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Research Paper

Vaccine package inserts and prescribing habits of obstetricians-gynecologists for maternal vaccination

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Pages 3761-3770 | Received 21 Mar 2021, Accepted 04 Jun 2021, Published online: 08 Jul 2021

References

  • Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NJ; Centers for Disease Control and Prevention. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep Morb Mortal Wkly Rep Recomm Rep. 2009;58(RR–8):1–52
  • Grohskopf LA, Sokolow LZ, Broder KR, Walter EB, Fry AM, Jernigan DB. Prevention and control of seasonal influenza with vaccines: recommendations of the advisory committee on immunization practices—United States, 2018–19 influenza season. MMWR Recomm Rep. 2018;67(3):1–20. doi:10.15585/mmwr.rr6703a1.
  • Liang JL. Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2018:67. doi:10.15585/mmwr.rr6702a1.
  • Razzaghi H, Kahn KE, Black CL, Lindley MC, Jatlaoui TC, Fiebelkorn AP, Havers FP, D’Angelo DV, Cheung A, Ruther NA. Influenza and Tdap vaccination coverage among pregnant women — United States, April 2020. MMWR Morb Mortal Wkly Rep. 2020;69(39):1391–97. doi:10.15585/mmwr.mm6939a2.
  • Omer SB. Maternal Immunization. N Engl J Med. 2017;376(13):1256–67. doi:10.1056/NEJMra1509044.
  • Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) in pregnant women and persons who have or anticipate having close contact with an infant aged <12 months --- Advisory Committee on Immunization Practices (ACIP), 2011. MMWR Morb Mortal Wkly Rep. 2011;60(41):1424–26.
  • Shakib JH, Korgenski K, Presson AP, Sheng X, Varner MW, Pavia AT, Byington CL. Influenza in infants born to women vaccinated during pregnancy. Pediatrics. 2016;137:6. doi:10.1542/peds.2015-2360.
  • Omer SB, Richards JL, Madhi SA, Tapia MD, Steinhoff MC, Aqil AR, Wairagkar N. Three randomized trials of maternal influenza immunization in Mali, Nepal, and South Africa: methods and expectations. Vaccine. 2015;33(32):3801–12. doi:10.1016/j.vaccine.2015.05.077.
  • Tapia MD, Sow SO, Tamboura B, Tégueté I, Pasetti MF, Kodio M, Onwuchekwa U, Tennant SM, Blackwelder WC, Coulibaly F, et al. Maternal immunisation with trivalent inactivated influenza vaccine for prevention of influenza in infants in Mali: a prospective, active-controlled, observer-blind, randomised phase 4 trial. Lancet Infect Dis. 2016;16(9):1026–35. doi:10.1016/S1473-3099(16)30054-8.
  • Steinhoff MC, Omer SB, Roy E, Arifeen SE, Raqib R, Dodd C, Breiman RF, Zaman K. Neonatal outcomes after influenza immunization during pregnancy: a randomized controlled trial. CMAJ Can Med Assoc J J Assoc Medicale Can. 2012;184(6):645–53. doi:10.1503/cmaj.110754.
  • Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Klein NP, Cheetham TC, Naleway AL, Lee GM, Hambidge S, Jackson ML, Omer SB, et al. Maternal Tdap vaccination: coverage and acute safety outcomes in the vaccine safety datalink, 2007–2013. Vaccine. 2016;34(7):968–73. doi:10.1016/j.vaccine.2015.12.046.
  • Sukumaran L, McCarthy NL, Kharbanda EO, Weintraub ES, Vazquez-Benitez G, McNeil MM, Li R, Klein NP, Hambidge SJ, Naleway AL, et al. Safety of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis and influenza vaccinations in pregnancy. Obstet Gynecol. 2015;126(5):1069–74. doi:10.1097/AOG.0000000000001066.
  • Munoz FM, Bond NH, Maccato M, Pinell P, Hammill HA, Swamy GK, Walter EB, Jackson LA, Englund JA, Edwards MS, et al. Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. JAMA. 2014;311(17):1760–69. doi:10.1001/jama.2014.3633.
  • Research C for DE and. Pregnant women: scientific and ethical considerations for inclusion in clinical trials. U.S. Food and Drug Administration. Published May 15, 2020. [accessed 2021 Feb 1]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pregnant-women-scientific-and-ethical-considerations-inclusion-clinical-trials.
  • Vojtek I, Dieussaert I, Doherty TM, Franck V, Hanssens L, Miller J, Bekkat-Berkani R, Kandeil W, Prado-Cohrs D, Vyse A, et al. Maternal immunization: where are we now and how to move forward? Ann Med. 2018;50(3):193–208. doi:10.1080/07853890.2017.1421320.
  • Gruber MF. The US FDA pregnancy lactation and labeling rule - implications for maternal immunization. Vaccine. 2015;33(47):6499–500. doi:10.1016/j.vaccine.2015.05.107.
  • Overcoming barriers and identifying opportunities for developing maternal immunizations: recommendations from the National Vaccine Advisory Committee (NVAC). Public Health Rep Wash DC 1974. 2017;132(3):271–84. doi:10.1177/0033354917698118.
  • Advisory Committee on Immunization Practices Centers for Disease Control and Prevention (CDC). Guiding principles for development of ACIP recommendations for vaccination during pregnancy and breastfeeding. MMWR Morb Mortal Wkly Rep. 2008;57(21):580.
  • Regan AK. The safety of maternal immunization. Hum Vaccines Immunother. 2016;12(12):3132–36. doi:10.1080/21645515.2016.1222341.
  • Top KA, Akrell C, Scott H, McNeil SA, Mannerfeldt J, Ortiz JR, Lambach P, MacDonald NE. Effect of package insert language on health-care providers’ perceptions of influenza vaccination safety during pregnancy. Lancet Glob Health. 2016;4(10). doi:10.1016/S2214-109X(16)30182-6
  • Omer SB, Beigi RH. Pregnancy in the Time of Zika: addressing barriers for developing vaccines and other measures for pregnant women. JAMA. 2016;315(12):1227–28. doi:10.1001/jama.2016.2237.
  • FDA Label Search. [accessed 2021 May 10]. https://labels.fda.gov/
  • ProQuad. Merck Sharp & Dohme Corp.; 2018.
  • Adacel (Tdap). Sanofi Pasteur; 2005.
  • Adacel (Tdap). Sanofi Pasteur; 2019.
  • FLUARIX. GlaxoSmithKline; 2015:24.
  • FLUARIX QUADRIVALENT. GlaxoSmithKline; 2018.
  • Elo S, Kyngäs H. The qualitative content analysis process. J Adv Nurs. 2008;62(1):107–15. doi:10.1111/j.1365-2648.2007.04569.x.
  • Top KA, Arkell C, Graham J, Scott H, McNeil SA, Mannerfeldt J, MacDonald NE. Do health care providers trust product monograph information regarding use of vaccines in pregnancy? A qualitative study. Can Commun Dis Rep. 2018;44(6):134–38. doi:10.14745/ccdr.v44i06a03
  • Manca TA, Graham JE, È D, Kervin M, Castillo E, Crowcroft NS, Fell DB, Hadskis M, Mannerfeldt JM, Greyson D, et al. Developing product label information to support evidence-informed use of vaccines in pregnancy. Vaccine. 2019;37(48):7138–46. doi:10.1016/j.vaccine.2019.09.063.
  • Asch DA, Jedrziewski MK, Christakis NA. Response rates to mail surveys published in medical journals. J Clin Epidemiol. 1997;50(10):1129–36. doi:10.1016/s0895-4356(97)00126-1.
  • Van Otterloo J, Richards JL, Seib K, Weiss P, Omer SB. Gift card incentives and non-response bias in a survey of vaccine providers: the role of geographic and demographic factors. PloS One. 2011;6(11):e28108. doi:10.1371/journal.pone.0028108.
  • Cunningham CT, Quan H, Hemmelgarn B, Noseworthy T, Beck CA, Dixon E, Samuel S, Ghali WA, Sykes LL, Jetté N, et al. Exploring physician specialist response rates to web-based surveys. BMC Med Res Methodol. 2015;15(1). doi:10.1186/s12874-015-0016-z
  • Rayburn W The obstetrician-gynecologist workforce in the United States : facts, figures, and implications 2011 - NLM Catalog - NCBI. In: American Congress of Obstetricians and Gynecologists; 2017. Accessed February 1, 2021. https://www-ncbi-nlm-nih-gov.proxy-hs.researchport.umd.edu/nlmcatalog/101542193
  • Kelly R Profile of Ob-gyn practice american college of obstetricians and gynecologists. Published online; 2003.

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