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- What: The FDA approved Arexvy, a respiratory syncytial virus (RSV) vaccine, for adults aged 60 years and older.
- When: Approved May 3, 2023; data published October 2, 2025, in the new England Journal of Medicine detailing Phase 3 trial results.
- Why it matters: RSV causes notable illness and hospitalization in older adults, and this is the first widely available vaccine to prevent it.
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RSV Vaccine Approved for Older Adults: A Breakthrough in Respiratory Protection
Understanding RSV and Why It’s a Threat to Seniors
Respiratory Syncytial Virus (RSV) is a common respiratory virus that usually causes mild,cold-like symptoms. Though, for older adults, RSV can lead to severe illness, including pneumonia and hospitalization. Prior to the progress of this vaccine, RSV was estimated to cause approximately 60,000-160,000 hospitalizations and 6,000-10,000 deaths annually among adults 65 years and older in the united States.
The virus spreads through close contact with infected individuals, often via respiratory droplets produced during coughing or sneezing. Older adults are particularly vulnerable due to age-related decline in immune function and the presence of underlying health conditions like heart disease and chronic obstructive pulmonary disease (COPD).
The Arexvy Vaccine: How it Works and Trial Results
Arexvy,manufactured by GSK,is a recombinant subunit vaccine containing a stabilized prefusion F protein. This protein is found on the surface of the RSV virus and is crucial for the virus to enter cells. by presenting this protein to the immune system, the vaccine triggers the production of antibodies that can neutralize the virus and prevent infection.
The Phase 3 PROTECT trial, published in the New England Journal of Medicine on October 2, 2025, involved nearly 25,000 adults aged 60 years and older. The trial demonstrated a vaccine efficacy of 82.6% against RSV-associated lower respiratory tract disease (LRTD) – defined as having at least two symptoms including cough, shortness of breath, wheezing, or fever – and 94.1% against severe LRTD requiring hospitalization. The median follow-up period was 9.4 months.
Importantly, the trial also assessed the safety of the vaccine. The most common side effects reported were local reactions at the injection site, such as pain, redness, and swelling, and systemic reactions like fatigue, muscle pain, and headache. Serious adverse events were rare and not definitively linked to the vaccine.
| Outcome | Vaccine Group (Efficacy %) | Placebo Group (%) |
|---|---|---|
| RSV-associated LRTD | 82.6 | 5.4 |
| Severe RSV-associated LRTD (Hospitalization) | 94.1 | 1.3 |
Who Should Get the RSV Vaccine?
The FDA approved Arexvy for adults aged 60 years and older. the Centers for Disease Control and Prevention (CDC) recommends that adults aged 60 years and older may receive a single dose of RSV vaccine, based on shared clinical decision-making with their healthcare provider.
Factors to consider when deciding whether to get vaccinated include individual risk of RSV infection