Health Canada has granted approval for Pfizer Canada's bivalent vaccine, Abrysvo, designed to safeguard two vulnerable groups from the respiratory syncytial virus (RSV) – newborns through maternal immunization and Canadians aged 60 and over.
This marks the first RSV vaccine in Canada authorized for use during pregnancy, offering protection to infants from birth to six months. The vaccine, administered as a single shot, targets lower respiratory tract disease caused by RSV. The U.S. FDA approved the vaccine for the same groups in 2023.
RSV is a contagious respiratory virus causing cold-like symptoms, with severe outcomes for vulnerable populations. Pregnant individuals receiving the Pfizer vaccine during the third trimester transfer antibodies to infants. The vaccine is also a one-shot dose for seniors. Last August, Health Canada approved an RSV vaccine for seniors from GSK, and in spring 2023, nirsevimab, an antibody drug for newborns and infants, gained approval.
RSV is a leading cause of hospitalization in infants, with the new vaccine and antibody drug potentially reducing its impact. Health Canada will collaborate with provinces to assess interest, demand, and timelines for introducing these products into RSV vaccination programs, targeting availability by the winter of 2024-25. Considerations include product accessibility and economic analyses for universal vaccination programs.
Amid the ongoing cold and flu season, the surge in RSV, influenza, and COVID-19 cases stresses emergency rooms. Dr. Fatima Kakkar emphasizes the urgent need for widespread availability of new tools to combat RSV, urging timely official recommendations and optimal timing by provincial committees. Pfizer Canada is actively assessing the vaccine's availability, consulting stakeholders on cost considerations and swift distribution to Canadians.