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John Campbell

FDA full approval for Pfizer

Bywebmaster

Oct 18, 2025



FDA Approves First COVID-19 Vaccine

EUA since December 11, 2020

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

U.S. Food and Drug Administration

Pfizer-BioNTech COVID-19 Vaccine

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

Continues to be available under emergency use authorization (EUA), 12 to 15s

and for a third dose in immunocompromise

Acting FDA Commissioner Janet Woodcock, M.D

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

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.

FDA statement

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.

Analyzed effectiveness and safety data from 20,000 vaccine and 20,000 placebo recipients

Vaccine was 91% effective in preventing COVID-19 disease

Safety, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects

Pain, redness and swelling at the injection site

Fatigue, headache, muscle or joint pain, chills, and fever

Rigorous evaluation of the post-authorization safety surveillance data

Myocarditis and pericarditis

Chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-june-25-2021

https://www.cdc.gov/mmwr/volumes/70/wr/mm7027e2.htm

52 million doses to 12–29 years

1,226 reports of myocarditis after mRNA vaccination 42,414

One in 42,414

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

Risk is highest in males 12 through 17 years of age

Short-term follow-up suggest that most individuals have had resolution of symptoms

Some individuals required intensive care support

Information is not yet available about potential long-term health outcomes

FDA and CDC, monitoring systems in place for early detection

Pfizer will

Conduct postmarketing studies to further assess the risks of myocarditis and pericarditis

Include an evaluation of long-term outcomes

Conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after vaccination during pregnancy

Source

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123 thoughts on “FDA full approval for Pfizer”

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