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Comirnaty

Generic name: COVID-19 Vaccine, mRNA
Dosage form: injection, for intramuscular use
Drug class: Viral vaccines

Medically reviewed by Melisa Puckey, BPharm. Last updated on Sep 13, 2022.

What is Comirnaty?

Comirnaty is the FDA-approved monovalent COVID-19 (coronavirus 2019) vaccine made by Pfizer for BioNTech. Comirnaty may help your body develop immunity to SARS-CoV-2, the virus that causes COVID-19.

  • Comirnaty is FDA-approved as a 2-dose series for the prevention of COVID-19 in individuals 12 years of age and older.
  • Comirnaty is also authorized under Emergency Use Authorization (EUA) to be administered to provide:
    • a two-dose primary series in individuals 12 through 15 years;
    • a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.
  • Comirnaty is no longer authorized as booster doses for individuals 12 years of age and older.

COVID-19 is a disease caused by infection from the coronavirus SARS-CoV-2. COVID-19 is predominantly a respiratory illness that can affect other organs. Symptoms range from mild symptoms through to severe illness leading to death. Common symptoms include fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

The vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown.

What is the difference between Comirnaty, Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent ?

Comirnaty and the Pfizer-BioNTech COVID-19 Vaccine (original-monovalent) contain the same vaccine. This is the original vaccine which contains one messenger RNA (mRNA) component of the original strain of SARS-CoV-2.  When used under the FDA approval the vaccine is called Comirnaty and when used under a EUA it is called Pfizer-BioNTech COVID-19 Vaccine.

The Pfizer-BioNTech COVID-19 Vaccine 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 (monovalent) has emergency use authorization to prevent COVID-19 as a: 

  • Three-dose primary series for individuals 6 months through 4 years of age. 
  • Two-dose primary series for individuals 5 years of age and older. 
  • Third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. 
  • Single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine. 

Pfizer-BioNTech COVID-19 Vaccine (monovalent) is no longer authorized as booster doses for individuals 12 years of age and older. 

Pfizer-BioNTech COVID-19 Vaccine, Bivalent has emergency use authorisation for use to prevent COVID-19 in individuals 12 years of age and older as a single booster dose administered at least 2 months after either: 

  • Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or 
  • Have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. 

Who should not get Comirnaty? 

You should not get Comirnaty or the Pfizer-BioNTech COVID-19 Vaccine if you: 

  • had a severe allergic reaction after a previous dose of this vaccine
  • had a severe allergic reaction to any ingredient of this vaccine. (See the list of ingredients at the end of this page.)

Before receiving Comirnaty

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

How is Comirnaty given?

Comirnaty is given to you as an injection into the muscle.

The vaccination series is 2 doses given 3 weeks apart.

If you receive one dose of the vaccine, you should receive a second dose of the vaccine 3 weeks later to complete the vaccination series.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. For patients 12 years and older who have certain kinds of immunocompromise, a third dose may be administered at least 4 weeks after the second dose.

Comirnaty side effects

Comirnaty may cause severe side effects including:

  • Allergic reactions. 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 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
  • Myocarditis and pericarditis. Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) is a rare side effect and has have occurred in some people who have received the vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine and most individuals have had resolution of symptoms with conservative management. You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine:
    • Chest pain
    • Shortness of breath
    • Feelings of having a fast-beating, fluttering, or pounding heart

Side effects can 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
  • tiredness
  • headache
  • muscle pain
  • chills
  • joint pain
  • fever
  • injection site swelling
  • injection site redness
  • nausea
  • feeling unwell
  • swollen lymph nodes (lymphadenopathy)
  • diarrhea
  • vomiting
  • arm pain

These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur.

The possible side effects of the vaccine are still being studied in clinical trials.

  • If you experience a severe allergic reaction, call 911, or go to the nearest hospital.
  • Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.
  • Report vaccine side effects to 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.

What should I avoid after receiving Comirnaty?

There is currently no data available to assess the administration of Comirnaty at the same time as other vaccines.

It is recommended to avoid receiving other vaccines without first seeking medical advice.

What other drugs will affect this vaccine?

Before receiving Comirnaty, 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:

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.

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

More about Comirnaty (sars-cov-2 mrna (tozinameran) vaccine)

Patient resources

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Pfizer-BioNTech COVID-19 Vaccine

Professional resources

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Further information

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