Pfizer-BioNTech COVID-19 Vaccine Overview and Safety/Pfizer COVID-19ワクチン情報

Pfizer-BioNTech COVID-19 Vaccine Overview and SafetyPfizer-BioNTech COVID-19 Vaccine Overview and Safety

Updated May 27, 2021

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CDC Monitoring Reports of Myocarditis and PericarditisCDC 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 individuals 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
Does NOT Contain: Eggs, preservatives, latexFull List of Ingredients [PDF – 7 pages]external icon

Who Should Get VaccinatedThe Pfizer-BioNTech vaccine is recommended for people aged 12 years and older.
Learn more about how CDC is making COVID-19 vaccine recommendations.

Who Should NOT Get VaccinatedIf 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 an mRNA COVID-19 vaccine.
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.
An allergic reaction is considered severe when a person needs to be treated with epinephrine or EpiPen© or if they must receive 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.
Get tips on possible side effects after getting a covid-19 vaccine.

Other Authorized and Recommended COVID-19 Vaccines in the United StatesModerna
Johnson & Johnson’s Janssen
You should get the first COVID-19 vaccine that is available to you. 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.

Safety Data Summary
In clinical trials, reactogenicity symptoms (side effects that happen within 7 days of getting vaccinated) were common but were mostly mild to moderate.
Side effects (such as fever, chills, tiredness, and headache) throughout the body were more common after the second dose of the vaccine.
Most side effects were mild to moderate. Relatively few people had  reactions that affected their ability to do daily activities.
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 aged 16 years and older, the Pfizer-BioNTech vaccine was 95% effective at preventing laboratory-confirmed COVID-19 illness in people without evidence of previous infection.
In clinical trials, the Pfizer-BioNTech vaccine was also highly effective at preventing laboratory-confirmed COVID-19 illness in adolescents aged 12–15 years, and the immune response in people aged 12–15 years was at least as strong as the immune response in people aged 16–25 years.
CDC will continue to provide updates as we learn more about how well the Pfizer-BioNTech vaccine works in real-world conditions.

Clinical Trial Demographic Information
Clinical trials for the Pfizer-BioNTech vaccine in people aged 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 were obesity (35%), diabetes (8%), and pulmonary disease (8%). Clinical trials for the Pfizer-BioNTech vaccine in people aged 12–15 years included people from the following racial, ethnic, 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 who participated in the trials: Aged 16 years and olderexternal icon Aged 12–15 yearsexternal icon hand holding medical light iconFor Healthcare WorkersPfizer-BioNTech COVID-19 Vaccine: General information, schedule and administration overview. Related PagesPossible Side Effects Safety of COVID-19 Vaccines Benefits of Getting Vaccinated How Vaccines Work mRNA Vaccines More InformationPfizer-BioNTech COVID-19 Vaccine Fact Sheet for Recipients and Caregivers [PDF – 6 pages] external icon MMWR: Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020 Safety and Reactogenicity Data