COVID-19 Vaccine, mRNA (Pfizer-BioNTech) (2026-2027 Formula)

The mRNA COVID-19 vaccine made by Pfizer-BioNTech, sold under the brand name Comirnaty, is used to protect adults aged 65 and older or people aged 5 through 64 years with an underlying condition that puts them at high risk for severe COVID-19 outcomes. It helps your body develop immunity to SARS-CoV-2, the virus that causes COVID-19.

• Given as a single 0.3 mL dose.
• The 2026-2027 Formula encodes the spike protein of the SARS-CoV-2 JN.1-descendant variant XFG.
• If you have had any COVID-19 vaccine before, wait at least 2 months before getting your dose.

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

It 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 body prepare to fight off the real COVID-19 virus if you are exposed to it.

Note: In the U.S., some states may have differing rules on vaccinations. Some states allow pharmacists to vaccinate adults directly, while others require a prescription for people outside the approved age and risk groups, and pharmacy chain policies vary. If you are unsure of your vaccination eligibility, check with your local healthcare provider or pharmacist.

The FDA approved the 2026-2027 Formula of Comirnaty on August 27, 2026. It replaces the 2025-2026 (LP.8.1) formula and is matched to the XFG variant.

• Ages 12 years and older: a single 0.3 mL dose containing 30 mcg modRNA, supplied in prefilled syringes labeled with gray borders.
• Ages 5 through 11 years: a single 0.3 mL dose containing 10 mcg modRNA, supplied in vials with blue caps and labeled with blue borders.

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

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

• have any allergies
• have had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
• 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.

Safety and effectiveness in individuals 5 years through 17 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 are based on data in this age group and in adults. Safety and effectiveness have not been established in children younger than 5 years of age. Evidence from clinical studies in individuals 6 months through 4 years of age strongly suggests that a single dose would be ineffective in individuals younger than 6 months of age.

Immunocompromised people

Immunocompromised people, including those receiving immunosuppressant therapy, may have a diminished immune response to this vaccine. In an open-label study of 87 immunocompromised people aged 5 years and older, the safety profile was similar to that seen in people who were not immunocompromised. That study had a small sample size and was stopped early, and its data do not establish how effective the vaccine is in immunocompromised people.

Pregnancy

Pregnant individuals infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with non-pregnant individuals.

There are no available data on use in pregnant women before 24 weeks gestation to inform about risks for major birth defects and miscarriage. A developmental toxicity study in female rats given the equivalent of a single human dose (original monovalent formula) revealed no evidence of harm to the fetus.

A randomized, placebo-controlled trial in pregnant women 18 years and older (Study 9) enrolled participants who received their first dose at 24 to 34 weeks gestation. The trial was terminated prematurely and failed to reach its target accrual, resulting in uncertainty regarding differences in outcomes. The available data are insufficient to establish or exclude a causal relationship with pre-eclampsia.

If you are pregnant, discuss your options with your healthcare provider.

Breastfeeding

It is not known whether this vaccine is excreted in human milk or its effects on the breastfed infant or milk production and excretion. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the vaccine and any potential adverse effects on the breastfed child.

Side effects that have been reported with Comirnaty or 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 reactions: pain, swelling, redness, arm pain
• General side effects: tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, swollen lymph nodes (lymphadenopathy), decreased appetite, diarrhea, vomiting, dizziness
• Fainting in association with the injection of the vaccine
• Febrile seizures (convulsions during a fever) in children 5 through 11 years of age.

How common are the most frequent side effects?

In clinical trials, the most commonly reported adverse reactions were:

• Ages 12 years and older (reported by 10% or more): injection site pain (up to 90.5%), fatigue (up to 77.5%), headache (up to 75.5%), chills (up to 49.2%), muscle pain (up to 45.5%), joint pain (up to 27.5%), fever (up to 24.3%), injection site swelling (up to 11.8%), and injection site redness (up to 10.4%).
• Ages 5 through 11 years (reported by 5% or more): injection site pain (up to 83.8%), fatigue (up to 51.9%), headache (up to 38.4%), injection site redness (up to 25.9%), injection site swelling (up to 20.0%), muscle pain (up to 18.1%), chills (up to 13.3%), fever (up to 7.8%), and joint pain (up to 7.6%).

Severe allergic reactions

There is a remote chance that this 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, the vaccination provider may ask you or your child to stay at the place where you or your child 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 the body
• Dizziness and weakness

Myocarditis and pericarditis

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 Comirnaty and Pfizer-BioNTech COVID-19 vaccines.

• Myocarditis and pericarditis following administration of mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age.
• In most of these people, symptoms began within a week following vaccination.
• Based on available data, estimated rates of myocarditis and/or pericarditis from 1 through 7 days after getting a dose of the 2023-2024 Formula of mRNA COVID-19 vaccines were approximately 8 cases per million doses in people 6 months through 64 years of age and approximately 27 cases per million doses in males 12 years through 24 years of age.

In most people who have had myocarditis or pericarditis after receiving an mRNA COVID-19 vaccine, symptoms have gone away a few days after receiving treatment with medicines used to reduce inflammation.

• In a study, follow-up information was collected on people who developed myocarditis after receiving the original formula of a COVID-19 vaccine; most people had received an mRNA COVID-19 vaccine.
• Some people in the study reported having heart symptoms approximately 3 months after developing myocarditis.
• Some people in the study had heart MRIs (scans that show detailed images of the heart muscle) initially after developing myocarditis and again approximately 5 months later.
• The initial and follow-up heart MRIs commonly showed signs of injury to the heart muscle, with improvement over time in most people. It is not known if these heart MRI findings might predict long-term heart effects of myocarditis.
• Studies are underway to find out if there are long-term heart effects in people who have had myocarditis after receiving an mRNA COVID-19 vaccine.

You should seek medical attention right away if you or your child has any of the following symptoms after receiving this vaccine, particularly during the 2 weeks after receiving a dose:

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

These could be symptoms of myocarditis or pericarditis.

Additional symptoms, particularly in children, may include:

• Fainting
• 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. 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.

This vaccine is given to you as an injection into a muscle, usually the deltoid muscle of the upper arm.

• 1 injection is usually given (0.3 mL).
• It is administered as a single dose for individuals 5 years of age and older.
• For individuals previously vaccinated with any COVID-19 vaccine, administer the dose at least 2 months after the last dose of 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, such as warfarin
• a medicine that affects your immune system, such as cyclosporine

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

Comirnaty

Active: nucleoside-modified messenger RNA (modRNA) encoding the spike glycoprotein of SARS-CoV-2 JN.1-descendant variant XFG: 30 mcg per 0.3 mL dose (ages 12 and older) or 10 mcg per 0.3 mL dose (ages 5 through 11).

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.

• This 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.

Comirnaty is manufactured for BioNTech Manufacturing GmbH, Mainz, Germany, by Pfizer Inc., New York, NY 10001.