Arexvy: first RSV vaccine for older adults expected to be available this fall

GlaxoSmithKline expects to introduce the first respiratory syncytial virus (RSV) vaccine for older adults this fall, before the start of the RSV season. Arexvy (respiratory syncytial virus vaccine, recombinant, AS01E adjuvanted) contains 120 µg RSV glycoprotein F (RSVPreF3) antigen per 0.5 mL. One vial of lyophilized antigen powder must be reconstituted with one vial of adjuvant suspension to form a reconstituted suspension for intramuscular injection.1 Arexvy is indicated for the prevention of lower respiratory tract disease caused by RSV in adults ≥ 60 years of age. The recommended dosage is a single 0.5 mL dose of reconstituted vaccine given by intramuscular injection, preferably in the deltoid muscle.1 The most common adverse effects of Arexvy are injection site pain, erythema and/or swelling, fever, chills, fatigue, myalgia, arthralgia, headache and rhinorrhea. Most adverse effects are mild to moderate and resolve within one to two days.1 One case of Guillain-Barré syndrome (GBS) and one case of suspected acute disseminated encephalomyelitis (ADEM) have been reported, but the relationship to vaccination is uncertain.1 Arexvy may be given concomitantly with inactivated quadrivalent seasonal influenza vaccine (standard dose, unadjuvanted), administered at a different injection site. The safety and efficacy of concomitant administration with other vaccines is unknown.1 Arexvy should be stored in a refrigerator (2°C to 8°C), in the original package to protect from light. After reconstitution, the vaccine should be administered promptly or stored in the refrigerator or at room temperature (up to 25°C) for a maximum of four hours.1 The National Advisory Committee on Immunization (NACI) is currently reviewing Arexvy and the Committee’s recommendations are forthcoming.2 In the United States, the Advisory Committee on Immunization Practices (ACIP) has reviewed the safety, immunogenicity and efficacy of RSV vaccines (Arexvy–GSK and an RSV vaccine by Pfizer that is under consideration by Health Canada) in older adults (≥ 60 years of age). The ACIP concluded that these RSV vaccines have demonstrated moderate to high efficacy in preventing RSV-associated lower respiratory tract disease and have the potential to prevent substantial morbidity and mortality among older adults. The ACIP recommends that adults aged ≥ 60 years may receive a single dose of RSV vaccine, using shared clinical decision-making. The ACIP also indicated that postmarketing surveillance will direct future guidance. The US Centers for Disease Control will monitor adverse events, including cases of GBS, ADEM and other inflammatory neurologic events after RSV vaccination.3 References 1. GlaxoSmithKline Inc. Arexvy (respiratory syncytial virus vaccine, recombinant, AS01E adjuvanted) product monograph. Mississauga, ON; August 4, 2023. (accessed August 31, 2023). 2. Government of Canada. Respiratory syncytial virus (RSV): Canadian Immunization Guide. For health professionals–notice. (accessed August 31, 2023). 3. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices — United States, 2023. MMWR Morb Mortal Wkly Rep 2023;72:793-801. (accessed August 31, 2023).

Arexvy: first RSV vaccine for older adults expected to be available this fall

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