Details for: SPIKEVAX BIVALENT (ORIGINAL / OMICRON BA.4/5) - COVID-19
Company: MODERNATX, INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02532352 | SPIKEVAX BIVALENT (ORIGINAL / OMICRON BA.4/5) | ELASOMERAN; DAVESOMERAN | 0.05 MG / ML; 0.05 MG / ML | DISPERSION | 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
SPIKEVAX Bivalent Original/Omicron BA.4/5 is a vaccine used to prevent the coronavirus disease 2019
(COVID-19) caused by the SARS-CoV-2 virus. It can be given to people aged 18 years and older.
The safety and effectiveness of a booster dose of SPIKEVAX Bivalent (elasomeran/davesomeran)
Original/Omicron BA.4/5 mRNA vaccine for individuals 18 years of age and older is inferred from studies
of a booster dose of SPIKEVAX Bivalent (Original/Omicron BA.1).
What it does
SPIKEVAX Bivalent Original/Omicron BA.4/5 works by causing the body to produce its own protection
(antibodies) against the SARS-CoV-2 virus that causes the COVID-19 infection. SPIKEVAX Bivalent
Original/Omicron BA.4/5 uses a molecule called messenger ribonucleic acid (mRNA, the genetic code for
a piece of the virus) to deliver the set of instructions that cells in your body can use to make antibodies
to help fight the virus that causes COVID-19. The vaccine is given by injection with a needle in the upper
arm.
You cannot get COVID-19 from this vaccine.
As with any vaccine, SPIKEVAX Bivalent Original/Omicron BA.4/5 may not fully protect all those who
receive it. Even after you have had the vaccine, continue to follow the recommendations of local public
health officials to prevent spread of COVID-19.
Individuals may not be optimally protected until after receiving the second dose of the vaccine.
When it should not be used
Do not receive SPIKEVAX Bivalent Original/Omicron BA.4/5 if:
- you are allergic to the active substance or any of the other ingredients of this vaccine (see What are the ingredients in SPIKEVAX Bivalent Original/Omicron BA.4/5?)
- you have had an allergic reaction to a previous dose of SPIKEVAX
- you currently have 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 ingredients: Elasomeran and davesomeran (mRNA)
What the non-medicinal ingredients are
Non-medicinal ingredients:
- acetic acid
- cholesterol
- DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine)
- PEG2000-DMG (1,2-dimyristoyl-rac-glycerol,methoxy-polyethyleneglycol)
- lipid SM-102
- sodium acetate trihydrate
- sucrose
- trometamol
- trometamol hydrochloride
- water for injection
What dosage form it comes in
White to off-white dispersion for injection provided in a multidose vial. For individuals 18 years of age the SPIKEVAX Bivalent Original/Omicron BA.4/5 dose is 50 micrograms.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SPIKEVAX Bivalent Original/Omicron BA.4/5. Talk about any health conditions or problems you may have, including if you:
- have any allergies
- have had previous problems following administration of SPIKEVAX 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
- have a high fever or severe infection
- have any serious illness
- have previously had episodes of myocarditis (inflammation of the heart muscle) and/or pericarditis (inflammation of the lining outside the heart)
- are pregnant, think you may be pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
There is limited information on the use of SPIKEVAX Bivalent Original/Omicron BA.4/5 with other vaccines. Tell your healthcare professional if you have recently received any other vaccine.
Proper use of this medication
How is SPIKEVAX Bivalent Original/Omicron BA.4/5 given:
- Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection) in your upper arm
- During and after each injection of the vaccine, your doctor, pharmacist or nurse will watch over you for around 15 minutes to monitor for signs of an allergic reaction.
Usual Dose:
A booster dose of 50 mcg may be administered intramuscularly at least 4 months after completion of a primary series and/or a previous booster dose in individuals 18 years of age or older.
Overdose:
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.
Side effects and what to do about them
Like all vaccines, SPIKEVAX Bivalent Original/Omicron BA.4/5 can cause side effects.
The following are common or very common side effects of SPIKEVAX Bivalent Original/Omicron BA.4/5.
Most of these side effects are mild and do not last long. Tell your doctor if you have side effects that
bother you:
- pain at the injection site
- tiredness
- headache
- muscle ache and stiffness
- chills
- fever
- swelling or redness at the injection site
- nausea and/or vomiting
- enlarged lymph nodes
- hypoaesthesia (decreased sense of touch or sensation, numbness) or paraesthesia (tingling, itching or pricking sensation)
- dizziness
Non-severe allergic reactions (such as rash, itching, hives or swelling of the face), severe allergic
reactions, erythema multiforme (red round patches on the skin) and facial paralysis / Bell’s palsy have
been reported with the administration of SPIKEVAX.
These are not all the possible side effects you may have when taking SPIKEVAX Bivalent
Original/Omicron BA.4-BA.5. 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.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to
interfere with your daily activities, tell your healthcare professional.
How to store
Your doctor or pharmacist is responsible storing, supplying and administering SPIKEVAX Bivalent
Original/Omicron BA.4/5, as well as disposing of any unused product correctly.
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 ModernaTX, Inc.
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 SPIKEVAX Bivalent Original/Omicron BA.4/5:
- 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 https://www.modernacovid19global.com/ca/, or by calling 1-866-MODERNA (1-866-663-3762).
This leaflet was prepared by ModernaTX, Inc.
Last Revised November 3, 2022