Lisa McHugh1, Helen S Marshall2, Kirsten P Perrett3, Terry Nolan3, Nicholas Wood4, Stephen B Lambert5, Peter Richmond6, Robert S Ware7, Paula Binks1, Michael J Binks1, Ross M Andrews1,8. 1. Menzies School of Health Research, Charles Darwin University, Tiwi, Northern Territory. 2. Women's and Children's Health Network, Robinson Research Institute and Adelaide Medical School, University of Adelaide, South Australia. 3. Murdoch Children's Research Institute, Royal Children's Hospital and School of Population and Global Health, University of Melbourne, Victoria. 4. National Centre for Immunisation Research and Surveillance, Sydney Children's Hospitals Network, Discipline of Child and Adolescent Health, University of Sydney, New South Wales. 5. Child Health Research Centre, School of Medicine, University of Queensland, Brisbane. 6. University of Western Australia, Division of Paediatrics and Vaccine Trials Group, Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia. 7. Menzies Health Institute Queensland, Griffith University, Brisbane. 8. National Centre for Epidemiology and Population Health, Australian National University, Canberra, Australian Capital Territory, Australia.
Abstract
Background: Inactivated influenza vaccine (IIV) and pertussis vaccination are recommended in pregnancy. Limited safety data exist for women who received IIV vaccine during the first trimester of pregnancy or received both vaccines in pregnancy. We assessed adverse birth outcomes between vaccinated and unvaccinated pregnancies. Methods: Among prospectively enrolled Australian "FluMum" participants (2012-2015), primary exposure was receipt and timing of IIV during pregnancy. Primary outcomes included preterm birth, low birthweight at term (LBWT), and small for gestational age (SGA). We compared birth outcomes for IIV in pregnancy with women unvaccinated in pregnancy using Cox proportional hazard ratios (HRs) with 95% confidence intervals (CIs). Adjusted HRs (aHRs) controlled for potential confounding variables. Sensitivity analyses were conducted in a subgroup of women who received pertussis vaccination during pregnancy to assess whether associations between IIV and adverse outcomes were maintained after adjusting for pertussis vaccination. Results: Among 8827 participants in our study, women who received IIV in pregnancy did not have an elevated risk of an adverse birth outcome compared with unvaccinated pregnant women: preterm births (HR, 1.10 [95% CI, .92-1.31]; P = .28); LBWT (HR, 1.05 [95% CI, .76-1.44]; P = .77); or SGA (HR, 0.99 [95% CI, .86-1.15]; P = .94). Adjustment for pertussis vaccination during pregnancy yielded similar results: preterm births (aHR, 1.05 [95% CI, .82-1.34]; P = .69); LBWT (aHR, 0.81 [95% CI, .50-1.29]; P = .37); SGA (aHR, 0.92 [95% CI, .74-1.14]; P = .43). There was no evidence of elevated risk by trimester of IIV. Conclusions: No significant associations were found between maternal IIV or pertussis vaccination in pregnancy and adverse birth outcomes, regardless of the trimester of pregnancy a vaccination was given compared to unvaccinated pregnancies.
Background: Inactivated influenza vaccine (IIV) and pertussis vaccination are recommended in pregnancy. Limited safety data exist for women who received IIV vaccine during the first trimester of pregnancy or received both vaccines in pregnancy. We assessed adverse birth outcomes between vaccinated and unvaccinated pregnancies. Methods: Among prospectively enrolled Australian "FluMum" participants (2012-2015), primary exposure was receipt and timing of IIV during pregnancy. Primary outcomes included preterm birth, low birthweight at term (LBWT), and small for gestational age (SGA). We compared birth outcomes for IIV in pregnancy with women unvaccinated in pregnancy using Cox proportional hazard ratios (HRs) with 95% confidence intervals (CIs). Adjusted HRs (aHRs) controlled for potential confounding variables. Sensitivity analyses were conducted in a subgroup of women who received pertussis vaccination during pregnancy to assess whether associations between IIV and adverse outcomes were maintained after adjusting for pertussis vaccination. Results: Among 8827 participants in our study, women who received IIV in pregnancy did not have an elevated risk of an adverse birth outcome compared with unvaccinated pregnant women: preterm births (HR, 1.10 [95% CI, .92-1.31]; P = .28); LBWT (HR, 1.05 [95% CI, .76-1.44]; P = .77); or SGA (HR, 0.99 [95% CI, .86-1.15]; P = .94). Adjustment for pertussis vaccination during pregnancy yielded similar results: preterm births (aHR, 1.05 [95% CI, .82-1.34]; P = .69); LBWT (aHR, 0.81 [95% CI, .50-1.29]; P = .37); SGA (aHR, 0.92 [95% CI, .74-1.14]; P = .43). There was no evidence of elevated risk by trimester of IIV. Conclusions: No significant associations were found between maternal IIV or pertussis vaccination in pregnancy and adverse birth outcomes, regardless of the trimester of pregnancy a vaccination was given compared to unvaccinated pregnancies.
Authors: Geraldo Duarte; Conrado Milani Coutinho; Daniel Lorber Rolnik; Silvana Maria Quintana; Ana Cláudia Rabelo E Silva; Liona C Poon; Fabrício da Silva Costa Journal: AJOG Glob Rep Date: 2021-09-03
Authors: Agustín Ciapponi; Ariel Bardach; Agustina Mazzoni; Tomás Alconada; Steven Anderson; Fernando J Argento; Jamile Ballivian; Karin Bok; Daniel Comandé; Emily Erbelding; Erin Goucher; Beate Kampmann; Ruth Karron; Flor M Munoz; María Carolina Palermo; Edward P K Parker; Federico Rodriguez Cairoli; María Victoria Santa; Andy Stergachis; Gerald Voss; Xu Xiong; Natalia Zamora; Sabra Zaraa; Mabel Berrueta; Pierre M Buekens Journal: medRxiv Date: 2021-06-06