دورية أكاديمية
Administration of the GSK Respiratory Syncytial Virus Vaccine to Pregnant Persons in Error.
| العنوان: | Administration of the GSK Respiratory Syncytial Virus Vaccine to Pregnant Persons in Error. |
|---|---|
| المؤلفون: | Moro PL; Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, and the Coronavirus and Other Respiratory Viruses Division and the Immunization Services Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; and the Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gallego R, Scheffey A, Fleming-Dutra KE, Hall E, Zhang B, Marquez P, Jones JM, Nair N, Broder KR |
| المصدر: | Obstetrics and gynecology [Obstet Gynecol] 2024 May 01; Vol. 143 (5), pp. 704-706. Date of Electronic Publication: 2024 Feb 23. |
| نوع المنشور: | 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*/chemically induced , Respiratory Syncytial Virus Vaccines*/adverse effects, Adult ; Female ; Humans ; Pregnancy ; Vaccination ; Medical Errors |
| مستخلص: | The GSK and Pfizer respiratory syncytial virus (RSV) vaccines are both indicated for adults aged 60 years and older, but only the Pfizer product is approved for use in pregnancy to prevent RSV-associated lower respiratory tract disease in infants aged younger than 6 months. To assess for vaccine administration errors (ie, administration of the GSK RSV vaccine to pregnant persons) VAERS (Vaccine Adverse Event Reporting System), a U.S. passive reporting system, was searched for the time period from August 2023 to January 2024. A total of 113 reports of these administration errors were identified. Most reports (103, 91.2%) did not describe an adverse event. These administration errors are preventable with proper education and training and other preventive measures. (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.) |
| References: | U.S. Food and Drug Administration. ABRYSVO package insert. Accessed November 30, 2023. https://www.fda.gov/vaccines-blood-biologics/abrysvo. Fleming-Dutra KE, Jones JM, Roper LE, Prill MM, Ortega-Sanchez IR, Moulia DL, et al. Use of the Pfizer respiratory syncytial virus vaccine during pregnancy for the prevention of respiratory syncytial virus–associated lower respiratory tract disease in infants: recommendations of the Advisory Committee on Immunization Practices—United States, 2023. MMWR Morb Mortal Wkly Rep 2023;72:1115–22. doi: 10.15585/mmwr.mm7241e1. (PMID: 10.15585/mmwr.mm7241e1) GSK. RSVPreF3 OA. Sponsor briefing document: vaccines and related biologic products advisory committee meeting (February 28–March 1, 2023). Accessed November 30, 2023. https://www.fda.gov/media/165621/download. U.S. Food and Drug Administration. AREXVY package insert. Accessed November 30, 2023. https://www.fda.gov/vaccines-blood-biologics/arexvy. Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine 2015;33:4398–405. doi: 10.1016/j.vaccine.2015.07.035. (PMID: 10.1016/j.vaccine.2015.07.035) Hibbs BF, Moro PL, Lewis P, Miller ER, Shimabukuro TT. Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000-2013. Vaccine 2015;33:3171–8. doi: 10.1016/j.vaccine.2015.05.006. (PMID: 10.1016/j.vaccine.2015.05.006) U.S. Food and Drug Administration. 21 C.F.R. part 600.80. Accessed November 30, 2023. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=600.80. Medical dictionary for regulatory activities (MedDRA). Accessed November 30, 2023. https://www.meddra.org/. Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, et al. Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons. N Engl J Med 2021;384:2273–82. doi: 10.1056/NEJMx210016. (PMID: 10.1056/NEJMx210016) DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Statistician 1999;53:177–90. doi: 10.2307/2686093. (PMID: 10.2307/2686093) McNeil MM, Gee J, Weintraub ES, Belongia EA, Lee GM, Glanz JM, et al. The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety. Vaccine 2014;32:5390–8. doi: 10.1016/j.vaccine.2014.07.073. (PMID: 10.1016/j.vaccine.2014.07.073) Centers for Disease Control and Prevention. Respiratory syncytial virus (RSV) vaccination coverage, pregnant persons, United States. Accessed November 30, 2023. https://www.cdc.gov/vaccines/imz-managers/coverage/rsvvaxview/pregnant-persons-coverage-intent.html. Wolicki J, Miller E. Epidemiology and prevention of vaccine-preventable diseases. Accessed November 30, 2023. https://www.cdc.gov/vaccines/pubs/pinkbook/vac-admin.html. |
| المشرفين على المادة: | 0 (Respiratory Syncytial Virus Vaccines) |
| تواريخ الأحداث: | Date Created: 20240223 Date Completed: 20240422 Latest Revision: 20240422 |
| رمز التحديث: | 20240422 |
| DOI: | 10.1097/AOG.0000000000005551 |
| PMID: | 38394669 |
| قاعدة البيانات: | MEDLINE |
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