How does this medication work? What will it do for me?
This medication belongs to a group of medications known as vaccines. It is used in people 12 years of age and older to prevent coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus. This vaccine increases a person's defences against coronavirus infection by introducing genetic information, in the form of messenger RNA, for a piece of virus into the body. This causes your body to produce pieces of the virus which then stimulate the production of your own antibodies (cells designed to attack that particular virus). These antibodies remain in the body ready to attack any future SARS-CoV-2 virus that may cause infection. You cannot get COVID-19 from the vaccine.
The Pfizer-BioNtech COVID-19 mRNA Vaccine has been granted authorization for sale under an Interim Order. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, safety and quality, but the manufacturer must meet additional terms and conditions.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
What form(s) does this medication come in?
Each vial of white-to-off-white, sterile, preservative-free, frozen suspension for intramuscular injection, contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Nonmedicinal 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, sucrose, and water for injection.
How should I use this medication?
This medication is given as an intramuscular (into the upper arm) injection. Once prepared, the volume of the dose is 0.3 mL. Two injections are needed to provide protection from the virus. The second dose must be given 21 days after the first dose.
Based on information from clinical trials, the vaccine was 95% effective in providing protection against COVID-19 infection beginning 1 week after the second dose.
It is important this vaccine be given exactly as recommended by your health care professional. If you miss an appointment to receive this vaccine, contact your health care professional as soon as possible to reschedule your appointment. All vaccines should be added to your immunization record.
This vaccine requires specific and extreme storage conditions. It must be kept frozen between -80°C to -60°C and protected from light, until ready for use. It will be stored, supplied and administered by a health care professional.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you are allergic to any ingredients of the medication.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- joint pain
- muscle pain
- redness, swelling, tenderness, or pain at place of injection
- swollen lymph nodes
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Seek immediate medical attention if any of the following occur:
- symptoms of a serious allergic reaction (such as hives, difficulty breathing, itchy rash on the hands or feet, or swelling of the face, tongue, or throat)
Be sure to mention any side effect to your doctor, as it may mean that you are allergic to the vaccine. If so, it would not be safe for you to have more doses of the same type of vaccine.
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
November 19, 2021
Health Canada has issued information concerning the use of the Pfizer-BioNTech COVID-19 vaccine. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Allergic reactions: Rarely, this vaccine may cause severe allergic reactions If you notice the signs of a severe allergic reaction (hives; trouble breathing or swallowing; or swelling of the lips, face, throat, or tongue), get medical attention immediately.
If you have had an allergic reaction with your first dose of the COIVD-19 vaccine, discuss this with your health care professional prior to receiving the second dose.
Bleeding: People with bleeding disorders, or those who are taking anticoagulants (blood thinners), may experience bruising after receiving an intramuscular injection. Tell your doctor about any bleeding problems you may have and discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Immune system: As with any vaccine, this vaccine may not be as effective for people with a weakened immune system (such as those who are on chemotherapy, who have had an organ transplant, have autoimmune diseases or who have HIV).
Other illness: If you have a high fever or other illness, discuss with your doctor about rescheduling your appointment to receive this vaccine after you have recovered. It is advisable to wait to receive this vaccine if you have an acute, severe illness with fever.
Vaccine protection: It usually takes 7 days after the second dose of the vaccine to develop protection against COVID-19 infection. As with any vaccine, this vaccine may not fully protect all people who receive it.
Pregnancy: This vaccine should not be used during pregnancy unless the benefits outweigh the risks. If you discover you may have been pregnant when you received this medication, contact your doctor immediately.
Breast-feeding: It is not known if this vaccine passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of this vaccine have not been determined for children and adolescents under the age of 12.
What other drugs could interact with this medication?
Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.
All material copyright MediResource Inc. 1996 – 2022. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Pfizer-BioNtech-COVID-19-mRNA-Vaccine