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Pfizer-BioNTech COVID-19 Vaccine Overview and Safety
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.
General Information
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
- 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.
- 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.
Learn more about possible side effects after getting a COVID-19 vaccine.
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
For Healthcare Workers
Pfizer-BioNTech COVID-19 Vaccine: General information, schedule and administration overview.