RSVPreF3 Antigen-AS01E (PF) Intramuscular
Respiratory syncytial virus (RSV) vaccine, adjuvanted is a recombinant stabilized pre-fusion F protein (RSVpreF3) antigen with an ASO1E adjuvant; the vaccine stimulates active immunity to RSV infection.[1][2]
Brand Name: Arexvy (PF) intramuscular
Class: Vaccines (80:12)
Table of Contents
Uses
Prevention of Lower Respiratory Tract Disease Caused by RSV in Older Adults
RSV vaccine, adjuvanted is used for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals >=60 years of age and in individuals 50-59 years of age who are at increased risk for LRTD caused by RSV.[1]
Clinical Experience
Efficacy of RSV vaccine, adjuvanted in adults >=60 years of age is based principally on a randomized, placebo-controlled, observer-blinded, clinical study (NCT04886596).[1][2] Patients with medically stable chronic medical conditions (e.g., diabetes, hypertension, or cardiac disease) were allowed to participate; however, patients who were immunocompromised due to disease or immunosuppressive treatments were excluded from the study.[1][2] The primary vaccine efficacy endpoint was prevention of a first episode of confirmed RSV A- and/or B-associated LRTD during the first season.[1][2] Lower respiratory symptoms were defined as new or increased sputum, new or increased cough, new or increased dyspnea; lower respiratory signs were defined as new or increased wheezing, crackles/rhonchi, respiratory rate >=20 respirations/minute, low or decreased oxygen saturation (O2saturation <95% or <=90% if baseline is <95%), or need for oxygen supplementation.[1][2] LRTD was defined as at least 2 lower respiratory symptoms/signs, including at least 1 lower respiratory sign for at least 24 hours, or at least 3 lower respiratory symptoms for at least 24 hours.[1][2]
Participants included in the study were randomized to receive either a single dose of RSV vaccine, adjuvanted or placebo.[1][2] The median age of participants was 69 years; 51.7% were female, 79.4% were white, 8.7% were Black, and 7.6% were Asian.[1] At baseline, 39.3% of participants had at least 1 comorbidity of interest; 19.7% of participants had an underlying cardiorespiratory condition (chronic obstructive pulmonary disease, asthma, any chronic respiratory/pulmonary disease, or chronic heart failure) and 25.8% of participants had endocrine and metabolic conditions (diabetes, advanced liver or renal disease).[1] The median duration of efficacy follow-up was 6.7 months.[1][2]
Efficacy data included 2 complete RSV seasons for Northern Hemisphere participants and 1 complete RSV season for Southern Hemisphere participants.[8] Compared to placebo, RSV vaccine, adjuvanted significantly reduced the risk of developing RSV-associated LRTD by 82.6% during the first RSV season and by 56.1% during the second season.[1][2] Vaccine efficacy against RSV A- and RSV B-associated LRTD cases was 84.6 and 80.9%, respectively.[1] Efficacy against RSV-related LRTD was more than 80% among participants 60 to 69 years of age and those 70 to 79 years of age; insufficient cases were available to determine efficacy for patients >=80 years of age.[2] The study was not powered to estimate efficacy against hospitalization, severe RSV illness requiring respiratory support, or death.[2]
The effectiveness of RSV vaccine, adjuvanted in individuals 50 through 59 years of age with chronic medical conditions was assessed by a comparison of RSV neutralizing antibody responses induced by the vaccine in this age group with the antibody responses induced by the vaccine in individuals 60 years of age and older.[1] The neutralizing antibody responses to RSV-A and RSV-B subtypes in individuals 50 through 59 years of age met the criteria for immunobridging; the difference in seroresponse rate was <=10%, which demonstrated noninferiority.[1]
Clinical Perspective
RSV causes respiratory tract infections in individuals of all age groups.[3][4] In older adults, RSV is a common cause of LRTD that can lead to severe disease requiring hospitalization for respiratory support, including supplemental oxygen and/or mechanical ventilation.[4] Infection rates, intensive care unit (ICU) stays, and mortality are similar among older adults hospitalized with respiratory viral infections caused by RSV and influenza.[3] Severity of RSV disease increases with age and comorbidities (e.g., chronic obstructive pulmonary disease, congestive heart failure, asthma).[3]
The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommends that all adults >=75 years of age receive a single dose of RSV vaccine.[8] ACIP also recommends that adults 60-74 years of age who are at increased risk of severe RSV disease receive a single dose of RSV vaccine.[8] Clinical considerations that place these adults at increased risk of severe RSV include chronic lung or respiratory disease, chronic cardiovascular disease, moderate or severe immune compromise, diabetes mellitus with end-organ damage, severe obesity (BMI >=40 kg/m2), neurologic or neuromuscular conditions causing impaired airway clearance or respiratory muscle weakness, advanced chronic kidney disease, chronic liver disease, chronic hematologic disorders, residence in a nursing home, and other chronic medical conditions that a healthcare provider determines increases risk of severe disease due to respiratory infection.[8] ACIP is continuing to evaluate recommendations for the use of RSV vaccines in adults <60 years of age pending additional data in this population.[9]
Dosage And Administration
General
Dispensing and Administration Precautions
Appropriate medications and supplies for managing allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following vaccine administration.[1][5]Syncope may occur following administration of injectable vaccines.[1][5] Procedures should be in place to avoid injury from fainting; if syncope develops, patients should be observed until the symptoms resolve.[1][5]
Administration
IM Administration
Respiratory syncytial virus (RSV) vaccine, adjuvanted suspension for injection is administered only by IM injection.[1] IM injections should preferably be made into the deltoid muscle.[2][5]
The vaccine preparation is supplied as a single-dose vial of lyophilized antigen component to be reconstituted with a vial of adjuvant suspension component.[1] Prepare the vaccine by reconstituting the lyophilized antigen component (sterile white powder) with the accompanying adjuvant suspension component (opalescent, colorless to pale brownish sterile liquid).[1] Use only the supplied adjuvant suspension component for reconstitution.[1] Using aseptic technique, withdraw the entire contents of the vial containing the adjuvant suspension component (liquid) with a sterile needle and syringe.[1] Slowly transfer entire contents of the syringe into the lyophilized antigen component vial.[1] Gently swirl the vial until the powder is completely dissolved; do not shake vigorously.[1] The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid and should not be used if it is discolored or contains particulates.[1] After reconstitution, administer the vaccine immediately or store under refrigeration (2-8°C) or at room temperature (up to 25oC); protect from light and use within 4 hours.[1] Discard the reconstituted vaccine if not used within 4 hours.[1]
To administer a dose of the vaccine, withdraw 0.5 mL of reconstituted vaccine for IM injection.[1]
RSV vaccine, adjuvanted lyophilized antigen and adjuvant suspension component vials should be stored at 2-8°C in the original carton, protected from light, prior to use.[1] Do not freeze.[1]
Dosage
Adult Dosage
Prevention of Lower Respiratory Tract Disease Caused by RSV in Older Adults
For the prevention of lower respiratory tract disease caused by RSV in adults >=60 years of age and adults 50 through 59 years of age at increased risk, a single 0.5 mL dose of RSV vaccine, adjuvanted should be administered by IM injection.[1]
Cautions
Contraindications
History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.[1]
Warnings/Precautions
Preventing and Managing Allergic Vaccine Reactions
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of RSV vaccine, adjuvanted.[1]
Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines, including RSV vaccine, adjuvanted.[1] Procedures should be in place to avoid injury from fainting.[1]
Altered Immunocompetence
Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to RSV vaccine, adjuvanted.[1]
Specific Populations
Pregnancy
RSV vaccine, adjuvanted is not approved for use in persons <50 years of age.[1]
In a randomized, controlled trial that enrolled pregnant individuals, preterm births were higher in those who received an investigational unadjuvanted RSV vaccine that contained the same RSVPreF3 antigen as RSV, adjuvanted.[1]
Lactation
RSV vaccine, adjuvanted is not approved for use in persons <50 years of age.[1] It is not known whether the vaccine is distributed into human milk; no human or animal data are available to assess vaccine effects on the breastfed infant or on milk production.[1] The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vaccination and any potential adverse effects on the breastfed child from the vaccine or from the underlying maternal condition (the susceptibility to disease prevented by the vaccine).[1]
Pediatric Use
RSV vaccine, adjuvanted is not approved for use in persons <50 years of age.[1] Evidence from animal models strongly suggests that RSV vaccine, adjuvanted is unsafe in children <2 years of age because of an increased risk of enhanced respiratory disease.[1] Safety and effectiveness of the vaccine in individuals 2 to 17 years of age have not been established.[1]
Geriatric Use
In the principal efficacy study, 55.8% of patients were 60-69 years of age, 36% were 70-79 years of age, and 8.2% were >=80 years of age.[1][2] Efficacy against RSV-related lower respiratory tract disease was 81% among participants 60 to 69 years of age and 93.8% among participants 70 to 79 years of age; insufficient cases were available to determine efficacy in patients >=80 years of age.[1]
Common Adverse Effects
The most common adverse reactions occurring in >=10% of patients 60 years of age and older receiving RSV vaccine, adjuvanted were injection site pain, fatigue, myalgia, headache, and arthralgia.[1]
The most common adverse reactions occurring in >=10% of patients 50 through 59 years of age receiving RSV vaccine, adjuvanted were injection site pain, fatigue, myalgia, headache, arthralgia, erythema, and swelling.[1]
Drug Interactions
Influenza Vaccine
In an open-label study, participants >=60 years of age received a single dose of RSV vaccine, adjuvanted (Arexvy®) and quadrivalent influenza virus vaccine inactivated (Fluarix®) simultaneously or separated by 1 month.[1] There was no evidence of interference in the immune response to any of the antigens contained in both concomitantly administered vaccines.[1] Data are not available for concomitant administration with other vaccines.[1]
Description
Respiratory syncytial virus vaccine, adjuvanted is a recombinant RSV glycoprotein F stabilized in pre-fusion conformation (RSVPreF3) with AS01E adjuvant.[1] The AS01E-based adjuvant is composed of 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota and QS-21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation.[1]
Respiratory syncytial virus vaccine, adjuvanted stimulates an immune response against RSVPreF3 to protect against lower respiratory tract disease (LRTD) caused by RSV.[1] RSV F glycoprotein (pre-fusion and post-fusion) mediates viral fusion and host-cell entry, elicits neutralizing antibodies, and is highly conserved across the 2 RSV subtypes (A and B).[2] In animal studies, significantly higher neutralizing activity occurred following immunization with pre-fusion forms of the F protein antigen compared to post-fusion forms.[2] Following vaccination with AS01E-adjuvanted formulations, RSV-specific CD4+ T-cell frequencies increased in older adults to similar levels to those observed in young adults.[2]
Advice To Patients
Advise patients of the potential benefits and risks of respiratory syncytial virus (RSV) vaccine, adjuvanted vaccination.[1]Advise patients about the potential for adverse reactions that have been observed following vaccine administration.[1]Provide the Vaccine Information Statements, which are available free of charge at the Centers for Disease Control and Prevention (CDC) website (https://www.cdc.gov/vaccines/hcp/vis/).[1]Clinicians or individuals can report any adverse reactions that occur following vaccination to the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or https://vaers.hhs.gov/.[1]Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.[1]Advise patients to inform their clinician if they are or plan to become pregnant or plan to breast-feed.[1]Inform patients of other important precautionary information.[1]
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
| Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
| Parenteral | Injectable suspension, for IM use only | Each 0.5 mL contains 120 mcg of recombinant respiratory syncytial virus glycoprotein F stabilized in pre-fusion conformation (RSVPreF3) antigen | Arexvy® (Supplied as a single-dose vial of lyophilized antigen component to be reconstituted with accompanying vial of adjuvant suspension component)) | GlaxoSmithKline |
Only references cited for selected revisions after 1984 are available electronically.
1. GlaxoSmithKline Biologicals SA. Arexvy®(Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted) prescribing information. Durham, NC; 2024 Aug. (https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1e50f275-002e-413f-a840-66ee3cb3740c&type=display)
2. Papi A, Ison MG, Langley JM, et al.; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):595-608. (PubMed: 36791160)
3. Kodama F, Nace DA, Jump RLP. Respiratory Syncytial Virus and Other Noninfluenza Respiratory Viruses in Older Adults. Infect Dis Clin North Am. 2017 Dec;31(4):767-790. (PubMed: 29079159) (DOI: 10.1016/j.idc.2017.07.006)
4. US Food and Drug Administration. Center for Biologics Evaluation and Research. Submission tracking number (STN): 125775: BLA Clinical review memorandum. From FDA website. Accessed 2023 Jun 13. (https://cacmap.fda.gov/vaccines-blood-biologics/arexvy)
5. Kroger A, Bahta L, Hunter P. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). Accessed on 2023 Jun 26. (https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf)
8. Britton A, Roper LE, Kotton CN, et al. Use of Respiratory Syncytial Virus Vaccines in Adults Aged >=60 Years: Updated Recommendations of the Advisory Committee on Immunization Practices -- United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:696-702.. (https://www.cdc.gov/mmwr/volumes/73/wr/mm7332e1.htm?s_cid=mm7332e1_w)
9. Melgar M, Britton A. Center for Disease Control and Prevention. RSV vaccination in adults: ACIP work group interpretations. October 24, 2024.
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