Health Canada Approves Pfizer's Bivalent Respiratory Syncytial Virus (RSV) Vaccine for Older Adults and Infants Through Maternal Immunization

2024-01-04

上市批准疫苗

[04-January-2024] Health Canada's approval of ABRYSVO helps to address the urgent need to minimize the spread of RSV infections – a disease with flu-like symptoms that can result in respiratory distress,1,2,3 and lead to serious infection such as bronchitis or pneumonia, requiring hospital treatment4 ABRYSVO is the only RSV vaccine authorized in Canada for maternal immunization KIRKLAND, QC, Jan. 4, 2024 /CNW/ - Pfizer Canada ULC announces today the Health Canada approval of ABRYSVOTM, its bivalent Respiratory Syncytial Virus (RSV) vaccine. The vaccine is indicated for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older by active immunization, and the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals. RSV is a common respiratory virus that causes mild disease with cold-like symptoms. In more vulnerable populations, like adults 60 and over, an RSV infection can be severe, especially among those with underlying respiratory or cardiac conditions.5 For infants, RSV infection can result in respiratory distress, especially in those less than six months of age, and those with higher risk factors such as congenital heart or lung disease, or prematurity.6,7,8 "RSV is a virus that we need to put a spotlight on. It spreads easily and it's not something you can completely avoid," said Laura Tamblyn Watts, founder and CEO of CanAge. "Older adults living in congregate settings or long-term care, which is over 500,000 Canadians,9 have a higher risk of becoming infected with RSV.10 It's important for all of us to be mindful of RSV prevention to help protect our loved ones and more vulnerable populations." "Today's announcement means Canada has a new option to help protect those most at risk from the severity of RSV infections," said Andréa Mueller, Primary Care Portfolio Lead at Pfizer Canada. "For those eligible to receive the vaccine, getting vaccinated means helping to ensure babies are protected from their first breath, and helping older adults continue doing what they love with minimized risk of becoming infected. At Pfizer, we take pride in our decades of experience in vaccines, helping to make a positive contribution to public health and the broader community." Respiratory viruses, including RSV, increase in the fall and winter months, and the impact of RSV on healthcare resources is significant. RSV infection can result in hospitalization, particularly for infants one year or younger, for whom there is an increased risk.11 Older adults also have some of the highest costs associated with the disease.12 The approval of Pfizer's vaccine will help to protect those at both early and later stages in life and will reduce the overall health and economic impact of RSV infection.12 "Vaccines are considered to be the most effective tool in public health for preventing illness and can help reduce the stress on our healthcare system and professionals including nurses, doctors, and others on the frontline," said Dr. Darine El-Chaâr, Maternal Fetal Medicine physician at The Ottawa Hospital. "Vaccines administered through maternal immunization can also help play a critical role in decreasing the gap of vulnerability in the first few months of an infant's life, as well as helping to protect their mothers, who may be at increased risk of severe disease compared with non-pregnant women."13 Pfizer Canada is currently assessing the timeline of availability for ABRYSVO and is committed to bringing supply of this vaccine to Canadians as quickly as possible. About Pfizer Canada Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified health care 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. ______________________________________ 1 Centers for Disease Control & Prevention. Respiratory Syncytial Virus Infection (RSV). 2 Vaccine. 2020 Mar 4; 38(11): 2435–2448. 3 Government of Canada. Respiratory syncytial virus (RSV): For health professionals. 4 The Lung Association. Respiratory Syncytial Virus (RSV). 5 Government of Canada. Respiratory syncytial virus: Canadian Immunization Guide. 6 Centers for Disease Control & Prevention. Respiratory Syncytial Virus Infection (RSV). 7 Vaccine. 2020 Mar 4; 38(11): 2435–2448. 8 Government of Canada. Respiratory syncytial virus (RSV): For health professionals. 9 Statistics Canada. Impacts of the COVID-19 pandemic in nursing and residential care facilities in Canada. 10 Health Link BC. Respiratory Syncytial Virus (RSV) Infection. 11 Wingert A, Pillay J, Moore DL, Guitard S, Vandermeer B, Dyson MP, Sinilaité A, Tunis M, Hartling L. Burden of illness in infants and young children hospitalized for respiratory syncytial virus: A rapid review. Can Commun Dis Rep 2021;47(9):381–96. 12 Rafferty, E., Paulden, M., Buchan, S.A. et al. Evaluating the Individual Healthcare Costs and Burden of Disease Associated with RSV Across Age Groups. PharmacoEconomics. 13 Esposito et al. RSV Prevention in All Infants: Which Is the Most Preferable Strategy? Front. Immunol. For further information: Corporate Affairs Canada 1-866-9PFIZER (1-866-973-4937) corporate.affairs.canada@pfizer.com SOURCE Pfizer Canada