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Influenza – Short Report

Seasonal influenza vaccine exposure in pregnancy: 5-year results from a pregnancy registry

Article: 1932213 | Received 18 Feb 2021, Accepted 13 May 2021, Published online: 03 Jun 2021

References

  • Buchy P, Badur S, Kassianos G, Preiss S, Tam JS. Vaccinating pregnant women against influenza needs to be a priority for all countries: an expert commentary. Int J Infect Dis. 2020;92:1–6. doi:10.1016/j.ijid.2019.12.019.
  • World Health Organisation. Vaccines against influenza WHO position paper – November 2012. Wkly Epidemiol Rec 2012;87:461–76.
  • Omer SB, Richards JL, Madhi SA, Tapia MD, Steinhoff MC, Aqil AR, Wairagkar N; for the BMGF Supported Maternal Influenza Immunization Trials Investigators Group. Three randomized trials of maternal influenza immunization in Mali, Nepal, and South Africa: methods and expectations. Vaccine. 2015;33:3801–12. doi:10.1016/j.vaccine.2015.05.077.
  • Madhi SA, Cutland CL, Kuwanda L, Weinberg A, Hugo A, Jones S, Adrian PV, Van Niekerk N, Treurnicht F, Ortiz JR, et al. Influenza vaccination of pregnant women and protection of their infants. N Engl J Med. 2014;371:918–31. doi:10.1056/NEJMoa1401480.
  • Steinhoff MC, Katz J, Englund JA, Khatry SK, Shrestha L, Kuypers J, Stewart L, Mullany LC, Chu HY, LeClerq SC, et al. Year-round influenza immunisation during pregnancy in Nepal: a phase 4, randomised, placebo-controlled trial. Lancet Infect Dis. 2017;17:981–89. doi:10.1016/S1473-3099(17)30252-9.
  • McMillan M, Porritt K, Kralik D, Costi L, Marshall H. Influenza vaccination during pregnancy: a systematic review of fetal death, spontaneous abortion, and congenital malformation safety outcomes. Vaccine. 2015;33:2108–17. doi:10.1016/j.vaccine.2015.02.068.
  • Ludvigsson JF, Strom P, Lundholm C, Cnattingius S, Ekbom A, Ortqvist A, Feltelius N, Granath F, Stephansson O. Maternal vaccination against H1N1 influenza and offspring mortality: population based cohort study and sibling design. BMJ. 2015;351:h5585. doi:10.1136/bmj.h5585.
  • McHugh L, Marshall HS, Perrett KP, Nolan T, Wood N, Lambert SB, Richmond P, Ware RS, Binks P, Binks MJ, et al. The safety of influenza and pertussis vaccination in pregnancy in a cohort of Australian Mother-Infant Pairs, 2012-2015: the FluMum Study. Clin Infect Dis. 2019;68:402–08. doi:10.1093/cid/ciy517.
  • Jeong S, Jang EJ, Jo J, Jang S. Effects of maternal influenza vaccination on adverse birth outcomes: a systematic review and Bayesian meta-analysis. PLoS One. 2019;14:e0220910. doi:10.1371/journal.pone.0220910.
  • Gliklich RE, Dreyer NA, Leavy MB, eds. Registries for evaluating patient outcomes: a user’s guide. 3rd ed. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014.
  • Lopez-Fauqued M, Zima J, Angelo M-G, Stegmann J-U. Results on exposure during pregnancy from a pregnancy registry for AS04-HPV-16/18 vaccine. Vaccine. 2017;35(40):5325–30. doi:10.1016/j.vaccine.2017.08.042.
  • Goss MA, Lievano F, Buchanan KM, Seminack MM, Cunningham ML, Dana A. Final report on exposure during pregnancy from a pregnancy registry for quadrivalent human papillomavirus vaccine. Vaccine. 2015;33(29):3422–28. doi:10.1016/j.vaccine.2015.04.014.
  • Conlin AM, Bukowinski AT, Gumbs GR. for the Department of Defense, Birth Infant Health Registry Team. Analysis of Pregnancy and Infant Health Outcomes among Women in the National Smallpox Vaccine in Pregnancy Registry Who Received Anthrax Vaccine Adsorbed. Vaccine 2015;33:4387–90. doi:10.1016/j.vaccine.2015.05.054.
  • Wilson E, Goss MA, Marin M, Shields KE, Seward JF, Rasmussen SA, Sharrar RG. Varicella vaccine exposure during pregnancy: data from 10 years of the pregnancy registry. J Infect Dis. 2008;197(Suppl 2):S178–184. doi:10.1086/522136.
  • Claeys C, Drame M, Garcia-Sicilia J, Zaman K, Carmona A, Tran PM, Miranda M, Martinon-Torres F, Thollot F, Horn M, et al. Assessment of an optimized manufacturing process for inactivated quadrivalent influenza vaccine: a phase III, randomized, double-blind, safety and immunogenicity study in children and adults. BMC Infect Dis. 2018;18:186. doi:10.1186/s12879-018-3079-8.
  • Rehman S, Ahmed D. Embryology, kidney, bladder, and ureter. Treasure Island (FL): StatPearls; 2020.
  • Mossey PA, Little J, Munger RG, Dixon MJ, Shaw WC. Cleft lip and palate. Lancet. 2009;374:1773–85. doi:10.1016/S0140-6736(09)60695-4.
  • Rawlins MD. Pharmacovigilance: paradise lost, regained or postponed? The William Withering Lecture 1994. J R Coll Physicians Lond. 1995;29:41–49.
  • Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health. 1995;85:1706–09. doi:10.2105/ajph.85.12.1706.
  • Centers for Disease Control and Prevention. Birth defects; 2021 Mar 05 [Accessed 2021 Apr 12]. http://www.cdc.gov/ncbddd/birthdefects/index.html
  • Chung CS, Myrianthopoulos NC. Factors affecting risks of congenital malformations. I. Analysis of epidemiologic factors in congenital malformations. Report from the Collaborative Perinatal Project. Birth Defects Orig Artic Ser. 1975;11:1–22.
  • Niebyl JR, Simpson JL. Chapter 8: drugs and environmental agents in pregnancy and lactation: embryology, teratology and epidemiology. In: Gabbe S, Niebyl J, Galan H, Jauniaux E, Landon M, Simpson J, Driscoll D editors. Obstetrics: normal and problem pregnancies. 6th ed. Philadelphia (PA): Saunders (Elsevier); 2012. p. 141.
  • Sinclair S, Cunnington M, Messenheimer J, Weil J, Cragan J, Lowensohn R, Yerby M, Tennis P. Advantages and problems with pregnancy registries: observations and surprises throughout the life of the International Lamotrigine Pregnancy Registry. Pharmacoepidemiol Drug Saf. 2014;23:779–86. doi:10.1002/pds.3659.
  • Bird ST, Gelperin K, Taylor L, Sahin L, Hammad H, Andrade SE, Mohamoud MA, Toh S, Hampp C. Enrollment and retention in 34 United States pregnancy registries contrasted with the manufacturer’s capture of spontaneous reports for exposed pregnancies. Drug Saf. 2018;41:87–94. doi:10.1007/s40264-017-0591-5.
  • Baril L, Rosillon D, Willame C, Angelo MG, Zima J, Van Den Bosch JH, Van Staa T, Boggon R, Bunge EM, Hernandez-Diaz S, et al. Risk of spontaneous abortion and other pregnancy outcomes in 15-25 year old women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom. Vaccine. 2015;33:6884–91. doi:10.1016/j.vaccine.2015.07.024.
  • Walsh LK, Donelle J, Dodds L, Hawken S, Wilson K, Benchimol EI, Chakraborty P, Guttmann A, Kwong JC, MacDonald NE, et al. Health outcomes of young children born to mothers who received 2009 pandemic H1N1 influenza vaccination during pregnancy: retrospective cohort study. BMJ. 2019;366:l4151. doi:10.1136/bmj.l4151.
  • Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Klein NP, Cheetham TC, Naleway A, Omer SB, Hambidge SJ, Lee GM, Jackson ML, et al. Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes. JAMA. 2014;312:1897–904. doi:10.1001/jama.2014.14825.
  • Zerbo O, Qian Y, Yoshida C, Fireman BH, Klein NP, Croen LA. Association between influenza infection and vaccination during pregnancy and risk of autism spectrum disorder. JAMA Pediatr. 2017;171:e163609. doi:10.1001/jamapediatrics.2016.3609.
  • U.S. Food and Drug Administration. Postapproval pregnancy safety studies guidance for industry. Draft Guidance. Rockville (MD); 2019 May. [Accessed 2021 Apr 12] https://www.fda.gov/media/124746/download