{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T00:18:00Z","timestamp":1792282680970,"version":"4.4.0"},"reference-count":92,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2025,1,21]],"date-time":"2025-01-21T00:00:00Z","timestamp":1737417600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.mdpi.com"],"crossmark-restriction":true},"short-container-title":["Vaccines"],"abstract":"<jats:p>Respiratory syncytial virus (RSV) causes significant morbidity and mortality, especially in young children and the elderly. RSV vaccine development puzzled vaccinologists for years. Safety concerns of initial formulations, the lack of an absolute correlate of protection, and the need for selecting appropriate virus attenuation and antigen\u2013adjuvant combinations contributed to delayed vaccine production. The recent stabilization of the RSV-F glycoprotein in the prefusion (preF) conformation that constitutes the primary target of RSV-neutralizing antibodies was key for efficient vaccine design. Two protein subunit vaccines (GSK\u2019s Arexvy and Pfizer\u2019s Abrysvo) and one mRNA RSV vaccine (Moderna\u2019s mRESVIA) are now available. This article aims to provide a comparative overview of the safety and efficacy of novel RSV vaccines that are approved for the prevention of RSV-lower respiratory tract disease (LRTD) in adults 60 years of age and older, with updated recommendations calling for the expansion of vaccination to all adults at increased risk for severe RSV disease. Abrysvo is the only vaccine indicated for use in pregnancy to prevent RSV-LRTD in infants from birth to 6 months of age. We provide a comparative assessment of the efficacy of approved RSV vaccines over a maximum of three seasons, summarizing currently available data. We conclude that despite the decreasing vaccine efficacy over time, which should be anticipated for a virus that is characterized by short-term immunity, efficacy was clinically meaningful over placebo. The increased risk of Guillain\u2013Barr\u00e9 syndrome post vaccination with Abrysvo or Arexvy, which prompted the FDA to require the inclusion of such warnings in the prescribing information of these two RSV vaccines, should be prioritized and investigated thoroughly. Furthermore, ongoing vaccine surveillance and further evaluation, particularly among immunocompromised patients, frail elderly subjects, and young infants that were under- or not represented in pivotal clinical trials, are necessary. As in the success story of combined pediatric vaccines, combination vaccines, conferring protection against several respiratory illnesses in one dose, could help improve vaccine acceptance and coverage rates in older adults.<\/jats:p>","DOI":"10.3390\/vaccines13020097","type":"journal-article","created":{"date-parts":[[2025,1,21]],"date-time":"2025-01-21T11:47:32Z","timestamp":1737460052000},"page":"97","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":42,"title":["Development, Current Status, and Remaining Challenges for Respiratory Syncytial Virus Vaccines"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7666-9198","authenticated-orcid":false,"given":"Cleo","family":"Anastassopoulou","sequence":"first","affiliation":[{"name":"Department of Microbiology, Medical School, National and Kapodistrian University of Athens, 11527 Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5778-9861","authenticated-orcid":false,"given":"Sne\u017eana","family":"Medi\u0107","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Faculty of Medicine, University of Novi Sad, 21000 Novi Sad, Serbia"},{"name":"Center for Disease Control and Prevention, Institute of Public Health of Vojvodina, 21000 Novi Sad, Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4670-5786","authenticated-orcid":false,"given":"Stefanos","family":"Ferous","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Medical School, National and Kapodistrian University of Athens, 11527 Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9691-9465","authenticated-orcid":false,"given":"Fotini","family":"Boufidou","sequence":"additional","affiliation":[{"name":"Neurochemistry and Biological Markers Unit, 1st Department of Neurology, Eginition Hospital, Medical School, National and Kapodistrian University of Athens, 11528 Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0656-4715","authenticated-orcid":false,"given":"Athanasios","family":"Tsakris","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Medical School, National and Kapodistrian University of Athens, 11527 Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,1,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"138","DOI":"10.1038\/s41541-023-00734-7","article-title":"The road to approved vaccines for respiratory syncytial virus","volume":"8","author":"Ruckwardt","year":"2023","journal-title":"NPJ Vaccines"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"2912","DOI":"10.1099\/jgv.0.000959","article-title":"ICTV Virus Taxonomy Profile: Pneumoviridae","volume":"98","author":"Rima","year":"2017","journal-title":"J. Gen. Virol."},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Bose, M.E., He, J., Shrivastava, S., Nelson, M.I., Bera, J., Halpin, R.A., Town, C.D., Lorenzi, H.A., Noyola, D.E., and Falcone, V. (2015). Sequencing and analysis of globally obtained human respiratory syncytial virus A and B genomes. PLoS ONE, 10.","DOI":"10.1371\/journal.pone.0120098"},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Shishir, T.A., Saha, O., Rajia, S., Mondol, S.M., Masum, H.U., Rahaman, M., Hossen, F., Bahadur, N.M., Ahmed, F., and Bin Naser, I. (2023). Genome-wide study of globally distributed respiratory syncytial virus (RSV) strains implicates diversification utilizing phylodynamics and mutational analysis. Sci. Rep., 13.","DOI":"10.1038\/s41598-023-40760-y"},{"key":"ref_5","first-page":"20499361221128091","article-title":"Clinical and biological consequences of respiratory syncytial virus genetic diversity","volume":"9","author":"Hultquist","year":"2022","journal-title":"Ther. Adv. Infect. Dis."},{"key":"ref_6","doi-asserted-by":"crossref","unstructured":"Hause, A.M., Henke, D.M., Avadhanula, V., Shaw, C.A., Tapia, L.I., and Piedra, P.A. (2017). Sequence variability of the respiratory syncytial virus (RSV) fusion gene among contemporary and historical genotypes of RSV\/A and RSV\/B. PLoS ONE, 12.","DOI":"10.1371\/journal.pone.0180623"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1113","DOI":"10.1126\/science.1234914","article-title":"Structure of RSV fusion glycoprotein trimer bound to a prefusion-specific neutralizing antibody","volume":"340","author":"McLellan","year":"2013","journal-title":"Science"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"eaaj1879","DOI":"10.1126\/sciimmunol.aaj1879","article-title":"Rapid profiling of RSV antibody repertoires from the memory B cells of naturally infected adult donors","volume":"1","author":"Gilman","year":"2016","journal-title":"Sci. Immunol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"339","DOI":"10.1016\/j.immuni.2018.01.005","article-title":"Infants Infected with Respiratory Syncytial Virus Generate Potent Neutralizing Antibodies that Lack Somatic Hypermutation","volume":"48","author":"Goodwin","year":"2018","journal-title":"Immunity"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"769","DOI":"10.1016\/j.immuni.2021.03.004","article-title":"Vaccination with prefusion-stabilized respiratory syncytial virus fusion protein induces genetically and antigenically diverse antibody responses","volume":"54","author":"Mukhamedova","year":"2021","journal-title":"Immunity"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"2047","DOI":"10.1016\/S0140-6736(22)00478-0","article-title":"Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: A systematic analysis","volume":"399","author":"Li","year":"2022","journal-title":"Lancet"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"S229","DOI":"10.1093\/cid\/ciab528","article-title":"Global Respiratory Syncytial Virus-Related Infant Community Deaths","volume":"73","author":"Mazur","year":"2021","journal-title":"Clin. Infect. Dis."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"e13031","DOI":"10.1111\/irv.13031","article-title":"Respiratory syncytial virus disease burden in adults aged 60 years and over older in high-income countries: A systematic literature review and meta-analysis","volume":"17","author":"Savic","year":"2023","journal-title":"Influenza Other Respir. Viruses"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"ofac300","DOI":"10.1093\/ofid\/ofac300","article-title":"Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis","volume":"9","author":"McLaughlin","year":"2022","journal-title":"Open Forum Infect. Dis."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"405","DOI":"10.1093\/oxfordjournals.aje.a120954","article-title":"An epidemiologic study of altered clinical reactivity to respiratory syncytial (RS) virus infection in children previously vaccinated with an inactivated RS virus vaccine","volume":"89","author":"Kapikian","year":"1969","journal-title":"Am. J. Epidemiol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"422","DOI":"10.1093\/oxfordjournals.aje.a120955","article-title":"Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine","volume":"89","author":"Kim","year":"1969","journal-title":"Am. J. Epidemiol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"298","DOI":"10.1128\/CMR.12.2.298","article-title":"Respiratory syncytial virus infection: Immune response, immunopathogenesis, and treatment","volume":"12","author":"Domachowske","year":"1999","journal-title":"Clin. Microbiol. Rev."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"599","DOI":"10.1203\/PDR.0b013e318175d0ff","article-title":"RSV infection\u2014An immune balancing act: Commentary on the article by Bem et al","volume":"63","author":"Verbsky","year":"2008","journal-title":"Pediatr. Res."},{"key":"ref_19","doi-asserted-by":"crossref","unstructured":"Anastassopoulou, C., Ferous, S., Medi\u0107, S., Siafakas, N., Boufidou, F., Gioula, G., and Tsakris, A. (2024). Vaccines for the Elderly and Vaccination Programs in Europe and the United States. Vaccines, 12.","DOI":"10.3390\/vaccines12060566"},{"key":"ref_20","unstructured":"Centers for Disease Control and Prevention (CDC) (2024, July 17). Respiratory Syncytial Virus Infection (RSV) (2024). [Internet], Available online: https:\/\/www.cdc.gov\/rsv\/causes\/index.html."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"487","DOI":"10.1007\/s40266-024-01118-9","article-title":"Respiratory Syncytial Virus Infection in Older Adults: An Update","volume":"41","author":"Alfano","year":"2024","journal-title":"Drugs Aging"},{"key":"ref_22","unstructured":"Jain, H., Schweitzer, J.W., and Justice, N.A. (2024, September 05). Respiratory Syncytial Virus Infection in Children. [Updated 2023 Jun 20], StatPearls [Internet], Available online: https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK459215\/."},{"key":"ref_23","first-page":"e36342","article-title":"Respiratory Syncytial Virus: A Comprehensive Review of Transmission, Pathophysiology, and Manifestation","volume":"15","author":"Kaler","year":"2023","journal-title":"Cureus"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"379","DOI":"10.1097\/QCO.0000000000000952","article-title":"The disease burden of respiratory syncytial virus in Infants","volume":"36","author":"Munro","year":"2023","journal-title":"Curr. Opin. Infect. Dis."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"528","DOI":"10.1038\/s41579-021-00535-6","article-title":"Transmissibility and transmission of respiratory viruses","volume":"19","author":"Leung","year":"2021","journal-title":"Nat. Rev. Microbiol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"S688","DOI":"10.1093\/infdis\/jiaa424","article-title":"Estimating Transmission Parameters for Respiratory Syncytial Virus and Predicting the Impact of Maternal and Pediatric Vaccination","volume":"222","author":"Teirlinck","year":"2020","journal-title":"J. Infect. Dis."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"2100619","DOI":"10.2807\/1560-7917.ES.2022.27.16.2100619","article-title":"Seasonality of respiratory syncytial virus and its association with meteorological factors in 13 European countries, week 40 2010 to week 39 2019","volume":"27","author":"Li","year":"2022","journal-title":"Euro Surveill."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"1663","DOI":"10.1016\/S0140-6736(22)01277-6","article-title":"Preparing for uncertainty: Endemic paediatric viral illnesses after COVID-19 pandemic disruption","volume":"400","author":"Messacar","year":"2022","journal-title":"Lancet"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"2095","DOI":"10.1093\/infdis\/jiac357","article-title":"Interactions Between Severe Acute Respiratory Syndrome Coronavirus 2 Replication and Major Respiratory Viruses in Human Nasal Epithelium","volume":"226","author":"Pizzorno","year":"2022","journal-title":"J. Infect. Dis."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"661","DOI":"10.2147\/IDR.S396434","article-title":"The Impact of the COVID-19 Pandemic on Respiratory Syncytial Virus Infection: A Narrative Review","volume":"16","author":"Chuang","year":"2023","journal-title":"Infect. Drug Resist."},{"key":"ref_31","doi-asserted-by":"crossref","unstructured":"Piralla, A., Chen, Z., and Zaraket, H. (2023). An update on respiratory syncytial virus. BMC Infect. Dis., 23.","DOI":"10.1186\/s12879-023-08730-x"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"418","DOI":"10.1016\/j.idnow.2021.05.004","article-title":"Pediatric Infectious Disease Group (GPIP) position paper on the immune debt of the COVID-19 pandemic in childhood, how can we fill the immunity gap?","volume":"51","author":"Cohen","year":"2021","journal-title":"Infect. Dis. Now."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"1539","DOI":"10.1093\/infdis\/jiad189","article-title":"Estimation of the number of respiratory syncytial virus-associated hospitalizations in adults in the European Union","volume":"228","author":"Spreeuwenberg","year":"2023","journal-title":"J. Infect. Dis."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"S103","DOI":"10.1093\/jpids\/piae027","article-title":"A Historical Perspective on Respiratory Syncytial Virus Prevention: A Journey Spanning Over Half a Century From the Setback of an Inactive Vaccine Candidate to the Success of Passive Immunization Strategy","volume":"13","author":"Noor","year":"2024","journal-title":"J. Pediatr. Infect. Dis. Soc."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1038\/nm.1894","article-title":"Lack of antibody affinity maturation due to poor Toll-like receptor stimulation leads to enhanced respiratory syncytial virus disease","volume":"15","author":"Delgado","year":"2009","journal-title":"Nat. Med."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1038\/nm0109-21","article-title":"Fixing a failed vaccine","volume":"15","author":"Varga","year":"2009","journal-title":"Nat. Med."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"429","DOI":"10.1016\/j.immuni.2019.08.007","article-title":"Immunological Lessons from Respiratory Syncytial Virus Vaccine Development","volume":"51","author":"Ruckwardt","year":"2019","journal-title":"Immunity"},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"e295","DOI":"10.1016\/S1473-3099(18)30292-5","article-title":"The respiratory syncytial virus vaccine landscape: Lessons from the graveyard and promising candidates","volume":"18","author":"Mazur","year":"2018","journal-title":"Lancet Infect. Dis."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"1679","DOI":"10.1093\/infdis\/jiu075","article-title":"Protecting the family to protect the child: Vaccination strategy guided by RSV transmission dynamics","volume":"209","author":"Graham","year":"2014","journal-title":"J. Infect. Dis."},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"e4223","DOI":"10.1093\/cid\/ciaa1866","article-title":"Reinfection with SARS-CoV-2: Implications for vaccines","volume":"73","author":"Cohen","year":"2021","journal-title":"Clin. Infect. Dis."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"100453","DOI":"10.1016\/j.lanepe.2022.100453","article-title":"Risk and severity of SARS-CoV-2 reinfections during 2020-2022 in Vojvodina, Serbia: A population-level observational study","volume":"20","author":"Anastassopoulou","year":"2022","journal-title":"Lancet Reg. Health Eur."},{"key":"ref_42","doi-asserted-by":"crossref","first-page":"e2255779","DOI":"10.1001\/jamanetworkopen.2022.55779","article-title":"Incidence, Risk, and Severity of SARS-CoV-2 Reinfections in Children and Adolescents Between March 2020 and July 2022 in Serbia","volume":"6","author":"Medic","year":"2023","journal-title":"JAMA Netw. Open"},{"key":"ref_43","doi-asserted-by":"crossref","unstructured":"Nduaguba, S.O., Tran, P.T., Choi, Y., and Winterstein, A.G. (2023). Respiratory syncytial virus reinfections among infants and young children in the United States, 2011\u20132019. PLoS ONE, 18.","DOI":"10.1371\/journal.pone.0281555"},{"key":"ref_44","doi-asserted-by":"crossref","unstructured":"Stephens, L.M., and Varga, S.M. (2021). Considerations for a Respiratory Syncytial Virus Vaccine Targeting an Elderly Population. Vaccines, 9.","DOI":"10.3390\/vaccines9060624"},{"key":"ref_45","doi-asserted-by":"crossref","first-page":"573","DOI":"10.1038\/nbt.1635","article-title":"Rationalizing the development of live attenuated virus vaccines","volume":"28","author":"Lauring","year":"2010","journal-title":"Nat. Biotechnol."},{"key":"ref_46","first-page":"259","article-title":"Live-attenuated respiratory syncytial virus vaccines","volume":"372","author":"Karron","year":"2013","journal-title":"Curr. Top. Microbiol. Immunol."},{"key":"ref_47","doi-asserted-by":"crossref","first-page":"1415","DOI":"10.1586\/erv.11.120","article-title":"Respiratory syncytial virus vaccine development","volume":"10","author":"Hurwitz","year":"2011","journal-title":"Expert. Rev. Vaccines"},{"key":"ref_48","doi-asserted-by":"crossref","first-page":"592","DOI":"10.1126\/science.1243283","article-title":"Structure-based design of a fusion glycoprotein vaccine for respiratory syncytial virus","volume":"342","author":"McLellan","year":"2013","journal-title":"Science"},{"key":"ref_49","doi-asserted-by":"crossref","first-page":"e00176-17","DOI":"10.1128\/JVI.00176-17","article-title":"Discovery of a Prefusion Respiratory Syncytial Virus F-Specific Monoclonal Antibody That Provides Greater In Vivo Protection than the Murine Precursor of Palivizumab","volume":"91","author":"Zhao","year":"2017","journal-title":"J. Virol."},{"key":"ref_50","doi-asserted-by":"crossref","first-page":"696","DOI":"10.15585\/mmwr.mm7332e1","article-title":"Use of Respiratory Syncytial Virus Vaccines in Adults Aged \u2265 60 Years: Updated Recommendations of the Advisory Committee on Immunization Practices\u2014United States, 2024","volume":"73","author":"Britton","year":"2024","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_51","unstructured":"(2024, November 30). GSK, 8 October 2024, London UK. GSK Presents Positive Data for Arexvy, Its Respiratory Syncytial Virus (RSV) Vaccine, Indicating Protection over Three RSV Seasons. Available online: https:\/\/www.gsk.com\/en-gb\/media\/press-releases\/gsk-presents-positive-data-for-arexvy-its-rsv-vaccine-indicating-protection-over-three-rsv-seasons\/."},{"key":"ref_52","doi-asserted-by":"crossref","first-page":"1459","DOI":"10.1056\/NEJMc2311560","article-title":"RENOIR Trial\u2014RSVpreF Vaccine Efficacy over Two Seasons","volume":"391","author":"Walsh","year":"2024","journal-title":"N. Engl. J. Med."},{"key":"ref_53","unstructured":"Das, R. (2024, January 26\u201328). Update on Moderna\u2019s RSV Vaccine, mRESVIA (mRNA-1345), in Adults \u2265 60 Years of Age [Presentation Slides]. Proceedings of the Advisory Committee on Immunization Practices meeting, Atlanta, GA, USA. Available online: https:\/\/www.cdc.gov\/acip\/downloads\/slides-2024-06-26-28\/06-RSV-Adult-Lloyd-508.pdf."},{"key":"ref_54","unstructured":"European Medicines Agency (2024, November 30). European Public Assessment Report (EPAR)-mRESVIA. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/mresvia-epar-product-information_en.pdf."},{"key":"ref_55","doi-asserted-by":"crossref","first-page":"595","DOI":"10.1056\/NEJMoa2209604","article-title":"Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults","volume":"388","author":"Papi","year":"2023","journal-title":"N. Engl. J. Med."},{"key":"ref_56","unstructured":"Food and Drug Administration (2024, November 30). Approval Letter: Arexvy. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration, Available online: https:\/\/www.fda.gov\/media\/167806\/download."},{"key":"ref_57","unstructured":"European Medicines Agency (2024, November 30). European Public Assessment Report (EPAR)-Arexvy. Available online: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/arexvy."},{"key":"ref_58","doi-asserted-by":"crossref","first-page":"761","DOI":"10.1093\/infdis\/jiac327","article-title":"Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1\/2 Randomized Clinical Trial","volume":"227","author":"Davis","year":"2023","journal-title":"J. Infect. Dis."},{"key":"ref_59","doi-asserted-by":"crossref","first-page":"489","DOI":"10.15585\/mmwr.mm7321a3","article-title":"Early Safety Findings Among Persons Aged \u2265 60 Years Who Received a Respiratory Syncytial Virus Vaccine\u2014United States, May 3, 2023-April 14, 2024","volume":"73","author":"Hause","year":"2024","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_60","doi-asserted-by":"crossref","first-page":"e13236","DOI":"10.1111\/irv.13236","article-title":"The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus-associated disease in breakthrough infections in adults \u2265 60\u2009years of age","volume":"18","author":"Curran","year":"2024","journal-title":"Influenza Other Respir. Viruses."},{"key":"ref_61","doi-asserted-by":"crossref","first-page":"1732","DOI":"10.1093\/cid\/ciae010","article-title":"Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons","volume":"78","author":"Ison","year":"2024","journal-title":"Clin. Infect. Dis."},{"key":"ref_62","unstructured":"Lloyd, P. (2024, January 26\u201328). Evaluation of Guillain-Barre Syndrome (GBS) Following RSV Vaccination Among Adults 65 Years and Older [Presentation Slides]. Proceedings of the Advisory Committee on Immunization Practices Meeting, Atlanta, GA, USA. Available online: https:\/\/www.cdc.gov\/acip\/downloads\/slides-2024-06-26-28\/04-RSV-Adult-Das-508.pdf."},{"key":"ref_63","doi-asserted-by":"crossref","first-page":"1009","DOI":"10.1056\/NEJMoa2305478","article-title":"RSV Prefusion F Protein-Based Maternal Vaccine\u2014Preterm Birth and Other Outcomes","volume":"390","author":"Dieussaert","year":"2024","journal-title":"N. Engl. J. Med."},{"key":"ref_64","unstructured":"Food and Drug Administration (2024, November 30). Approval Letter: Abrysvo. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration, Available online: https:\/\/www.fda.gov\/media\/168890\/download."},{"key":"ref_65","unstructured":"European Medicines Agency (2024, November 30). European Public Assessment Report (EPAR)-Abrysvo. Available online: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/abrysvo."},{"key":"ref_66","doi-asserted-by":"crossref","first-page":"1357","DOI":"10.1093\/infdis\/jiab612","article-title":"A Randomized Phase 1\/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine","volume":"225","author":"Walsh","year":"2022","journal-title":"J. Infect. Dis."},{"key":"ref_67","doi-asserted-by":"crossref","first-page":"2054","DOI":"10.1093\/infdis\/jiac189","article-title":"A Phase 1\/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine with and Without Adjuvant in Healthy Older Adults","volume":"226","author":"Baber","year":"2022","journal-title":"J. Infect. Dis."},{"key":"ref_68","doi-asserted-by":"crossref","first-page":"2377","DOI":"10.1056\/NEJMoa2116154","article-title":"Vaccine Efficacy in Adults in a Respiratory Syncytial Virus Challenge Study","volume":"386","author":"Zareba","year":"2022","journal-title":"N. Engl. J. Med."},{"key":"ref_69","doi-asserted-by":"crossref","first-page":"1465","DOI":"10.1056\/NEJMoa2213836","article-title":"Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults","volume":"388","author":"Walsh","year":"2023","journal-title":"N. Engl. J. Med."},{"key":"ref_70","doi-asserted-by":"crossref","first-page":"1105","DOI":"10.1001\/jama.2024.15775","article-title":"Investigating Respiratory Viruses in the Acutely Ill (IVY) Network. RSV Vaccine Effectiveness Against Hospitalization Among US Adults 60 Years and Older","volume":"332","author":"Surie","year":"2024","journal-title":"JAMA"},{"key":"ref_71","doi-asserted-by":"crossref","first-page":"1615","DOI":"10.1056\/NEJMoa2106062","article-title":"Prefusion F Protein-Based Respiratory Syncytial Virus Immunization in Pregnancy","volume":"386","author":"Center","year":"2022","journal-title":"N. Engl. J. Med."},{"key":"ref_72","doi-asserted-by":"crossref","first-page":"1451","DOI":"10.1056\/NEJMoa2216480","article-title":"Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants","volume":"388","author":"Kampmann","year":"2023","journal-title":"N. Engl. J. Med."},{"key":"ref_73","unstructured":"(2024, September 14). FDA Abrysvo, Available online: https:\/\/www.fda.gov\/media\/168889\/download."},{"key":"ref_74","unstructured":"Food and Drug Administration (2024, September 14). Approval Letter: mRESVIA. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration, Available online: https:\/\/www.fda.gov\/media\/179015\/download."},{"key":"ref_75","doi-asserted-by":"crossref","first-page":"2233","DOI":"10.1056\/NEJMoa2307079","article-title":"Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults","volume":"389","author":"Wilson","year":"2023","journal-title":"N. Engl. J. Med."},{"key":"ref_76","doi-asserted-by":"crossref","first-page":"ofac492.312","DOI":"10.1093\/ofid\/ofac492.312","article-title":"234. Safety and immunogenicity of mRNA-1345, an mRNA-Based RSV vaccine in younger and older adult cohorts: Results from a phase 1, randomized clinical trial","volume":"9","author":"Chen","year":"2022","journal-title":"Open Forum Infect. Dis."},{"key":"ref_77","doi-asserted-by":"crossref","first-page":"136","DOI":"10.1016\/j.ijcard.2022.04.024","article-title":"Temporal relationship of myocarditis and pericarditis following COVID-19 vaccination: A pragmatic approach","volume":"358","author":"Anastassopoulou","year":"2022","journal-title":"Int. J. Cardiol."},{"key":"ref_78","doi-asserted-by":"crossref","first-page":"e647","DOI":"10.1093\/infdis\/jiae081","article-title":"Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12-Month Booster in a Phase 1 Clinical Trial in Healthy Older Adults","volume":"230","author":"Shaw","year":"2024","journal-title":"J. Infect. Dis."},{"key":"ref_79","doi-asserted-by":"crossref","first-page":"e996","DOI":"10.1093\/infdis\/jiae316","article-title":"Humoral Immunogenicity of mRNA-1345 RSV Vaccine in Older Adults","volume":"230","author":"Goswami","year":"2024","journal-title":"J. Infect. Dis."},{"key":"ref_80","unstructured":"(2024, November 30). RSV Vaccine Guidance for Older Adults, Available online: https:\/\/www.cdc.gov\/rsv\/hcp\/vaccine-clinical-guidance\/older-adults.html."},{"key":"ref_81","unstructured":"(2024, August 15). Pfizer Announces Top-Line Results of Abrysvo for RSV in Immunocompromised Adults. News Release. Pfizer. Published August 2. Available online: https:\/\/www.businesswire.com\/news\/home\/20240812622927\/en\/Pfizer-Announces-Top-Line-Results-of-ABRYSVO%C2%AE-for-RSV-in-Immunocompromised-Adults."},{"key":"ref_82","doi-asserted-by":"crossref","unstructured":"Alnaimat, F., Sweis, J.J.G., Jansz, J., Modi, Z., Prasad, S., AbuHelal, A., Vagts, C., Hanson, H.A., Ascoli, C., and Novak, R.M. (2023). Vaccination in the Era of Immunosuppression. Vaccines, 11.","DOI":"10.3390\/vaccines11091446"},{"key":"ref_83","doi-asserted-by":"crossref","first-page":"e002456","DOI":"10.1136\/fmch-2023-002456","article-title":"Association of COVID-19 with respiratory syncytial virus (RSV) infections in children aged 0-5 years in the USA in 2022: A multicentre retrospective cohort study","volume":"11","author":"Wang","year":"2023","journal-title":"Fam. Med. Community Health"},{"key":"ref_84","unstructured":"(2024, September 14). AAP Pavilizumab Guidelines. Available online: https:\/\/publications.aap.org\/pediatrics\/article\/152\/1\/e2023061803\/192153\/Palivizumab-Prophylaxis-in-Infants-and-Young."},{"key":"ref_85","unstructured":"(2024, September 14). CDC Nirvesimab, Available online: https:\/\/www.cdc.gov\/mmwr\/volumes\/72\/wr\/mm7234a4.htm."},{"key":"ref_86","doi-asserted-by":"crossref","first-page":"152","DOI":"10.1016\/j.pedneo.2023.04.015","article-title":"Cost-effectiveness of nirsevimab and palivizumab for respiratory syncytial virus prophylaxis in preterm infants 29\u201334 6\/7 weeks\u2019 gestation in the United States","volume":"65","author":"Yu","year":"2024","journal-title":"Pediatr. Neonatol."},{"key":"ref_87","unstructured":"CDC (2024, September 14). RSV Vaccine Guidance for Pregnant People, Available online: https:\/\/www.cdc.gov\/vaccines\/vpd\/rsv\/hcp\/pregnant-people-faqs.html#:~:text=Is%20there%20a%20preferred%20option,to%20the%20infant%20after%20birth."},{"key":"ref_88","unstructured":"CDC (2024, September 14). Emergency Preparedness and Response, Available online: https:\/\/emergency.cdc.gov\/newsletters\/coca\/2024\/012624.html#:~:text=In%20most%20of%20the%20continental,the%20infant%20against%20RSV%2Dassociated."},{"key":"ref_89","doi-asserted-by":"crossref","first-page":"1065","DOI":"10.15585\/mmwr.mm7239a4","article-title":"Influenza, Tdap, and COVID-19 Vaccination Coverage and Hesitancy Among Pregnant Women\u2014United States, April 2023","volume":"72","author":"Razzaghi","year":"2023","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_90","doi-asserted-by":"crossref","unstructured":"Sienicka, A., Pisula, A., Pawlik, K.K., Dobrowolska-Redo, A., Kacperczyk-Bartnik, J., and Romejko-Wolniewicz, E. (2023). The Obstetrician\u2019s Role in Pregnant Women\u2019s Decision-Making Process Regarding Influenza and COVID-19 Vaccination. Vaccines, 11.","DOI":"10.3390\/vaccines11101608"},{"key":"ref_91","doi-asserted-by":"crossref","first-page":"100829","DOI":"10.1016\/j.lanepe.2023.100829","article-title":"Protecting infants against RSV disease: An impact and cost-effectiveness comparison of long-acting monoclonal antibodies and maternal vaccination","volume":"38","author":"Hodgson","year":"2024","journal-title":"Lancet Reg. Health Eur."},{"key":"ref_92","doi-asserted-by":"crossref","first-page":"1880","DOI":"10.1001\/jama.2024.7370","article-title":"Combined Vaccines Against COVID-19, Flu, and Other Respiratory Illnesses Could Soon Be Available","volume":"331","author":"Rubin","year":"2024","journal-title":"JAMA"}],"updated-by":[{"DOI":"10.3390\/vaccines13040354","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2025,1,21]],"date-time":"2025-01-21T00:00:00Z","timestamp":1737417600000}}],"container-title":["Vaccines"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2076-393X\/13\/2\/97\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,3]],"date-time":"2025-08-03T14:52:45Z","timestamp":1754232765000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2076-393X\/13\/2\/97"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1,21]]},"references-count":92,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2025,2]]}},"alternative-id":["vaccines13020097"],"URL":"https:\/\/doi.org\/10.3390\/vaccines13020097","relation":{},"ISSN":["2076-393X"],"issn-type":[{"value":"2076-393X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1,21]]}}}