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bivalent prefusion-stabilized F glycoprotein RSV vaccine; RSVpreF vaccine (Arexvy, Abrysvo)

Tradename: Arexvy, Abrysvo (FDA-approved May 2023) [4] - RSV pre-fusion F glycoprotein mRNA 0.1 MG/ML Prefilled Syringe (Mresvia) Indications: - prevention of respiratory syncytial virus (RSV) infection - in elderly (86% vaccine efficacy) [5] - RSV vaccine effective against hospitalization among US adults >= 60 years [13] - in infants of pregnant mothers [6] - may prevent severe RSV in infants - vaccine efficacy 82% at 90 days, 69% at 180 days - may not prevent RSV that is not severe - vaccine efficacy 57% at 90 days, 51% at 180 days* - reduces RSV-associated lower respiratory tract disease in infants but increases preterm birth rate. [10] - Abrysvo FDA-approved to treat adults 18-59 years at increased risk for RSV [14] * GSK says vaccine provides protection from RSV for 2 seasons [7] * Cypress study says vaccine provides protection from RSV for 3 seasons [12] * immune responses to RSV vaccines fall short in older people with weakened immunity [15] * 77% protective against RSV-related ED visits & 80% against RSV-related hospitalization in adults >= 60 years [17] * 3 year effectiveness in preventing lower RSV infection 83% in season 1 to 48% in season 3 [18] - a second dose did not confer benefit Contraindications: * safe & effective to administer RSV vaccine & influenza vaccine at same time [9] Dosage: - single dose IM (deltoid) Adverse effects: - injection site pain - fatigue - headache - myalgia - arthralgia - no premature delivery for infants of pregnant mothers - in elderly - Guillain-Barre syndrome, Miller-Fisher syndrome - increased risk of Guillain-Barre syndrome (GBS) during the 42 days following vaccination with Abrysvo or Arexvy [16] - 5 cases/million doses Abrysvo & 1.5 cases/million doses Arexvy [11] - delayed allergic reactions Notes: - Glaxo's Arexvy vaccine U.S. FDA approved in May 2023 - Pfizer's U.S. FDA approved in May 2023 - Moderna's mRNA-1345 vaccine

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References

  1. Falsey AR, Williams K, Gymnopoulou E et al Efficacy and Safety of an Ad26.RSV.preF-RSV preF Protein Vaccine in Older Adults. N Engl J Med 2023; 388:609-620 PMID: 36791161 https://www.nejm.org/doi/full/10.1056/NEJMoa2207566
  2. Papi A, Ison MG, Langley JM et al Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med 2023; 388:595-608 PMID: 36791160 https://www.nejm.org/doi/full/10.1056/NEJMoa2209604
  3. Walsh EE, Perez Marc G, Zareba AM et al Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults. N Engl J Med 2023; 388:1465-1477 PMID: 37018468 https://www.nejm.org/doi/full/10.1056/NEJMoa2213836
  4. Moderna. Jan 17, 2023 Moderna Announces mRNA-1345, an Investigational Respiratory Syncytial Virus (RSV) Vaccine, Has Met Primary Efficacy Endpoints in Phase 3 Trial in Older Adults. https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-mRNA-1345-an-Investigational-Respiratory-Syncytial-Virus-RSV-Vaccine-Has-Met-Primary-Efficacy-Endpoints-in-Phase-3-Trial-in-Older-Adults/default.aspx - Ingram I FDA Approves First-Ever RSV Vaccine. Respiratory syncytial virus vaccine indicated for adults 60 and up. MedPage Today May 3, 2023 https://www.medpagetoday.com/infectiousdisease/uritheflu/104319
  5. Walsh EE et al. Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults. N Engl J Med 2023 Apr 20; 388:1465. PMID: 3701846 https://www.nejm.org/doi/10.1056/NEJMoa2213836
  6. Kampmann B et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med 2023 Apr 20; 388:1451. PMID: 37018474 https://www.nejm.org/doi/10.1056/NEJMoa2216480
  7. Constantino AK GSK says RSV vaccine for older adults provides protection over two seasons. CNBC. Health and Science. June 21, 2023 https://www.cnbc.com/2023/06/21/gsk-rsv-vaccine-for-older-adults-provides-long-term-protection.html
  8. Wilson E, Goswami J, Baqui AH et al Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. N Engl J Med. 2023 Dec 14;389(24):2233-2244. PMID: 38091530 Clinical Trial. https://www.nejm.org/doi/10.1056/NEJMoa2307079
  9. Athan E, Baber J, Quan K et al Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered with Seasonal Inactivated Influenza Vaccine in Older Adults. Clin Infect Dis. 2023 Nov 22:ciad707. PMID: 37992000
  10. Dieussaert I, Hyung Kim J, Luik S, et al. RSV Prefusion F Protein-Based Maternal Vaccine - Preterm Birth and Other Outcomes. N Engl J Med. 2024 Mar 14;390(11):1009-1021 PMID: 38477988 https://www.nejm.org/doi/10.1056/NEJMoa2305478
  11. Hause AM, Moro PL, Baggs J et al. Early Safety Findings Among Persons Aged >= 60 Years Who Received a Respiratory Syncytial Virus Vaccine - United States, May 3, 2023-April 14, 2024. MMWR Morb Mortal Wkly Rep 2024;73:489-494 https://www.cdc.gov/mmwr/volumes/73/wr/mm7321a3.htm
  12. Falsey AR, Hosman T, Batian AR et al Long-term efficacy and immunogenicity of Ad26.RSV.preF-RSV preF protein vaccine (CYPRESS): a randomised, double-blind, placebo-controlled, phase 2b study. Lancet Infectious Diseases. 2024. May 24 PMID: 38801826 https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(24)00226-3/abstract
  13. Surie D et al. RSV vaccine effectiveness against hospitalization among US adults 60 years and older. JAMA 2024 Sep 4; [e-pub]. PMID: 39230920 PMCID: PMC11375516 (available on 2025-03-04) https://jamanetwork.com/journals/jama/fullarticle/2823011
  14. Ferruggia K FDA Approves Abrysvo to Treat Adults 18 to 59 Years of Age at Increased Risk for RSV. Pharmacy Times. Oct 23, 2024 https://www.pharmacytimes.com/view/fda-approves-abrysvo-to-treat-adults-18-to-59-years-of-age-at-increased-risk-for-rsv
  15. Karaba AH et al Antibody Response to Respiratory Syncytial Virus Vaccination in Immunocompromised Persons. JAMA. Published online December 30, 2024 Not yet indexed in PubMed https://jamanetwork.com/journals/jama/fullarticle/2828677
  16. FDA Safety Communication. Jan 7, 2025 FDA Requires Guillain-Barre Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and
  17. Payne AB, Watts JA, Mitchell PK et al. Respiratory syncytial virus (RSV) vaccine effectiveness against RSV-associated hospitalisations and emergency department encounters among adults aged 60 years and older in the USA, October, 2023, to March, 2024: A test-negative design analysis. Lancet 2024 Oct 19; 404:1547-1559. PMID: 39426837 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01738-0/abstract
  18. Ison MG et al. Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three respiratory syncytial virus seasons (AReSVi-006): A multicentre, randomised, observer-blinded, placebo-controlled, phase 3 trial. Lancet Respir Med 2025 Jun; 13:517. PMID: 40245915 https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(25)00048-7/abstract - Fry SE et al. Effectiveness and safety of respiratory syncytial virus vaccine for US adults aged 60 years or older. JAMA Netw Open 2025 May 9; 8:e258322 PMID: 40343698 PMCID: PMC12065041 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2833776