Novavax Nuvaxovid COVID-19 vaccine

All COVID-19 vaccines authorized in Canada are proven safe, effective and of high quality.

On this page

• Who the vaccine is indicated for
• Effectiveness
• Dosage
• Vaccine ingredients
• Possible side effects
• Vaccine review, approval and monitoring
• Get vaccinated

Who the vaccine is indicated for

Novavax Nuvaxovid COVID-19 vaccine

The vaccine is authorized for use in people who are 12 years of age and older. The safety and effectiveness in people younger than 12 years of age have not yet been established for the vaccine.

This vaccine is also authorized as a booster for people who are 18 years of age and older.

Novavax Nuvaxovid XBB.1.5 Omicron subvariant COVID-19 vaccine

This vaccine is authorized for use in people who are 12 years of age and older. It may be given to people who have been previously vaccinated or who have not been previously vaccinated.

Effectiveness

Clinical trials with the original COVID-19 vaccine showed that beginning 1 week after the second dose, the vaccine was:

• 90% effective in protecting trial participants age 18 and above against COVID-19
• 80% effective in protecting trial participants age 12 to 17 against COVID-19

A booster dose of the original COVID-19 vaccine was shown to increase the immune response against COVID-19 in trial participants age 18 and above. At the time of the analysis, the Delta variant of concern (VOC) was the predominant variant.

Data on Novavax's investigational Omicron-containing vaccines showed a more potent immune response to closely strain-matched vaccine formulations and had no new safety concerns.

Dosage

Primary series

The dosing schedule authorized by Health Canada:

• 12 years and older (2 doses of 5 micrograms, 21 days apart)

Booster dose

A booster dose (5 micrograms) of the original COVID-19 vaccine may be given in the muscle in people 18 years of age about 6 months after the second dose.

XBB.1.5 Omicron subvariant COVID-19 vaccine dose (6 months after previous vaccination)

A single dose (5 micrograms) of this vaccine may be given to people 12 years of age and older who have been vaccinated with a previously or currently marketed Canadian COVID-19 vaccine about 6 months after the second dose of the primary series.

Your province or territory decides when people receive their doses of the vaccine.

These decisions are based on public health recommendations and the latest evidence.

• Find out how provinces and territories are making COVID-19 vaccine decisions

Vaccine ingredients

Medicinal ingredient

• SARS-CoV-2 recombinant spike (rS) protein (original or Omicron XBB.1.5 strain)
• Matrix-M adjuvant
  • composed of 40 nanometer particles based on saponin extracted from the soap bark tree (Quillaja saponaria Molina)
  • helps stimulate an immune response to the vaccine

Other ingredients

Non-medicinal ingredients

• disodium hydrogen phosphate heptahydrate
• hydrochloric acid (for adjustment of pH)
• polysorbate 80
• sodium chloride
• sodium dihydrogen phosphate monohydrate
• sodium hydroxide (for adjustment of pH)
• water for injection

For adjuvant:

• cholesterol
• phosphatidylcholine
• potassium chloride
• potassium dihydrogen phosphate
• disodium hydrogen phosphate dihydrate
• sodium chloride

Possible side effects

After getting vaccinated, it's common to have temporary side effects. These can last a few hours to a few days after vaccination.

This is the body's natural response, as it's working hard to build protection against the disease.

Common vaccine side effects may include:

Rare vaccine side effects

A severe allergic (anaphylaxis) reaction is rare. Signs and symptoms of anaphylaxis may include:

• hives (bumps on the skin that are often very itchy)
• swelling of the lips, face, tongue or airway
• difficulty breathing
• increased heart rate
• loss of consciousness
• sudden low blood pressure
• abdominal pain, vomiting and diarrhea

Call emergency services if you develop or witness any serious symptoms that could be an allergic reaction after vaccination.

Reporting a possible serious reaction

Contact your health care provider if you experience:

• a side effect following vaccination with a COVID-19 vaccine
• any persistent, new or worsening symptoms

Health care providers must report possible reactions following vaccination to their local public health authority. The public health authority then reports them to the Public Health Agency of Canada.

Reported allergic reactions and side effects to COVID-19 vaccines are published weekly in our Reported side effects following COVID-19 vaccination report.

Vaccine review, approval and monitoring

Health Canada's independent drug review process is recognized around the world for its high standards and rigor. Our decisions are based only on scientific and medical evidence showing that vaccines are safe and effective. The benefits must outweigh any risks.

The XBB.1.5 COVID-19 vaccine was authorized for use in Canada under the Food and Drug Regulations.

Find detailed technical information such as the product monograph and the regulatory decision summary:

• Novavax Nuvaxovid vaccine regulatory information
• XBB.1.5 Omicron subvariant COVID-19 vaccine regulatory information

As COVID-19 vaccines are administered across Canada, our safety monitoring is ongoing. The Public Health Agency of Canada, Health Canada, and provincial and territorial health authorities continue to:

• monitor the use of all COVID-19 vaccines closely
• examine and assess any new safety concerns

Learn about the side effects we're currently monitoring.

Get vaccinated

How to get vaccinated near you

Related links

• COVID-19: Proof of vaccination
• Number of doses given in Canada
• Canada's vaccine supply and donation strategy
• All drugs and vaccines approved for COVID-19
• COVID-19 vaccines for children and youth
• National Vaccine Catalogue
• What to expect at your vaccination
• Interim Order respecting the importation, sale and advertising of drugs for use in relation to COVID-19