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Are your patients asking about  COVID-19 vaccine options?

NUVAXOVID®:

A protein-based, non-mRNA
COVID-19 vaccine option1

NUVAXOVID® is the only protein-based, non-mRNA COVID-19 vaccine in Canada1*

NUVAXOVID® COVID-19 Vaccine (Recombinant protein, Adjuvanted) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

 

*Comparative clinical significance is unknown.

Impact of COVID-19

COVID-19 is an ongoing public health concern2,3

Key facts and statistics about COVID-19 in Canada

COVID-19 continued to be the largest driver of hospitalizations for vaccine-preventable respiratory diseases in 20242,4:

COVID-19 activity starts to increase in late spring/summer and was consistently higher from September to January based on the past 3 surveillance periods (2022-23 to 2024-25)2

>40% of vaccine-preventable hospitalizations were related to COVID‑194*

1,028 total deaths from COVID-19 in Canada from August 2025 to June 20263†


Data for NUVAXOVID® and its effects on vaccine efficacy are presented elsewhere on this site. The effects of NUVAXOVID® on hospitalizations have not been evaluated as pre-defined endpoints in prospectively designed, well-controlled, randomized trials.

* In 2024, there were about 57,700 hospitalizations in Canada for vaccine-preventable respiratory diseases.

† Reported by participating provinces and territories between August 24, 2025 and June 26, 2026.

What is NUVAXOVID®?

NUVAXOVID® is the only protein-based, non-mRNA COVID-19 vaccine in Canada.*
It is used to help prevent COVID-19 caused by the SARS-CoV-2 virus in individuals 12 years of age and older.
 

What are the key features of NUVAXOVID®?

Protein-based

NUVAXOVID® directly provides the spike (S) protein to elicit B- and T-cell immune responses1†

Spike protein-specific  immune response

NUVAXOVID® is composed of purified full-length SARS-CoV-2 recombinant S protein nanoparticle and Matrix-M adjuvant, which enhance the magnitude of the S protein-specific immune response1,5†

Ready to use

NUVAXOVID® is available in pre-filled syringes, no freezing or thawing needed.1

  • Store prefilled syringes between 2°C to 8°C (36°F to 46°F) for a maximum of 6 months. Keep in the outer carton to protect from light.1

Please see the NUVAXOVID® Product Monograph for complete information on dosing and administration.
 

* Comparative clinical significance is unknown.

† Clinical significance is unknown.

What are the efficacy data for NUVAXOVID®?

NUVAXOVID® was studied in two Phase 3 pivotal trials evaluating efficacy and safety in a combined ~39,000 patients aged 18 and older1

  • Patients received 2 doses of either NUVAXOVID® (Original, Wuhan strain) or placebo1
  • Primary endpoint: efficacy in preventing PCR-confirmed symptomatic mild, moderate, or severe COVID-19 from 7 days after the second dose1
     

Efficacy of NUVAXOVID® in preventing COVID-19 in PREVENT-19 and UK Studies (primary endpoint; PP-EFF analysis set)1,6,7

PREVENT-19 Study (N=25,452): 90.4% vaccine efficacy (95% CI 82.9, 94.6; p<0.001)

  • COVID-19 Cases: 14/17,312 (0.1%) with NUVAXOVID® vs. 63/8,140 (0.8%) with placebo
  • Mean Disease Incidence Rate Per Year Per 1,000 People: 3.26 with NUVAXOVID® vs. 34.01 with placebo

UK Study (N=14,039): 89.7% vaccine efficacy (95% CI: 80.2, 94.6)

  • COVID-19 Cases: 10/7,020 (0.1%) with NUVAXOVID® vs. 96/7,019 (1.4%) with placebo
  • Mean Disease Incidence Rate Per Year Per 1,000 People: 6.53 with NUVAXOVID® vs. 63.43 with placebo
     

PREVENT-19: No NUVAXOVID® patients were hospitalized due to COVID-19 during the pivotal trial8

Studied in a Phase 3, randomized, placebo-controlled, pivotal trial evaluating efficacy and safety in over 25,000 patients aged 18 and older. A post-hoc analysis was performed to identify all hospitalizations among the efficacy analysis population.1,8*

Protection from moderate-to-sever COVID-191,8

Secondary endpoint: Vaccine efficacy in preventing moderate-to-severe disease 
(95% CI: 87.0, 100.0) N=25,452

Protection from COVID-19 hospitalization8

Post-hoc analysis: Vaccine efficacy against hospitalization (95% CI: 83.1, 100.0) N=25,482†

PREVENT-19: NUVAXOVID® was effective in adolescents aged 12-171

The efficacy of NUVAXOVID® in patients aged 12 through 17 years of age was evaluated in an expansion trial of almost 1,800 patients who received 2 doses of NUVAXOVID® or placebo 21 days apart.1‡

Efficacy in preventing COVID-19 in PREVENT-19 (primary endpoint; PP-EFF analysis set)1§

PREVENT-19 Study (N=1,799): 79.5% vaccine efficacy (95% CI: 46.8, 92.1)§

PREVENT-19 (2019nCoV-301) Study Design1,6

An ongoing Phase 3, multi-centre, randomized, observer-blinded, placebo-controlled clinical trial evaluating efficacy and safety in 29,949 adults aged 18 and older in the United States and Mexico. Primary endpoint was efficacy in preventing PCR-confirmed symptomatic mild, moderate, or severe COVID-19 from 7 days after the second dose (90.4%) (95% CI 82.9, 94.6; p<0.001) (N=25,452). Participants were stratified by age (18 to 64 years and ≥65 years) and assigned in a 2:1 ratio to receive 2 doses of NUVAXOVID® (Original, Wuhan strain) or placebo 21 days apart. Data was based  on strains circulating at time of study. Moderate disease was defined as fever and evidence of lower respiratory tract infection. Severe disease was defined as clinically significant tachypnea, tachycardia, or hypoxia; receipt of intensive respiratory support; major dysfunction of one or more organ systems; admission to an intensive care unit; or death.
 

UK (2019nCoV-302) Study Design1,7
An ongoing Phase 3, multi-centre, randomized, observer-blinded, placebo-controlled study conducted in 15,187 patients aged 18 and older in the United Kingdom. Primary endpoint was virologically confirmed mild, moderate, or severe COVID-19 infection with an onset at least 7 days after the second injection in patients who were serologically negative at baseline (89.7%)  (95% CI: 80.2, 94.6) (N=14,039). Patients were stratified by age (18 to 64 years; 65 to 84 years) to receive 2 doses of NUVAXOVID® (Original, Wuhan strain) or placebo 21 days apart.  Data based on strains circulating at time of study.
 

PP-EFF=Per-Protocol Efficacy.

* In the per-protocol efficacy analysis of the Phase 3 trial including 25,482 participants, 4 hospitalizations were identified: 0 among NUVAXOVID® COVID-19 vaccine recipients (n=17,312) and  4 among placebo (n=8,140), resulting in a vaccine efficacy against hospitalization of 100% (95% CI: 28.8, 100.0).8

† With the removal of the central laboratory testing requirements pre-specified in the per-protocol efficacy analysis, 12 total (8 additional) COVID-19-associated hospitalizations were identified among the expanded efficacy population: 0 among NUVAXOVID® COVID-19 vaccine recipients and12 among placebo recipients resulting in a vaccine efficacy against hospitalization of 100%  (95% CI: 83.1, 100.0).8

‡ A descriptive efficacy analysis in adolescent patients 12 through 17 years of age occurred in an expansion portion of the Phase 3 multicentre, randomized, observed-blinded, placebo-controlled PREVENT-19 trial. Patients were assigned in a 2:1 ratio to receive two doses of NUVAXOVID® (Original, Wuhan strain) or placebo. Median age was 14.0 years. Median interval between doses of study vaccine was 22 days (range 14–43 days).1
§ COVID-19 cases occurred in 6/1,205 participants (0.5%; mean annual incidence rate: 2.90 per 1,000 people) who received NUVAXOVID® vs. 14/594 participants (2.4%; mean annual incidence rate: 14.20 per 1,000 people) who received placebo.1

What is the safety profile of NUVAXOVID®?

NUVAXOVID® was generally well tolerated in clinical trials1

The safety profile of NUVAXOVID® (Original, Wuhan strain) was evaluated from an interim analysis of pooled data from 3 clinical trials conducted in the United Kingdom (Study 1), the United States and Mexico (Study 2), and South Africa (Study 3)1

  • At the time of the analysis, a total of 48,698 patients aged 18+ received at least one dose of NUVAXOVID® (Original, Wuhan strain) or placebo1
  • The safety profile was also evaluated in an ongoing Phase 3 multicentre, randomized, observer-blinded, placebo-controlled study (Study 2019nCoV-301) in which 12,738 participants received an open-label booster dose of the vaccine at least 6 months after the 2-dose primary series.1

48,000+ patients were evaluated across 3 clinical trials1

Median duration was ≤2 days 
for local events and ≤1 day for systemic events.1

The majority of adverse reactions were mild-to-moderate severity1*

Of the pooled reactogenicity data, which includes participants ≥18 years of age who received at least one dose of NUVAXOVID® 
(Original, Wuhan strain) (n=21,395) or placebo (n=12,197), the most frequent adverse reactions were:1

  • Injection site tenderness (68%)
  • Injection site pain (56%)
  • Fatigue (45%)
  • Myalgia (44%)
  • Headache (41%)
  • Malaise (35%)
  • Arthralgia (20%)
  • Nausea/vomiting (11%)

What is the dosing schedule for NUVAXOVID®?

The recommended dosing schedule for NUVAXOVID® is as follows1:

For individuals who have previously been vaccinated with a previously or currently marketed Canadian COVID-19 vaccine series

  • Administer intramuscularly as a single dose 
(0.5 mL) in individuals 12 years of age and older at least 6 months after the most recent dose of an authorized COVID-19 vaccine
  • No dose adjustment is required based 
on age

For individuals who have not previously been vaccinated with a previously or currently marketed Canadian COVID-19 vaccine series

  • Administer intramuscularly as a two-dose series of 0.5 mL each in individuals 12 years of age and older
  • The second dose is administered 3 weeks after the first dose
  • There are no data available on the interchangeability of NUVAXOVID® with other COVID-19 vaccines to complete

Please see the NUVAXOVID® Product Monograph for complete information on dosing and administration.

NUVAXOVID® resources for healthcare professionals

Helpful resources are available for download below. 

NUVAXOVID® HCP Brochure

Download

Clinical use:

The safety and effectiveness of NUVAXOVID® for individuals 12 years of age and older are based on data from studies which evaluated the booster vaccination with NUVAXOVID® XBB.1.5 (NVX-CoV2601) vaccine and the primary series and booster vaccination with NUVAXOVID® (Original, Wuhan strain) vaccine, and supported by a study of a booster dose of an investigational vaccine targeting the Omicron BA.5 variant of SARS-CoV-2 in individuals 18 years of age and older, and by a study of a booster dose of an investigational vaccine targeting the Omicron BA.1 variant of SARS-CoV-2 in individuals 18 to 64 years of age.

Pediatrics: Clinical studies of NUVAXOVID® (Original, Wuhan strain) included participants ≥ 12 years of age to < 18 years of age and their data contributes to the overall assessment of safety and effectiveness of NUVAXOVID® in this pediatric population.

Geriatrics: Clinical studies of NUVAXOVID® (Original, Wuhan strain) and NUVAXOVID® XBB.1.5 and an investigational vaccine targeting the Omicron BA.5 variant of SARS-CoV-2 include participants 65 years of age and older, and their data contribute to the overall assessment of the safety and effectiveness of NUVAXOVID®.

Relevant warning and precautions:

  • Individuals suffering from an acute severe febrile illness or acute infection
  • Vaccination with NUVAXOVID® may not protect all recipients
  • Acute allergic reactions
  • Cardiovascular, including myocarditis and pericarditis
  • Caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder
  • Driving and operating machinery
  • Unknown impact on fertility
  • Diminished immune response
  • Syncope
  • Pregnancy and nursing women
  • Pediatrics
  • Geriatrics

For more information:

Please consult the Product Monograph at https://pdf.hres.ca/dpd_pm/00084074.PDF for important information relating to adverse reactions, interactions and dosing information. The Product Monograph is also available by calling 1-800-265-7927.

  1. NUVAXOVID® Product Monograph. Sanofi Vaccines Canada Ltd., March 6, 2026.
  2. Public Health Agency of Canada. An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI): Guidance on the use of COVID-19 vaccines starting fall 2026. Published June 2026. https://publications.gc.ca/collections/collection_2026/aspc-phac/HP40-376-2026-eng.pdf
  3. Government of Canada. COVID-19: Canadian respiratory virus surveillance report. June 26, 2026. Accessed July 30, 2026. 
https://health-infobase.canada.ca/respiratory-virus-surveillance/covid-19.html
  4. Canadian Institute for Health Information. Public health prevents diseases and makes health care systems more resilient. April 16, 2026. Accessed May 06, 2026. 
https://www.cihi.ca/en/priority-indicators-for-public-health-systems-in-canada/interconnection-with-health-care-systems
  5. Government of Canada. COVID-19 vaccines: Canadian Immunization Guide. Updated September 2025. Accessed July 9, 2026. 
https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-26-covid-19-vaccine.html
  6. Dunkle LM, Kotloff KL, Gay CL, et al. Efficacy and safety of NVX-CoV2373 in adults in the United States and Mexico. N Engl J Med. 2022;386(6):531-543. doi:10.1056/ NEJMoa2116185
  7. Heath PT, Galiza EP, Baxter DN, et al. Safety and efficacy of NVX-CoV2373 Covid-19 vaccine. N Engl J Med. 2021;385(13):1172-1183. doi:10.1056/NEJMoa2107659


Last reviewed: September 25, 2026

*Comparative clinical significance is unknown.

NUVAXOVID® is a registered trademark of Sanofi Group. 
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© 2026 Sanofi Vaccines Canada Ltd. All rights reserved.  

MAT-CA-2600989-v1.0 - 09/2026