Help protect against COVID-19

Has Pfizer-BioNTech COVID-19 Vaccine been used before?

In a clinical trial, approximately 1200 individuals 6 months through 23 months of age, approximately 1800 individuals 2 through 4 years of age, and approximately 3100 individuals 5 through 11 years of age have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine (Original monovalent).

In clinical trials, 60 individuals 6 months through 4 years of age and 113 individuals 5 through 11 years of age received a dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) is made in the same way as Pfizer‑BioNTech COVID‑19 Vaccine (Original monovalent) and Pfizer‑BioNTech COVID 19 Vaccine, Bivalent, but it encodes the spike protein of SARS‑CoV‑2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5). Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent are no longer authorized for use in the United States.

Will Pfizer-BioNTech COVID-19 Vaccine give my child COVID-19?

No. This vaccine does not contain SARS-CoV-2 and cannot give your child COVID-19.

How is Pfizer-BioNTech COVID-19 Vaccine given?

The vaccine is given as an injection into the muscle.

Who should NOT get Pfizer-BioNTech COVID-19 Vaccine?

A person should NOT get Pfizer-BioNTech COVID-19 Vaccine if they had a severe allergic reaction after a previous dose of any Pfizer-BioNTech COVID-19 vaccine or to any ingredients in these vaccines.

What are the risks of Pfizer-BioNTech COVID-19 Vaccine?

There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, your child’s vaccination provider may ask your child to stay at the place where he or she received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

• difficulty breathing
• swelling of the face and throat
• a fast heartbeat
• a bad rash all over your child’s body
• dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following Pfizer-BioNTech COVID-19 vaccines have occurred most commonly in adolescent males 12 through 17 years of age. In most of these individuals, symptoms began within a few days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after your child receives a dose of the vaccine:

• Chest pain
• Shortness of breath or difficulty breathing
• Feelings of having a fast-beating, fluttering, or pounding heart

Additional symptoms, particularly in children, may include:

• Fainting
• Unusual and persistent irritability
• Unusual and persistent poor feeding
• Unusual and persistent fatigue or lack of energy
• Persistent vomiting
• Persistent pain in the abdomen
• Unusual and persistent cool, pale skin

Side effects that have been reported with Pfizer-BioNTech COVID-19 vaccines include:

• Severe allergic reactions
• Non-severe allergic reactions, such as rash, itching, hives, or swelling of the face
• Myocarditis (inflammation of the heart muscle)
• Pericarditis (inflammation of the lining outside the heart)
• Injection site pain/tenderness
• Tiredness
• Headache
• Muscle pain
• Chills
• Joint pain
• Fever
• Injection site swelling
• Injection site redness
• Nausea
• Feeling unwell
• Swollen lymph nodes (lymphadenopathy)
• Decreased appetite
• Diarrhea
• Vomiting
• Arm pain
• Fainting in association with injection of the vaccine
• Dizziness
• Irritability

These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. Call your child's vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

What are the benefits of Pfizer-BioNTech COVID-19 Vaccine?

FDA has authorized Pfizer-BioNTech COVID-19 Vaccine to provide protection against COVID-19.

The duration of protection against COVID-19 is currently unknown.

What should I tell my child’s vaccination provider?

Tell the vaccination provider about all of your child’s medical conditions, including if your child:

• has any allergies
• has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
• has a fever
• has a bleeding disorder or is on a blood thinner
• is immunocompromised or is on a medicine that affects their immune system
• has received another COVID-19 vaccine
• has ever fainted in association with an injection