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Pfizer vaccine still NOT fully approved by FDA
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<blockquote data-quote="Aldebaran" data-source="post: 76190069" data-attributes="member: 251418"><p>As of August 23rd, it has been widely reported that the Pfizer drug has now been fully approved by the FDA to be used to vaccinate against Covid19. Up until that time, it was authorized for emergency use.</p><p></p><p>Lo and behold, on the FDA's own website, it is shown that the Pfizer drug is still under Emergency Use Authorization. Here's text from page 2 of the link:</p><p></p><p>"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."</p><p></p><p><span style="font-size: 15px"><u>Also from the end of page 4 and continuing to the middle of page 5:</u></span></p><p></p><p>"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 Page 5 – Pfizer Inc. 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. I. 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. <strong>There is no adequate, approved, and available alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19. </strong></p><p><strong></strong></p><p><strong><a href="https://www.fda.gov/media/150386/download" target="_blank">https://www.fda.gov/media/150386/download</a> </strong></p></blockquote><p></p>
[QUOTE="Aldebaran, post: 76190069, member: 251418"] As of August 23rd, it has been widely reported that the Pfizer drug has now been fully approved by the FDA to be used to vaccinate against Covid19. Up until that time, it was authorized for emergency use. Lo and behold, on the FDA's own website, it is shown that the Pfizer drug is still under Emergency Use Authorization. Here's text from page 2 of the link: "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." [SIZE=4][U]Also from the end of page 4 and continuing to the middle of page 5:[/U][/SIZE] "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 Page 5 – Pfizer Inc. 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. I. 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. [B]There is no adequate, approved, and available alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19. [URL]https://www.fda.gov/media/150386/download[/URL] [/B] [/QUOTE]
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Pfizer vaccine still NOT fully approved by FDA
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