GSK RSV Vaccine Summary

AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)

Purpose

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

Presentations and Indications

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).

CDC recommends a single dose of RSV vaccines for:

  • All adults ages 75 and older
  • Adults ages 60-74 who are at increased risk of severe RSV disease

Ordering and Return Policy

Minimum Initial Order

AREXVY is supplied in a 10 pack. The minimum order would be equal to one pack of 10.

Order directly on GSKDirect.

Pre-ordering or Reservation Programs

Pre-ordering or reservation programs are not offered for AREXVY.

Return Policy

Unopened Vaccine

Arexvy return policy is upon expiry date.

Opened Vaccine

Arexvy return policy is upon expiry date.

For additional questions, please go to GSK Help Center.

Storage Requirements

Must be stored refrigerated (between 2⁰C and 8⁰C)

Diluent Type and Volume

AREXVY is supplied as 2 components: A single-dose vial of lyophilized antigen component (powder) and a single-dose vial of adjuvant suspension component (liquid) (packaged without syringes or needles).

Cap and Label Color (For vials)

AREXVY is supplied in 2 vials that must be reconstituted prior to administration. Vial 1 is an adjuvant suspension component (liquid) with a brown flip cap and gold metal skirt. Vial 2 is a Lyophilized antigen component (powder) in a mustard flip cap and silver (clear) metal skirt.

Doses

AREXVY
How the vaccine is supplied Single-dose vials
Number of doses per vial N/A
Dosage
For injectable suspension. AREXVY is supplied as a single-dose vial of lyophilized antigen component to be reconstituted with the accompanying vial of adjuvant suspension component. A single dose after reconstitution is 0.5 mL.
Dose volume 0.5 mL
Reconstitution Yes

Shelf Life

Shelf Life GSK
Unopened, frozen vaccine Do not freeze. Discard if the vaccine has been frozen.
Unopened, refrigerated vaccine The shelf life may vary based on when the vaccine is received by the end user. It also varies for the 2 components of AREXVY:
  • Antigen component: 24 months from time of manufacturing
  • Adjuvant component: 36 months from time of manufacturing
Opened, refrigerated vaccine Administer immediately or store in the refrigerator between 2°C and 8°C (36°F to 46°F) or at room temperature [up to 25°C (77°F)] for up to 4 hours prior to use.
Opened, room temperature vaccine Administer immediately or store in the refrigerator between 2°C and 8°C (36°F to 46°F) or at room temperature [up to 25°C (77°F)] for up to 4 hours prior to use.

Additional Information

Date of FDA authorization: May 3, 2023

Currently available

Temperature excursions between 1.5°C to 8.4°C can be rounded to 2°C to 8°C.

Temperature excursion guidance