Tumor Lysis Syndrome: Symptoms, Causes & Treatment
- What: The first FDA-approved vaccines too prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).
- When: Approved May 2023, with initial rollout for the 2023-2024 RSV season; updated data published September 18, 2025.
- Why it matters: RSV is a common respiratory virus that can cause severe illness, especially in infants and older adults.
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RSV Vaccine Breakthrough: Protecting Infants and Older Adults
Understanding the RSV Threat
Respiratory Syncytial Virus (RSV) is a pervasive and often underestimated respiratory pathogen. While often causing mild, cold-like symptoms, RSV can lead to severe illness, notably in infants, young children, and older adults. Before the advent of these vaccines, RSV was responsible for an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths annually among adults 65 years and older in the United States. Infants are also highly vulnerable, with nearly all children infected by age two.
The virus spreads through respiratory droplets produced when an infected person coughs or sneezes. Symptoms typically include a runny nose, decreased appetite, cough, sneezing, fever, and wheezing. In severe cases, RSV can lead to bronchiolitis (inflammation of the small airways in the lungs) and pneumonia.
The Landmark Vaccine Approvals
In May 2023, the Food and Drug Administration (FDA) approved the first RSV vaccines for both older adults and for the prevention of RSV in infants through maternal vaccination. This represents a monumental achievement in infectious disease prevention. Two vaccines were approved for adults 60 years and older: Arexvy (GSK) and Abrysvo (Pfizer). Abrysvo also received approval for maternal immunization to protect infants.
the vaccines utilize different technologies. Arexvy is a recombinant subunit vaccine containing a stabilized prefusion F protein, while Abrysvo employs a bivalent RSV prefusion F protein vaccine. Both aim to elicit an immune response that neutralizes the virus before it can cause severe illness.
Clinical Trial Results: Efficacy and Safety
Data published in the New England journal of Medicine on September 18, 2025, provides further insight into the real-world effectiveness of these vaccines. Studies demonstrated a significant reduction in RSV-associated LRTD among vaccinated adults. The RSV vaccine efficacy against severe disease in older adults ranged from 82.6% to 94.1% depending on the specific vaccine and study population.
Maternal vaccination with Abrysvo has shown promising results in protecting infants. Clinical trials indicated a considerable decrease in medically attended RSV-associated LRTD in infants born to vaccinated mothers, with efficacy rates exceeding 80% for at least six months after birth.
Safety profiles were generally favorable. Common side effects included pain at the injection site, fatigue, muscle aches, and headache. Serious adverse events were rare and not consistently linked to the vaccines.
| Vaccine | Target Population | Efficacy (Severe Disease) | Common Side Effects |
|---|---|---|---|
| Arexvy (GSK) | Adults 60+ | 82.6% – 94.1% | Pain at injection site, fatigue, muscle aches, headache |
| Abrysvo (Pfizer) | Adults 60+ & infants (via maternal vaccination) | 82.6% –
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