Moderna RSV page 3 of 3 4C (near RSV) Data: Animal Data: In a developmental toxicity study, 0.2 mL of a vaccine formulation containing 96 mcg of nucleoside modified mRNA per dose (a full human dose of mRESVIA contains 50 mcg of nucleoside modified mRNA) was administered to female rats by the intramuscular route on four occasions: 28 and 14 days prior to mating, and on gestation days 1 and 13. No vaccine related fetal malformations or variations and no adverse effects on postnatal development were observed in the study. The developmental toxicity study revealed no evidence of impaired female fertility. Lactation It is not known whether mRESVIA is excreted in human milk. No human or animal data are available to assess the effects of mRESVIA on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mRESVIA and any potential adverse effects on the breastfed child from mRESVIA or from the underlying maternal condition. For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine. Pediatric Use Safety and effectiveness of mRESVIA in individuals younger than 18 years of age have not been established. Geriatric Use Of the total number of participants (N = 36,412) who received mRESVIA or placebo in Study 1 (NCT05127434), 22,554 (61.9%) were 60 to 69 years of age, 10,972 (30.1%) were 70 to 79 years of age, and 2,886 (7.9%) were 80 years of age and older. Patient Counseling Information Advise the vaccine recipient or caregiver to read the FDA-approved patient labeling (INFORMATION FOR RECIPIENTS AND CAREGIVERS). Prior to administration of mRESVIA: • Inform vaccine recipient or caregiver of the potential benefits and risks of vaccination with mRESVIA • Instruct vaccine recipient or caregiver to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System at 1-800-822-7967 and www.vaers.hhs.gov. This product’s labeling may have been updated. For the most recent prescribing information, please visit modernatx.com/products/mresvia or mRESVIApro.com. Manufactured for: Moderna US, Inc. 5 Vaughn Drive Princeton, NJ 08540 ©2026 Moderna All rights reserved. mRESVIA is a trademark of Moderna Patent(s): www.modernatx.com/patents Revised: 04/2026 US-RSV-2400076 mRESVIA (Respiratory Syncytial Virus Vaccine) Brief Summary for HCPs Indications and Usage mRESVIA is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in • individuals 60 years of age and older. • individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Contraindications Do not administer mRESVIA to individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of mRESVIA. Warnings and Precautions • Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of mRESVIA. • Syncope: Syncope (fainting) may occur in association with administration of injectable vaccines, including mRESVIA. Procedures should be in place to avoid injury from fainting. • Altered Immunocompetence: Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a diminished immune response to mRESVIA. Adverse Reactions In a clinical trial conducted in participants 60 years of age and older, the most commonly reported (≥10%) adverse reactions were injection-site pain (55.9%), fatigue (30.8%), headache (26.7%), myalgia (25.6%), arthralgia (21.7%), axillary (underarm) swelling or tenderness (15.2%), and chills (11.6%). In a clinical trial conducted in participants 18 through 59 years of age at increased risk for LRTD caused by RSV, the most commonly reported (≥10%) adverse reactions were injection site pain (73.9%), fatigue (36.9%), headache (33.3%), myalgia (28.9%), arthralgia (22.7%), chills (19.9%), axillary (underarm) swelling or tenderness (17.1%), and nausea/vomiting (10.8%). Use in Specific Populations Pregnancy Risk Summary: All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no human data to establish whether there is a vaccine- associated risk with use of mRESVIA in pregnancy. A developmental toxicity study was performed in female rats administered a vaccine formulation that included approximately twice the amount of nucleoside-modified messenger ribonucleic acid (mRNA), encoding the same RSV fusion (F) glycoprotein stabilized in the prefusion conformation, as in mRESVIA. The vaccine formulation was administered twice prior to mating and twice during gestation. The study revealed no evidence of harm to the fetus due to the vaccine (see Data).
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