾病疫苗"新闻稿中写道:

"Today,the U.S.Food and Drug Administration approved the first COVID-19 vaccine.The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine,and will now be marketed as Comirnaty…"

今天,美国食品和药物管理局批准了第一个2019冠状病毒疾病疫苗。这种疫苗被称为辉瑞生物技术2019冠状病毒疾病疫苗,现在将作为混合疫苗销售......"

"To support the FDA's approval decision today,the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population."

"为了支持 FDA 今天的批准决定,FDA 审查了支持 EUA 的临床试验的最新数据,包括在更多临床试验人群中进行更长时间的随访。"

The FDA,in this news release,is again asserting that the Pfizer vaccine is now approved,and makes a clear distinction between the prior EUA and this new approval.

在这份新闻稿中,FDA 再次断言辉瑞公司的疫苗现在已经获得批准,并且在之前的 EUA 和这次新的批准之间做出了明确的区分。

Next,we move to a letter,also dated August 23,sent from the FDA to BioNTech Manufacturing GmbH,and Pfizer Inc.The letter is marked,"BLA Approval."BLA stands for"Biologics License Application."Here are key quotes:

接下来,我们转向一封日期也是823日的信件,由美国食品和药物管理局发给 BioNTech 制造公司和辉瑞公司。这封信上写着"BLA 批准"BLA 代表"生物制品许可证申请"以下是一些关键的引言:

"Please refer to your Biologics License Application(BLA)submitted and received on May 18,2021,under section 351(a)of the Public Health Service Act(PHS Act)for COVID-19 Vaccine,mRNA."

请参阅您于2021518日根据《公共卫生服务法》第351(a)条提交并收到的关于2019冠状病毒疾病疫苗的生物制品许可证申请

"We are issuing Department of Health and Human Services U.S.License No.2229 to BioNTech Manufacturing GmbH,Mainz,Germany…Under this license,you are authorized to manufacture the product,COVID-19 Vaccine,mRNA…You may label your product with the proprietary name,COMIRNATY…"

"我们向美因茨 BioNTech Manufacturing GmbH 颁发美国卫生与公众服务部第2229号许可证......根据这一许可证,你被授权制造该产品,2019冠状病毒疾病疫苗,mRNA......你可以在你的产品上标注专利名称,COMIRNATY......"

The FDA officially licensed this vaccine.This is approval.It is not merely a continuation of Emergency Use Authorization(EAU).

FDA 正式许可这种疫苗。这是批准。它不仅仅是紧急使用授权(EAU)的延续。

And now we come to another key FDA document,a letter sent to Pfizer Inc.on August 23,2021(addressed to Ms.Elisa Harkins).It also mentions the full licensure(approval)of the vaccine:

现在我们来看看另一份关键的 FDA 文件,一封2021823日寄给辉瑞公司的信(寄给 Elisa Harkins 女士)。它还提到了疫苗的完全许可(批准):

"On August 23,2021,FDA approved the biologics license application(BLA)submitted by BioNTech Manufacturing GmbH for COMIRNATY(COVID-19 Vaccine,mRNA)for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older."

2021823日,美国食品及药物管理局批准了 BioNTech Manufacturing GmbH 提交的生物制品许可证申请,用于主动免疫,以预防16岁及以上人群 SARS-CoV-2引起的2019冠状病毒疾病2019冠状病毒疾病

This letter is further acknowledgement that the vaccine has been fully approved.

这封信进一步确认疫苗已经得到充分批准。

FDA 真的批准了辉瑞公司的 COVID 疫苗吗?等等,什么?|乔恩•拉波波特

Now we enter the thick weeds of the letter,during a discussion of how Emergency Use Authorization will continue to be used.The language is very dense.It's taken me a while to separate out the strands.

现在,我们进入了信件的厚草,在讨论如何紧急使用授权将继续使用。语言非常复杂。我花了好长时间才把它们分离出来。

To help you with what I'm going to untangle,understand that the FDA is making a distinction between what we could call the"old Pfizer vaccine"and the"new Pfizer vaccine."They are identical in their ingredients.They are the same vaccine.But the"old vaccine"vials were granted Emergency Use Authorization(EUA)before the August 23rd FDA full licensure of the vaccine;and the"new vaccine"vials will certainly be used under full licensure(approval).

为了帮助你理解我将要解开的谜团,请理解 FDA 正在区分我们所说的"老辉瑞疫苗""新辉瑞疫苗"它们的成分是一样的。它们是同一种疫苗。但是在823日美国食品和药物管理局对"旧疫苗"进行全面许可之前,"旧疫苗"瓶已经获得了紧急使用授权(EUA);"新疫苗"瓶肯定会在全面许可(批准)下使用。

Splitting hairs?Yes.But in order to understand what the FDA is saying in this letter,you have to grasp the distinction between"the old"and"the new."

吹毛求疵?是的。但是为了理解 FDA 在这封信中所说的,你必须理解"旧的""新的"之间的区别

The"old"vaccine is labeled"Pfizer-BioNTech COVID-19 vaccine,"and the"new"vaccine is labeled"COMIRNATY."Again,they are exactly the same vaccine.

这种""疫苗被标记为"辉瑞生物技术2019冠状病毒疾病疫苗",而""疫苗则被标记为"COMIRNATY"同样,它们是完全相同的疫苗。

The FDA letter to Pfizer(the one addressed to Ms.Elisa Harkins)states:

美国食品药品监督管理局给辉瑞公司的信(其中一封是给伊丽莎·哈金斯女士的)写道:

"On August 23,2021,having concluded that revising this EUA[Emergency Use Authorization for the vaccine]is appropriate to protect the public health or safety…FDA is reissuing the August 12,2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses,and to authorize use of COMIRNATY(COVID-19 Vaccine,mRNA)under this EUA for certain uses that are not included in the approved BLA."

"2021823日,FDA 得出结论,修订本 EUA[疫苗紧急使用授权]是适当的,以保护公众健康或安全......FDA 正在重新发布2021812日的授权信函的全部内容和修订,以澄清欧盟将继续为辉瑞生物技术公司的2019冠状病毒疾病疫苗提供事先授权的适应症和用途,并授权使用本 EUA 下的 COMIRNATY(2019冠状病毒疾病疫苗,mRNA)用于未包括在批准的 BLA 中的某些用途。"

The"old vaccine"will continue to have EUA status:it can be injected in people 12 and older,and it can be used as a third dose for certain immunocompromised individuals.

"旧疫苗"将继续具有 EUA 地位:它可以在12岁以上的人群中注射,也可以作为某些免疫缺陷个体的第三剂使用。

The"new vaccine"—which has full FDA approval—CONTINUES TO ALSO HAVE EUA STATUS—and therefore it too can be injected in people 12 and older,and used as a third dose for certain immunocompromised individuals.

这种"新疫苗"已获得美国食品药品监督管理局(FDA)的全面批准,仍然具有 EUA 状态,因此也可以在12岁及以上的人群中注射,并作为某些免疫力低下的个体的第三剂使用。

Strange?Yes.The"new"and fully approved vaccine retains its former EUA status.It's BOTH fully approved and certified as an emergency experimental product.

奇怪吗?是的。"新的"和完全批准的疫苗保留其原欧盟地位。这是一个完全被认可的紧急实验产品。

I believe the FDA reasoning goes this way:the agency wants to make sure vials carrying the label of the"new"fully approved vaccine can be injected into people to whom the full approval doesn't apply—people between 12 and 15,and certain immunocompromised people,as a third shot.In other words,people covered under EUA status.

我相信 FDA 的推理是这样的:该机构希望确保带有""完全批准的疫苗标签的小瓶可以注射到那些没有得到完全批准的人身上,作为第三针,这些人包括1215岁之间的人,以及某些免疫力低下的人。换句话说,人们被覆盖在 EUA 的地位。

If you continue to read this FDA letter,you'll see this reasoning spelled out.

如果你继续读这封 FDA 的信,你会看到这个推理被详细说明。

Bottom line,and my conclusion:The FDA has fully approved the"new vaccine"AND it has also retained the Emergency Use Authorization(EUA)for the"new vaccine."Both.

底线,和我的结论:FDA 已经完全批准了"新疫苗",并且它还保留了"新疫苗"的紧急使用授权(EUA)两者都有。

FDA 真的批准了辉瑞公司的 COVID 疫苗吗?等等,什么?|乔恩•拉波波特

—So what does all this mean for people who want to find a workable reason for refusing the vaccine?

那么,对于那些想找到拒绝接种疫苗的可行理由的人来说,这一切意味着什么呢?

For example,suppose you work for a major corporation or a government agency,and you're told you must get the shot.You say,"No,I won't take the shot,because the FDA never approved it.It's still an experimental medicine,because it only has EUA status."

例如,假设你为一家大公司或政府机构工作,你被告知必须拍照。你说,"不,我不会注射,因为 FDA 从来没有批准过。它仍然是一种实验性药物,因为它只具有 EUA 地位。"

I believe you'll lose.You'll be told,"The FDA HAS approved it."

我相信你会输,你会被告知,"食品药品管理局已经批准了。"

Suppose you take a somewhat different approach.You say,"I'll need to see the actual vial containing the vaccine you want to inject me with.Is it labeled'Pfizer-BioNTech COVID-19 vaccine'(the'old'vaccine)or'COMIRNATY'(the'new'vaccine)?"

假设您采取了一种稍微不同的方法。你说,"我需要看看你想给我注射的疫苗的真实瓶子。它的标签是'辉瑞生物技术2019冠状病毒疾病疫苗'(''疫苗)还是''疫苗?"

Your boss says,"What difference does it make?Either way,it's the same vaccine."

你的老板说,"这有什么区别吗?不管怎样,这是同一种疫苗。"

And you say,"Not legally speaking.I understand it may take some time for the new shipments of the COMIRNATY to arrive.I won't take the Pfizer-BioNTech shot because it only has Emergency Use Status,and therefore it's an experimental medicine.Under federal law,I have the right to refuse an experimental medicine.I'm invoking that right."

Will that fly?

这能行吗?

I'm giving you non-lawyer opinions here.Understand this.

我给你的不是律师的意见,你要明白。

It's possible this approach could buy you time.Maybe your boss will suddenly become a bit nervous—he tells you he's going to talk to his company/agency attorneys,and he'll get back to you.

这种方法可能会为你赢得时间。也许你的老板会突然变得有点紧张ーー他告诉你他要和他的公司/机构的律师谈谈,然后他会回复你。

Or maybe he threatens to fire you on the spot,and he tells you to hire(and pay through the nose for)a lawyer.You do.Do you think your argument will stand up in court?I don't.Maybe I'm wrong.I'd like to be wrong about that.

或者,他威胁说要当场解雇你,让你雇一个律师(并且花大价钱雇一个)。你知道。你认为你的论点在法庭上站得住脚吗?我不知道。也许我错了。我倒希望这是错的。

Maybe your lawyer will suggest other approaches.A religious exemption,for example.Or,depending on the circumstances,a medical exemption.

也许你的律师会建议其他的方法,比如宗教豁免,或者,根据情况,医疗豁免。

But after reading the FDA documents I've cited above,I say that if you think the FDA hasn't actually approved the vaccine,you're mistaken.

但是,在阅读了我上面引用的 FDA 文件之后,我说,如果你认为 FDA 实际上没有批准这种疫苗,那你就错了。

This country,and other countries,are being split into the vaccinated and the unvaccinated.Communities are dividing.Families are dividing and fracturing.It isn't a pretty picture.

这个国家和其他国家正在被分为接种疫苗和未接种疫苗的国家。社区正在分裂。家庭正在分裂和破裂。这并不是一幅美丽的图画。

Here in America,we're used to living life as usual and believing that coercion isn't going to come to our front doors.Despite the lockdowns and the mask mandates and the vast financial destruction of the past year,many people still think things are"all right."

在美国,我们习惯于过着平常的生活,相信高压统治不会来到我们的家门口。尽管在过去的一年里面临着封锁和面具命令以及巨大的金融破坏,许多人仍然认为一切都"很好"

That's not true.

不是这样的。

I support all legal efforts to keep freedom of choice alive.I support the unions that are demanding NO VACCINE MANDATES.I also support those governors who are defending their states against COVID restrictions and vaccine mandates.People who criticize these governors because they aren't perfect or are partially compromised are barking up the wrong tree.We need all the help we can get.

我支持所有保持选择自由的法律努力。我支持那些要求没有疫苗授权的联盟。我也支持那些捍卫自己的州反对因疟疾而受到限制和强制接种疫苗的州长们。那些批评这些管理者不够完美或部分妥协的人是找错了目标。我们需要所有能得到的帮助。

However,as far I'm concerned,putting all our eggs in the basket of court cases,legal filings,unions,and governors is shortsighted,to say the least.

然而,就我个人而言,把所有的鸡蛋都放在法庭案件、法律文件、工会和州长的篮子里,至少可以说是目光短浅的。

Freedom always needs more.Freedom needs brave business owners to stay open and maskless,despite government edicts.Freedom needs parents to keep showing up at school board meetings,to demand an end to COVID restrictions and mandates.

自由总是需要更多。自由需要勇敢的企业主不顾政府的法令,保持开放和不戴面具。自由需要父母不断地出现在学校董事会会议上,要求结束对 Covid 的限制和命令。

Most of all,freedom needs patriots,in the best sense of the word,to do what people in Europe and Australia are doing:come out in the street in great numbers.Over and over.

最重要的是,自由需要爱国者,在最好的意义上,去做欧洲和澳大利亚人正在做的事情:大批人走上街头。一遍又一遍。

Not by the thousands.By the millions.

不是以千计,而是以百万计。

For as long as it takes.

只要需要。

The enemies of freedom have to feel the heat.They have to see that the people can't be forced beyond a certain point.

自由的敌人必须感受到热度。他们必须明白,人民不能被迫超过一定的界限。

Whether we like it or not,whether we know it or not,the day is coming when,not the minority,but the majority of us will know we are living under tyranny.

不管我们喜欢与否,不管我们知不知道,总有一天,不是少数人,而是大多数人会知道我们生活在暴政之下。

Not just insanity;tyranny.

不仅仅是精神错乱,还有暴政。

We will know it in ways that are undeniable.

我们将以不可否认的方式了解它。

Some of us already know it.

我们中的一些人已经知道了。

We're all living through a test of faith.Each individual;and whatever he/she has faith IN.How deep is that faith?How strong?

我们都在经受信仰的考验。每个人,以及他/她所信任的任何事物。这种信仰有多深?有多强大?

FDA 真的批准了辉瑞公司的 COVID 疫苗吗?等等,什么?|乔恩•拉波波特

SOURCES:

来源:

(rushed sources list;to be indexed)

(匆忙的源列表;被索引)

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

https://www.fda.gov/media/151710/download

https://www.fda.gov/media/150386/download

childrenshealthdefense.org/defender/mainstream-media-fda-approval-pfizer-vaccine/

https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures

https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx

FDA 真的批准了辉瑞公司的 COVID 疫苗吗?等等,什么?|乔恩•拉波波特

(To read about Jon's mega-collection,The Matrix Revealed,click here.)

(点击这里阅读乔恩的超级收藏《黑客帝国》。)

FDA 真的批准了辉瑞公司的 COVID 疫苗吗?等等,什么?|乔恩•拉波波特

Jon Rappoport

乔恩·拉波波特

The author of three explosive collections,THE MATRIX REVEALED,EXIT FROM THE MATRIX,and POWER OUTSIDE THE MATRIX,Jon was a candidate for a US Congressional seat in the 29th District of California.He maintains a consulting practice for private clients,the purpose of which is the expansion of personal creative power.Nominated for a Pulitzer Prize,he has worked as an investigative reporter for 30 years,writing articles on politics,medicine,and health for CBS Healthwatch,LA Weekly,Spin Magazine,Stern,and other newspapers and magazines in the US and Europe.Jon has delivered lectures and seminars on global politics,health,logic,and creative power to audiences around the world.You can sign up for his free NoMoreFakeNews emails here or his free OutsideTheRealityMachine emails here.

作为《黑客帝国》、《黑客帝国-重装上阵》和《黑客帝国-矩阵革命》这三部剧集的作者,乔恩曾是美国加州第29选区国会议员的候选人。他为私人客户提供咨询服务,目的是扩大个人的创造力。获得普利策奖提名后,他作为一名调查记者工作了30年,为美国和欧洲的哥伦比亚广播公司健康观察,洛杉矶周刊,旋转杂志,斯特恩和其他报纸和杂志撰写关于政治,医学和健康的文章。乔恩为世界各地的听众发表了关于全球政治、健康、逻辑和创造力的演讲和研讨会。你可以在这里注册他的免费邮件或者在这里注册他的免费邮件。

来源:

https://blog.nomorefakenews.com/2021/08/25/did-fda-really-approve-the-pfizer-covid-vaccine-wait-what/

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  • 本文由 发表于 2021年8月27日10:15:44
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