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MotherToBaby

Medications and More during pregnancy and breastfeeding

Seasonal Influenza Vaccine (Flu Shot)

Selected References:

  • American Academy of Pediatrics. 2025. Recommendations for Prevention and Control of Influenza in Children, 2025–2026: Policy Statement. Pediatrics. doi: 10.1542/peds.2025-073620. Available at: https://doi.org/10.1542/peds.2025-073620. [Accessed 8/2025].
  • Becerra-Culqui TA, et al. 2022. Prenatal influenza vaccination or influenza infection and autism spectrum disorder in offspring. Clin Infect Dis; 75(7):1140-1148.
  • Centers for Disease Control and Prevention. 2024. Flu Season. Available at https://www.cdc.gov/flu/about/season.html. [Accessed 8/2025].
  • Centers for Disease Control and Prevention. 2024. Flu Vaccine Safety and Pregnancy. Available at: https://www.cdc.gov/flu/vaccine-safety/vaccine-pregnant.html [Accessed 8/2025].
  • Centers for Disease Control and Prevention. 2025. Influenza Vaccine Safety Considerations during Pregnancy or while Breastfeeding. Available at: https://www.cdc.gov/flu/hcp/vax-summary/vaccine-safety-pregnant.html. [Accessed 8/2025].
  • Centers for Disease Control and Prevention. 2024. Vaccines for Family and Caregivers. Available at: https://www.cdc.gov/vaccines-pregnancy/about/vaccines-family-caregivers.html. [Accessed 8/2025].
  • Conlin AMS, et al. 2018. A follow-up comparative safety analysis of pandemic H1N1 vaccination during pregnancy and risk of infant birth defects among U.S. military mothers. Vaccine, 36(20):2855-2860.
  • Chaiken SR, et al. 2022. Cost-effectiveness of influenza vaccination during pregnancy. J Matern Fetal Neonatal Med; 35(25):5244-5252.
  • Chambers CD, et al. 2013. Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants. Vaccine, 31(44):5026-5032.
  • Donahue JG, e al. 2019. Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15. Vaccine, 37(44):6673-6681.
  • Fabiani M, et al. 2015. A/H1N1 pandemic influenza vaccination: A retrospective evaluation of adverse maternal, fetal and neonatal outcomes in a cohort of pregnant women in Italy. Vaccine, 33(19):2240-2247.
  • Fell DB, et al. 2024. Effectiveness of influenza vaccination during pregnancy against laboratory-confirmed seasonal influenza among infants under 6 months of age in Ontario, Canada. J Infect Dis. 25;230(1):e80-e92.
  • Foo DYP, et al. 2020. Early childhood health outcomes following in utero exposure to influenza vaccines: a systematic review. Pediatrics, 146(2):e20200375.
  • Getahun D, et al. 2019. Association between seasonal influenza vaccination with pre- and postnatal outcomes. Vaccine, 37(13):1785-1791.
  • Getahun D, et al. 2024. Safety of the seasonal influenza vaccine in 2 successive pregnancies. JAMA Netw Open. 7(9):e2434857.
  • Grohskopf LA, et al. 2024. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2024–25 Influenza Season. MMWR Recomm Rep 2024;73(No. RR-5):1–25.
  • Gunatilaka A, et al.2023. Protective effect of maternal immunization on birth outcomes: A data linkage study. Int J Gynaecol Obstet. 162(1):51-57.
  • Gunnes N, et al. 2020. Seasonal and pandemic influenza during pregnancy and risk of fetal death: a Norwegian registry-based cohort study. Eur J Epidemiol, 35(4):371-379.
  • Haberg S, et al. 2013. Risk of fetal death after pandemic influenza virus infection or vaccination. N Engl J Med, 368(4):333-340.
  • Hall C, et al. 2025. Receipt of Tdap or Influenza vaccine during pregnancy and odds of clinical chorioamnionitis: A nested case-control study. Pharmacoepidemiol Drug Saf. 34(4):e70147.
  • Hunagund S, et al. 2022. Effects of vaccination against influenza, pertussis, and COVID-19 on human milk antibodies: Current evidence and implications for health equity. Front Immunol; 13:910383.
  • Hviid A, et al. 2017. Association between pandemic influenza A (H1N1) vaccination in pregnancy and early childhood morbidity in offspring. JAMA Pediatr, 171(3):239-248.
  • Irving SA, et al. 2013. Trivalent inactivated influenza vaccine and spontaneous abortion. Obstet Gynecol, 121(1):159-165.
  • Kharbanda EO, et al. 2013. Inactivated influenza vaccine during pregnancy and risks for adverse obstetric events. Obstet Gynecol, 122(3):659-667.
  • Kharbanda EO, et al. 2017. First trimester influenza vaccination and risks for major structural birth defects in offspring. J Pediatr, 187:234-239.e4.
  • Lee H, et al. 2025. Association of Influenza Vaccination During Pregnancy with Health Outcomes in Mothers and Children: A Population-Based Cohort Study. Clin Pharmacol Ther. 117(5):1381-1392.
  • Legge A, et al. 2014. Rates and determinants of seasonal influenza vaccination in pregnancy and association with neonatal outcomes. CMAJ, 186(4):E157-E163.
  • Ludvigsson JF, et al. 2015. Maternal vaccination against H1N1 influenza and offspring mortality: population-based cohort study and sibling design. BMJ, 351:h5585.
  • Ludvigsson JF, et al. 2020. Maternal influenza A(H1N1) immunization during pregnancy and risk for autism spectrum disorder in offspring : a cohort study. Ann Intern Med, 173(8):597-604.
  • Malange V, et al, Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS). 2025. Influenza vaccination during early pregnancy and risk of major birth defects, US Birth Defects Study To Evaluate Pregnancy exposureS, 2014-2019. Vaccine. 59:127297.
  • McHugh L, et al. 2017. Birth outcomes for Australian mother-infant pairs who received an influenza vaccine during pregnancy, 2012-2014: the FluMum study. Vaccine, 35(10):1403-1409.
  • Mehrabadi A, et al. 2021. Association of maternal influenza vaccination during pregnancy with early childhood health outcomes. JAMA, 325(22):2285-2293.
  • Moro PL, et al. 2011. Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the Vaccine Adverse Event Reporting System, 1990-2009. Am J Obstet Gynecol, 204(2):146.e1-146.e1467.
  • Moro PL et al. 2021. Reports of cell-based influenza vaccine administered during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2013-2020. Vaccine, 39(4):678-681.
  • Munoz FM, et al. 2005: Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol, 192(4):1098-1106.
  • Nassar AH, et al. 2023. Vaccination in pregnancy. Int J Gynaecol Obstet; 162(1):18-23.
  • Neuzil KM, et al. 1998. Impact of influenza on acute cardiopulmonary hospitalizations in pregnant women. Am J Epidemiol, 148(11):1094-1102.
  • Nordin JD, et al. 2014. Maternal influenza vaccine and risks for preterm or small for gestational age birth. J Pediatr, 164(5):1051-1057.e2.
  • Nwoji U. 2022. Seasonal influenza vaccine exposure in pregnancy: 5-year results from a pregnancy registry. Hum Vaccin Immunother, 18(1):1932213.
  • Ohfuji S, et al. 2020. Safety of influenza vaccination on adverse birth outcomes among pregnant women: a prospective cohort study in Japan. Int J Infect Dis, 93:68-76.
  • Palmsten K, et al. 2023. Influenza vaccination during pregnancy and risk of selected major structural congenital heart defects, National Birth Defects Prevention Study 2006-2011. Birth Defects Res; 115(1):88-95.
  • Pasternak B, et al. 2012. Risk of adverse fetal outcomes following administration of a pandemic influenza A (H1N1) vaccine during pregnancy. JAMA, 308(2):165-174.
  • Poehling KA, et al, New Vaccine Surveillance Network. 2011. Impact of maternal immunization on influenza hospitalizations in infants. Am J Obstet Gynecol, 204(6 Suppl 1):S141-8.
  • Pool V, Iskander J. 2006 Safety of influenza vaccination during pregnancy. Am J Obstet Gynecolc 194:1200; author reply 1201.
  • Regan AK, et al. 2024. Maternal influenza vaccination and associated risk of fetal loss: A claims-based prospective cohort study. Vaccine. 42(26):126256.
  • Regan AK, et al. 2023. Risk of miscarriage in relation to seasonal influenza vaccination before or during pregnancy. Obstet Gynecol. 142(3):625-635.
  • Robinson C, et al. 2022. A prospective cohort study on pregnancy outcomes of persons immunized with a seasonal quadrivalent inactivated influenza vaccine during pregnancy. Vaccines (Basel). 10(10):1577.
  • Romano CJ et al. 2021. History of pandemic H1N1-containing influenza vaccination and risk for spontaneous abortion and birth defects. Vaccine, 39(44):6553-6562.
  • Sakala IG, et al. 2023. Developmental and reproductive safety of Advax-CpG55.2™ adjuvanted COVID-19 and influenza vaccines in mice. Vaccine. :S0264-410X(23)01007-1.
  • Shaikh H, et al. 2023. Safety and protective effects of influenza vaccination in pregnant women on pregnancy and birth outcomes in Pune, India: A cross-sectional study. Vaccines (Basel). 11(6):1034.
  • Sheffield J, et al. 2004. The efficacy and safety of influenza vaccination in pregnancy. Am J Obstet Gynecol, 191(6 Suppl):S66.
  • Siston A, et al. 2010, Pandemic 2009 influenza A(H1N1) virus illness among pregnant women in the United States. JAMA, 303(15):1517-1525.
  • Tamma et al. 2009. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol, 201(6):547-552.
  • Thompson MG, et al. 2018. Influenza vaccine effectiveness in preventing influenza-associated hospitalizations during pregnancy: a multi-country retrospective test negative design study, 2010–2016. Clin Infect Dis, 68(9):1444–1453.
  • Xie S, et al. 2023. The association between maternal influenza vaccination during pregnancy and adverse birth outcomes in the United States: Pregnancy risk Assessment Monitoring System (PRAMS). Vaccine. 41(13):2300-2306.
  • Zaman K, et al. 2008. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med, 359(15):1555-1564.
  • Zasztowt-Sternicka M, et al. 2025. Immunogenicity of inactivated quadrivalent influenza vaccine in pregnant women, including the level of postvaccination antibodies in umbilical cord blood. Vaccine. 19;53:127047.
  • Zerbo O, et al. 2017. Association between influenza infection and vaccination during pregnancy and risk of autism spectrum disorder. JAMA Pediatr, 171(1):e163609.
  • Zerbo O, et al. 2025. Influenza vaccination during pregnancy and infant influenza in the first 6 months of life. Obstet Gynecol. 146(2): e36-e42.

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