PULSE: RSV News

Expanded age indication for GSK’s AREXVY, the first respiratory syncytial virus (RSV) vaccine approved in Canada for adults aged 50-59 at increased risk

Mississauga, ON - GSK’s AREXVY (respiratory syncytial virus vaccine - recombinant, AS01E adjuvanted) has been approved in Canada for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 50-59 years of age who are at increased risk for RSV disease.2 In Canada, the vaccine was previously approved for use in adults aged 60 and older and is strongly recommended by the National Advisory Committee on Immunization (NACI) for all adults 75 years and older and those aged 60 and above in nursing homes and other chronic care facilities. NACI also recommends that adults aged 60-74 years may consider RSV vaccination in consultation with a health care provider.3

A systematic review of studies in the US showed that RSV is estimated to cause 42,000 hospitalizations* each year in adults aged 50-64 years old.4 Further, among Canadian adults aged 50 and older hospitalized with RSV, about 98 per cent have at least one chronic condition.5 Adults with chronic medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes, are at increased risk for severe consequences from an RSV infection compared to those without these conditions.6,7 RSV can exacerbate these conditions and lead to pneumonia, hospitalization, or death.8

Michelle Horn, Interim Country Medical Director, GSK, said: “The natural age-related decline in immune function we all experience, which can increase our vulnerability to viruses like RSV, becomes more evident the older we get. Not surprisingly, incidence of RSV-associated hospitalizations in adults starts to increase at the age of 50. For adults with underlying medical conditions, RSV can worsen these conditions and lead to serious consequences. We are proud to be the first to provide a vaccine to help protect Canadians aged 50-59 at increased risk of lower respiratory tract disease caused by RSV.”

The expanded age indication is based on the positive results from a phase III trial [NCT05590403] evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to underlying medical conditions.

Approval of an expanded age indication for AREXVY in Canada follows similar approvals in the US and the EU. GSK has also filed regulatory submissions to extend the use of its RSV vaccine to adults aged 50-59 at increased risk in Japan and other geographies with regulatory decisions undergoing review. Trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over are expected to read out later in 2024. The safety and effectiveness of Arexvy in adults aged 18-49 at increased risk for RSV disease and immunocompromised adults aged 18 and over are still under investigation and authorization has not yet been granted in any country.

For more information: https://tinyurl.com/bdcwv873

Single dose of Arexvy protects for three seasons new study concludes

Boston, MA – According to a poster presented at the recent CHEST 2024 annual meeting a single dose of Arexvy provides protection against RSV-LRTD in older adults over three seasons and has an acceptable safety profile. The highly anticipated topline results from the season 3 readout of AReSVi-006, the phase III trial assessing efficacy and safety of GSK’s Arexvy vaccine in adults aged ≥60 years were recently released at the Chest Conference in Boston. 

The key conclusions the researchers made were that a single dose of RSVPreF3 OA (AREXVY) provided protection against RSV-confirmed lower respiratory tract disease (RSV-LRTD) over 3 RSV seasons (median follow-up of 30.6 months), including: 

o   62.9% efficacy against RSV-LRTD (97.5% CI: 46.7, 74.8) 

o   67.4% efficacy against Severe RSV-LRTD (95% CI: 42.4, 82.7) 

o   70.2% efficacy against medically attended RSV-LRTD (95% CI: 50.1, 83.1) 

Efficacy was consistent across RSV-A and -B subtypes and among participants at increased risk of severe RSV disease including those with comorbidities, increasing age, and pre-frail status. And, RSVPreF3 OA had an acceptable safety profile over 3 seasons, with no cases of Guillain-Barré syndrome or acute disseminated encephalomyelitis reported (median safety follow-up 31.7 months).

The poster was presented by Ison et al. at the CHEST 2024 Annual Meeting: View the poster

Quebec offers free respiratory syncytial virus (RSV) vaccine for priority groups in residential settings

Quebec City, PQ - Following the efforts made in recent months to improve the Quebec Immunization Program (PQI), the Minister of Health, Christian Dubé, and the Minister responsible for Seniors and Minister for Health, Sonia Bélanger, in accordance with the advice of the Quebec Immunization Committee, are announcing that the respiratory syncytial virus (RSV) vaccine will be free for priority clients in residential settings in order to minimize the risk of complications and frequent hospitalizations. This free vaccination program is aimed at those most at risk, namely people aged 60 and over residing in long-term care centres (CHSLDs) and intermediate resource-support for the autonomy of seniors (RI-SAPA) as well as people aged 75 and over living in private seniors' residences (RPAs). It should be noted that RSV vaccines, like the influenza and COVID-19 vaccines, will be offered this fall in residences by mobile teams from health care facilities. This vaccine will also be available at local service points for residents wishing to travel there to receive their fall vaccination. Respiratory syncytial virus (RSV) is a highly contagious virus that causes respiratory and lung infections. It can cause more serious infections or worsen existing medical conditions, which can lead to hospitalization and even death.

For more information: https://www.quebec.ca/nouvelles/actualites/details/quebec-offre-gratuitement-le-vaccin-contre-le-virus-respiratoire-syncytial-vrs-pour-les-groupes-prioritaires-en-milieu-dhebergement-58210

New survey reveals widespread lack of awareness about Respiratory Syncytial Virus (RSV) among older Canadians, despite health risks for this population

“Almost half (46%) of older Canadians surveyed had never heard of RSV, despite a large majority (65%) reporting having had a respiratory illness in the previous 12 months”

MISSISSAUGA, ON – With healthy ageing becoming a topic of interest for many as our population in Canada continues to grow older, data from a new survey has highlighted significant gaps in knowledge among older Canadians about respiratory syncytial virus (RSV), which is a common contagious respiratory virus. The virus can lead to severe outcomes, including pneumonia and hospitalization, and can have lasting impact on adults’ daily function and independence. The online survey, commissioned by GSK, assessed the awareness and attitudes of a representative sample of 1,000 Canadians aged 50 and above towards RSV and other respiratory illnesses, as well as the impact of these conditions on their life.

Public health impact of RSV infections

RSV is a leading cause of respiratory illness in adults. According to the most recent data available, RSV is estimated to have caused more than 5 million infections, 470,000 hospitalizations and 33,000 deaths among those aged 60 and above in high-income countries including Canada and the United States in 2019.

Despite this high incidence, 46% of older Canadians surveyed had never heard of RSV. Even among those at increased risk of becoming seriously ill from an RSV infection due to an underlying medical condition, awareness remained low with less than 1 in 5 (18%) claiming to have at least moderate knowledge of RSV.

Impacts of Respiratory Viruses

The survey also provided insight about the impact of respiratory viruses like RSV on the daily activities of older Canadians. Among the 65% of respondents that reported suffering from a respiratory infection in the last 12 months (COVID-19, flu, RSV, or other):

• 39% reported that it took them more than two weeks to recover. For those aged 60 and older, recovery took three or more weeks for most (72%)
• Nearly two thirds (65%) reported it disrupted their daily activities
• Three out of five (60%) reported it affected their sleep
• 43% said it had affected their social events
• Almost one third (29%) said it affected their ability to attend work

In addition to impact on daily activities, respondents reported worry about different life events that respiratory infections, including RSV, could cause them to miss. The most common concerns were:

• family occasions (52%)
• holidays (52%)
• milestones such as birthdays (42%)

Beyond just missing out on important life events, studies have shown that about one-third of older adults hospitalized with RSV experience acute functional decline and may never regain their pre-infection functioning. In addition, eight per cent saw an ongoing loss of independence six months after hospitalization.

Marni Freeman, Country Medical Director, GSK Canada said: “RSV is a highly contagious virus and a major cause of respiratory illness in older adults. Those who are immunocompromised or suffer from underlying medical conditions such as chronic heart or lung disease, are at an even greater risk of severe outcomes. What may be of particular concern for many are the potential longer-term impacts of the virus that affect their level of independence and ability to fully take part in life’s cherished moments. The survey results highlight that more education is needed to ensure the full burden of disease is understood as well as ways to prevent it.”

Various methods can help to reduce the risk of catching or spreading respiratory infections, including RSV. These include avoiding close contact with those who are unwell, practising good hygiene such as regular handwashing and coughing into a handkerchief, as well as vaccination. The survey aims to encourage more people to speak to their healthcare professional for guidance on how to reduce their risk of developing the potential serious consequences of RSV.

For citations and more information: https://tinyurl.com/45fvbwsr

NACI releases statement on the prevention of respiratory syncytial virus disease in older adults

The National Advisory Committee on Immunization (NACI) is an External Advisory Body that provides the Public Health Agency of Canada (PHAC) with independent, ongoing and timely medical, scientific, and public health advice in response to questions from PHAC relating to immunization. In addition to burden of disease and vaccine characteristics, PHAC has expanded the mandate of NACI to include the systematic consideration of programmatic factors in developing evidence based recommendations to facilitate timely decision-making for publicly funded vaccine programs at provincial and territorial levels.

Respiratory syncytial virus (RSV) is a common respiratory virus, and infants and older adults are at higher risk due to RSV. RSV can cause serious respiratory disease in older adults, particularly those at increased risk due to chronic medical conditions. RSV has a seasonal pattern of activity where infections are usually more common in the winter with variation in the timing and magnitude of the peak. This statement focuses on the protection of adults at risk for severe RSV disease (including death and admission to hospital or intensive care units [ICU] due to age, medical conditions, setting and other potential factors. Health Canada has recently authorized two vaccines, both based on the prefusion stabilized F protein (preF), to protect adults from RSV: • RSVPreF3 (Arexvy, GSK) is an AS01E adjuvanted vaccine authorized with an indication for all adults 60 years of age and over. • RSVpreF (Abrysvo TM, Pfizer) is an unadjuvanted vaccine authorized with an indication for all adults 60 years of age and over. This formulation is also authorized for pregnant women and pregnant people who are 32 to 36 weeks of gestation to protect infants from RSV.

NACI recommends RSV immunization programs for adults 75 years of age and older, particularly for older adults with chronic health conditions who are at increased risk of severe RSV disease. NACI also recommends RSV immunization programs for adults 60 years of age and older who are residents of nursing homes and other chronic care facilities. Severe RSV disease in adults is most common in advanced age and in those with certain chronic health conditions or other risk factors. Adults with chronic health conditions who are at increased medical risk for severe RSV disease are highlighted in List 1. In addition, adults may be at increased risk of severe RSV disease due to factors that intersect with social determinants of health. For individuals who may seek vaccination outside of a public health program, NACI recommends that RSV vaccines may be considered as an individual decision by adults 60 to 74 years of age in consultation with their health care provider. It is unknown at this time if these vaccines can be boosted by subsequent doses, and therefore healthy individuals who are less than 75 years of age may want to discuss deferring vaccination with their health care providers to a future time when they may be at greater risk. If an individual over the age of 75 is not included in a publicly funded program, NACI recommends vaccination for these individuals, particularly for those adults at increased risk of severe RSV disease. The RSV vaccine is optimally administered just before the start of the RSV season. Jurisdictions are encouraged to define the RSV season and administer RSV vaccines based on local epidemiology (prior to the COVID-19 pandemic, the RSV season was typically November to April).

For more information: https://tinyurl.com/33nbnkz7

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?