Pfizer-BioNTech COVID-19 Vaccine Overview and Safety
EMA and CDC Monitoring Reports of Myocarditis and Pericarditis
EMA and CDC have 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. EMA and CDC continue to recommend COVID-19 vaccination for anyone 12 years of age and older.
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
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 .
Key facts from the European Medicines Agency about the COVID-19 Vaccines .
Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine .
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.
An immediate allergic reaction means a reaction within 4 hours of exposure, including symptoms such as hives, swelling, or wheezing (respiratory distress).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given the vaccine if you have:
- Ever had a severe allergic reaction or breathing problems after any other vaccine injection or after you were given COVID-19 mRNA Vaccine BNT162b2 in the past.
- A severe illness with high fever (however, a mild fever or upper airway infection, like a cold, are not reasons to delay vaccination).
- A weakened immune system, such as due to HIV infection, or are on a medicine that affects your immune system.
- A bleeding problem, bruise easily or use a medicine to inhibit blood clotting.
Very rare cases of inflammation of the heart (myocarditis or pericarditis) have been reported following vaccination with COVID-19 mRNA Vaccine BNT162b2. These have happened most often in younger men and shortly after the second dose of the vaccine. Most of these cases were mild and people recovered soon after with simple treatment and rest. It is important that you urgently seek medical attention if you experience new onset of symptoms such as chest pain, shortness of breath or feelings of having a fast-beating, fluttering, or pounding heart.
As with any vaccine, COVID-19 mRNA Vaccine BNT162b2 may not fully protect all those who receive it. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses.
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 and EMA will continue to provide updates as we learn more about the safety of the Pfizer-BioNTech vaccine in real-world conditions.
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.