mRESVIA

mRESVIA is a vaccine used to immunize adults aged 60 years and older against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV). It may also be given to adults 18 through 59 years at increased risk for severe RSV disease. mRESVIA is administered as a one-time intramuscular injection into the upper arm by a healthcare provider.

• At least one-third of adults aged 18 through 59 have an underlying condition, such as diabetes, cardiovascular disease, or respiratory disease, that puts them at risk of severe RSV disease.
• Vaccination may not protect everybody who receives it.

mRESVIA works by encoding for a particular protein present on the RSV virus. When given, it instructs your body to make a harmless piece of the RSV virus, which your immune system recognizes as foreign and creates antibodies against it. These antibodies target the pre-F form of this RSV protein and can help your body fight the RSV infection. mRESVIA is a modified RNA vaccine and does not contain RSV. It cannot give you RSV or lower respiratory tract disease.

mRESVIA gained FDA approval on 31 May 2024 for adults 60 years and older, and was the third vaccine approved for RSV, and the only modified RNA vaccine. This approval was extended to include adults 18 through 59 years at increased risk of severe RSV disease on June 12, 2025.

Tell your healthcare provider about all of your medical conditions, including if you:

• have any allergies
• had a severe allergic reaction after receiving a previous dose of any other vaccine
• have a fever
• have a bleeding disorder or are on a blood thinner
• are immunocompromised or are on a medicine that affects your immune system
• have received any other RSV vaccine
• have ever fainted in association with an injection
• are under the age of 18
• are pregnant. mRESVIA is not approved for use during pregnancy.

Read the FDA-approved patient labeling information for recipients and caregivers before receiving mRESVIA. If you would like more information, talk to your healthcare provider, visit mRESVIA.com, or call 1-866-MODERNA (1-866-663-3762).

The most common side effects of mRESVIA in adults 60 years and older are:

• injection site reactions, such as pain, swelling, or tenderness at the injection site
• fatigue/tiredness
• headache
• muscle or joint pain
• underarm swelling or tenderness
• chills.

The most common side effects of mRESVIA in adults 18 through 59 years are:

• injection site pain
• fatigue
• headache
• muscle or joint pain
• underarm swelling or tenderness
• chills
• nausea or vomiting.

Serious side effects and warnings

mRESVIA may cause the following serious side effects:

• Severe allergic reactions. Rarely, mRESVIA could cause a severe allergic reaction. This would usually occur within a few minutes to one hour after getting a dose of mRESVIA. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine. Signs of a severe allergic reaction may include: trouble breathing swelling of your face and throat a fast heartbeat a rash dizziness and weakness.
• Fainting. This may occur following the administration of vaccines, such as mRESVIA. Sit or lie down during the vaccination to avoid injury from fainting.
• A diminished immune response in people who are immunocompromised.

mRESVIA is for people aged 18 years and older. It should not be given to children, adolescents, or pregnant women.

These may not be all of the possible side effects of mRESVIA. Ask your healthcare provider about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or https://vaers.hhs.gov.

mRESVIA is given as an injection into the muscle, usually the deltoid muscle of the outer, upper arm.

• The dose is 0.5 mL.

Because of the small risk of an allergic reaction occurring, you may be asked to stay for a short time at the place where you received your vaccine and where appropriate medical treatment is available.

Active: messenger ribonucleic acid (mRNA) that encodes for the RSV F glycoprotein

Inactive: lipids (SM-102, polyethylene glycol dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2- distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, water

mRESVIA does not contain a preservative.

mRESVIA is manufactured for Moderna US, Inc., in Princeton, NJ 08540.