Details for: COMIRNATY - COVID-19
Company: BIONTECH MANUFACTURING GMBH
|DIN||DIN name||Active Ingredient(s)||Strength||Dosage Form||Route of Administration|
|02509210||COMIRNATY||TOZINAMERAN||30 MCG / 0.3 ML||SUSPENSION||INTRAMUSCULAR|
Regulatory Decision Summary
Regulatory Decision Summary
Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
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 is a vaccine used to prevent COVID-19 disease caused by the SARS-CoV-2 virus.
COMIRNATY can be given to people from 12 years of age and older.
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 and will require two doses given 21 days apart.
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 have had both doses of 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 should not receive COMIRNATY if:
- you are allergic to any of the ingredients in this vaccine (see What the medicinal ingredient is and What the non-medicinal ingredients are)
- you had a severe allergic reaction after a previous dose of this vaccine
- you have any symptoms that could be due to COVID-19. Talk with your healthcare professional about your symptoms and getting a COVID-19 test. Your healthcare professional will advise you when you are able to receive the vaccine.
What the medicinal ingredient is
Medicinal ingredient: mRNA
What the non-medicinal ingredients are
- ALC-0315 = ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
- ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
- dibasic sodium phosphate dihydrate
- monobasic potassium phosphate
- potassium chloride
- sodium chloride
- water for injection
What dosage form it comes in
White to off-white suspension (to be diluted) provided in a multiple dose vial of 6 doses.
After dilution, the vial contains 6 doses of 0.3 mL, with 30 micrograms mRNA each.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive COMIRNATY. Talk about any health conditions or problems you may have, including if you:
- have had any problems following previous administration of COMIRNATY 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 your 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:
It may take until 7 days after the second dose of COMIRNATY to develop protection against COVID-19. As with any vaccine, COMIRNATY 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.
Interactions with this medication
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
There is no information on the use of COMIRNATY with other vaccines.
Tell your healthcare professional if you have recently received any other vaccine.
Proper use of this medication
How COMIRNATY is given:
COMIRNATY is given after dilution as an injection of 0.3 mL, preferably into a muscle of your upper arm.
You will receive 2 injections, given 3 weeks apart. It is very important that you return for the second injection, or the vaccine may not work as well.
If you have any further questions on the use of COMIRNATY, ask your healthcare professional.
If you forget to go back to your healthcare professional at the scheduled time for your next dose, ask your healthcare professional for advice.
Side effects and what to do about them
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
- injection site pain
- muscle pain
- joint pain
Common: may affect more than 1 in 100 and up to 1 in 10 people
- injection site redness
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 and facial paralysis / Bell’s palsy have been reported.
These are not all the possible side effects you may have when taking COMIRNATY. If you experience any side effects not listed here, tell your healthcare professional.
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, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Should you 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 experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Your health care provider should inform your local public health department of any serious side effects after vaccination.
How to store
COMIRNATY 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.
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 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: September 16, 2021
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