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FDA从来没有批准Pfizer新冠疫苗在美国使用?

发表时间：2022-01-24 09:44

FDA从来没有批准Pfizer新冠疫苗在美国使用?

有网友留言给出FDA网站链接来证明疫苗已经被批准。

但是同时YouTube视频下面留言中，我看到这样的解释是：没有在美国国内被批准。

“The Cormirnaty HAS been approved outside the US but not in the US. Pfizer “vaccine” is still being administered in the US as experimental and not approved, effectiveness & safety unknown. It’s called EUA - Emergency Use Authorization - can only be used if there are no alternative effective meds available (which we know there are) so those meds are being denied in many hospitals/clinics so Pfizer /gov’t can continue to push the vax.”

“They are misleading everyone. Approval was given to a product called Comirnaty, which is produced by BioNtech, a company outside the U.S. with an identical vaccine to Pfizer, but it is not available in the U.S. There are requirements that the company has to meet with respect to safety concerns before it can be marketed in the U.S.”

“A federal judge recently ruled that the vaccines that are currently being pushed (specifically Pfizrrr) is NOT fully licensed. （Judge Allen Winsor of the U.S. District Court for the Northern District of Florida made the ruling. Search away!）”

当前共有10条评论
天雅：
09:51
我是买车都得让 dealer 把他们的广告牌从车上拿下的人，不愿为他们做免费的广告。。。当然就不会甘当白鼠，参与实验拉。
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天雅：
09:48
打过疫苗的可以去这个网站查自己打的是那个批次的，付效应有多大。
http://howbadismybatch.info/pfizer.html
看过这网站的统计数字后，更证实了这是一个由各国政府協助推进的大药商的全球实验。
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FreeHiker：
00:10
無奈啊，明顯的證據擺出來有人還是不肯接受，非要繼續幫助主（要）流（氓）媒體欺騙下去。現在連媒體都已經有轉向的苗頭了，畢竟紙包不住火啊。
我勸已經被騙接種的早日積極正視現實啊。誰沒有家人、朋友被騙？
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FreeHiker：
19:09
再補充一個細節。今年1月3日版修訂的Pfizer授權書 (可從https://www.fda.gov/media/150386/download 下載) 繼續明確區分COMIRNATY和Pfizer-BioNTech COVID?19 Vaccine，前者已是licensed，而後者的EUA被强調。注意第19頁Y條款：
Y. All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID?19 Vaccine clearly and conspicuously shall state that:
? 【This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA】, ......
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FreeHiker 回复渔阳山人：
18:54
您的看法就是他們想要的結果啊，也許90%以上的媒體都在騙，所以受騙的人不少。我給你一個細節，連FDA自己也不敢在法律角度說因爲Comirnaty獲批就等同於Pfizer-BioNTech COVID-19 Vaccine獲批：
看https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna 最後一段話，尤其是“The products are 【legally distinct】”，所以他們只能在醫學角度玩游戲說“can be used interchangeably”（你若是從醫學角度認可，我也不跟您爭）。
Is Comirnaty interchangeable with other COVID-19 vaccines?
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the two EUA authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older, when prepared according to their respective instructions for use, can be used interchangeably without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.

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雪梅回复渔阳山人：
18:43
视频留言中有人这样解释
“They are misleading everyone. Approval was given to a product called Comirnaty, which is produced by BioNtech, a company outside the U.S. with an identical vaccine to Pfizer, but it is not available in the U.S. There are requirements that the company has to meet with respect to safety concerns before it can be marketed in the U.S.”

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渔阳山人回复 FreeHiker：
16:40
说的就是辉瑞的mRNA疫苗，是Pfizer和BioNTech共同开发的，什么叫“没上市”啊？您现在知道了，下次就不会搞错啦。
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FreeHiker：
15:07
樓下的沒有仔細看，【正式】獲批的Comirnaty疫苗根本沒有在美國上市，這在法律上沒有模糊空間，不能拿所謂“成分相同”的別的疫苗代替，只有政客和媒體故意玩文字游戲欺騙大衆。換句話説，美國上市的幾種Covid疫苗依然受限於EUA，即緊急授權；如果説得再大白話一些，自願接種美國Covid疫苗的算作參加醫學試驗。
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渔阳山人：
12:39
FDA已于2021年8月23日正式批准Pfizer-BioNTech疫苗，链接如下：
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

请不要瞎说了。
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Siubuding：
11:59
Google "has fda approved pfizer booster" or "has fda approved pfizer vaccine".
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