Pfizer-BioNTech COVID-19 vaccine

Pronunciation: fai-zuh be-yon-tech kow-vid nine-teen vak-seen
Generic name: COVID-19 Vaccine, mRNA
Brand name: Pfizer-BioNTech COVID-19 vaccine 2024-2025 Formula
Dosage form: suspension for intramuscular injection
Drug class: Viral vaccines

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 27, 2024.

What is the Pfizer-BioNTech COVID-19 vaccine?

The Pfizer-BioNTech COVID-19 vaccine 2024-2025 Formula is an mRNA COVID-19 vaccine that may help your child develop immunity to SARS-CoV-2, the virus that causes COVID-19.

• The number of doses depends on age, vaccination status, and immune system status.
• The Pfizer-BioNTech COVID-19 vaccine has been updated for 2024-2025 to cover Omicron KP.2.

The Pfizer-BioNTech COVID-19 vaccine does not contain any live virus particles, including those of SARS-CoV-2, the virus that causes COVID-19. It cannot give your child COVID-19, although it may not protect everyone who receives the vaccine.

The Pfizer-BioNTech COVID-19 vaccine is an mRNA vaccine, which means its mechanism of action is to use messenger RNA (mRNA) to provide instructions for making the spike protein of the COVID-19 virus. Your body then recognizes this spike protein as foreign and produces antibodies and T cells to attack it. This helps your child's body prepare to fight off the real COVID-19 virus if they are exposed to it.

The Pfizer-BioNTech COVID-19 vaccine has been granted Emergency Use Authorization (EUA) for children aged 6 months through 11 years. It is not an FDA-approved vaccine.

• Under the EUA, there is an option to accept or refuse to receive this vaccine. Should you decide for your child not to receive this vaccine, it will not change the standard medical care.
• Comirnaty is the COVID-19 vaccine made by Pfizer and BioNTech which is approved for adults and adolescents 12 years and older.

Pfizer-BioNTech COVID-19 vaccine side effects

The most common side effects of the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months through 23 months include:

• Injection site redness, swelling, and tenderness
• Decreased appetite
• Drowsiness
• Fever
• Irritability.

The most common side effects of the Pfizer-BioNTech COVID-19 vaccine in children aged 2 through 11 years include:

• Injection site redness, swelling, and tenderness
• Chills
• Diarrhea
• Fatigue
• Fever
• Headache
• New or worsened joint pain
• New or worsened muscle pain
• Vomiting.

Other side effects that have been reported with the Pfizer-BioNTech COVID-19 vaccine include:

• Severe and non-severe allergic reactions (see below)
• Myocarditis and pericarditis (see below)
• Nausea
• Feeling unwell
• Swollen lymph nodes (lymphadenopathy)
• Arm pain
• Fainting in association with an injection of the vaccine
• Dizziness
• Irritability
• Febrile seizures (convulsions during a fever).

Serious side effects and warnings

There is a remote chance that the Pfizer-BioNTech COVID-19 vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

• Difficulty breathing
• Swelling of your face and throat
• A fast heartbeat
• A bad rash all over your body
• Dizziness and weakness.

If your child experiences a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

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, including the Pfizer-BioNTech COVID-19 and Comirnaty vaccines. Myocarditis and pericarditis following mRNA 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 you or your child have any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:

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

Additional symptoms of myocarditis, 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.

These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 vaccine. Ask your healthcare provider about any side effects that concern you. Report vaccine side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html.

In addition, you can report side effects to Pfizer Inc. at 1-800-438-1985 or www.pfizersafetyreporting.com.

Before receiving the Pfizer-BioNTech COVID-19 vaccine

You should not get the Pfizer-BioNTech COVID-19 vaccine if you have had a severe allergic reaction to a previous dose of the Pfizer-BioNTech COVID-19, Comirnaty, or any of the components of the vaccine (see "Ingredients' below).

Tell your vaccination provider about all of your medical conditions, including if you:

• have any allergies
• have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
• have a fever
• have a bleeding disorder or are on a blood thinner
• are immunocompromised or are on a medicine that affects your immune system
• are pregnant or plan to become pregnant
• are breastfeeding
• have received another COVID-19 vaccine
• have ever fainted in association with an injection
• are pregnant
• are breastfeeding.

The safety and effectiveness of the Pfizer-BioNTech COVID-19 vaccine 2024-2025 Formula has not been evaluated in children less than 12 years of age, but data is available for previous vaccine formulations that were manufactured using the same process.

Evidence from clinical studies strongly suggests that a single dose of the Pfizer-BioNTech COVID-19 vaccine is ineffective in individuals younger than 6 months of age.

Pregnancy

MRNA COVID-19 vaccines are generally considered safe for use during pregnancy and major health organizations, including the CDC, ACOG, and AAP, recommend COVID-19 vaccination for pregnant individuals.

Observational data from pregnant people who have received mRNA COVID-19 vaccines have not identified any safety concerns for pregnant people or their babies. The vaccine can be administered at any time during pregnancy. Pregnant individuals are at increased risk for severe illness from COVID-19 compared to non-pregnant people and vaccination during pregnancy can help protect both the mother and the baby. Antibodies generated by the vaccine can pass to the fetus, potentially providing some protection to the newborn.

Breastfeeding

It is not known whether mRNA COVID-19 vaccines are excreted in human milk or their effects on the breastfed infant or milk production/excretion. Consider the benefits versus the risks.

How is the Pfizer-BioNTech COVID-19 vaccine given?

The Pfizer-BioNTech COVID-19 vaccine is given to your child as an injection into a muscle, usually the deltoid muscle of the upper arm.

• How many injections of the Pfizer-BioNTech COVID-19 vaccine your child gets depends on their age, vaccination, and health status.
• The duration of protection that the Pfizer-BioNTech COVID-19 vaccine provides against COVID-19 is currently unknown.

Pfizer-BioNTech COVID-19 vaccine dosage

Children aged 6 months through 4 years of age

Use the yellow cap Pfizer-BioNTech COVID-19 vaccine multi-dose vial (each dose delivers 3 mcg of modified RNA)

Unvaccinated children: 3 doses of Pfizer-BioNTech COVID-19 vaccine are recommended

• The first 2 doses are administered 3 weeks apart.
• The third dose is administered at least 8 weeks after the second dose.

Children who have received 1 previous dose of a Pfizer-BioNTech COVID-19 vaccine: 2 doses of Pfizer-BioNTech COVID-19 vaccine are recommended.

• The first dose is administered 3 weeks after the previous dose.
• The second dose is administered at least 8 weeks after the first dose.

Children who have received 2 previous doses of a Pfizer-BioNTech COVID-19 vaccine: 1 dose of the Pfizer-BioNTech COVID-19 vaccine is recommended.

• A single dose is administered at least 8 weeks after the last previous dose of a Pfizer-BioNTech COVID-19 vaccine.

Children aged 5 through 11 years of age

Use the blue cap Pfizer-BioNTech COVID-19 vaccine single-dose vial. Each dose delivers 10 mcg of modified RNA.

• A single dose of the Pfizer-BioNTech COVID-19 vaccine is administered to children who have not yet received a COVID-19 vaccine (2024-2025 Formula).
• You must wait at least 8 weeks after the last previous dose of any COVID-19 vaccine.

Immunocompromised children aged 6 months through 11 years of age

Immunocompromised children may receive additional doses of the Pfizer-BioNTech COVID-19 Vaccine. Talk to your healthcare provider about this.

• Vaccinations may not provide full immunity to COVID-19 in people who are immunocompromised; therefore, your child should continue to maintain physical precautions to help prevent COVID-19.
• Your child’s close contacts should be vaccinated as appropriate.

What other drugs will affect the Pfizer-BioNTech COVID-19 vaccine?

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products your child takes. Tell your healthcare provider if your child takes:

• a blood thinner, such as warfarin
• a medicine that affects your immune system, such as cyclosporine

Also, tell your healthcare provider if your child has received any other COVID-19 vaccines.

Pfizer-BioNTech COVID-19 vaccine ingredients

Active: messenger RNA (mRNA)

Other ingredients: lipids (((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, and cholesterol), tromethamine, tromethamine hydrochloride, and sucrose.

The Pfizer-BioNTech COVID-19 vaccine for use in children aged 6 months through 4 years of age also contains sodium chloride.

• The Pfizer-BioNTech COVID-19 vaccine does not contain preservatives.
• The vial stoppers are not made with natural rubber latex.
• The prefilled syringe tip cap and plunger stopper are not made with natural rubber latex.
• Each dose contains 0.3 mL of liquid.

There are 2 doses of Pfizer-BioNTech COVID-19 vaccine available:

• Yellow cap for children 6 months through 4 years: multiple-dose vial requires dilution before use.
  • After dilution, each 0.3 mL dose of Pfizer-BioNTech COVID-19 vaccine is formulated to contain 3 mcg of nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage KP.2.
• Blue cap for children 5 years through 11 years: single-dose vial. No dilution is required.
  • Each 0.3 mL dose of Pfizer-BioNTech COVID-19 vaccine is formulated to contain 10 mcg of a modRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage KP.2.

Who makes the Pfizer-BioNTech COVID-19 vaccine?

Pfizer Inc. manufactures the Pfizer-BioNTech COVID-19 vaccine for BioNTech Manufacturing GmbH.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer