bivalent prefusion-stabilized F glycoprotein RSV vaccine; RSVpreF vaccine (Arexvy, Abrysvo)
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Introduction
Tradename: Arexvy, Abrysvo (FDA-approved May 2023)[4]
Indications
- prevention of respiratory syncytial virus (RSV) infection
- in elderly (86% vaccine efficacy)[5]
- 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]
- may prevent severe RSV in infants
- 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]
Contraindications
* safe & effective to administer RSV vaccine & influenza vaccine at same time[9]
Dosage
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
- 5 cases/million doses Abrysvo & 1.5 cases/million doses Arexvy[11]
- delayed allergic reactions
- Guillain-Barre syndrome, Miller-Fisher syndrome
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
More general terms
References
- ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/36791161 https://www.nejm.org/doi/full/10.1056/NEJMoa2207566
- ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/36791160 https://www.nejm.org/doi/full/10.1056/NEJMoa2209604
- ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/37018468 https://www.nejm.org/doi/full/10.1056/NEJMoa2213836
- ↑ 4.0 4.1 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 - ↑ 5.0 5.1 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: https://www.ncbi.nlm.nih.gov/pubmed/3701846 https://www.nejm.org/doi/10.1056/NEJMoa2213836
- ↑ 6.0 6.1 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: https://www.ncbi.nlm.nih.gov/pubmed/37018474 https://www.nejm.org/doi/10.1056/NEJMoa2216480
- ↑ 7.0 7.1 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
- ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/38091530 Clinical Trial. https://www.nejm.org/doi/10.1056/NEJMoa2307079
- ↑ 9.0 9.1 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: https://www.ncbi.nlm.nih.gov/pubmed/37992000
- ↑ 10.0 10.1 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: https://www.ncbi.nlm.nih.gov/pubmed/38477988 https://www.nejm.org/doi/10.1056/NEJMoa2305478
- ↑ 11.0 11.1 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
- ↑ 12.0 12.1 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: https://www.ncbi.nlm.nih.gov/pubmed/38801826 https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(24)00226-3/abstract
- ↑ 13.0 13.1 Surie D et al. RSV vaccine effectiveness against hospitalization among US adults 60 years and older. JAMA 2024 Sep 4; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/39230920 PMCID: PMC11375516 (available on 2025-03-04) https://jamanetwork.com/journals/jama/fullarticle/2823011
- ↑ 14.0 14.1 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
Patient information
respiratory syncitial virus (RSV) vaccine patient information