Landmark approvals in May 2023
Prior to 2023, there was no approved vaccine for Respiratory Syncytial Virus (RSV) in older adults, despite the virus causing significant morbidity and mortality in this population. The medical community’s long search for an effective vaccine finally came to fruition in May 2023 with two separate approvals by the U.S. Food and Drug Administration (FDA).
Arexvy: The first to market
GlaxoSmithKline (GSK) received the first FDA approval for an RSV vaccine for older adults. The vaccine, named Arexvy, was approved on May 3, 2023, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older. This historic moment marked the beginning of a new era in preventing severe respiratory illness for seniors.
Abrysvo: The second option
Just weeks later, on May 31, 2023, the FDA approved a second RSV vaccine, Abrysvo from Pfizer. This approval was also for the prevention of LRTD in individuals 60 years of age and older. Later in the same year, Abrysvo also received an additional indication for use in pregnant individuals to protect newborns from severe RSV illness, a unique feature among the initial vaccines.
The evolving landscape of RSV vaccination
CDC recommendations and shared decision-making
Following the FDA’s approvals, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) issued its recommendations. On June 21, 2023, ACIP recommended that adults aged 60 years and older may receive a single dose of an RSV vaccine based on shared clinical decision-making. This involves a discussion with a healthcare provider about individual risk factors.
A third vaccine enters the market
In May 2024, Moderna’s mRNA-based RSV vaccine, mRESVIA, received FDA approval for adults 60 years and older. The CDC now recommends a single dose of any of the three FDA-licensed RSV vaccines for eligible adults. All three have shown high effectiveness against RSV-associated hospitalizations in older adults.
A comparison of the three RSV vaccines for older adults
The FDA has approved three RSV vaccines for older adults. You can find detailed information about each vaccine, including their approval dates and specific indications, on the {Link: CDC website https://www.cdc.gov/rsv/vaccines/adults.html}.
Safety and side effects
Clinical trials and ongoing surveillance track RSV vaccine safety. Common side effects are usually mild and include injection site reactions, fatigue, headache, and muscle pain. While rare, serious neurological conditions like Guillain-Barré syndrome (GBS) have been reported. However, health authorities emphasize that preventing severe RSV disease and death outweighs potential risks for older adults. Adverse events are reported to the Vaccine Adverse Event Reporting System (VAERS).
Accessing the RSV vaccine
Availability and administration
Eligible adults can get the vaccine at various locations. The CDC suggests late summer or early fall is ideal, before RSV season begins. It can be given with other vaccines like flu and COVID-19 shots.
Insurance coverage
Medicare Part D covers the RSV vaccine with no cost for seniors. Most private plans should also cover it without co-pays for those meeting CDC recommendations, but check coverage beforehand.
What if you've already had a dose?
The RSV vaccine is not currently recommended annually. A single dose is considered sufficient for eligible adults as of 2025. Monitoring continues regarding the duration of protection and if revaccination will be needed. The latest guidance is available on the {Link: CDC website https://www.cdc.gov/rsv/vaccines/adults.html}.
Conclusion
The FDA's approval of multiple RSV vaccines since May 2023 has significantly improved preventive care for older adults. With Arexvy, Abrysvo, and mRESVIA, seniors have access to protection against this dangerous respiratory illness. Understanding approval timelines, recommendations, and options helps seniors and providers make informed health decisions.
