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Pfizer-BioNTech COVID-19 Vaccine Overview and Safety

Updated June 24, 2021
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CDC Monitoring Reports of Myocarditis and Pericarditis

CDC has received increased reports of myocarditis and pericarditis in adolescents and young adults after COVID-19 vaccination. The known and potential benefits of COVID-19 vaccination outweigh the known and potential risks, including the possible risk of myocarditis or pericarditis. We continue to recommend COVID-19 vaccination for anyone 12 years of age and older.

Learn When to Seek Medical Care

General Information

Name: BNT162b2

Manufacturer: Pfizer, Inc., and BioNTech

Type of Vaccine: mRNA

Number of Shots: 2 shots, 21 days apart

How Given: Shot in the muscle of the upper arm

Does NOT Contain: Eggs, preservatives, latex, metals
Full List of Ingredients

Who Should Get Vaccinated
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 an mRNA COVID-19 vaccine(such as polyethylene glycol), you should not get either of the mRNA COVID-19 vaccines.
  • If you had a severe or immediate allergic reaction after getting the first dose of an mRNA COVID-19 vaccine, you should not get a second dose of either of the mRNA COVID-19 vaccines.
  • 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 an mRNA COVID-19 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:

  • Pain
  • Redness
  • Swelling

Throughout the rest of your body:

  • Tiredness
  • Headache
  • Muscle pain
  • Chills
  • Fever
  • Nausea

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.

Other Authorized and Recommended COVID-19 Vaccines in the United States

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-19 vaccines 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.
  • 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 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 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%).

Learn more about demographic information for people 16 years and olderexternal icon who participated in the trials.

Clinical Trial Demographic Information: 12–15 Year Olds

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

Learn more about demographic information for people 12–15 years oldexternal icon who participated in the trials

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For Healthcare Workers

Pfizer-BioNTech COVID-19 Vaccine: General information, schedule and administration overview.