Neoadjuvant Nivolumab Chemotherapy Lung Cancer Treatment
- 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 November 20, 2025, in the New England Journal of Medicine detailing efficacy and safety.
- Why it matters: RSV causes meaningful illness and mortality in older adults,frequently enough leading to pneumonia and hospitalization.
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, particularly those with underlying health conditions, RSV can be severe. It’s a leading cause of pneumonia,bronchitis,and hospitalization,and contributes significantly to excess mortality during flu season. Prior to the availability of a vaccine,the CDC estimated that RSV caused approximately 60,000-160,000 hospitalizations and 6,000-10,000 deaths among adults 65 years and older annually.
The virus spreads through respiratory droplets produced when an infected person coughs or sneezes. Older adults are more vulnerable due to age-related decline in immune function and the prevalence of chronic conditions like heart disease and chronic obstructive pulmonary disease (COPD).
The Arexvy Vaccine: how It Works and trial Results
Arexvy, developed 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 pivotal Phase 3 clinical trial, published in the New England Journal of Medicine on November 20, 2025, involved nearly 24,636 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 including cough, shortness of breath, wheezing, or fever. Efficacy against severe LRTD, requiring hospitalization, was 94.1%.
The study also assessed safety. Common side effects included injection-site pain, fatigue, muscle aches, headache, and joint pain. Serious adverse events were rare and not significantly different between the vaccine and placebo groups. However, a small increased risk of Guillain-Barré syndrome (GBS) was observed, a rare neurological disorder, prompting ongoing monitoring.
| Outcome | Vaccine Group (Efficacy %) | Placebo Group (%) |
|---|---|---|
| RSV-associated LRTD | 82.6 | 5.4 |
| Severe RSV-associated LRTD (Hospitalization) | 94.1 | 1.1 |
Who Should Get the RSV Vaccine?
The FDA approved Arexvy for adults aged 60 years and older. The CDC recommends that adults in this age group may receive a single dose of RSV vaccine, based on shared clinical decision-making with their healthcare provider.
This means the decision should be individualized, considering the patient’s risk factors, health status, and preferences.
Individuals with certain medical conditions, such as heart failure, chronic lung disease, diabetes, and weakened immune systems, are at higher risk