【縛雞之見】
FDA的藥證，是給BioNTech Manufacturing GmbH的Comirnaty
The Pfizer-BioNTech
vaccine will be no longer existing, instead, a new brand of Comirnaty
(koe-mir’-na-tee) takes place. 以後武漢肺炎，沒有BNT疫苗，也沒有Pfizer疫苗，而是正名為Comirnaty (koe-mir’-na-tee)，正好是六月到七月間行政院在質疑與卡關的名稱。
注意，Comirnaty是給16歲以上使用。
但12-15歲的，以及第三劑仍在EUA裡面（EUA仍有效？）。
美國是個偉大的國家，對於審查標準沒有放鬆，包括心肌炎等都有說明。而且質疑且提問的人，不會被罵不健康。
FDA Approves First COVID-19 Vaccine FDA 20210823
Approval Signifies Key Achievement
for Public Health
Today,
the U.S. Food and Drug Administration 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
(koe-mir’-na-tee), 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.
“The FDA’s approval of this vaccine
is a milestone as we continue to battle the COVID-19 pandemic. While this and
other vaccines have met the FDA’s rigorous, scientific standards for emergency
use authorization, as the first FDA-approved COVID-19 vaccine, the public can
be very confident that this vaccine meets the high standards for safety,
effectiveness, and manufacturing quality the FDA requires of an approved
product,” said Acting FDA Commissioner Janet
Woodcock, M.D. “While millions of people have
already safely received COVID-19 vaccines, we recognize that for some,
the FDA approval of a vaccine may now instill additional confidence to get
vaccinated. Today’s milestone puts us one step closer to altering the course of
this pandemic in the U.S.”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19
Vaccine has been available under EUA in individuals 16 years of age and older,
and the authorization was expanded to
include those 12 through 15 years of age on May
10, 2021. EUAs can be used by
the FDA during public health emergencies to provide access to medical products
that may be effective in preventing, diagnosing, or treating a disease,
provided that the FDA determines that the known and potential benefits of a
product, when used to prevent, diagnose, or treat the disease, outweigh the
known and potential risks of the product.
FDA-approved
vaccines undergo the agency’s standard process for reviewing
the quality, safety and effectiveness of medical products.
For all vaccines, the FDA evaluates data
and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is
submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously
submitted that supported the EUA, such as preclinical
and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality,
and inspections of the sites where the
vaccine is made. The agency conducts its own analyses of the information in the BLA
to make sure the vaccine is safe and effective and meets
the FDA’s standards for approval.
Comirnaty
contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic
of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine
is that their immune system will ultimately react defensively to the virus that
causes COVID-19. The mRNA in Comirnaty
is only present in the body for a short time and is
not incorporated into - nor does it alter - an individual’s genetic material.
Comirnaty has the same formulation as
the EUA vaccine and is administered as a series of two
doses, three weeks apart.
“Our scientific and medical experts
conducted an incredibly thorough and thoughtful
evaluation of this vaccine. We
evaluated scientific data and information included in hundreds
of thousands of pages, conducted our own
analyses of Comirnaty’s safety and effectiveness, and performed a
detailed assessment of the manufacturing processes, including inspections of
the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s
Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19
public health crisis continues in the U.S. and that the public is counting on
safe and effective vaccines. The public
and medical community can be confident that although we approved this vaccine
expeditiously, it was fully in keeping with our existing high standards for
vaccines in the U.S."
FDA Evaluation of Safety and
Effectiveness Data for Approval for 16 Years of Age and Older
The
first EUA,
issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16
years of age and older was based
on safety and effectiveness data from a randomized, controlled,
blinded ongoing clinical trial of thousands of individuals.
To
support the FDA’s approval decision today, the FDA
reviewed updated data from the clinical trial which supported the EUA
and included a longer duration of follow-up in a
larger clinical trial population.
Specifically,
in the FDA’s review for approval, the agency
analyzed effectiveness data from approximately 20,000 vaccine and
20,000 placebo recipients ages 16 and older who did not have
evidence of the COVID-19 virus infection within a week of receiving the second
dose. The safety
of Comirnaty was evaluated in approximately
22,000 people who received the vaccine and 22,000 people who received a placebo 16 years
of age and older.
Based on results from
the clinical trial, the vaccine was 91% effective
in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the
second dose. Overall, approximately
12,000 recipients have been followed for at least 6 months.
The most
commonly reported side effects by those clinical trial participants who
received Comirnaty were pain, redness and swelling at the injection site,
fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing
COVID-19 and potentially serious outcomes including hospitalization and death.
Additionally,
the FDA
conducted a rigorous evaluation of the post-authorization safety
surveillance data pertaining to myocarditis
and pericarditis following administration of the Pfizer-BioNTech
COVID-19 Vaccine and has determined that the data demonstrate increased risks,
particularly within the seven days following the second dose. The observed risk
is higher among males under 40 years of age compared to females and older males.
The observed
risk is highest in males 12 through 17 years of age. Available data from short-term follow-up
suggest that most individuals have had resolution of symptoms. However, some
individuals required intensive care support. Information is not
yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes
a warning about these risks.
Ongoing Safety
Monitoring
The FDA
and Centers for Disease Control and Prevention have monitoring systems in place
to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company
to conduct postmarketing studies to further
assess the risks of myocarditis and pericarditis following vaccination with
Comirnaty. These studies will include an
evaluation of long-term outcomes among
individuals who develop myocarditis following vaccination with Comirnaty. In addition, although
not FDA requirements, the company has committed
to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and
infant outcomes after receipt of Comirnaty during pregnancy.
The FDA
granted this application Priority
Review. The
approval was granted to BioNTech Manufacturing GmbH.
Related Information
###
The FDA,
an agency within the U.S. Department of Health and Human Services, protects the
public health by assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human use, and
medical devices. The agency also is
responsible for the safety and security of our nation’s food supply, cosmetics,
dietary supplements, products that give off electronic radiation, and for
regulating tobacco products.
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