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 |
|---|---|---|---|---|---|
| 02532018 | COMIRNATY ORIGINAL/OMICRON BA.1 | TOZINAMERAN; RILTOZINAMERAN | 15 MCG / 0.3 ML; 15 MCG / 0.3 ML | SUSPENSION | INTRAMUSCULAR |
Summary Reports
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:
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:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada 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).
This leaflet was prepared by Pfizer Canada ULC.
Last Revised: October 21, 2022