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Recommendations

SOGC Recommendations

NACI Recommendations

CIQ Recommendations

About RSV

About RSV

Infants at Risk

Individuals ≥ 60 Years of Age

About ABRYSVO

Reconstitution and Storage

Dosing and Administration

Mechanism of Action

Efficacy and Safety Profiles

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MATISSE Study Design

MATISSE Data

MATISSE Safety Profile

RENOIR Study Design

RENOIR Data

RENOIR Safety Profile

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Pfizer Respiratory Vaccine Portfolio
Frequently asked questions1 About RSVAre all infants at risk for RSV?

Almost all infants get an RSV infection by the time they are 2 years old.1

When are infants the most vulnerable?

Hospitalization rates are the highest in infants, especially within the first 2 months 
of life.2*

*ABRYSVO is not indicated to prevent RSV-associated hospitalization/death.

ABRYSVO did not have a statistically significant result in the hospitalization endpoint in the maternal/infant indication.

What are some risk factors for severe infection in infants?

Risk factors include chronological age, prematurity, congenital lung disease or congenital heart disease, or a weakened immune system.1

What are some risk factors for severe infection in individuals ≥ 60 years of age?

Risk factors include cardiac or pulmonary disorders (COPD, asthma, etc.), diabetes and other metabolic diseases, chronic renal disease, or chronic liver disease.1*

*ABRYSVO is not indicated to prevent severe LRTD caused by RSV in individuals 60 years of age and older.

Does RSV affect all age groups?

Yes. However, RSV disease burden is the greatest in the first 2 years of life and in older adults.3

About ABRYSVOWhat is ABRYSVO?

The only vaccine indicated in both RSV-caused LRTD in individuals ≥ 60 years of age and RSV-caused LRTD/severe LRTD in infants from birth to 6 months of age.4*

ABRYSVO (respiratory syncytial virus stabilized prefusion F subunit vaccine) is a bivalent vaccine indicated for:5

  • Active immunization of pregnant individuals from 32 through 36 weeks’ gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age.
  • The prevention of LRTD caused by RSV in individuals 60 years of age and older by active immunization.
How is ABRYSVO’s safety profile?

Among maternal participants in the MATISSE trial, the most frequently reported adverse reactions were vaccination site pain (40.6%), headache (31.0%), fatigue (46.1%), and myalgia (26.5%), and among older adults in the RENOIR trial, the most frequently reported adverse reaction was vaccination site pain (10.5%).5

In both trials, the majority of reactions were mild to moderate in severity.

  • MATISSE trial: Resolved within 2–3 days of onset
  • RENOIR trial: Resolved within 1–2 days of onset
Solicited local and systemic adverse reactions were not studied in infant participants.
Who can receive ABRYSVO?

ABRYSVO can be administered to pregnant individuals in the third trimester (from 32 through 36 weeks’ gestation).

ABRYSVO can also be administered to individuals ≥ 60 years of age.5

Is ABRYSVO a bivalent vaccine?*

Yes, ABRYSVO is a bivalent vaccine.

Does ABRYSVO contain an adjuvant component?

ABRYSVO is adjuvant-free.*

RSV: respiratory syncytial virus; COPD: chronic obstructive pulmonary disease; LRTD: lower respiratory tract disease; SOGC: Society of Obstetricians and Gynaecologists of Canada; NACI: National Advisory Committee on Immunization; CIQ: Comité sur l’immunisation du Québec
*Comparative clinical significance has not been established.
More Efficacy and Safety Profiles

Investigate ABRYSVO’s efficacy and safety profiles in infants and individuals ≥ 60 years of age.

Recommendations

Learn more about SOGC, NACI, and CIQ recommendations.

References:Government of Canada. Respiratory syncytial virus (RSV): Canadian immunization guide. Accessed September 19, 2024. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/respiratory-syncytial-virus.html.Government of Canada. Respiratory syncytial virus (RSV): for health professionals. Accessed September 19, 2024. https://www.canada.ca/en/public-health/services/diseases/respiratory-syncytial-virus-rsv/health-professionals.html.Killikelly A et al. Overview of the respiratory syncytial virus vaccine candidate pipeline in Canada. Can Commun Dis Rep. 2020;46(4):56–61.Data on file. Pfizer Canada ULC. January 17, 2025.ABRYSVO Product Monograph. Pfizer Canada ULC. May 29, 2024.
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