e********8
发帖数: 929 | 1 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 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。 | e********8
发帖数: 929 | 2 https://www.fda.gov/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-
biontech-covid-19-vaccine
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.
所以仍然是EUA，只不过加上了12015岁和第三针？ | e********8
发帖数: 929 | 3 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. | w******8
发帖数: 5 | 4 16岁以上full approval，其他的EUA
: https://www.fda.gov/coronavirus-disease-2019-covid-19/comirnaty-and-
pfizer-
: biontech-covid-19-vaccine
: 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.
: 所以仍然是EUA，只不过加上了12015岁和第三针？
【在 e********8 的大作中提到】
: 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.
| e********8
发帖数: 929 | 5 仔细读分析，还像有猫腻
now
【在 w******8 的大作中提到】
: 16岁以上full approval，其他的EUA
:
:
: https://www.fda.gov/coronavirus-disease-2019-covid-19/comirnaty-and-
: pfizer-
:
: biontech-covid-19-vaccine
:
: 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
| b**l
发帖数: 33123 | 6 C’mon man, this is the letter of “BLA APPROVAL”:
https://www.fda.gov/media/151710/download
【在 e********8 的大作中提到】
: 仔细读分析，还像有猫腻
:
: now
| e********8
发帖数: 929 | 7 请仔细读，p4-p5的conclusion：
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. | e********8
发帖数: 929 | 8 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:
II.
Pfizer-BioNTech COVID‐19 Vaccine to prevent COVID-19.
Scope of Authorization
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
10
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope
of this authorization is limited as follows:
• Pfizer Inc. will supply Pfizer-BioNTech COVID‐19 Vaccine either
directly or through
authorized distributor(s),
11
to emergency response stakeholders
12
as directed by the U.S.
9 Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-
19 in individuals 16 years of age and older, there is not sufficient
approved vaccine available for distribution to this population in its
entirety at the time of reissuance of this EUA. Additionally, there are no
products that are approved to prevent COVID-19 in individuals age 12 through
15, or that are approved to provide an additional dose to the
immunocompromised population described in this EUA.
10 No other criteria of issuance have been prescribed by regulation under
Section 564(c)(4) of the Act.
11 “Authorized Distributor(s)” are identified by Pfizer Inc. or, if
applicable, by a U.S. government entity, such as the Centers for Disease
Control and Prevention (CDC) and/or other designee, as an entity or entities
allowed to distribute authorized Pfizer-BioNTech COVID‐19 Vaccine.
12 For purposes of this letter, “emergency response stakeholder” refers to
a public health agency and its delegates that have legal responsibility and
authority for responding to an incident, based on political or geographical
boundary lines (e.g., city, county, tribal, territorial, State, or Federal)
, or functional (e.g., law enforcement or public health range) or sphere of
authority to administer, deliver, or distribute vaccine in an emergency
situation. In some cases (e.g., depending on a state or local jurisdiction’
s COVID-19 vaccination response organization and plans), there might be
overlapping roles and responsibilities among “emergency response
stakeholders” and “vaccination providers” (e.g., if a local health
department is administering COVID-19 vaccines; if a pharmacy is acting in an
Page 6 – Pfizer Inc.
government, including the Centers for Disease Control and Prevention (CDC)
and/or
other designee, for use consistent with the terms and conditions of this EUA;
• The Pfizer-BioNTech COVID‐19 Vaccine covered by this authorization
will be administered by vaccination providers13 and used only to prevent
COVID-19 in
individuals ages 12 and older; and
• Pfizer-BioNTech COVID‐19 Vaccine may be administered by a
vaccination provider
without an individual prescription for each vaccine recipient.
This authorization also covers the use of the licensed COMIRNATY (COVID-19
Vaccine, mRNA) product 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. | e********8
发帖数: 929 | 9 Section 564(c) of the Act
An Emergency Use Authorization (EUA) under Section 564 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act)1 allows for the special use of drugs and
other medical products during certain types of emergencies.2 The EUA
authority was added by the Project BioShield Act of 2004, which amended the
FD&C Act, among other things.3
https://www.astho.org/Programs/Preparedness/Public-Health-Emergency-Law/
Emergency-Use-Authorization-Toolkit/Section-564-of-the-Federal-Food,-Drug,-
and-Cosmetic-Act-Fact-Sheet/ | m**********s
发帖数: 518 | 10 臥槽，MSM這都能曲解、造假、帶節奏。細思極恐lol | e********8
发帖数: 929 | 11 这个approval是加这个新名字/商标- COMIRNATY (COVID-19 Vaccine, mRNA) 的
approval | e********8
发帖数: 929 | |
|
