The US Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people ages 16 and older. This is the first coronavirus vaccine approved by the FDA, and is expected to open the door to more vaccine mandates. 是个好事儿，希望多些成年人去打，保护自己免得重症。
读新闻，划重点 https://www.cnbc.com/2021/08/23/fda-pfizer-biontech-covid-vaccine-wins-full-approval-clearing-path-to-mandates.html It also allows the shot to stay on the market once the pandemic is over and the U.S. is no longer considered in an “emergency.” Pfizer and BioNTech have said they expect to generate billions from the vaccine. Under full approval, the companies could also decide to charge more for the vaccines, health experts say. Pfizer and BioNTech also plan to ask the FDA to approve a third dose as a booster shot following full approval. Last week, the Biden administration said it was preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20.
读新闻，划重点 https://www.cnbc.com/2021/08/23/fda-pfizer-biontech-covid-vaccine-wins-full-approval-clearing-path-to-mandates.html It also allows the shot to stay on the market once the pandemic is over and the U.S. is no longer considered in an “emergency.” Pfizer and BioNTech have said they expect to generate billions from the vaccine. Under full approval, the companies could also decide to charge more for the vaccines, health experts say. Pfizer and BioNTech also plan to ask the FDA to approve a third dose as a booster shot following full approval. Last week, the Biden administration said it was preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20. maiqi 发表于 2021-08-23 10:25
FDA approves 的是什么鬼我们不知道 但是这则消息基本坐实了 it's not about the virus, it's all about the vaccine.
确实啊，写的很清楚，还是ＥＵＡ。 还增加了一个过期时间和心肌炎警告。 On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. 主媒彻底不要脸裸奔了。
确实啊，写的很清楚，还是ＥＵＡ。 还增加了一个过期时间和心肌炎警告。 On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. 主媒彻底不要脸裸奔了。 maiqi 发表于 2021-08-23 10:44
不清楚，但是下面一段明确写的是ＥＵＡ． Page 5, 这个地方的定义很明确，这就是紧急使用emergency use。有了alternative疗法这个就失效了。 Section 564(c) of the Act就是紧急使用的ｌａｗ，在这里 https://astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Section-564-of-the-Federal-Food,-Drug,-and-Cosmetic-Act-Fact-Sheet/ Criteria for Issuance of Authorization I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because: A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and C. There is no adequate, approved, and available9 alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19.10
不清楚，但是下面一段明确写的是ＥＵＡ． Page 5, 这个地方的定义很明确，这就是紧急使用emergency use。有了alternative疗法这个就失效了。 Section 564(c) of the Act就是紧急使用的ｌａｗ，在这里 https://astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Section-564-of-the-Federal-Food,-Drug,-and-Cosmetic-Act-Fact-Sheet/ Criteria for Issuance of Authorization I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because: A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and C. There is no adequate, approved, and available9 alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19.10
确实啊，写的很清楚，还是ＥＵＡ。 还增加了一个过期时间和心肌炎警告。 On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. 主媒彻底不要脸裸奔了。 maiqi 发表于 2021-08-23 10:44
十六歲以上是 BLA 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.
确实啊，写的很清楚，还是ＥＵＡ。 还增加了一个过期时间和心肌炎警告。 On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. 主媒彻底不要脸裸奔了。 maiqi 发表于 2021-08-23 10:44
你太不要脸了，太不要脸了，太不要脸了。说三遍 你quote的这一段的前一段是什么？ 你为啥不一起放出来？ 原文在这里， 第二页的第一段： https://www.fda.gov/media/150386/download 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. 那个还剩下的EUA是指12-15岁的。 16岁以上的就是BLA
你太不要脸了，太不要脸了，太不要脸了。说三遍 你quote的这一段的前一段是什么？ 你为啥不一起放出来？ 原文在这里， 第二页的第一段： https://www.fda.gov/media/150386/download 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. 那个还剩下的EUA是指12-15岁的。 16岁以上的就是BLA surge 发表于 2021-08-23 11:06
这一段一个字都没有提１２－１６岁，为什么跟前一段不是一起的？ 你仔细去看看，整篇文章，包括最后一段， Page１２ Conditions Related to Printed Matter, Advertising, and Promotion 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, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Page 13 IV. Duration of Authorization This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act. 通篇引用的５６４ｌａｗ就是ＥＵＡ ｌａｗ。
这一段一个字都没有提１２－１６岁，为什么跟前一段不是一起的？ 你仔细去看看，整篇文章，包括最后一段， Page１２ Conditions Related to Printed Matter, Advertising, and Promotion 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, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Page 13 IV. Duration of Authorization This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act. 通篇引用的５６４ｌａｗ就是ＥＵＡ ｌａｗ。 maiqi 发表于 2021-08-23 11:12
你真是好笑。 再看第一页的最后一段的引用5
5 In the May 10, 2021 revision, FDA authorized Pfizer-BioNTech Vaccine for the prevention of COVID-19 in individuals 12 through 15 years of age, as well as for individuals 16 years of age and older. 人家先说12-15和16岁以上在5/10的revision都是EUA，接下来说从今天起16岁以上都是BLA，full approval了。你还在鸡蛋里挑骨头说人家接下来一段一个字没有提12-16，以此为理由质疑。 你看文章不是总体一起看的？人家逻辑这么清楚你还要怎么样？
我觉得我英语不错，我读来读去包括最后的conclusion引用的都是５６４ EUA law。 III. Conditions of Authorization Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization: C. Pfizer Inc. will ensure that the terms of this EUA are made available to all relevant stakeholders (e.g., emergency response stakeholders, authorized distributors, and vaccination providers) involved in distributing or receiving authorized Pfizer-BioNTech COVID‑19 Vaccine. Pfizer Inc. will provide to all relevant stakeholders a copy of this letter of authorization and communicate any subsequent amendments that might be made to this letter of authorization and its authorized labeling. 俺也不是FDA的，你们要觉得已经full approve就是吧。 反正这个世界早就是平行的了。 end of discussion
我觉得我英语不错，我读来读去包括最后的conclusion引用的都是５６４ EUA law。 III. Conditions of Authorization Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization: C. Pfizer Inc. will ensure that the terms of this EUA are made available to all relevant stakeholders (e.g., emergency response stakeholders, authorized distributors, and vaccination providers) involved in distributing or receiving authorized Pfizer-BioNTech COVID‑19 Vaccine. Pfizer Inc. will provide to all relevant stakeholders a copy of this letter of authorization and communicate any subsequent amendments that might be made to this letter of authorization and its authorized labeling. 俺也不是FDA的，你们要觉得已经full approve就是吧。 反正这个世界早就是平行的了。 end of discussion maiqi 发表于 2021-08-23 11:29
You should delete your posts on EUA. The vaccine was fully approved for 16+ and you're just spreading misinformation
我觉得我英语不错，我读来读去包括最后的conclusion引用的都是５６４ EUA law。 III. Conditions of Authorization Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization: C. Pfizer Inc. will ensure that the terms of this EUA are made available to all relevant stakeholders (e.g., emergency response stakeholders, authorized distributors, and vaccination providers) involved in distributing or receiving authorized Pfizer-BioNTech COVID‑19 Vaccine. Pfizer Inc. will provide to all relevant stakeholders a copy of this letter of authorization and communicate any subsequent amendments that might be made to this letter of authorization and its authorized labeling. 俺也不是FDA的，你们要觉得已经full approve就是吧。 反正这个世界早就是平行的了。 end of discussion maiqi 发表于 2021-08-23 11:29
5 In the May 10, 2021 revision, FDA authorized Pfizer-BioNTech Vaccine for the prevention of COVID-19 in individuals 12 through 15 years of age, as well as for individuals 16 years of age and older. 人家先说12-15和16岁以上在5/10的revision都是EUA，接下来说从今天起16岁以上都是BLA，full approval了。你还在鸡蛋里挑骨头说人家接下来一段一个字没有提12-16，以此为理由质疑。 你看文章不是总体一起看的？人家逻辑这么清楚你还要怎么样？ surge 发表于 2021-08-23 11:28
既然研究了这么多。写个长贴。 https://www.fda.gov/media/150386/download 首先第一段，这是说我们pandemic，所以才有ＥＵＡ的基础。 On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19).1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act)是啥？就是ＥＵＡ ｌａｗhttps://astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Section-564-of-the-Federal-Food,-Drug,-and-Cosmetic-Act-Fact-Sheet/ 后面是被断章取义的一段。 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. On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA). 首先，无论申请任何啥，都要填这个表格，叫做biologics license application (BLA)。 表格在此 https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber 这次辉瑞公司给他家的疫苗起了个品牌名，叫COMIRNATY (COVID-19 Vaccine, mRNA)。之前是没这个品牌名的。第一段说approve the application并没有说明是什么样子的approval，approve for emergency use也是approval。下一段给了具体的解释，仍然是在ＥＵＡ框架下。 然后，introduction最后一段，结论 Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. Additionally, as specified in subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. 再看下面每一个section，都是emergency use。 白纸黑字在这里写着。 用的法律文件都是ＥＵＡ的，扯什么别的。 搞笑
既然研究了这么多。写个长贴。 https://www.fda.gov/media/150386/download 首先第一段，这是说我们pandemic，所以才有ＥＵＡ的基础。 On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19).1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act)是啥？就是ＥＵＡ ｌａｗhttps://astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Section-564-of-the-Federal-Food,-Drug,-and-Cosmetic-Act-Fact-Sheet/ 后面是被断章取义的一段。 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. On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA). 首先，无论申请任何啥，都要填这个表格，叫做biologics license application (BLA)。 表格在此 https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber 这次辉瑞公司给他家的疫苗起了个品牌名，叫COMIRNATY (COVID-19 Vaccine, mRNA)。之前是没这个品牌名的。第一段说approve the application并没有说明是什么样子的approval，approve for emergency use也是approval。下一段给了具体的解释，仍然是在ＥＵＡ框架下。 然后，introduction最后一段，结论 Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. Additionally, as specified in subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. 再看下面每一个section，都是emergency use。 白纸黑字在这里写着。 用的法律文件都是ＥＵＡ的，扯什么别的。 搞笑 maiqi 发表于 2021-08-23 12:03
既然研究了这么多。写个长贴。 https://www.fda.gov/media/150386/download 首先第一段，这是说我们pandemic，所以才有ＥＵＡ的基础。 On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19).1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act)是啥？就是ＥＵＡ ｌａｗhttps://astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Section-564-of-the-Federal-Food,-Drug,-and-Cosmetic-Act-Fact-Sheet/ 后面是被断章取义的一段。 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. On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA). 首先，无论申请任何啥，都要填这个表格，叫做biologics license application (BLA)。 表格在此 https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber 这次辉瑞公司给他家的疫苗起了个品牌名，叫COMIRNATY (COVID-19 Vaccine, mRNA)。之前是没这个品牌名的。第一段说approve the application并没有说明是什么样子的approval，approve for emergency use也是approval。下一段给了具体的解释，仍然是在ＥＵＡ框架下。 然后，introduction最后一段，结论 Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. Additionally, as specified in subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. 再看下面每一个section，都是emergency use。 白纸黑字在这里写着。 用的法律文件都是ＥＵＡ的，扯什么别的。 搞笑 maiqi 发表于 2021-08-23 12:03
這個比例 是過 EUA 的比例啊 For patients at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of casirivimab and imdevimab-treated patients on average compared to 9% in placebo-treated patients.
回复 1楼nowid的帖子 FDA warns firm after hundreds of dog deaths and illnesses; other firms warned about import violations By News Desk on August 23, 2021 As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.
别处看到这个，值得贴一下 One-Third Of New Drugs Had Safety Problems After FDA Approval "All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective," he says. "Nothing could be further from the truth. We learn tremendous amounts about a product only once it's on the market and only after use among a broad population." https://www.npr.org/sections/health-shots/2017/05/09/527575055/one-third-of-new-drugs-had-safety-problems-after-fda-approval
你们就消停消停吧 信里说的很清楚 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. 其它大段大段的都是在说正式批准范围以外的，比如12-15岁和第三针的EUA还存在和怎么存在 你看到的事实不代表全部事实好吗
无论在哪里，原始文件上明确说的，emergency use authorization 而且有限期的。emergency没有了这个就失效了。 IV. Duration of Authorization Page 13 – Pfizer Inc. This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act. 至于为什么很多媒体其他的都让你觉得好像是full approval. that is a good question and you should ask yourself that question.
无论在哪里，原始文件上明确说的，emergency use authorization 而且有限期的。emergency没有了这个就失效了。 IV. Duration of Authorization Page 13 – Pfizer Inc. This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act. 至于为什么很多媒体其他的都让你觉得好像是full approval. that is a good question and you should ask yourself that question.
别处看到这个，值得贴一下 One-Third Of New Drugs Had Safety Problems After FDA Approval "All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective," he says. "Nothing could be further from the truth. We learn tremendous amounts about a product only once it's on the market and only after use among a broad population." https://www.npr.org/sections/health-shots/2017/05/09/527575055/one-third-of-new-drugs-had-safety-problems-after-fda-approval Seeking668 发表于 2021-08-23 12:26
是个好事儿，希望多些成年人去打，保护自己免得重症。
🔥 最新回帖
洪波说的好！一个警察只负责维持公共秩序不保护个人安危的国家，你觉得mandate会是为你的利益考虑的结果？
就是你这样的人形成的，接受不了多样性，自己说服不了别人就妄想专政。
这话说的，记忆力只有八分钟吗？大选以前数据没有完成。三期临床是事先定了数据出来的标准的，疫苗组和对照组的病例数要达到一个数字，大选前没有达到这个数字，连揭盲都不能做，根本不能得出结论。我记得数据出来以后有很多报道，其中一个就是说BNT的老总周末接到电话说可以揭盲了，周一数据就出来了。那是在大选以后。 科学数据不是根据总统的意志行事的
🛋️ 沙发板凳
然后对照组就消失了
对变种无效的事实就可以彻底被掩埋了
不打疫苗的不会因为full approval就改变主意的，他们有的是别的理由
https://www.cnbc.com/2021/08/23/fda-pfizer-biontech-covid-vaccine-wins-full-approval-clearing-path-to-mandates.html
It also allows the shot to stay on the market once the pandemic is over and the U.S. is no longer considered in an “emergency.”
Pfizer and BioNTech have said they expect to generate billions from the vaccine. Under full approval, the companies could also decide to charge more for the vaccines, health experts say.
Pfizer and BioNTech also plan to ask the FDA to approve a third dose as a booster shot following full approval. Last week, the Biden administration said it was preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20.
clinical trial要到2023 但是已经批了 呵呵
这不很正常嘛？不懂就不要乱叫。 我娃小那阵子申请去过几年phase 3b和phase 4 trial 压力小点
你应该得诺贝尔奖！第一个华人诺贝尔奖。
你们管这叫fully approved？坑傻子吧？
FDA approves 的是什么鬼我们不知道
但是这则消息基本坐实了 it's not about the virus, it's all about the vaccine.
新闻写的full approval
不看原文，就知道看主媒。你们都被卖了还帮药厂数钱。不信自己去看看FDA文档。根本不是FDA批准的drug。
https://t.co/qaTNymroKB?amp=1
啥意思，直接得新冠会有你说的这种S蛋白吗？合着再过几十年剩下的都是没打疫苗的。不过根据我周围看到的，没打疫苗的有些是高知，地球的未来就指望他们了！应该拍个这样题材的灾难电影。
你们都别吵，FDA有平民版说明，16+头两针正式批准，12-15和第三针还是EUA
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
如果在細胞中遇上了 來自另一種病毒 的 反轉錄蛋白
那是有可能
你楼下反疫苗的说clinical trial要做到2023，你这个反疫苗的又说对照组消失…你们能不能内部先吵好再来发帖
确实啊，写的很清楚，还是ＥＵＡ。
还增加了一个过期时间和心肌炎警告。
On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis.
主媒彻底不要脸裸奔了。
我不是专业的,不进DNA病情期间的病毒蛋白都是暂时的.但疫苗这么大的mRNA量进去,会不会运气不好被逆转录了变成长久的问题?
你读得懂英语吗？那这里面approved BLA是指什么？你故意不把approved BLA加粗，希望人miss这句话，居心何在？
不可以 可以mandate不可以投诉不可以sue
哇 真是太sneaky了 很难想象背后没有组织或者高人指点
不清楚，但是下面一段明确写的是ＥＵＡ．
Page 5, 这个地方的定义很明确，这就是紧急使用emergency use。有了alternative疗法这个就失效了。
Section 564(c) of the Act就是紧急使用的ｌａｗ，在这里 https://astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Section-564-of-the-Federal-Food,-Drug,-and-Cosmetic-Act-Fact-Sheet/
Criteria for Issuance of Authorization I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because: A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and C. There is no adequate, approved, and available9 alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19.10
且不和你争“反疫苗”几个大字，我只知道“捧疫苗”内部很快要分裂了，估计会分为2针派，3针派，4针派，。。。。自己数
你读文章只读一段？这一段说的是BLA（有年龄之类的限制）之外的EUA的情形
十六歲以上是 BLA
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.
哈哈哈哈那人特意进来捣乱的吧
你太不要脸了，太不要脸了，太不要脸了。说三遍
你quote的这一段的前一段是什么？ 你为啥不一起放出来？ 原文在这里， 第二页的第一段： https://www.fda.gov/media/150386/download
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.
那个还剩下的EUA是指12-15岁的。 16岁以上的就是BLA
猪媒也已经开始造势说疫苗打得早的现在已经无效了，催扎针小狂人们赶紧去打booster。
藥物來不及
你發現患病 到用藥物治
中間的時間差 肺已經廢了
你根本没看懂你给的那个link吧，什么乱七八糟的. 就是辉瑞的COVID疫苗，16岁以上被full approval。不然的话， 你说说是批准的是什么drug?
应该去问问他这个疫苗是不是真有效
这一段一个字都没有提１２－１６岁，为什么跟前一段不是一起的？
你仔细去看看，整篇文章，包括最后一段，
Page１２
Conditions Related to Printed Matter, Advertising, and Promotion
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, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Page 13
IV. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.
通篇引用的５６４ｌａｗ就是ＥＵＡ ｌａｗ。
乙肝艾滋病什么好像是逆转录进DNA的吧,那样的病人是不是打这个疫苗被逆转录的风险高很多?
你可以继续当对照组，没人拦着
现在疫苗就是个工具，下面就要揪斗反革命了。
明人不做暗事。有话版上说呗，私信个啥嘞？ 俺不喜欢私信。
知道为什么吗
因为outpatient不给用药都打发回家自生自灭了
把给轻症病人的药用在住院病人上说没用，所以大家得打疫苗。
请一针一针下去自便吧
所以我寧可打 棘蛋白
只要有反轉錄的病毒
跟這 mRNA 放一起
誰曉得會出啥事...
現在也沒啥特效藥啊
就一堆中藥在號稱
台灣還真靠口罩
不過得是對的口罩
反mRNA不等于反所有疫苗，更不等于反口罩。 不要混搅概念。
你真是好笑。 再看第一页的最后一段的引用5
5 In the May 10, 2021 revision, FDA authorized Pfizer-BioNTech Vaccine for the prevention of COVID-19 in individuals 12 through 15 years of age, as well as for individuals 16 years of age and older.
人家先说12-15和16岁以上在5/10的revision都是EUA，接下来说从今天起16岁以上都是BLA，full approval了。你还在鸡蛋里挑骨头说人家接下来一段一个字没有提12-16，以此为理由质疑。 你看文章不是总体一起看的？人家逻辑这么清楚你还要怎么样？
III. Conditions of Authorization Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization: C. Pfizer Inc. will ensure that the terms of this EUA are made available to all relevant stakeholders (e.g., emergency response stakeholders, authorized distributors, and vaccination providers) involved in distributing or receiving authorized Pfizer-BioNTech COVID‑19 Vaccine. Pfizer Inc. will provide to all relevant stakeholders a copy of this letter of authorization and communicate any subsequent amendments that might be made to this letter of authorization and its authorized labeling.
俺也不是FDA的，你们要觉得已经full approve就是吧。 反正这个世界早就是平行的了。 end of discussion
单抗在初期有效果吗?如果医生开的出的话.
You should delete your posts on EUA. The vaccine was fully approved for 16+ and you're just spreading misinformation
用misinformation这词也太抬举了吧，这年头misinfo都成秘密的事实的代名词了
那帖子就是一个英文不好的人的错误解读
所以导致的spreading错误信息，哪里说错了
目前有效，但是大多数人都不合格
真不要脸！这说的是16岁以下的。你造的这种谣言，估计糊弄真的傻子。
我只能说这个世界上有的人真是paranoid到了极点。的确，MSM 的话不能全信，但凡是MSM说的都不信也是有病到了一定程度。自己认为自己英语不错，不相信MSM， NewsMax总不算MSM了吧。去看看现在的头版头条是什么？
这和当年拜登sworn in以后，一群人在网上说一切都是假的，拜登没有进白宫，都是MSM在摄影棚里拍出来糊弄大家的一样。
唉，平行世界。
拜登的确没进白宫
大家一起颤抖吧，疫苗上已加过期日期
我们没有造谣。你在这造谣。 另外，对于有些不打疫苗的人，我很理解。每个人都有自己选择。如果能戴口罩保持距离，不打疫苗也可以。我反对的是散播谣言的人。
真是的，现在美国最不缺的就是对照组，ICU里多的是。。。
感觉今天反疫苗的昏了头了，鸡蛋里挑骨头不说，挑到个鸡蛋皮就激动得跳起来了。
看这个我实在忍不住笑了，骂大街的即视版
你也不看看是谁先骂人的？简直泼妇一样。好好讨论不行吗？非要破口大骂？
https://www.fda.gov/media/150386/download
首先第一段，这是说我们pandemic，所以才有ＥＵＡ的基础。
On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19).1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section
Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act)是啥？就是ＥＵＡ ｌａｗ https://astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Section-564-of-the-Federal-Food,-Drug,-and-Cosmetic-Act-Fact-Sheet/
后面是被断章取义的一段。
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.
On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA).
首先，无论申请任何啥，都要填这个表格，叫做biologics license application (BLA)。 表格在此 https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber 这次辉瑞公司给他家的疫苗起了个品牌名，叫COMIRNATY (COVID-19 Vaccine, mRNA)。之前是没这个品牌名的。第一段说approve the application并没有说明是什么样子的approval，approve for emergency use也是approval。下一段给了具体的解释，仍然是在ＥＵＡ框架下。
然后，introduction最后一段，结论
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. Additionally, as specified in subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
再看下面每一个section，都是emergency use。 白纸黑字在这里写着。 用的法律文件都是ＥＵＡ的，扯什么别的。 搞笑
这和我的理解一样，文档没把eua字眼去掉，这还是前段时候紧急批准的延续，并没有fully approved。
好奇你是不是这个领域的，这么执着。 FDA官网都Annouce了：
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
這個比例 是過 EUA 的比例啊
For patients at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of casirivimab and imdevimab-treated patients on average compared to 9% in placebo-treated patients.
FDA warns firm after hundreds of dog deaths and illnesses; other firms warned about import violations By News Desk on August 23, 2021 As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.
看了。这个声明虽然用了一些唬人的title, 但是重要的地方都含混带过。没什么价值。 最原始的文件才是准确的。因为原始的文件才是有legal responsibility。
这位层主让我想到有位专家在华人上引经据典，证明United State of America 是个corporation， 不是一个country。
One-Third Of New Drugs Had Safety Problems After FDA Approval
"All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective," he says. "Nothing could be further from the truth. We learn tremendous amounts about a product only once it's on the market and only after use among a broad population."
https://www.npr.org/sections/health-shots/2017/05/09/527575055/one-third-of-new-drugs-had-safety-problems-after-fda-approval
所以你是律师？你觉得如果上court，这个算没批？
哈哈，一般人还真难以做这个联想。
你们就消停消停吧
信里说的很清楚 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.
其它大段大段的都是在说正式批准范围以外的，比如12-15岁和第三针的EUA还存在和怎么存在
你看到的事实不代表全部事实好吗
无论在哪里，原始文件上明确说的，emergency use authorization
而且有限期的。emergency没有了这个就失效了。
IV. Duration of Authorization Page 13 – Pfizer Inc. This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.
至于为什么很多媒体其他的都让你觉得好像是full approval. that is a good question and you should ask yourself that question.
谁是小丑？一天到晚甘愿被主媒洗脑的才是小丑。我看你是被坑的次数不够多。
mm,这个疫苗是被100%批准的，时间到了，这个一定要发生的，这是一个好事呀，喜欢疫苗的会被疫苗保护到他们应该去的地方，不喜欢疫苗的会去不同的地方。热闹会越来越大。。。好看
不得不说华人上砖家真多哈哈哈
嗯，来解释一下口罩方面的flip flop吧。
正常，很多长期毒性好几年才看得出来，一般三期临床之后向FDA申请，批准后上市，上市后的大量使用才是四期临床，这期间如果有不可接受的副作用会被叫停，或者加black box warning。这是医药发展的代价，无可避免，总体是利大大大于弊的。
我不认为这个所谓的批准有任何意义。不打的还是不会打。打过的也没几个愿意多扎几针。大规模强制扎针只能把美国变大号的法国，澳大利亚。猪媒妄想先从军队入手强制，更是痴心妄想。military是最抗拒疫苗的组织之一，仅次于医生群体。
你在开玩笑吧？fox从来都是猪媒。只是披着保守派外衣的猪媒。
有意义呀，可以强制了嘛，名正言顺。没事，不用反抗，病毒会反噬，疫苗越强，变异的病毒越强。下面真是热闹大了，只是可怜了很多人而已，白白的。。
那我们帮你点个赞吧 ：）
只有中国出来的顺民才会这么想。澳大利亚法国还没强制呢，已经打成一团了。百万人上街，绞架都抬出来了。法国老百姓又不是没砍过皇帝皇后脖子。安安静静不反抗？那根本不是美国。等着瞧吧。
如果如实报道FDA fully approves Pfizer COVID vaccine 就是猪媒的话，那OAN， NewsMax呢？
都被买通了，都是要骗朕
可以为国做贡献啊
M家申请要晚一个月，再等一个月估计也就批准。