Moderna RSV Vaccine Summary

mRESVIA

Purpose

The following product summary can be used by product providers to prepare orders for fall and winter virus season.

Presentations and Indications

mRESVIA is indicated for active immunization for the prevention of LRTD caused by RSV in individuals 60 years of age and older.

Ordering and Return Policy

Minimum Initial Order

When ordering vaccines directly from Moderna, there is a minimum order of 10 doses.

Pre-ordering or Reservation Programs

Pre-ordering or reservation programs are offered for mRESVIA.

Return Policy

Unopened Vaccine

Unused vaccine that meets the requirements of Moderna's Return Goods Policy can be returned.

Customers can call 1-866-MODERNA (1-866-663-3762) for information on reservations and ordering.

Opened Vaccine

Unused Moderna pre-filled syringes are returnable that meet the requirements of Moderna's Return Goods Policy.

Storage Requirements

  • Must be stored frozen (between -40⁰C and -15⁰C)
  • Must be stored refrigerated (between 2⁰C and 8⁰C)

Storage and Handling

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Frozen Storage

Store frozen between -40°C to -15°C (-40°F to 5°F).

Storage after Thawing

Store at 2°C to 8°C (36°F to 46°F):

  • Pre-filled plastic syringes may be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days prior to use. Storage at 8°C to 25°C (46°F to 77°F):
  • Pre-filled plastic syringes may be stored between 8°C to 25°C (46°F to 77°F) for a total of 24 hours after removal from refrigerated conditions. Discard the pre-filled syringe if not used within this time. Syringes should not be returned to the refrigerator after being thawed at room temperature.
  • Total storage at 8°C to 25°C (46°F to 77°F) must not exceed 24 hours.
  • Do not refreeze once thawed. Do not shake.

Diluent Type and Volume

N/A

Doses

mRESVIA
How the vaccine is supplied Manufacturer-filled syringes
Number of doses per vial N/A
Dosage Administer a single dose (0.5 mL)
mRESVIA is supplied as follows: NDC 80777-345-90 Carton of 1 single-dose pre-filled plastic syringe in a blister pack containing 1 dose of 0.5 mL (NDC 80777-345-01). NDC 80777-345-96 Carton of 10 single-dose pre-filled plastic syringes, each syringe containing 1 dose of 0.5 mL (NDC 80777-345-01). Each carton contains 5 blisters, and each blister contains two syringes. Use one syringe per person per dose.
Dose volume 0.5 mL
Reconstitution No

Shelf Life

Shelf Life mRESVIA
Unopened, frozen vaccine 18 months until the expiration date printed on the vials and cartons.
Unopened, refrigerated vaccine 30 days
Opened, refrigerated vaccine N/A - Supplied as Pre-Filled Syringe
Opened, room temperature vaccine N/A - Supplied as Pre-Filled Syringe

Additional Information

FDA approval on May 31, 2024

To be determined

Please contact Moderna at: 1 866 MODERNA (1-866-663-3762) for questions on mRESVIA vaccine temperature excursions.