14/04/23

Indications under review include prevention of RSV in infants from birth through 6 months of age by immunization of pregnant individuals, and in individuals 60 years of age and older.

KIRKLAND, QC, April 14, 2023, 2023 - Pfizer Canada ULC announced today that Health Canada has accepted for review the New Drug Submission for its bivalent Respiratory Syncytial Virus (RSV) vaccine. The vaccine is currently under review for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through six months of age by active immunization of pregnant individuals, and the prevention of acute respiratory disease and lower respiratory tract disease caused by RSV in individuals 60 years of age and older by active immunization.

RSV is a common respiratory virus that causes mild disease with cold-like symptoms, or a more severe disease especially in infants and older adults. RSV infection in infants can result in respiratory distress, especially in infants less than six months of age, and those with a higher risk (such as congenital heart or lung disease). In older adults, RSV is also associated with increased morbidity and mortality.^[1],[2],[3]

“The recent surge of RSV in Canada, which contributed to significant illness in patients and continued strain on our healthcare system, highlights the need for a vaccine to help reduce the burden associated with this infectious disease, particularly for the sake of higher-risk individuals and their loved ones,” said Andréa Mueller, Internal Medicine and Vaccines Portfolio Lead at Pfizer Canada. “We’re proud of our dedication and innovation that has led to this important step, and we look forward to continuing our collaboration with Health Canada and government partners to work on bringing this awaited vaccine candidate to Canadians.”

RSV is currently the most common respiratory viral pathogen among infants and young children, with two in 10 children needing urgent medical attention.^[4] In Canada, RSV infections account for 9 per cent of all hospital admissions among infants for causes not related to birth.^[4]

Health Canada's acceptance for review of Pfizer's RSV vaccine for both older adult and maternal immunization follows that of the US Food and Drug Administration (FDA) as well as that of the European Medicines Agency (EMA).

About Pfizer Canada
Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified healthcare portfolio includes some of the world's best known and most prescribed medicines and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, Twitter or YouTube.

For further information:
Corporate Affairs Canada
1-866-9PFIZER (1-866-973-4937)
[email protected]



[1] Centers for Disease Control & Prevention. Respiratory Syncytial Virus Infection (RSV). https://www.cdc.gov/rsv/index.html

[2] Vaccine. 2020 Mar 4; 38(11): 2435–2448. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7049900/

[3] Government of Canada. Respiratory syncytial virus (RSV): For health professionals. https://www.canada.ca/en/public-health/services/diseases/respiratory-syncytial-virus-rsv/health-professionals.html

[4] CMAJ Open “Health care costs of hospitalization of young children for respiratory syncytial virus infections: a population-based matched cohort study.” October 2021. https://www.cmajopen.ca/content/9/4/E948