GSK seeks expanded use for RSV vaccine

Health Canada has accepted a Supplementary New Drug Submission (SNDS) to expand the use of Arexvy to include adults aged 50-59 at increased risk for RSV disease. GSK's RSV vaccine, Arexvy, accepted for review by Health Canada for prevention of RSV disease in adults aged 50-59 at increased risk | GSK Canada. This is based on a trial that demonstrated the immune response following vaccination in adults 50-59 years of age with comorbidities that increase the risk of RSV (including COPD) was non-inferior to adults 60 years of age and over where the vaccine’s efficacy has already been demonstrated. These data were most recently presented at conference in February: Respiratory Syncytial Virus Prefusion F Protein Vaccine (RSVPreF3 OA) Is Immunogenic and Well-Tolerated in Adults 50–59 Years, Including Adults at Increased Risk for RSV Disease | GSK. 

For more information: https://tinyurl.com/4pfhfps3

GOLD releases RSV Update for 2024

The Global Initiative for Chronic Obstructive Lung Disease (GOLD)* released a new 2024 update. The report includes RSV vaccination recommendations. GOLD is now aligned with the US Centers for Disease Control and Prevention (CDC) and their recommendations for RSV vaccination. Importantly, RSV is the first and only vaccine to be included in the GOLD 2024 report with Evidence Level A+ 

The Global Initiative for Chronic Lung Disease (GOLD) is a global organization that works with health care professionals and public health officials around the world to raise awareness of chronic obstructive lung disease (COPD) and to improve prevention and treatment of this lung disease. GOLD develops evidence-based strategy documents for COPD management to improve the lives of people with COPD. GOLD committees are made up of leading experts from around the world.  

The GOLD report also includes recommendations for shingles, influenza, COVID-19, pneumococcal and pertussis vaccinations. The addition of an RSV vaccine recommendation with “Evidence Level A” further emphasizes the importance of vaccination for protecting people with COPD who are at risk of severe RSV-associated lower respiratory tract disease. Evidence Level A: is a designation that randomized controlled trials (RCTs) have been undertaken implying that a rich body of high quality evidence has been reported without any significant limitation or bias. 

The Centre for Disease Control and Prevention (CDC) recommends the new respiratory syncytial virus (RSV) vaccine for individuals over 60 years and/or with chronic heart or lung disease. 

More information on RSV and older adults is available through the CDC website: www.cdc.gov/rsv/high-risk/older-adults

Health Canada approves 1st RSV vaccine for adults age 60 and over

Ottawa, ON CTV reports that Health Canada has approved the first vaccine for respiratory syncytial virus (RSV) for adults age 60 and over, but its use may be "limited" during this fall's respiratory virus season. Doctors have been calling for an RSV vaccine for seniors because although the virus is common, older people are much more likely to become severely ill and require hospitalization. RSV season in Canada usually starts in the late fall and lasts until spring.

In a news release, manufacturer GSK said a randomized clinical trial showed the vaccine, called Arexvy, was 82 per cent effective at preventing lower respiratory tract disease caused by RSV compared to seniors who got a placebo. The company said it was 94 per cent effective at preventing the illness in seniors with underlying medical conditions.

Dr. Samir Sinha, director of geriatrics at Mount Sinai and University Health Network hospitals in Toronto, welcomed the vaccine's approval, saying that the significant risk RSV poses for seniors has been "underappreciated." "When we think about RSV, we often think about how it can be problematic in children under one year of age. But when you actually look at all the data that's come out, it shows that the mortality rates in older adults is six-fold that of what you'd have in a child under one, which is the most at-risk pediatric population," he said. Seniors are at increased risk of severe illness from RSV because their immune systems have waned over time, Sinha said. They are also more likely to have underlying conditions, including lung and heart issues, that the virus can make worse. Sinha said he hoped the RSV vaccine would become available for all seniors, noting that he will be advising all of his older patients to get it. But if there is only a limited amount, Sinha said, governments should at least give the vaccine to all long-term care residents "given their heightened vulnerability to RSV infections." Federal, provincial and territorial governments should also provide the RSV vaccine for free, he said, as cost would be a barrier to many seniors. For most people, including children, RSV usually causes a mild infection that goes away within a couple of weeks, according PHAC's website.

In an email to The Canadian Press, the Public Health Agency of Canada (PHAC) said the RSV vaccine would likely be available for "limited use during the 2023/2024 fall/winter respiratory virus season." The agency said the National Advisory Committee on Immunization (NACI) is not expected to issue guidance on RSV vaccination for older adults until 2024. In the meantime, "it will be up to provinces and territories to determine if their current RSV programs would be adjusted to include Arexvy," PHAC said. "The Government of Canada will work with provinces and territories to determine potential demand and timelines should they decide to introduce Arexvy into their RSV vaccination programs."

For more information: RSV in adults: Canada approves vaccine | CTV News  

First RSV vaccine for older adults approved in Canada - Press release 

Mississauga, ON - Arexvy (respiratory syncytial virus vaccine) has been approved in Canada for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. Arexvy is the first RSV vaccine for older adults to be approved in Canada. RSV is a common, contagious virus that affects the lungs and respiratory airways. The virus can affect all ages, but the impact of RSV in older adults is significant. RSV caused an estimated 470,000 hospitalizations and 33,000 deaths in those aged 60 years and above in high-income countries in 2019. 

Marni Freeman, Country Medical Director, GSK, said: "A solution for RSV infection has been something scientists have been pursuing for decades. With the approval of Arexvy, we are excited to be able to offer an option to help protect the nearly 10 million Canadians aged 60 and older3 who are at risk of RSV disease. We’re hopeful that with a vaccine now available for older Canadians, the virus’ burden on our healthcare system will also be dramatically improved. We look forward to working with provincial, territorial, and national health authorities to ensure older Canadians at greatest risk of RSV infection can access the vaccine.” 

RSV season in Canada is typically from October until May, with most cases occurring in the winter months. For most people, the virus causes cold-like symptoms, but for older adults and adults with certain health conditions it can lead to more serious infection and complications such as pneumonia, hospitalization and even death.5,6 Older adults are at greater risk due in-part to the natural decline in immune function with age. Underlying medical conditions such as diabetes, chronic heart and lung disease6 can be exacerbated by RSV, leading to severe outcomes. 

Henry Roberts, Executive Committee Member, COPD Canada, said: “Even if people with COPD or other chronic conditions have been taking sufficient steps to manage their illness, RSV can still have a serious impact on their health. Until now, RSV was one of the major respiratory infectious diseases with no vaccine or specific treatment available for older adults. Having the opportunity to receive a vaccine that can prevent RSV infection for older Canadians, including those who are at higher risk of severe outcomes, is a welcome advancement and is a major step forward from a public health perspective.” 

Across multiple studies, the vaccine was generally well tolerated with an acceptable safety profile. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, and headache. These were typically mild to moderate and transient. Approval of GSK’s RSV older adult vaccine in Canada follows authorizations in the US, Europe and the UK. Regulatory reviews are ongoing in Japan and several other countries. Arexvy is expected to be available in Canada ahead of the 2023/24 peak RSV season. 

For more information: https://tinyurl.com/5n8mwm6hHow prevalent is RSV and is it a seasonal virus?

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