Comirnaty (Biontech Manufacturing, PM 00086127): Uses, Side Effects and Dosage

What COMIRNATY is used for:

• COMIRNATY is a vaccine used to provide protection against COVID-19 disease caused by the SARS-CoV-2 virus.
• COMIRNATY can be given to people 6 months of age and older.

How COMIRNATY works:

The vaccine causes our body to produce protection (such as antibodies) that prevent the COVID-19 virus from entering our cells to make us sick. The vaccine uses a new method (messenger RNA - mRNA, the genetic code for a piece of the virus) to help our bodies make protection against the virus. The vaccine is given by injection with a needle in the upper arm.

You cannot get COVID-19 from the vaccine.

As with any vaccine, COMIRNATY may not fully protect all those who receive it. Even after you/your child have had the vaccine, continue to follow the recommendations of local public health officials to prevent spread of COVID-19.

The ingredients in COMIRNATY are:

Medicinal ingredient: mRNA encoding SARS-CoV-2 spike protein

The mRNA encoding spike protein is derived from Omicron variant XFG.

Non-medicinal ingredients:

• ALC-0315 = ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
• ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
• cholesterol
• DSPC = 1,2-distearoyl-sn-glycero-3-phosphocholine
• sodium chloride*
• sucrose
• tromethamine
• tromethamine hydrochloride
• water for injection

* present only in the vial with yellow cap/label border (for age 6 months to 4 years) following dilution with 0.9% Sodium Chloride Injection USP.

COMIRNATY comes in the following dosage forms:

Suspension for intramuscular injection, provided as follows (not all presentations may be available):

For 12 Years of Age and Older:

• Multiple Dose Vial with Dark Gray Cap and Dark Gray Label Border (DO NOT DILUTE): 6 doses of 0.3 mL (30 micrograms mRNA/0.3 mL).
• Single Dose Prefilled Syringe: 1 dose of 0.3 mL (30 micrograms mRNA/0.3 mL).

For Age 5 Years to 11 Years:

• Single Dose Vial with Light Blue Cap and Light Blue Label Border (DO NOT DILUTE): 1 dose of 0.3 mL (10 micrograms mRNA/0.3 mL).
• Multiple Dose Vial with Dark Blue Cap and Dark Blue Label Border (DO NOT DILUTE): 6 doses of 0.3 mL (10 micrograms mRNA/0.3 mL).

For Age 6 Months to 4 Years:

• Multiple Dose Vial with Yellow Cap and Yellow Label Border (DILUTE PRIOR TO USE): 3 doses of 0.3 mL after dilution (3 micrograms mRNA/0.3 mL).

You/your child should not receive COMIRNATY if:

• you/your child are allergic to any of the ingredients in this vaccine (see The ingredients in COMIRNATY are).
• you/your child had a severe allergic reaction after a previous dose of any COMIRNATY vaccine.
• you/your child have any symptoms that could be due to COVID-19. Talk with your/your child’s healthcare professional about your/your child’s symptoms and getting a COVID-19 test. Your/your child’s healthcare professional will advise you when you/your child are able to receive the vaccine.

To help avoid side effects and ensure proper use, talk to your/your child’s healthcare professional before you/your child receive COMIRNATY. Talk about any health conditions or problems you may have, including if you/your child:

• have had any problems following a previous dose of any COMIRNATY vaccine, such as an allergic reaction or breathing problems
• have any allergies
• have a weakened immune system due to a medical condition or are on a medicine that affects the immune system
• have previously had episodes of myocarditis (inflammation of the heart muscle) and/or pericarditis (inflammation of the outer lining of the heart)
• have a history of febrile convulsions
• are feeling nervous about the vaccination process or have ever fainted in association with an injection
• have a bleeding problem, bruise easily or use a blood thinning medication

• are pregnant, think you may be pregnant or plan to become pregnant

• are breast-feeding

Other warnings you should know about:

• As with any vaccine, COMIRNATY may not fully protect all those who receive it.

• Some of the effects of vaccination mentioned under “Possible side effects from receiving COMIRNATY” may temporarily affect your ability to drive or use machines. Wait until these effects have worn off before you drive or use machines.

Tell your/your child’s healthcare professional about all the medicines you/your child take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

COMIRNATY may be given at the same time as a flu vaccine in adults 18 to 64 years of age.

In adults 18 years of age and older, COMIRNATY may be given at the same time as a pneumococcal conjugated vaccine (PCV), or at the same time as an unadjuvanted recombinant protein respiratory syncytial virus (RSV) vaccine.

In older adults 65 years of age and older, COMIRNATY may be given at the same time as a high dose flu and an unadjuvanted recombinant protein RSV vaccine.

Tell your healthcare professional if you/your child have recently received any other vaccine.

How COMIRNATY is given:

Usual dose:

For 12 Years of Age and Older

COMIRNATY is given as an injection of 0.3 mL, preferably into a muscle of the upper arm.

You will receive 1 injection, regardless whether you have received a COVID-19 vaccine before.

If you were previously vaccinated with a COVID-19 vaccine, you should not receive a dose of COMIRNATY until at least 3 to 6 months after the most recent dose.

For Age 5 Years to 11 Years

COMIRNATY is given as an injection of 0.3 mL, preferably into a muscle of the upper arm.

Your child will receive 1 injection, regardless whether he/she has received a COVID-19 vaccine before.

If your child was previously vaccinated with a COVID-19 vaccine, he/she should not receive a dose of COMIRNATY until at least 6 months after the most recent dose.

For Age 6 Months to 4 Years

COMIRNATY is given as an injection of 0.3 mL, into a muscle of the thigh in infants from 6 to less than 12 months of age. In infants and children 1 year of age or older, it is given as an injection of 0.3 mL into a muscle of the thigh or into a muscle of the upper arm.

If your child has not completed a COVID-19 primary vaccination course, your child will receive a maximum of 3 injections (the total number of doses required as primary course). It is recommended to receive the second dose 3 weeks after the first dose followed by a third dose at least 8 weeks after the second dose to complete the three-dose course.

If your child has previously completed a COVID-19 primary vaccination course, your child will receive 1 injection. If your child was previously vaccinated with a COVID-19 vaccine, your child should not receive a dose of COMIRNATY until at least 6 months after the most recent dose.

If you have any further questions on the use of COMIRNATY, ask your healthcare professional.

Overdose:

Your healthcare professional may monitor you for 30 minutes in case of overdose.

Missed dose:

If you forget to go back to your healthcare professional at the scheduled time for your/your child’s next dose, ask your/your child’s healthcare professional for advice.

Possible side effects from using COMIRNATY:

Like all vaccines, COMIRNATY can cause side effects, although not everybody gets them.

Side effects may occur at the following frequencies:

Very common: may affect more than 1 in 10 people

• irritability (6 months to 23 months)
• injection site pain/tenderness, swelling
• tiredness
• headache
• muscle pain
• chills
• joint pain
• fever
• diarrhea

Common: may affect more than 1 in 100 and up to 1 in 10 people

• injection site redness (“very common” in 6 months to 11 years and in immunocompromised individuals 2 years of age and older)
• nausea
• vomiting (“very common” in pregnant women 18 years of age and older and in immunocompromised individuals 2 to 18 years of age)
• rash (6 months to 23 months)
• enlarged lymph nodes (more frequently observed after the booster dose)

Uncommon: may affect more than 1 in 1000 and up to 1 in 100 people

• feeling unwell
• arm pain
• feeling weak or lack of energy/sleepy
• decreased appetite (“very common” in 6 months to 23 months)
• excessive sweating
• night sweats

Non-severe allergic reactions (such as rash, itching, hives or swelling of the face), severe allergic reactions, facial paralysis / Bell’s palsy, erythema multiforme (skin reaction or lesion; red spots or patches), hypoesthesia (reduced or loss of sensation) and paresthesia (“tingling sensation”) have been reported.

Myocarditis (inflammation of the heart muscle) and/or pericarditis (inflammation of the outer lining of the heart) have been reported following COMIRNATY administration. Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as shortness of breath, palpitations and chest pain, and seek immediate medical attention should these occur. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often in younger males, and more often after the second dose or first booster dose compared to the first dose. Most cases of myocarditis and pericarditis recover. Some cases required intensive care support and fatal cases have been seen.

There is a remote chance that COMIRNATY could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of COMIRNATY. For this reason, the vaccination provider may ask you/your child to stay at the place where the vaccine was received for monitoring after vaccination. Should you/your child develop any serious symptoms or symptoms that could be an allergic reaction, seek medical attention right away. Symptoms of an allergic reaction include:

• hives (bumps on the skin that are often very itchy)
• swelling of the face, tongue or throat
• difficulty breathing
• a fast heartbeat
• dizziness and weakness

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

Your/your child’s health care provider should inform your local public health department of any serious side effects after vaccination.

These are not all the possible side effects you/your child may have when receiving COMIRNATY. If you/your child experience a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your/your child’s healthcare professional.

Storage:

COMIRNATY should be stored, supplied and administered by a healthcare professional.

Keep out of reach and sight of children.

If you want more information about COMIRNATY:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website [www.pfizer.ca]; or by calling 1-800-463-6001 (Pfizer Medical Information).

BioNTech Manufacturing GmbH

An der Goldgrube 12

Mainz, Rhineland-Palatinate, Germany 55131

Imported and distributed by:

Pfizer Canada ULC

17,300 Trans-Canada Highway

Kirkland, Quebec, Canada H9J 2M5

Date of Authorization: 2026-09-10

®BioNTech SE, Pfizer Canada ULC Licensee