The U.S. Food and Drug Administration (FDA) has broadened approval for Moderna’s respiratory syncytial virus (RSV) vaccine, mRESVIA, to include all adults—with certain restrictions.
Originally approved in 2024 for adults 60 and older, the vaccine now also covers adults aged 18 to 59 who are at higher risk of severe RSV illness. The decision follows clinical trials showing strong immune responses in younger adults with underlying health conditions.
What is RSV?
RSV is a common respiratory virus that spreads through coughs, sneezes, or touching contaminated surfaces. While most people experience mild cold-like symptoms, it can be dangerous for infants, older adults, and those with weakened immune systems. Vaccines like mRESVIA offer crucial protection.
How Effective Is the Vaccine?
Studies confirmed that younger at-risk adults (18-59) developed the same level of protective antibodies as older adults (60+). The vaccine works against both major RSV strains (RSV-A and RSV-B).
How Does mRESVIA Work?
The RNA-based vaccine teaches the body to recognize a harmless piece of the RSV virus, triggering an immune response without causing infection.
Safety and Side Effects
In trials, the vaccine was well-tolerated, with common side effects including:
- Pain at the injection site
- Fatigue, headache, muscle/joint pain
- Chills, nausea, fever, or hives
Who Should Get It?
- Adults 60+ (no restrictions)
- Adults 18-59 with higher risk factors (chronic lung/heart disease, weakened immunity, etc.)
Precautions
Patients should inform their doctor about:
- Any allergies or past severe vaccine reactions
- Current illnesses or fever
- Bleeding disorders or use of blood thinners
- A weakened immune system or related medications
Previous RSV vaccination or fainting after shots
Though rare, severe allergic reactions are possible. Patients may be monitored briefly after vaccination.
Availability
Moderna expects to distribute mRESVIA in the U.S. for the 2025-2026 RSV season.
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