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Details for: MODERNA COVID-19 VACCINE / VACCIN DE MODERNA CONTRE LA COVID-19

Company: MODERNA THERAPEUTICS INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02510014MODERNA COVID-19 VACCINEMRNA-1273 SARS-COV-2100 MCG / MLSUSPENSIONINTRAMUSCULAR

Summary Reports

Regulatory Decision Summary
Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Product Monograph

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

Moderna COVID-19 Vaccine is a vaccine used to prevent the coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus. It can be given to adults aged 18 years and older.

What it does

Moderna COVID-19 Vaccine works by causing the body to produce its own protection (antibodies) against the SARS-CoV-2 virus that causes the COVID-19 infection. Moderna COVID-19 Vaccine uses a molecule called messenger ribonucleic acid (mRNA) to deliver the set of instructions that cells in the 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 and will require two doses given one month apart.

As with any vaccine, Moderna 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.

Individuals may not be optimally protected until after receiving the second dose of the vaccine.

You cannot get COVID-19 from this vaccine.

When it should not be used

Do not use Moderna COVID-19 Vaccine if:

  • you are allergic to the active substance or any of the other ingredients of this vaccine
  • you have had an allergic reaction to a previous dose of Moderna COVID-19 Vaccine
  • 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: mRNA

What the non-medicinal ingredients are

Non-medicinal ingredients:

  • 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC),
  • acetic acid,
  • cholesterol,
  • PEG2000 DMG (1,2-dimyristoyl-rac-glycerol,methoxy-polyethyleneglycol),
  • lipid SM-102,
  • sodium acetate,
  • sucrose,
  • tromethamine
  • tromethamine hydrochloride,
  • water for injection.
What dosage form it comes in

White to off-white suspension for injection, 0.20 mg/mL, provided in a multiple dose vial of 10 doses of 0.5mL, each dose containing 100 micrograms of mRNA.

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Moderna COVID-19 Vaccine. Talk about any health conditions or problems you may have, including if you:

  • Have any allergies or previous problems following administration of Moderna COVID-19 Vaccine such as an allergic reaction or breathing problems
  • Have a bleeding problem, bruise easily or use a blood thinning medication
  • Have a high fever or severe infection
  • Have any serious illness
  • Have a weakened immune system due to a medical condition or are on a medicine that affects your immune system.
  • Are pregnant, think you may be pregnant or plan to become pregnant
  • Are breastfeeding or plan to breastfeed
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 Moderna COVID-19 Vaccine with other vaccines. Tell your healthcare professional if you have recently received any other vaccine.

Proper use of this medication

How is Moderna COVID-19 Vaccine 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

Moderna COVID-19 Vaccine will be given to you as two 0.5 mL injections. 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.

Overdose

In the event of suspected overdose with Moderna 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.

Side effects and what to do about them

Like all vaccines, Moderna COVID-19 Vaccine can cause side effects

The following are common or very common side effects of Moderna COVID-19 Vaccine. Most of these side effects are mild and do not last long. Tell your doctor if you or your child 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

These are not all the possible side effects you may have when taking Moderna COVID-19 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 immediately 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

Do not use this vaccine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

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 Moderna Therapeutics 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 Moderna COVID-19 Vaccine:

This leaflet was prepared by Moderna Therapeutics Inc.

Last Revised December 23, 2020

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