The National Health Surveillance Agency (Anvisa) has approved the expansion of the use of the Arexvy vaccine (recombinant with adjuvant against Respiratory Syncytial Virus) from the bio-pharmaceutical GSK for adults aged 50 and over at increased risk (comorbidities).
The extension of the Adjuvanted RSV vaccine for adults aged 50 to 59 offers another form of protection for a highly vulnerable group at serious risk of severe complications. ‘This decision aligns Brazil with global best practices, ensuring that patients with fragile health have access to essential vaccines for their quality of life and longevity. It is crucial for patients and physicians to start this conversation about RSV prevention for adults in their routine calendar,’ says Isabella Ballalai, director of the Brazilian Society of Immunizations.
The Importance of Expanded Vaccination for at-Risk Populations
RSV is not just a concern for children. Often seen as harmless because it resembles a cold, this virus can pose a serious threat to adults and the elderly, especially those over 50 with increased risk factors such as heart disease, asthma, COPD, and diabetes. Studies show that individuals 50 years and older with heart failure are up to 7.6 times more likely to be hospitalized due to RSV.
‘It is crucial to warn the population about the risks of RSV for adults and the elderly. Studies indicate that RSV can account for up to 15% of cases of community-acquired pneumonia in adults. Many cases are mistaken for a common cold due to symptoms like runny nose, cough, fever, and malaise. Moreover, there is another factor to consider: intradomiciliary transmission, where young children, often infected with RSV, can transmit the virus to older adults, such as grandparents. Older adults in contact with children with RSV are 22.6 times more likely to be infected by this virus. All of this reinforces the need for preventive measures and the importance of vaccination, one of the primary forms of protection, especially for at-risk adults,’ alerts infectious disease specialist Lessandra Michelin.
Clinical Data Support Approval
The basis for the expanded use is supported by results from a global phase III trial showing a strong immune response in adults 50 to 59 with chronic conditions, comparable to the response in adults aged 60 and older. The study assessed the immunogenicity and safety of the vaccine in this group, providing robust evidence of Arexvy’s ability to reduce the risk of Lower Respiratory Tract Disease (LRTD) caused by RSV.
Moreover, data from a study with 25,000 participants aged 60 and older in 17 countries demonstrate that a single dose of Arexvy provides protection against RSV for at least three virus circulation seasons, equivalent to 30 months. This is the only RSV vaccine with efficacy and safety data available for that duration of protection.
‘These studies underscore the importance of prevention, particularly in adults with pre-existing conditions who may be at higher risk of RSV-related complications. Scientific data show that Arexvy is up to 82.6% effective in preventing lung and lower respiratory tract infections caused by RSV in people aged 60 and older. In severe respiratory conditions in individuals with at least one comorbidity, efficacy is approximately 94%. Given that adults aged 50 and over at increased risk have shown a comparable immune response to those aged 60+, we can ensure that this expansion represents a positive impact for these patients,’ explains the infectious disease specialist.
Safety and Adverse Events
Data analysis also indicates that the Arexvy vaccine has a favorable safety profile. The most common adverse events are generally mild to moderate and short-lived (average of 1 to 2 days). The most frequently reported reactions include pain, redness, and swelling at the injection site (local reactions), headache (cephalalgia), fatigue, muscle pain (myalgia), and joint pain (arthralgia). Vaccination should be postponed in cases of moderate to severe acute febrile illness. It is contraindicated for individuals with known hypersensitivity to any vaccine component. The decision to vaccinate should always be discussed with a healthcare professional.
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