دورية أكاديمية

Understanding New Recommendations for Respiratory Syncytial Virus Prevention in Pregnancy.

التفاصيل البيبلوغرافية
العنوان: Understanding New Recommendations for Respiratory Syncytial Virus Prevention in Pregnancy.
المؤلفون: Horgan R; Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virginia; and the Division of Maternal-Fetal Medicine, Duke University, Durham, North Carolina., Hughes BL, Waller J, Hage Diab Y, Saade G
المصدر: Obstetrics and gynecology [Obstet Gynecol] 2024 Apr 01; Vol. 143 (4), pp. 484-490. Date of Electronic Publication: 2024 Feb 08.
نوع المنشور: Review; Journal Article
اللغة: English
بيانات الدورية: Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0401101 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-233X (Electronic) Linking ISSN: 00297844 NLM ISO Abbreviation: Obstet Gynecol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2004- : Hagerstown, MD : Lippincott Williams & Wilkins
Original Publication: New York.
مواضيع طبية MeSH: Respiratory Syncytial Virus Infections*/prevention & control , Respiratory Syncytial Virus Infections*/drug therapy , Respiratory Syncytial Viruses*, Female ; Humans ; Infant ; Infant, Newborn ; Pregnancy ; Antibodies, Monoclonal ; Immunization ; United States ; Vaccination ; Practice Guidelines as Topic
مستخلص: Respiratory syncytial virus (RSV) is a significant cause of infant morbidity and mortality worldwide with peak hospitalization rates for RSV-mediated illnesses between 2 and 3 months of life. Until very recently, prevention strategies for RSV involved primarily passive immunization of neonates at high risk with monoclonal antibodies and promotion of breastfeeding. The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices now recommends passive immunization of all neonates with monoclonal antibodies during RSV season, and the American Association of Pediatrics has endorsed this practice. The U.S. Food and Drug Administration (FDA) recently approved a vaccination for RSV in pregnancy. The CDC's Advisory Committee on Immunization Practices has recently recommended RSV vaccination for all pregnant patients between 32 and 36 weeks of gestation who are anticipated to deliver during RSV season if they are not planning nirsevimab for their infants. This recommendation has been endorsed by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine. In this clinical perspective, we review the scientific evidence, potential concerns, challenges, and future considerations for RSV vaccination in pregnancy.
Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest.
(Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)
References: Walsh EE, Hall CB. Respiratory syncytial virus (RSV). Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases 2015:1948–60.e3. doi: 10.1016/B978-1-4557-4801-3.00160-0. (PMID: 10.1016/B978-1-4557-4801-3.00160-0)
Obando-Pacheco P, Justicia-Grande AJ, Rivero-Calle I, Rodríguez-Tenreiro C, Sly P, Ramilo O, et al. Respiratory syncytial virus seasonality: a global overview. J Infect Dis 2018;217:1356–64. doi: 10.1093/infdis/jiy056. (PMID: 10.1093/infdis/jiy056)
Hall CB, Weinberg GA, Blumkin AK, Edwards KM, Staat MA, Schultz AF, et al. Respiratory syncytial virus–associated hospitalizations among children less than 24 months of age. Pediatrics 2013;132:e341–8. doi: 10.1542/peds.2013-0303. (PMID: 10.1542/peds.2013-0303)
Stein RT, Bont LJ, Zar H, Polack FP, Park C, Claxton A, et al. Respiratory syncytial virus hospitalization and mortality: systematic review and meta‐analysis. Pediatr Pulmonol 2017;52:556–69. doi: 10.1002/ppul.23570. (PMID: 10.1002/ppul.23570)
Arriola CS, Kim L, Langley G, Anderson EJ, Openo K, Martin AM, et al. Estimated burden of community-onset respiratory syncytial virus–associated hospitalizations among children aged <2 years in the United States, 2014–15. J Pediatr Infect Dis Soc 2020;9:587–95. doi: 10.1093/jpids/piz087. (PMID: 10.1093/jpids/piz087)
Rha B, Curns AT, Lively JY, Campbell AP, Englund JA, Boom JA, et al. Respiratory syncytial virus–associated hospitalizations among young children: 2015–2016. Pediatrics 2020;146:20193611. doi: 10.1542/peds.2019-3611. (PMID: 10.1542/peds.2019-3611)
Fleming-Dutra K. Evidence to recommendations framework: Pfizer maternal RSVpreF vaccine. Advisory Committee on Immunization Practices; 2023.
Fauroux B, Simões EA, Checchia PA, Paes B, Figueras-Aloy J, Manzoni P, et al. The burden and long-term respiratory morbidity associated with respiratory syncytial virus infection in early childhood. Infect Dis Ther 2017;6:173–97. doi: 10.1007/s40121-017-0151-4. (PMID: 10.1007/s40121-017-0151-4)
Simões EA, Bont L, Manzoni P, Fauroux B, Paes B, Figueras-Aloy J, et al. Past, present and future approaches to the prevention and treatment of respiratory syncytial virus infection in children. Infect Dis Ther 2018;7:87–120. doi: 10.1007/s40121-018-0188-z. (PMID: 10.1007/s40121-018-0188-z)
Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, et al. Nirsevimab for prevention of RSV in healthy late-preterm and term infants. N Engl J Med 2022;386:837–46. doi: 10.1056/NEJMoa2110275. (PMID: 10.1056/NEJMoa2110275)
Jones JM, Fleming-Dutra KE, Prill MM, Roper LE, Brooks O, Sánchez PJ, et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices—United States, 2023. MMWR Morb Mortal Wkly Rep 2023;72:920–5. doi: 10.15585/mmwr.mm7234a4. (PMID: 10.15585/mmwr.mm7234a4)
Lanari M, Prinelli F, Adorni F, Di Santo S, Faldella G, Silvestri M, et al. Maternal milk protects infants against bronchiolitis during the first year of life: results from an Italian cohort of newborns. Early Hum Dev 2013;89(suppl 1):S51–7. doi: 10.1016/S0378-3782(13)70016-1. (PMID: 10.1016/S0378-3782(13)70016-1)
Venkatesan P. First RSV vaccine approvals. Lancet Microbe 2023;4:e577. doi: 10.1016/S2666-5247(23)00195-7. (PMID: 10.1016/S2666-5247(23)00195-7)
Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, et al. Single-dose nirsevimab for prevention of RSV in preterm infants. N Engl J Med 2020;383:415–25. doi: 10.1056/NEJMoa1913556. (PMID: 10.1056/NEJMoa1913556)
Wodi AP, Murthy N, McNally V, Cineas S, Ault K. Advisory Committee on Immunization Practices recommended immunization schedule for children and adolescents aged 18 years or younger—United States, 2023. MMWR Morb Mortal Wkly Rep 2023;72:137–40. doi: 10.15585/mmwr.mm7206a1. (PMID: 10.15585/mmwr.mm7206a1)
Simoes EA. Respiratory syncytial virus infection. Lancet 1999;354:847–52. doi: 10.1016/S0140-6736(99)80040-3. (PMID: 10.1016/S0140-6736(99)80040-3)
Messina A, Germano C, Avellis V, Tavella E, Dodaro V, Massaro A, et al. New strategies for the prevention of respiratory syncytial virus (RSV). Early Hum Dev 2022;174:105666. doi: 10.1016/j.earlhumdev.2022.105666. (PMID: 10.1016/j.earlhumdev.2022.105666)
Firan M, Bawdon R, Radu C, Ober RJ, Eaken D, Antohe F, et al. The MHC class I-related receptor, FcRn, plays an essential role in the maternofetal transfer of γ-globulin in humans. Int Immunol 2001;13:993–1002. doi: 10.1093/intimm/13.8.993. (PMID: 10.1093/intimm/13.8.993)
Wilcox CR, Holder B, Jones CE. Factors affecting the FcRn-mediated transplacental transfer of antibodies and implications for vaccination in pregnancy. Front Immunol 2017;8:1294. doi: 10.3389/fimmu.2017.01294. (PMID: 10.3389/fimmu.2017.01294)
Glenn GM, Fries LF, Thomas DN, Smith G, Kpamegan E, Lu H, et al. A randomized, blinded, controlled, dose-ranging study of a respiratory syncytial virus recombinant fusion (F) nanoparticle vaccine in healthy women of childbearing age. J Infect Dis 2016;213:411–22. doi: 10.1093/infdis/jiv406. (PMID: 10.1093/infdis/jiv406)
Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol 2012;2012:985646. doi: 10.1155/2012/985646. (PMID: 10.1155/2012/985646)
Chu HY, Tielsch J, Katz J, Magaret AS, Khatry S, LeClerq SC, et al. Transplacental transfer of maternal respiratory syncytial virus (RSV) antibody and protection against RSV disease in infants in rural Nepal. J Clin Virol 2017;95:90–5. doi: 10.1016/j.jcv.2017.08.017. (PMID: 10.1016/j.jcv.2017.08.017)
Capella C, Chaiwatpongsakorn S, Gorrell E, Risch ZA, Ye F, Mertz SE, et al. Prefusion F, postfusion F, G antibodies, and disease severity in infants and young children with acute respiratory syncytial virus infection. J Infect Dis 2017;216:1398–406. doi: 10.1093/infdis/jix489. (PMID: 10.1093/infdis/jix489)
Glezen WP, Paredes A, Allison JE, Taber LH, Frank AL. Risk of respiratory syncytial virus infection for infants from low-income families in relationship to age, sex, ethnic group, and maternal antibody level. J Pediatr 1981;98:708–15. doi: 10.1016/s0022-3476(81)80829-3. (PMID: 10.1016/s0022-3476(81)80829-3)
Stensballe LG, Ravn H, Kristensen K, Agerskov K, Meakins T, Aaby P, et al. Respiratory syncytial virus neutralizing antibodies in cord blood, respiratory syncytial virus hospitalization, and recurrent wheeze. J Allergy Clin Immunol 2009;123:398–403. doi: 10.1016/j.jaci.2008.10.043. (PMID: 10.1016/j.jaci.2008.10.043)
Saso A, Kampmann B. Vaccination against respiratory syncytial virus in pregnancy: a suitable tool to combat global infant morbidity and mortality? Lancet Infect Dis 2016;16:e153–63. doi: 10.1016/S1473-3099(16)00119-5. (PMID: 10.1016/S1473-3099(16)00119-5)
Madhi SA, Polack FP, Piedra PA, Munoz FM, Trenholme AA, Simões EAF, et al. Respiratory syncytial virus vaccination during pregnancy and effects in infants. N Engl J Med 2020;383:426–39. doi: 10.1056/NEJMoa1908380. (PMID: 10.1056/NEJMoa1908380)
Muňoz FM, Swamy GK, Hickman SP, Agrawal S, Piedra PA, Glenn GM, et al. Safety and immunogenicity of a respiratory syncytial virus fusion (F) protein nanoparticle vaccine in healthy third-trimester pregnant women and their infants. J Infect Dis 2019;220:1802–15. doi: 10.1093/infdis/jiz390. (PMID: 10.1093/infdis/jiz390)
U.S. Food and Drug Administration. Sponsor briefing document: Vaccines and Related Biological Products Advisory Committee Meeting, March 1, 2023. Accessed October 12, 2023. https://fda.gov/media/165622/download.
Boytchev H. Maternal RSV vaccine: further analysis is urged on preterm births. BMJ 2023;381:1021. doi: 10.1136/bmj.p1021. (PMID: 10.1136/bmj.p1021)
U.S. Food and Drug Administration. FDA approves first vaccine for pregnant individuals to prevent RSV in infants. Accessed October 17, 2023. https://fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants#:∼:text=Today%2C%20the%20U.S.%20Food%20and,through%206%20months%20of%20age.
Kampmann B, Madhi SA, Munjal I, Simões EAF, Pahud BA, Llapur C, et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med 2023;388:1451–64. doi: 10.1056/NEJMoa2216480. (PMID: 10.1056/NEJMoa2216480)
Maternal respiratory syncytial virus vaccination. American College of Obstetrics and Gynecology. 2023. Accessed October 5, 2023. https://acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccination.
Wesley C, Winckworth LC. Respiratory syncytial virus vaccination in pregnancy is not effective enough at reducing infant infections. Arch Dis Child Educ Pract Ed 2022;107:389. doi: 10.1136/archdischild-2020-321368. (PMID: 10.1136/archdischild-2020-321368)
Novavax announces topline results from phase 3 PrepareTM trial of ResVax™ for prevention of RSV disease in infants via maternal immunization. Accessed September 20, 2023. https://ir.novavax.com/press-releases/2019-02-28-Novavax-Announces-Topline-Results-from-Phase-3-PrepareTM-Trial-of-ResVax-TM-for-Prevention-of-RSV-Disease-in-Infants-via-Maternal-Immunization.
Pfizer. Pfizer announces positive top-line data of phase 3 global maternal immunization trial for its bivalent respiratory syncytial virus (RSV) vaccine candidate. 2022. Accessed September 20, 2023. https://pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-data-phase-3-global.
Centers for Disease Control and Prevention. Preterm birth. Accessed September 20, 2023. https://cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm.
Kachikis A, Eckert LO, Englund JA. The history of maternal immunization. In: Leuridan EE, Nunes MC, Jones CE, editors. Maternal immunization, Academic Press; 2020. p. 3–24.
Kweder S, Thor S, Vasisht K, Yao L, Everett D. Global regulators envision paradigm shift toward inclusion of pregnant and breastfeeding women in clinical research for medicines and vaccines. Accessed October 12, 2023. https://www.fda.gov/news-events/fda-voices/global-regulators-envision-paradigm-shift-toward-inclusion-pregnant-and-breastfeeding-women-clinical.
Razzaghi H, Kahn KE, Calhoun K, Garacci E, Skoff TH, Ellington SR, et al. Influenza, Tdap, and COVID-19 vaccination coverage and hesitancy among pregnant women—United States, April 2023. MMWR Morb Mortal Wkly Rep 2023;72:1065–71. doi: 10.15585/mmwr.mm7239a4. (PMID: 10.15585/mmwr.mm7239a4)
Marchand G, Masoud AT, Grover S, King A, Brazil G, Ulibarri H, et al. Maternal and neonatal outcomes of COVID-19 vaccination during pregnancy, a systematic review and meta-analysis. NPJ Vaccines 2023;8:103–8. doi: 10.1038/s41541-023-00698-8. (PMID: 10.1038/s41541-023-00698-8)
Influenza in pregnancy: prevention and treatment. ACOG Committee Statement No. 7. American College of Obstetricians and Gynecologists. Obstet Gynecol 2024;143:e24–30. doi: 10.1097/AOG.0000000000005479. (PMID: 10.1097/AOG.0000000000005479)
Gatt D, Martin I, AlFouzan R, Moraes TJ. Prevention and treatment strategies for respiratory syncytial virus (RSV). Pathogens 2023;12:154. doi: 10.3390/pathogens12020154. (PMID: 10.3390/pathogens12020154)
Nyiro JU, Sande C, Mutunga M, Kiyuka PK, Munywoki PK, Scott JAG, et al. Quantifying maternally derived respiratory syncytial virus specific neutralising antibodies in a birth cohort from coastal Kenya. Vaccine 2015;33:1797–801. doi: 10.1016/j.vaccine.2015.02.039. (PMID: 10.1016/j.vaccine.2015.02.039)
Chu HY, Steinhoff MC, Magaret A, Zaman K, Roy E, Langdon G, et al. Respiratory syncytial virus transplacental antibody transfer and kinetics in mother-infant pairs in Bangladesh. J Infect Dis 2014;210:1582–9. doi: 10.1093/infdis/jiu316. (PMID: 10.1093/infdis/jiu316)
Peterson JT, Zareba AM, Fitz-Patrick D, Essink BJ, Scott DA, Swanson KA, et al. Safety and immunogenicity of a respiratory syncytial virus prefusion F vaccine when coadministered with a tetanus, diphtheria, and acellular pertussis vaccine. J Infect Dis 2022;225:2077–86. doi: 10.1093/infdis/jiab505. (PMID: 10.1093/infdis/jiab505)
Jones J. Clinical considerations for RSVpreF maternal vaccine and nirsevimab. Accessed October 12, 2023. https://cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/05-RSV-Mat-Ped-Jones-508.pdf.
Shoukat A, Abdollahi E, Galvani AP, Halperin SA, Langley JM, Moghadas SM. Cost-effectiveness analysis of nirsevimab and maternal RSVpreF vaccine strategies for prevention of respiratory syncytial virus disease among infants in Canada: a simulation study. Lancet Reg Health Am 2023;28:100629. doi: 10.1016/j.lana.2023.100629. (PMID: 10.1016/j.lana.2023.100629)
Reuters. Pfizer says its RSV vaccine will have $295 per dose list price for maternal use. Accessed October 5, 2023. https://xm.com/research/markets/allNews/reuters/pfizer-says-its-rsv-vaccine-will-have-295-per-dose-list-price-for-maternal-use-53647835.
American Academy of Pediatrics. Nirsevimab (Beyfortus) product & ordering information. Accessed October 5, 2023. https://aap.org/en/patient-care/respiratory-syncytial-virus-rsv-prevention/nirsevimab-beyfortus-product--ordering-information/#:∼:text=Nirsevimab%20purchase%20cost,200mg%20dose%20(Two%20100mg%20doses).
Shi T, McAllister DA, O'Brien KL, Simoes EAF, Madhi SA, Gessner BD, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet 2017;390:946–58. doi: 10.1016/S0140-6736(17)30938-8. (PMID: 10.1016/S0140-6736(17)30938-8)
المشرفين على المادة: 0 (Antibodies, Monoclonal)
تواريخ الأحداث: Date Created: 20240208 Date Completed: 20240325 Latest Revision: 20240417
رمز التحديث: 20240418
DOI: 10.1097/AOG.0000000000005524
PMID: 38330405
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-233X
DOI:10.1097/AOG.0000000000005524