{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T02:21:35Z","timestamp":1789611695708,"version":"build-2803163510"},"reference-count":39,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T00:00:00Z","timestamp":1713830400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>Review available data from clinical trials of nirsevimab for efficacy and safety in the setting of respiratory syncytial virus (RSV) prophylaxis in infants and children, while exploring nirsevimab\u2019s role in clinical practice and highlighting continuing questions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data sources:<\/jats:title>\n                    <jats:p>A literature search of PubMed was conducted utilizing the phrases \u201cnirsevimab\u201d and \u201cmedi8897.\u201d Additional references were identified through found references. Organizational guidelines, medication labeling, and regulatory organization presentations were utilized.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study selection and data extraction:<\/jats:title>\n                    <jats:p>Relevant clinical trials investigating nirsevimab in infants and children were included as well as other references on pharmacology, pharmacokinetics, and pharmacoeconomics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data synthesis:<\/jats:title>\n                    <jats:p>Nirsevimab, a once-a-season monoclonal antibody, demonstrated a 79.5% (95% CI, 65.9-87.7; P &lt; 0.00001) lower incidence of RSV-associated medically attended lower respiratory tract infections (MA RSV-associated LRTI) and 77.3% (95% CI, 50.3-89.7; P = 0.0002) reduction in hospitalizations for RSV-associated MA-LRTI across 2 placebo-controlled studies. Nirsevimab demonstrated comparable safety to placebo with minor dermatologic reactions being the most common adverse event (0.9% vs 0.6%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to patient care and clinical practice in comparison with existing agents:<\/jats:title>\n                    <jats:p>Nirsevimab was approved by the US Food and Drug Administration, and recommended by the Advisory Committee on Immunization Practices and American Academy of Pediatrics for broad administration to infants entering their first RSV season and at risk patients during their second RSV season. Questions remain over efficacy in infants born &lt; 29-week gestation and other economical considerations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Nirsevimab demonstrated clinical efficacy in reducing RSV-associated MA-LRTI and RSV-associated hospitalizations in infants and was well tolerated.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280241243357","type":"journal-article","created":{"date-parts":[[2024,4,24]],"date-time":"2024-04-24T00:46:30Z","timestamp":1713919590000},"page":"81-91","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":8,"title":["Nirsevimab: Expansion of Respiratory Syncytial Virus Prevention Options in Neonates, Infants, and At-Risk Young Children"],"prefix":"10.1177","volume":"59","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-2189-6475","authenticated-orcid":false,"given":"J. Hunter","family":"Fly","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacy and Translational Science, College of Pharmacy, The University of Tennessee Health Science Center, Memphis, TN, USA"},{"name":"Le Bonheur Children\u2019s Hospital, Memphis, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7873-3157","authenticated-orcid":false,"given":"Lea S.","family":"Eiland","sequence":"additional","affiliation":[{"name":"Harrison College of Pharmacy, Auburn University, Auburn, AL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7920-6954","authenticated-orcid":false,"given":"Jeremy S.","family":"Stultz","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy and Translational Science, College of Pharmacy, The University of Tennessee Health Science Center, Nashville, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,4,23]]},"reference":[{"key":"bibr1-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1016\/B978-1-4557-4801-3.00160-0"},{"key":"bibr2-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(22)00478-0"},{"key":"bibr3-10600280241243357","unstructured":"Centers for Disease Control Prevention. RSV surveillance & research. Updated July 27, 2023. Accessed January 19, 2024. https:\/\/www.cdc.gov\/rsv\/research\/index.html#ref11"},{"key":"bibr4-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiac216"},{"key":"bibr5-10600280241243357","unstructured":"Palivizumab [package insert]. MedImmune, LLC; November 2021."},{"key":"bibr6-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2014-1666"},{"key":"bibr7-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1128\/CVI.00609-15"},{"key":"bibr8-10600280241243357","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm7229a4"},{"key":"bibr9-10600280241243357","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm7241e1"},{"key":"bibr10-10600280241243357","unstructured":"Beyfortus (nirsevimab-alip) [package insert]. Astrazenca AB; July 2023."},{"key":"bibr11-10600280241243357","unstructured":"American Academy of Pediatrics. ACIP and AAP recommendations for nirsevimab. August 15, 2023. Accessed September 18, 2023. https:\/\/publications.aap.org\/redbook\/resources\/25379\/AAP-Recommendations-for-the-Prevention-of-RSV"},{"key":"bibr12-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.aaj1928"},{"key":"bibr13-10600280241243357","doi-asserted-by":"publisher","DOI":"10.3390\/vaccines9090961"},{"key":"bibr14-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0000000000001916"},{"key":"bibr15-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1913556"},{"key":"bibr16-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2110275"},{"key":"bibr17-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc2214773"},{"key":"bibr18-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2022.10.041"},{"key":"bibr19-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc2112186"},{"key":"bibr20-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2309189"},{"key":"bibr21-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-4642(22)00321-2"},{"key":"bibr22-10600280241243357","unstructured":"National Library of Medicine. Evaluate the safety and tolerability, for nirsevimab in immunocompromised children (MUSIC), NCT04484935. Updated November 2023. Accessed March 1, 2024. https:\/\/clinicaltrials.gov\/study\/NCT04484935"},{"key":"bibr23-10600280241243357","unstructured":"National Library of Medicine. A study to assess safety, pharmacokinetics anti-drug antibody and anti-RSV antibody after 2 doses of nirsevimab (JUBILUS), NCT06042049. Updated November 2023. Accessed March 1, 2024. https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT06042049"},{"key":"bibr24-10600280241243357","unstructured":"National Library of Medicine. Evaluate the safety and efficacy of nirsevimab in healthy preterm and term infants in China (CHIMES), NCT05110261. Updated October 2023. Accessed October 29, 2023. https:\/\/clinicaltrials.gov\/study\/NCT05110261"},{"key":"bibr25-10600280241243357","unstructured":"Food Drug Administration. June 8, 2023: meeting of the antimicrobial drugs advisory committee meeting announcement. Updated June 8, 2023. Accessed February 14, 2024. https:\/\/www.fda.gov\/advisory-committees\/advisory-committee-calendar\/june-8-2023-meeting-antimicrobial-drugs-advisory-committee-meeting-announcement-06082023"},{"key":"bibr26-10600280241243357","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2024.29.6.2400046"},{"key":"bibr27-10600280241243357","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2024.29.4.2400033"},{"key":"bibr28-10600280241243357","unstructured":"Centers for Disease Control and Prevention, Jones J. Evidence to recommendations framework: nirsevimab updates. Updated February 2023. Accessed September 16, 2023. https:\/\/www.cdc.gov\/vaccines\/acip\/meetings\/downloads\/slides-2023-02\/slides-02-23\/rsv-pediatric-04-jones-508.pdf"},{"key":"bibr29-10600280241243357","unstructured":"Centers for Disease Control Prevention. Vaccines for children program. Updated August 18, 2023. Accessed September 16, 2023. https:\/\/www.cdc.gov\/vaccines\/programs\/vfc\/about\/index.html"},{"key":"bibr30-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-023-02316-5"},{"key":"bibr31-10600280241243357","unstructured":"Abryvso (Respiratory Syncytial Virus Vaccine) [package insert]. Pfizer, Inc; August 2023."},{"key":"bibr32-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.0023"},{"key":"bibr33-10600280241243357","unstructured":"Palivizumab. Lexicomp online, pediatric and neonatal lexi-drugs online. UpToDate Inc.; July 30, 2021. Accessed September 18, 2023. https:\/\/online.lexi.com"},{"key":"bibr34-10600280241243357","unstructured":"Respiratory Syncytial Virus Vaccine (Recombinant). Lexicomp online, pediatric and neonatal lexi-drugs online. UpToDate, Inc.; July 30, 2021. Accessed September 18, 2023. https:\/\/online.lexi.com"},{"key":"bibr35-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiac488"},{"key":"bibr36-10600280241243357","unstructured":"Centers for Disease Control and Prevention, Hutton D. Economic analysis of nirsevimab in pediatric populations. Updated February 23, 2023. Accessed September 16, 2023. https:\/\/www.cdc.gov\/vaccines\/acip\/meetings\/downloads\/slides-2023-02\/slides-02-23\/RSV-Pediatric-02-Hutton-508.pdf"},{"key":"bibr37-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2023.09.003"},{"key":"bibr38-10600280241243357","unstructured":"Centers for Disease Control Prevention. Limited availability of nirsevimab in the United States\u2014interim CDC recommendations to protect infants from respiratory syncytial virus (RSV) during the 2023\u20132024 respiratory virus season. Accessed October 29, 2023. https:\/\/emergency.cdc.gov\/han\/2023\/han00499.asp"},{"key":"bibr39-10600280241243357","doi-asserted-by":"publisher","DOI":"10.1093\/jpids\/piad113"}],"container-title":["Annals of Pharmacotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280241243357","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10600280241243357","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280241243357","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T11:13:39Z","timestamp":1777374819000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10600280241243357"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4,23]]},"references-count":39,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,1]]}},"alternative-id":["10.1177\/10600280241243357"],"URL":"https:\/\/doi.org\/10.1177\/10600280241243357","relation":{},"ISSN":["1060-0280","1542-6270"],"issn-type":[{"value":"1060-0280","type":"print"},{"value":"1542-6270","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4,23]]}}}