Pfizer-BioNTech COVID-19 Vaccine

Generic name: COVID-19 (coronavirus 2019) vaccine, Pfizer [ KOE-vid-19 koe-ROE-na-vye-rus-VAX-een ]
Brand names: Pfizer-BioNTech COVID-19 Vaccine PF, Comirnaty
Dosage form: intramuscular suspension (30 mcg/0.3 mL)
Drug class: Viral vaccines

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 12, 2022.

What is the Pfizer-BioNTech COVID-19 Vaccine?

The Pfizer-BioNTech COVID-19 Vaccine may help your body develop immunity to SARS-CoV-2, the virus that causes COVID-19. The Pfizer COVID-19 Vaccine has Emergency Use Authorisation (EUA) by the FDA to be used in specific groups to help prevent severe disease and death from COVID-19.

Original Pfizer-BioNTech COVID-19 Vaccine

The original Pfizer-BioNTech COVID-19 Vaccine is monovalent and contains one messenger RNA (mRNA) component of the original straion of SARS-CoV-2.

The original Pfizer-BioNTech COVID-19 Vaccine (monovalent) contains the same vaccine as Comirnaty. The EUA approved original vaccine has the name Pfizer-BioNTech COVID-19 and when it is used as a FDA approved medicine it has the brand name Comirnaty.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.

Pfizer-BioNTech COVID-19 Vaccine does not contain coronavirus and cannot give you COVID-19. This vaccine will not treat an active COVID-19 infection. Like any vaccine, the Pfizer COVID-19 vaccines may not provide protection in every person.

What is COVID-19?

COVID-19 is a serious disease caused by a coronavirus called SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). COVID-19 is spread from person to person through the air.

COVID-19 can affect your lungs or other organs. Symptoms may be mild or serious and include fever, chills, cough, sore throat, shortness of breath, tiredness, body aches, headache, loss of taste or smell, runny or stuffy nose, nausea, vomiting, or diarrhea.

Warnings

Becoming infected with COVID-19 is much more dangerous to your health than receiving Pfizer-BioNTech COVID-19 Vaccine.

If you have a certain type of reaction after the first dose of Pfizer-BioNTech COVID-19 Vaccine, your healthcare provider will determine if you can safely receive the second dose.

Before taking this medicine

You should not receive Pfizer-BioNTech COVID-19 Vaccine if you've ever had a severe allergic reaction to a Pfizer COVID-19 vaccine. Your healthcare provider will determine whether any reaction you have would prevent you from safely getting the second dose.

If you are infected with COVID-19, are waiting for testing results, or are exposed to someone infected with COVID-19: You may not be able to receive Pfizer-BioNTech COVID-19 Vaccine until you have no symptoms and/or your required quarantine period has ended. Receiving Pfizer-BioNTech COVID-19 Vaccine will not make you less contagious to other people if you are infected with COVID-19 but you have no symptoms.

Ask your doctor if you are unsure about any COVID-19 treatments you received.

To make sure Pfizer-BioNTech COVID-19 Vaccine is safe for you, tell your doctor if:

• you have a fever;

• you have any allergies;

• you have had inflammation in or around your heart (myocarditis or pericarditis);

• you have bleeding problems, or if you use a blood thinner (warfarin, Coumadin, Jantoven);

• you have a weak immune system caused by disease or by using certain medicine;

• you are pregnant or breastfeeding;

• you've received any other COVID-19 vaccine; or

• you have fainted after receiving an injection.

COVID-19 is more likely to cause serious illness or death in a pregnant woman. Not all risks are known yet, but Pfizer-BioNTech COVID-19 Vaccine is likely to be less harmful than becoming infected with COVID-19 during pregnancy.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of COVID-19 vaccine on the baby.

How is Pfizer-BioNTech COVID-19 Vaccine given?

The Pfizer COVID-19 vaccine is given as an injection (shot) given into a muscle, in a primary series of 2 or 3 shots depending on age and whether you are immunocompromised. It may also be used as a booster in certain age groups.
Pfizer-BioNTech COVID-19 Vaccines are available in a number of different formulations and strengths, some required dilution and some do not.  It is important that the correct formulation is selected and dispensed correctly.

Pfizer-BioNTech COVID-19 Vaccine (bnt162b2) For ages 6 months to < 5 years

Three-dose primary series:  3 doses (each 0.2 mL dose contains 3 mcg modRNA). Initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose.
Three-dose primary series for for patients who turn from 4 to 5 years of age between any of their primary series may receive:

• a 2-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 5 through 11 years of age (each 0.2 mL dose containing 10 mcg modRNA, supplied in multiple dose vials with orange caps and labels with orange borders).
  OR
• a 3-dose primary series initiated with the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age (each 0.2 mL dose containing 3 mcg modRNA, supplied in multiple dose vials with maroon caps). Each of Doses 2 and 3 may be with:
  • Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age (supplied in multiple dose vials with maroon caps), or
  • Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 5 years through 11 years of age (supplied in multiple dose vials with orange caps and labels with orange borders).

For more detailed information on dosage click here: Pfizer-BioNTech COVID-19 Vaccine (bnt162b2) For ages 6 months to < 5 years. 

Pfizer-BioNTech COVID-19 Vaccine (bnt162b2) For age 5 years to <12 years

Primary series: 2 doses (0.2 mL each) 3 weeks apart in individuals 5 through 11 years of age.
Third primary series dose: (0.2 mL) at least 28 days following the second dose is authorized for administration to individuals 5 through 11 years of age with certain kinds of immunocompromise.
Booster dose: Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized as booster doses for individuals 5 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information.

For more detailed information on dosage click here: Pfizer-BioNTech COVID-19 Vaccine (bnt162b2)  For age 5 years to <12 years.

Pfizer-BioNTech COVID-19 Vaccine (bnt162b2) For age 12 years of and older:

Primary series: 2 doses (0.3 mL each) given 3 weeks apart in individuals 12 years of age or older.
Third primary series dose: (0.3 mL) at least 28 days following the second dose is authorized for administration to individuals at least 12 years of age with certain kinds of immunocompromise.
Booster dose: Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized as booster doses for individuals 12 years of age and older. Instead Pfizer-BioNTech COVID-19 Vaccine, Bivalent now has EUA as a booster dose. See below for more information.

For more detailed information on dosage click here: Pfizer-BioNTech COVID-19 Vaccine (bnt162b2) For age 12 years of and older.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (original and omicron BA.4/BA.5) For individuals 5 years of age and older

Booster dose:  as a single booster dose administered at least 2 months after either:

• completion of primary vaccination with any authorized or approved monovalent1 COVID-19 vaccine, or
• receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

For more detailed information on dosage click here: Pfizer-BioNTech COVID-19 Vaccine, Bivalent (original and omicron BA.4/BA.5) For individuals 5 years of age and older.

Comirnaty (monovalent): For age 12 years of and older:

Primary series: Comirnaty is FDA approved for use as a two-dose primary series given 3 weeks apart for the prevention of COVID-19.
Third primary series dose: Comirnaty has emergency use authorisation to be used as a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

For more detailed information on dosage click here: Comirnaty (monovalent): For age 12 years of and older

What happens if I overdose?

An overdose of Pfizer-BioNTech COVID-19 Vaccine is unlikely to occur.

What should I avoid after receiving Pfizer-BioNTech COVID-19 Vaccine?

Avoid receiving other vaccines without first seeking medical advice.

Pfizer-BioNTech COVID-19 Vaccine side effects

Get emergency medical help if you have signs of an allergic reaction to Pfizer-BioNTech COVID-19 Vaccine: hives, rash; dizziness, weakness, fast heartbeats; difficult breathing; swelling of your face, lips, tongue, or throat.

Your vaccination provider may want to watch you for a short time after your shot, to make sure you don't have an allergic reaction. You will be treated quickly if you have a reaction right after you receive the vaccine.

You should not receive this vaccine again if the first shot caused a severe allergic reaction. Your doctor or vaccination provider will determine if you can safely receive another COVID-19 vaccine.

Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine.

Some people receiving Pfizer-BioNTech COVID-19 Vaccine had inflammation of the heart muscle or the lining around the heart within a few days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have:

• chest pain;

• shortness of breath; or

• fast or pounding heartbeats or fluttering in your chest.

Not all possible side effects are known.

Common Pfizer-BioNTech COVID-19 Vaccine side effects may include:

• fever, chills, swollen glands, not feeling well;

• pain, redness, or swelling where the shot was given;

• feeling tired; or

• headache, muscle pain, joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

You may also use a smartphone-based program called V-safe to communicate with the Centers for Disease Control and Prevention (CDC) about any health problems you have after receiving a COVID-19 vaccine.

What other drugs will affect Pfizer-BioNTech COVID-19 Vaccine?

Before receiving Pfizer-BioNTech COVID-19 Vaccine, tell your vaccination provider about all other vaccines you have received and all medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Ingredients

Comirnaty (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent include the following ingredients: mRNA and 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).

Additional Ingredients:
Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older contains 1 of the following sets of additional ingredients; ask the vaccination provider which version is being administered:  potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose OR  tromethamine, tromethamine hydrochloride, and sucrose.

 Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older contains the following additional ingredients:  tromethamine, tromethamine hydrochloride, and sucrose

Comirnaty (COVID-19 Vaccine, mRNA) contains 1 of the following sets of additional ingredients; ask the vaccination provider which version is being administered:  potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose OR  tromethamine, tromethamine hydrochloride, and sucrose.

Popular FAQ

Further information

• Your vaccination provider, pharmacist, or doctor can provide more information about Pfizer-BioNTech COVID-19 Vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Pfizer-BioNTech COVID-19 Vaccine only for the indication prescribed.

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

Medical Disclaimer

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