Details for: NUVAXOVID - COVID-19
Company: NOVAVAX INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02525364 | NUVAXOVID | SARS-COV-2 RECOMBINANT SPIKE PROTEIN | 5 MCG / 0.5 ML | SUSPENSION | INTRAMUSCULAR |
Summary Reports
Regulatory Decision Summary
Regulatory Decision Summary
Regulatory Decision Summary
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
NUVAXOVID is a vaccine used to prevent the coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus. It can be given to individuals aged 12 years and older.
What it does
NUVAXOVID causes the immune system (the body’s natural defences) to produce antibodies and specialised
white blood cells that work against the virus, to give protection against COVID-19. Noneof the ingredients in
this vaccine can cause COVID-19.
The vaccine is given by injection with a needle in the upper arm and will require two doses given 3 weeks
apart.
As with any vaccine, NUVAXOVID 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 publichealth 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 NUVAXOVID 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 NUVAXOVID
- 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 willadvise you when you are able to receive the vaccine.
What the medicinal ingredient is
Medicinal ingredients: 5 micrograms of purified SARS-CoV-2 recombinant spike protein as the active substance.
What the non-medicinal ingredients are
Non-medicinal ingredients:
- Disodium hydrogen phosphate heptahydrate
- Sodium dihydrogen phosphate monohydrate
- Sodium chloride
- Polysorbate 80
- Sodium hydroxide
- Hydrochloric acid
- Water for Injection
The Matrix-M adjuvant contains saponin, cholesterol, phosphatidylcholine, potassium dihydrogen phosphate disodium hydrogen phosphate dihydrate, sodium chloride and potassium chloride.
What dosage form it comes in
Colourless to slightly yellow, clear to mildly opalescent suspension provided in a clear multidose glass vial with a rubber stopper and a blue flip-off top. Each multidose vial contains 10 doses each of 0.5 mL.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NUVAXOVID. Talk about any health conditions or problems you may have, including if you:
- Have any allergies or previous problems following administration of NUVAXOVID, such as an allergic reaction or breathing problems
- Have ever fainted following any needle injection
- Have a bleeding problem, bruise easily or use a blood thinning medication
- Have a high fever or severe infection
- Have any serious illness
- Your immune system does not work properly (immunodeficiency) or you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or cancer medicines)
- 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 NUVAXOVID with other vaccines. Tell your healthcare professional if you have recently received any other vaccine.
Proper use of this medication
How is NUVAXOVID 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:
NUVAXOVID will be given to you as two 0.5 mL injections. Each injection will be given on a separate visit 3 weeks apart. It is very important that you return for the second injection, or the vaccine may not work as well.
Booster dose:
A booster dose of NUVAXOVID may be given approximately 6 months after completion of the second dose of the primary series in individuals 18 years of age and 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, NUVAXOVID can cause side effects.
The following are common or very common side effects of NUVAXOVID. Most of theseside effects are mild and
do not last long. Tell your doctor if you have side effects that bother you:
- headache
- feeling sick (nausea) or getting sick (vomiting)
- muscle ache
- joint pain
- tenderness or pain where the injection is given
- feeling very tired (fatigue)
- generally feeling unwell (malaise)
- redness where the injection is given
- swelling where the injection is given
- fever (> 38°C)
- chills
- pain or discomfort in the arm, hand, leg and/or foot (pain in the extremity)
These are not all the possible side effects you may have when taking NUVAXOVID. 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:
- feeling faint or light-headed
- changes in your heartbeat
- shortness of breath
- wheezing
- swelling of your lips, face, or throat
- hives or rash
- nausea or vomiting
- stomach pain
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 asdisposing
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 [Sponsor Name]
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 (http://www.phac-aspc.gc.ca/im/aefi-essi-form-eng.php) and send it to your local
Health Unit.
More information
If you want more information about NUVAXOVID:
- 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 www.NovavaxCovidVaccine.com,or by calling
1-855-239-9172.
This leaflet was prepared by Novavax, Inc.Last Revised: December 6, 2022