Pfizer-BioNTech COVID-19 Vaccine

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

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 19, 2023.

What is the Pfizer-BioNTech COVID-19 Vaccine?

The Pfizer-BioNTech COVID-19 Vaccine 2023-2024 Formula (COVID-19 Vaccine, mRNA) is a vaccine made by Pfizer and BioNTech that may help your body develop immunity to SARS-CoV-2, the virus that causes COVID-19. The Pfizer-BioNTech COVID-19 Vaccine is an FDA-approved vaccine for adults and adolescents aged 12 years and also has emergency use authorization (EUA) for children aged 6 months to 11 years.

This updated vaccine contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 and trials have shown it shows substantially improved responses against multiple Omicron XBB-related sublineages, including XBB.1.5, XBB.1.16, and XBB.2.3, compared to the Omicron BA.4/BA.5-adapted bivalent vaccine. Pre-clinical data also demonstrate that serum antibodies induced by the 2023-2024 updated vaccine effectively neutralize the recently emerged Omicron BA.2.86 (Pirola) and the globally dominant Omicron-related EG.5.1 (Eris) subvariant when compared to the previous bivalent vaccine.

For individuals previously vaccinated with any COVID-19 vaccine, administer the Pfizer-BioNTech COVID-19 Vaccine at least 2 months after the last dose of the COVID-19 vaccine.

The Pfizer-BioNTech COVID-19 Vaccine 2023-2024 Formula is indicated as a single dose for most adults and children 5 years of age and older. Children aged less than 5 may be eligible to receive additional doses of this vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.

The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) was FDA-approved and granted EUA on September 11, 2023.

Warnings

Contraindicated in people who have had a severe allergic reaction (such as anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.

Postmarketing data has revealed there is an increased risk of myocarditis and pericarditis, particularly within the first week following vaccination. The highest observed risk for the Pfizer-BioNTech COVID-19 Vaccine is in males aged 12 years through 17 years of age.

Fainting may occur in association with vaccine administration, including the Pfizer-BioNTech COVID-19 Vaccine. Tell your healthcare provider if you are prone to fainting and take measures to protect yourself from injury (such as lying down).

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have less of a response to the Pfizer-BioNTech COVID-19 Vaccine.

Who should not receive 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 Vaccine (also called Comirnaty) or any of the components of the vaccine (see "Ingredients' below).

There is insufficient data to inform women about vaccine-associated risks during pregnancy, but very limited animal studies have revealed no evidence of harm to the fetus. Pregnant women infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with non-pregnant women.

It is not known whether the Pfizer-BioNTech COVID-19 Vaccine is excreted in human milk or its effects on the breastfed infant or milk production/excretion. Consider the benefits versus the risks.

Safety and effectiveness have not been established in children less than 12 years of age. 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.

Before receiving the Pfizer-BioNTech COVID-19 Vaccine

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 the Pfizer-BioNTech COVID-19 vaccine given?

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

The usual dosage is 0.3mL

What are the side effects of the Pfizer-BioNTech COVID-19 vaccine?

The Pfizer-BioNTech COVID-19 vaccine 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 may 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) are rare side effects that have occurred in some people who have received the vaccine. In most, symptoms began within a few days following the vaccine, and symptoms resolved 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.

Other common side effects include:

Pain at the injection site (up to 91%)
Tiredness (up to 78%)
Headache (up to 76%)
Chills (up to 49%)
Muscle pain (up to 46%)
Joint pain (up to 28%)
Fever (up to 24%)
Injection site swelling (up to 12%)
Injection site redness (up to 10%).

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

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 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.

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 you are taking or plan to take. Tell your healthcare provider if you take:

a blood thinner
a medicine that affects your immune system.

Also, tell your healthcare provider if you have received any other COVID-19 vaccines.

Ingredients

Active: Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) is formulated to contain 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).

Other ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose.

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.

Storage

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Do not refreeze thawed vials or prefilled syringes.

The Pfizer-BioNTech COVID-19 Vaccine vials and prefilled syringes may arrive frozen at ultra-cold conditions in thermal containers with dry ice.
Once received frozen vials and prefilled syringes may be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 10 weeks.
Alternatively, frozen vials and prefilled syringes may be stored in an ultra-low temperature freezer at −90°C to −60°C (−130°F to −76°F). Do not store vials and prefilled syringes at −25°C to −15°C (−13°F to 5°F). Once thawed, they should not be refrozen.
If not previously thawed at 2°C to 8°C (35°F to 46°F), allow the Pfizer-BioNTech COVID-19 Vaccine single-dose vials to thaw at room temperature [up to 25°C (77°F)] for 30 minutes.
Thawed single dose vials may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours.

Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vials, prefilled syringes, and cartons.

Frozen prefilled syringes should be thawed in the carton, preferably at 2°C to 8°C (35°F to 46°F) for 2 hours. A full carton of prefilled syringes may also be thawed at room temperature [up to 25°C (77°F)] for 60 minutes.
Prefilled syringes thawed in the carton by either method may be stored in the refrigerator for 10 weeks and at room temperature [8°C to 25°C (46°F to 77°F)] for 12 hours before use.
If individual frozen prefilled syringes are thawed at room temperature outside of the carton, they can be kept at room temperature and must be used within 4 hours of thawing.
After removing the tip cap and attaching an appropriate needle, the prefilled syringe should be used immediately. If it cannot be used immediately, it must be used within 4 hours.

Manufacturer

BioNTech Manufacturing GmbH.

Pfizer Inc.

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