Nerandomilast in Pulmonary Fibrosis: A Review
- 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 significant 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. However, for older adults, RSV can lead to severe illness, including pneumonia and hospitalization. Before the development 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, similar to the common cold or flu. Symptoms can include a runny nose, cough, fever, and shortness of breath. Older adults are particularly vulnerable because their immune systems weaken with age, making them less able to fight off the infection effectively.
The Arexvy Vaccine: How It Works and Trial Results
arexvy, developed by GSK, is a recombinant subunit vaccine. It contains a stabilized prefusion F protein, which is a key protein on the surface of the RSV virus. This protein triggers an immune response, preparing the body to fight off the virus if exposed.The vaccine does not use a live virus, making it safe for older adults with weakened immune systems.
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 results demonstrated a vaccine efficacy of 82.6% against RSV-associated lower respiratory tract disease (LRTD) – defined as having at least two symptoms like cough, shortness of breath, or wheezing – and 94.1% against severe LRTD requiring hospitalization. These findings were consistent across various subgroups, including those with underlying medical conditions.
| Outcome | Vaccine Efficacy |
|---|---|
| RSV-associated LRTD | 82.6% |
| Severe RSV-associated LRTD (hospitalization) | 94.1% |
Safety Profile and Potential Side Effects
The Arexvy vaccine was generally well-tolerated in clinical trials. the most common side effects reported were pain at the injection site, fatigue, muscle aches, headache, and joint pain. Serious adverse events were rare and not definitively linked to the vaccine. A small number of participants experienced Guillain-Barré syndrome (GBS), a rare neurological disorder, but the causal relationship to the vaccine remains under inquiry.
It’s critically important to note that, as with any vaccine, individuals should discuss any concerns or pre-existing medical conditions with their healthcare provider before receiving the Arexvy vaccine.
who Should Get the RSV vaccine?
The FDA approved Arexvy for adults aged 60 years and older to provide protection against RSV-related illness. the CDC’s ACIP will provide specific recommendations regarding who should prioritize vaccination. Factors considered will likely include age, underlying health conditions,