Details for: SPIKEVAX - PREVIOUSLY/AUPARAVANT - COVID-19 VACCINE MODERNA
Company: MODERNATX, INC.
|DIN||DIN name||Active Ingredient(s)||Strength||Dosage Form||Route of Administration|
|02510014||SPIKEVAX||MRNA-1273 SARS-COV-2||100 MCG / 0.5 ML||DISPERSION||INTRAMUSCULAR|
Regulatory Decision Summary
Regulatory Decision Summary
Regulatory Decision Summary
Regulatory Decision Summary
Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Public Release of Clinical Information - SPIKEVAX
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 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 12 years and older.
What it does
SPIKEVAX works by causing the body to produce its own protection (antibodies) against the SARS-CoV-2 virus
that causes the COVID-19 infection. SPIKEVAX 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. The primary vaccination series will require two doses given 4 weeks apart.
You cannot get COVID-19 from this vaccine.
As with any vaccine, SPIKEVAX 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 use SPIKEVAX if:
- you are allergic to the active substance or any of the other ingredients of this vaccine (see What the medicinal ingredient is or What the non-medicinal ingredients are)
- 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 (mRNA)
What the non-medicinal ingredients are
- acetic acid
- DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine)
- PEG2000-DMG (1,2-dimyristoyl-rac-glycerol,methoxy-polyethyleneglycol)
- lipid SM-102
- sodium acetate trihydrate
- trometamol hydrochloride
- water for injection
What dosage form it comes in
White to off-white dispersion for injection provided in a multidose vial of 10 doses. Each dose in the primary vaccination series is 0.5 mL and contains 100 micrograms of elasomeran (mRNA). The dose for the booster is 0.25 mL and contains 50 micrograms of elasomeran.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SPIKEVAX. 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 no information on the use of SPIKEVAX with other vaccines. Tell your healthcare professional if you have recently received any other vaccine.
Proper use of this medication
How is SPIKEVAX 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.
SPIKEVAX will be given to you as two 0.5 mL injections (called the primary vaccination series). Each
injection will be given on a separate visit 1 month apart. It is very important that you return for the
second injection, or the vaccine may not work as well.
The booster dose is given as one 0.25 mL injection. The booster dose may be given on a separate visit at least 6 months after completion of the primary vaccination series in individuals 18 years of age and older.
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 can cause side effects
The following are common or very common side effects of SPIKEVAX. 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
- muscle ache and stiffness
- swelling or redness at the injection site
- nausea and/or vomiting
- enlarged lymph nodes
- hypoaesthesia (decreased sense of touch or sensation, numbness)
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 SPIKEVAX. 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 this vaccine, 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 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.
If you want more information about SPIKEVAX:
- 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 12, 2021
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