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- What: Teh 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 important illness and hospitalization in older adults, and this is the first widely available vaccine too prevent it.
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. Before the availability of a 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 weakens the respiratory system,making individuals more vulnerable to secondary infections and exacerbating existing conditions like chronic obstructive pulmonary disease (COPD) and heart failure.
The impact of RSV extends beyond individual health.Hospitalizations strain healthcare resources, especially during peak season, and contribute to significant healthcare costs. The pandemic highlighted the importance of protecting vulnerable populations from respiratory viruses,and the development of an RSV vaccine represents a major step forward in public health preparedness.
The Arexvy Vaccine: Trial Results and Efficacy
The approval of arexvy (GSK) on May 3, 2023, marked a turning point in RSV prevention. Phase 3 clinical trial data, published in the New England Journal of medicine on October 2, 2025, demonstrated the vaccine’s efficacy. The study,involving nearly 25,000 adults aged 60 years and older,showed that Arexvy was 82.6% effective in preventing RSV-associated lower respiratory tract disease (LRTD) – defined as having at least two symptoms, such as cough, shortness of breath, or wheezing – with a severity score of 3 or higher.
Specifically, the trial revealed:
- Overall Efficacy: 82.6% against RSV-LRTD.
- Efficacy in those with underlying conditions: The vaccine demonstrated efficacy across various subgroups, including those with pre-existing conditions like cardiovascular disease, respiratory disease, and diabetes.
- Safety Profile: The most common side effects reported were local reactions at the injection site (pain, redness, swelling) and systemic reactions like fatigue, muscle pain, headache, and joint pain. Serious adverse events were rare and not definitively linked to the vaccine.
Who Should Get the RSV Vaccine?
The FDA approved Arexvy for adults aged 60 years and older. Though, the CDC’s ACIP will provide specific recommendations regarding who should receive the vaccine. These recommendations will likely consider factors such as individual health status, risk of exposure, and shared clinical decision-making between patients and their healthcare providers.
Currently, the CDC recommends that adults aged 60 years and older may receive a single dose of RSV vaccine, based on shared decision-making with their healthcare provider. This means a discussion about the
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