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Details for: COMIRNATY ORIGINAL/OMICRON BA.1 - COVID-19

Company: BIONTECH MANUFACTURING GMBH

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02532018COMIRNATY ORIGINAL/OMICRON BA.1TOZINAMERAN; RILTOZINAMERAN15 MCG / 0.3 ML; 15 MCG / 0.3 MLSUSPENSIONINTRAMUSCULAR

Summary Reports

Regulatory Decision Summary
Product Monograph

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

COMIRNATY Original/Omicron BA.1 is a vaccine used to provide protection against COVID-19 disease caused by the SARS-CoV-2 virus.

COMIRNATY Original/Omicron BA.1 can be given to people 12 years of age and older as a booster dose.

What it does

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 Original/Omicron BA.1 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.

When it should not be used

You/your child should not receive COMIRNATY Original/Omicron BA.1 if:

  • you/your child are allergic to any of the ingredients in this vaccine (see What the medicinal ingredient is and What the non-medicinal ingredients are)
  • you/your child had a severe allergic reaction after a previous dose of COMIRNATY or COMIRNATY Original/Omicron BA.1 this 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.
What the medicinal ingredient is

Medicinal ingredient: mRNA (tozinameran and riltozinameran)

What the non-medicinal ingredients are

Non-medicinal ingredients: The non-medicinal ingredients differ depending on which version of the vaccine is given. If you are uncertain, check with your vaccination provider.

For 12 Years of Age and Older: DO NOT DILUTE (Vial with Gray Cap and Gray Label Border):

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

For 12 Years of Age and Older:

Vial with Gray Cap and Gray Label Border (DO NOT DILUTE):
White to off-white suspension provided in a multiple dose vial of 6 doses of 0.3 mL, with 30 micrograms mRNA (15 mcg Original and 15 mcg Omicron BA.1) each.

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your/your child’s healthcare professional before you/your child receive COMIRNATY Original/Omicron BA.1. Talk about any health conditions or problems you/your child may have, including if you/your child:

  • have had any problems following a previous dose of COMIRNATY, or COMIRNATY Original/Omicron BA.1 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 and/or pericarditis
  • 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 Original/Omicron BA.1 may not fully protect all those who receive it. Some of the effects of vaccination mentioned under “Side effects and what to do about them” 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.

Interactions with this medication

There is no information on the use of COMIRNATY Original/Omicron BA.1 with other vaccines.

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

Proper use of this medication

How COMIRNATY Original/Omicron BA.1 is given:

Usual Dose:

For 12 Years of Age and Older:

COMIRNATY Original/Omicron BA.1 is given as an injection of 0.3 mL, preferably into a muscle of the upper arm.

COMIRNATY Original/Omicron BA.1 is given as a booster dose to adults and adolescents from 12 years of age and older who have been previously vaccinated with COMIRNATY or COMIRNATY Original/Omicron BA.1.

If you have any further questions on the use of COMIRNATY Original/Omicron BA.1, ask your healthcare professional.

Overdose:

In the event of suspected overdose with COMIRNATY Original/Omicron BA.1, contact your regional poison control centre.

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.

Side effects and what to do about them

In clinical trials, the side effects from using the COMIRNATY booster and the COMIRNATY Original/Omicron BA.1 booster were similar.

Like all vaccines, COMIRNATY Original/Omicron BA.1 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

  • injection site pain, 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
  • nausea
  • vomiting

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

  • enlarged lymph nodes
  • feeling unwell
  • arm pain
  • feeling weak or lack of energy/sleepy
  • decreased appetite
  • 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.

These are not all the possible side effects you/your child may have when taking COMIRNATY Original/Omicron BA.1. If you/your child experience any side effects not listed here, tell your/your child’s healthcare professional.

There is a remote chance that COMIRNATY Original/Omicron BA.1 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 Original/Omicron BA.1. 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.

How to store

COMIRNATY Original/Omicron BA.1 should be stored, supplied and administered by a healthcare professional.

Keep out of reach and sight of children.

Reporting side effects

Reporting Suspected Side Effects for Vaccines

For the general public: Should you experience a side effect following immunization, please report it to your healthcare professional.

Should you require information related to the management of the side effect, please contact your healthcare professional. The Public Health Agency of Canada, Health Canada and Pfizer Canada ULC cannot provide medical advice.

For healthcare professionals: If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (https://www.canada.ca/en/public-health/services/immunization/reporting-adverse-events-following-immunization/form.html) and send it to your local Health Unit.

More information

If you want more information about COMIRNATY Original/Omicron BA.1:

This leaflet was prepared by Pfizer Canada ULC.

Last Revised: October 21, 2022

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