Pfizer-BioNTech COVID-19

Pfizer-BioNTech COVID-19 Vaccine Overview and Safety
(also known as COMIRNATY)

General Information
Name: BNT162b2
Manufacturer: Pfizer, Inc., and BioNTech
Type of Vaccine: mRNA

Number of Shots: 2 shots, 21 days apart
Moderately to severely immunocompromised people should
get an additional shot (3rd dose) at least 28 days after their
2nd shot. Other groups of people are recommended to get a
booster shot at least 6 months after getting their 2nd shot.
How Given: Shot in the muscle of the upper arm
Does NOT Contain: Eggs, preservatives, latex, metals
Full List of Ingredients
Brand name: COMIRNATY

Pfizer-BioNTech ( COMIRNATY) Name Change
Pfizer-BioNTech (COMIRNATY) received U.S. Food and Drug Administration (FDA) approval on August 23, 2021, for individuals
16 years of age and older. Once vaccines are approved by the FDA, companies can market the vaccines under brand names.
COMIRNATY is the brand name for the Pfizer-BioNTech COVID-19 Vaccine. Now that the FDA-authorized Pfizer-BioNTech
COVID-19 vaccine has been approved by the FDA for individuals 16 years of age and older, it will be marketed as COMIRNATY.
The use of the name Pfizer-BioNTech will still be used for individuals 12-15 years old since this age group has not been
approved. There has been no change in the formulation of the vaccine since the name change.

Who Should Get Vaccinated
• The Pfizer-BioNTech vaccine is recommended for people 12 years and older.
• Learn more about how the Centers for Disease Control and Prevention (CDC) is making COVID-19 vaccine
recommendations.

Who Should NOT Get Vaccinated
• If you have had a severe allergic reaction (anaphylaxis) or an Immediate allergic reaction, even if it was not severe,
to any ingredient in the Pfizer-BioNTech COVID-19 vaccine (such as polyethylene glycol), you should not get this
vaccine.
• If you had a severe or immediate allergic reaction after getting the first dose of a Ptlzer-BloNTech COVID-19
vaccine, you should not get a second dose of either of this vaccine.
• A severe allergic reaction is one that needs to be treated with epinephrine or EpiPen or with medical care. Learn
about common side effects of COVID-19 vaccines and when to call a doctor.

An immediate allergic reaction means a reaction within 4 hours of exposure, including symptoms such as hives,
• swelling. or wheezing (respiratory distress).
If you aren’t able to get this vaccine, you may still be able to get a different type of COVID-19 vaccine. Get more
information for people with allergies.

Possible Side Effects
In the arm where you got the shot: Throughout the rest of your body:
• Pain • Tiredness
• Redness • Headache
• Swelling • Muscle pain
These side effects happen within a day or two of getting the vaccine. They are normal signs that your body is building
protection and should go away within a few days.
Learn more about possible side effects after getting a COVID-19 vaccine

Throughout the rest of your body:
• Tiredness
• Headache
• Muscle pain
• Chills
• Fever
• Nausea

Other authorized and recommended COVID-19 vaccines in the United States
• Moderna
• Johnson & Johnson’s Janssen
You should get a COVID-19 vaccination as soon as possible. Do not wait for a specific brand. All currently authorized and
recommended COVID-19 vaccines are safe and effective, and CDC does not recommend one vaccine over another.
COVID-19vacclnes are not interchangeable. If you received a Pfizer-BioNTech or Moderna COVID-19 vaccine, you should
get the same product for your second shot.

Safety Data Summary
• In clinical trials, reactogenicity symptoms (side effects that happen within 7 days of getting vaccinated) were common but
were mostly mild. Some people had side effects that affected their ability to do daily activities.
• Side effects (such as fever, chills, tiredness, and headache) throughout the body were more common after the second
dose of the vaccine.
• Cases of myocarditis and pericarditis in adolescents and young adults have been reported more often after getting the
second dose than after the first dose of one of the two mRNA COVID-19 vaccines, Pfizer-BioNTech or Moderna. These
reports are rare and the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks,
Including the possible risk of myocarditis or perlcarditis.
• CDC will continue to provide updates as we learn more about the safety of the Pfizer-BioNTech vaccine in real-world
conditions.
Learn more about vaccine safety monitoring after a vaccine is authorized or approved for use.

How Well the Vaccine Works
• Based on evidence from clinical trials in people 16 years and older, the Pfizer-BioNTech (COMIRNATY) vaccine was 95%
effective at preventing laboratory-confirmed infection with the virus that causes COVID-19 in people who received two
doses and had no evidence of being previously infected.
• In clinical trials, the Pfizer-BioNTech vaccine was also highly effective at preventing laboratory-confirmed COVID-19
infection in adolescents 12-15 years old, and the immune response in people 12-15 years old was at least as strong as
the immune response in people 16-25 years old.
• The vaccine was also highly effective in clinical trials at preventing COVID-19 among people of diverse age, sex, race, and
ethnicity categories and among people with underlying medical conditions.
• Evidence shows mRNA COVID-19 vaccines offer similar protection in real-world conditions as they have in clinical trial
settings-reducing the risk of COVID-19, including severe illness by 90% or more, among people who are fully vaccinated.
• CDC will continue to provide updates as we learn more.
• Based on evidence from clinical trials in people 16 years and older, the Pfizer-BioNTech (COMIRNATY) vaccine was 95%
effective at preventing laboratory-confirmed infection with the virus that causes COVID-19 in people who received two
doses and had no evidence of being previously infected.
• In clinical trials, the Pfizer-BioNTech vaccine was also highly effective at preventing laboratory-confirmed COVID-19
infection in adolescents 12-15 years old, and the immune response in people 12-15 years old was at least as strong as
the immune response in people 16-25 years old.
• The vaccine was also highly effective in clinical trials at preventing COVID-19 among people of diverse age, sex, race, and
ethnicity categories and among people with underlying medical conditions.
• Evidence shows mRNA COVID-19 vaccines offer similar protection in real-world conditions as they have in clinical trial
settings-reducing the risk of COVID-19, including severe illness by 90% or more, among people who are fully vaccinated.
• CDC will continue to provide updates as we learn more.

Clinical Trial Demographic Information: 16 Years and Older

Clinical trials for the Pfizer-BioNTech (COMIRNATY) vaccine in people 16 years and older included people from the following
racial and ethnic, age, and sex categories:
Race
• 82% White
• 10% African American
• 4%Asian
• 3% other races, multiracial, or race not reported
• <1 % Native Hawaiian or Other Pacific Islander
• <1% American Indian or Alaska Native

Ethnicity
• 73% not Hispanic or Latino
• 26% Hispanic or Latino
• <1 % not reported
Sex
• 51% male
• 49% female
Age
• 58% 16 to 55 years
• 42% 55 years and older
• 21 % 65 years and older
• 4% 75 years and older
The most frequent underlying medical conditions among clinical trial participants were obesity (35%), diabetes (8%), and
pulmonary disease (8%)

Clinical Trial Demographic Information: 12-15 Years Old
OS~
Clinical trials for the Pfizer-BioNTech vaccine in people 12-15 years old Included people from the following racial and ethnic,
age, and sex categories:
Race
• 86%White
• 5% African American
• 6%Asian
• <3% other race, multiracial, or race not reported
• <1% Native Hawaiian or Other Pacific Islander
• <1% American Indian or Alaska Native

Ethnicity
• 88% not Hispanic or Latino
• 12% Hispanic or Latino
• <1% not reported
Sex
• 51% male
• 49%female

Related Pages
> Possible Side Effects
> Safety of COVID-19 Vaccines
> Benefits of Getting Vaccinated
> How Vaccines Work
mRNA Vaccines
For Healthcare Workers
Pfizer-BioNTech COVIO-19 Vaccine: General information, schedule and administration overview.

Boosters Doses

General information

  • 2-dose series for initial vaccination
  • mRNA vaccine
  • FDA approved for ages 16+
  • Available under emergency use authorization (EUA) for ages 5–15

Learn more about boosters and additional doses below. If you’re eligible for an additional dose, it’s recommended you receive the same manufacturer as your primary series. For booster doses, the CDC allows eligible people to choose which COVID-19 vaccine they receive.

Pfizer-BioNTech booster dose

What is a booster dose?

A booster dose is recommended when the immune response to the initial 2-dose series of the Pfizer-BioNTech vaccine has likely decreased over time.

Who is eligible?

The CDC recommends a booster dose of the Pfizer-BioNTech COVID-19 vaccine to be administered at least 6 months after completion of the primary series to individuals ages 18+.

Pfizer-BioNTech additional dose


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