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FDA到底approve 当前的辉瑞疫苗了吗？看Dr. Robert Malone 怎么说。

string2(反正死不了那就活着吧)
Two separate letters were sent out yesterday by the FDA.The first letter explained that the CURRENT Pfizer vaccine is STILL listed under emergency use (EUA).The second letter gave approval for the UPCOMING Pfizer vaccine "Comirnaty" that does not currently exist AND will no longer have the liability shield that the current vaccine has.
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Last Updated: 2021-8-24
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Replies, comments and Discussions:

  • 枫下家园 / 医药保健 / FDA到底approve 当前的辉瑞疫苗了吗？看Dr. Robert Malone 怎么说。 -string2(反正死不了那就活着吧); 2021-8-24 {337} (#13940808@0) +4
    Two separate letters were sent out yesterday by the FDA.The first letter explained that the CURRENT Pfizer vaccine is STILL listed under emergency use (EUA).The second letter gave approval for the UPCOMING Pfizer vaccine "Comirnaty" that does not currently exist AND will no longer have the liability shield that the current vaccine has.
    • 是的，FDA在欺骗美国人民！ -111111(快乐老家); 2021-8-24 (#13940845@0) +3
    • 看FDA文件第2页最后一段 - 紧急授权的叫 Pfizer-BioNTech COVID-19 Vaccine，FDA批准的叫COMIRNATY (COVID- 19 Vaccine, mRNA). Footnote 8 里说2个东西不一样，但可以交换用，不影响安全和效果。没说到底有什么差别😅 -returntoffice(等等); 2021-8-24 (#13940850@0) +2
      • 嗯，问题是使用现在的疫苗是不是自动拿掉liability shield ？还是说一定要那个商标Comirnaty的疫苗才没有liability shield？ -string2(反正死不了那就活着吧); 2021-8-24 (#13940867@0) +1
        • 这个商标的就有liability, 现在使用的疫苗是无商标的，还是紧急使用，没有liability 。哎，魔术家都是在你眼前变戏法的。 -newvest1(新衣); 2021-8-24 (#13940877@0) +4
          • 嗯，这就很清楚了 -string2(反正死不了那就活着吧); 2021-8-24 (#13940883@0) +2
      • 有懂法律文件的吗？ Footnote 8里的“ The products are legally distinct with certain differences that do not impact safety or effectiveness”。这个“or”有没有问题？ -string2(反正死不了那就活着吧); 2021-8-24 (#13941003@0)
    • 我的天，这是真的吗?用这样的方式愚民? -newvest1(新衣); 2021-8-24 (#13940856@0) +5
      • 不是一直都是用这种方法愚民吗！ -evelyn123(Eva); 2021-8-24 (#13940863@0) +4
      • 信息战，心理战 -string2(反正死不了那就活着吧); 2021-8-24 (#13940873@0) +2
    • +1 谢谢分享，看来MSM又忽悠了一些看文章不仔细的打C19疫苗。 -nazacalines(游戏); 2021-8-24 (#13940898@0) +1
    • 好笑啊。Pfizer-BioNTech 疫苗就是Comirnaty，因为在市场上卖，必然要有个商标，即 Comirnaty，很正常。同样道理，药品都不是以药厂命名的，而是用商标命名和购买。如上面‘新衣’等人所说，渔民就是容易被阴谋论者所渔弄。 -viewing(viewing); 2021-8-24 (#13940946@0) +9
      • 你真的这么理解？ -111111(快乐老家); 2021-8-24 (#13940950@0) +1
        • Moderna 的疫苗估计在一个月后被批准，Moderna还没有给他的孩子起名，但据说内部表决最受欢迎的是以 Spikevax 这个名字命名。 -viewing(viewing); 2021-8-24 (#13940971@0) +4
      • 嗯，其实都是鱼，不是渔民，被哪个渔民钓到愚弄，就看运气了，哈哈😄 -newvest1(新衣); 2021-8-24 (#13940994@0) +2
        • 阴谋论者发了言论，看到很多渔民被渔（打字自动显示渔民，就听之任之了），心理正在暗笑呢。“9/11飞机撞楼是美国政府指使的” 这个说法和论证至今还在网上，而且还有渔民相信。 -viewing(viewing); 2021-8-24 (#13941008@0) +6
          • 你要是一点也不起疑心，那自由社会的信息都浪费了。 -newvest1(新衣); 2021-8-24 (#13941020@0) +5
          • 的确如此。现在还有人以为美国大选作弊，用投票机作弊。而且坚定认为加拿大也一样。“正常人都不会相信的”，不知道有没有鱼 -moonhalf(走啊走); 2021-8-24 (#13941161@0) +2
            • 有啥奇怪的，有人连加拿大总理是性侵犯都不承认，虽然总理自己都承认了 -itwriting(halfpercent); 2021-8-24 (#13941187@0) +1
              • 哪个总理？都是犯人了？ -moonhalf(走啊走); 2021-8-24 (#13941209@0) +1
    • 这些官方文件，没人指点，根本不知道巧。补充：被批准的 COMIRNATY被FDA要求做包括心肌炎的各种studies。根据辉瑞提供的时间表，最晚的2027年完成。 -string2(反正死不了那就活着吧); 2021-8-24 {2985} (#13941290@0) +2

      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. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of 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. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Page 7 – STN BL 125742/0 – Elisa Harkins Disease 2019 (COVID-19) Vaccine,” 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 11, 2021 Progress Report Submission: September 30, 2021 Interim Report 1 Submission: March 31, 2022 Interim Report 2 Submission: September 30, 2022 Interim Report 3 Submission: March 31, 2023 Interim Report 4 Submission: September 30, 2023 Interim Report 5 Submission: March 31, 2024 Study Completion: March 31, 2024 Final Report Submission: September 30, 2024

      6. Study C4591021 substudy to describe the natural history 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: January 31, 2022 Study Completion: March 31, 2024 Final Report Submission: September 30, 2024

      7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network). 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: November 30, 2021 Study Completion: December 31, 2026 Page 8 – STN BL 125742/0 – Elisa Harkins Final Report Submission: May 31, 2027

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