PFIZER-BIONTECH COVID-19 VACCINE

https://www.cvdvaccine.ca/files/Canadian%20Patient%20Medication%20Information.pdf

https://www.mayoclinic.org/drugs-supplements/sodium-phosphate-dibasic-and-sodium-phosphate-monobasic-oral-route/side-effects/drg-20060675

https://www.webmd.com/drugs/2/drug-63290/potassium-phosphate-monobasic-oral/details

PATIENT MEDICATION INFORMATION

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

PFIZER-BIONTECH COVID-19 VACCINE

COVID-19 mRNA Vaccine, Suspension for Intramuscular Injection

Health Canada has authorized the sale of this COVID-19 vaccine under an Interim Order.

This leaflet is a summary and will not tell you everything about this vaccine. Talk to your

healthcare professional about your medical condition and treatment and ask if there is any

new information about Pfizer-BioNTech COVID-19 Vaccine.

What is Pfizer-BioNTech COVID-19 Vaccine used for?

Pfizer-BioNTech COVID-19 Vaccine is a vaccine used to prevent COVID-19 disease caused by

the SARS-CoV-2 virus.

Pfizer-BioNTech COVID-19 Vaccine can be given to people from 16 years of age and older.

How does Pfizer-BioNTech COVID-19 Vaccine work?

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, Pfizer-BioNTech COVID-19 Vaccine 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.

What are the ingredients in Pfizer-BioNTech COVID-19 Vaccine?

Medicinal ingredient: mRNA

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

• 1,2-Distearoyl-sn-glycero-3-phosphocholine

• cholesterol

• dibasic sodium phosphate dihydrate

• monobasic potassium phosphate

• potassium chloride

• sodium chloride

Pfizer-BioNTech COVID-19 Vaccine [COVID-19 mRNA Vaccine] Product Monograph Page 24 of 26

• sucrose

• water for injection

Pfizer-BioNTech COVID-19 Vaccine comes in the following dosage forms:

White to off-white suspension (to be diluted) provided in a multiple dose vial of 5 doses.

After dilution, the vial contains 5 doses of 0.3 mL, with 30 micrograms mRNA each.

You should not receive Pfizer-BioNTech COVID-19 Vaccine if:

• you are allergic to any of the ingredients in this vaccine (see What are the ingredients

in Pfizer-BioNTech COVID-19 Vaccine?)

• 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.

To help avoid side effects and ensure proper use, talk to your healthcare professional before

you receive Pfizer-BioNTech COVID-19 Vaccine. Talk about any health conditions or

problems you may have, including if you:

• have had any problems following previous administration of Pfizer-BioNTech COVID-19

Vaccine such as an allergic reaction or breathing problems.

• have a weakened immune system due to a medical condition or are on a medicine that

affects your immune system.

• 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 Pfizer-BioNTech COVID-19 Vaccine to develop

protection against COVID-19. As with any vaccine, Pfizer-BioNTech COVID-19 Vaccine may not

fully protect all those who receive it.

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 Pfizer-BioNTech COVID-19 vaccine with other vaccines.

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

How Pfizer-BioNTech COVID-19 Vaccine is given:

Usual dose:

Pfizer-BioNTech COVID-19 Vaccine is given after dilution as an injection of 0.3 mL into a muscle

of your upper arm.

Pfizer-BioNTech COVID-19 Vaccine [COVID-19 mRNA Vaccine] Product Monograph Page 25 of 26

You will receive 2 injections, given 21 days 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 Pfizer-BioNTech COVID-19 Vaccine, ask your

healthcare professional.

Overdose:

In the event of suspected overdose with Pfizer-BioNTech COVID-19 Vaccine, contact your

regional poison control centre.

Missed Dose:

If you forget to go back to your healthcare professional at the scheduled time for your next

dose, ask your healthcare professional for advice.

What are possible side effects from using Pfizer-BioNTech COVID-19 Vaccine?

Like all vaccines, Pfizer-BioNTech COVID-19 Vaccine can cause side effects.

Side effects may occur at the following frequencies:

Very common: may affect more than 1 in 10 people

• pain at injection site

• tiredness

• headache

• muscle pain

• chills

• joint pain

• fever

Uncommon: may affect up to 1 in 100 people

• enlarged lymph nodes

These are not all the possible side effects you may have when taking Pfizer-BioNTech COVID19 Vaccine. If you experience any side effects not listed here, tell your healthcare professional.

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

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

Pfizer-BioNTech COVID-19 Vaccine [COVID-19 mRNA Vaccine] Product Monograph Page 26 of 26

Your health care provider should inform your local public health department of any serious

side effects after vaccination.

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/publichealth/services/immunization/reporting-adverse-events-following-immunization/form.html)

and send it to your local Health Unit.

Storage:

Pfizer-BioNTech COVID-19 Vaccine should be stored, supplied and administered by a

healthcare professional.

Keep out of reach and sight of children.

If you want more information about Pfizer-BioNTech COVID-19 Vaccine:

• 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/drugproducts/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 DEC 9, 2020