OBJECTIVE: The 2009-2010 A/H1N1 pandemic provided a unique setting to study the safety of MF59-adjuvanted vaccination in pregnancy. STUDY DESIGN: This was an observational cohort study of the safety of an MF59-adjuvanted A/H1N1 vaccine (Focetria) conducted among 4508 pregnant women (2295 vaccinated vs 2213 unvaccinated), with 3 month follow-up of neonates. RESULTS: No maternal deaths or abortions occurred among the vaccinated women. No differences between the vaccinated and unvaccinated cohorts were observed for gestational diabetes, preeclampsia, stillbirth, low birthweight, neonatal deaths, or congenital malformations. The risk of premature birth was significantly decreased among the vaccinated women (adjusted proportional hazard, 0.69; 95% confidence interval, 0.51-0.92). No differences were observed in rates of congenital malformations after vaccination in the first (2.1%), second (2.7%), or third (2.1%) trimesters. CONCLUSION: There was no evidence of a safety risk for MF59-adjuvanted A/H1N1 vaccination in pregnant women; protection was observed against premature birth.
OBJECTIVE: The 2009-2010 A/H1N1 pandemic provided a unique setting to study the safety of MF59-adjuvanted vaccination in pregnancy. STUDY DESIGN: This was an observational cohort study of the safety of an MF59-adjuvanted A/H1N1 vaccine (Focetria) conducted among 4508 pregnant women (2295 vaccinated vs 2213 unvaccinated), with 3 month follow-up of neonates. RESULTS: No maternal deaths or abortions occurred among the vaccinated women. No differences between the vaccinated and unvaccinated cohorts were observed for gestational diabetes, preeclampsia, stillbirth, low birthweight, neonatal deaths, or congenital malformations. The risk of premature birth was significantly decreased among the vaccinated women (adjusted proportional hazard, 0.69; 95% confidence interval, 0.51-0.92). No differences were observed in rates of congenital malformations after vaccination in the first (2.1%), second (2.7%), or third (2.1%) trimesters. CONCLUSION: There was no evidence of a safety risk for MF59-adjuvanted A/H1N1 vaccination in pregnant women; protection was observed against premature birth.
Authors: Gabriela Vazquez-Benitez; Elyse O Kharbanda; Allison L Naleway; Heather Lipkind; Lakshmi Sukumaran; Natalie L McCarthy; Saad B Omer; Lei Qian; Stanley Xu; Michael L Jackson; Vinutha Vijayadev; Nicola P Klein; James D Nordin Journal: Am J Epidemiol Date: 2016-07-22 Impact factor: 4.897
Authors: Allison L Naleway; Stephanie A Irving; Michelle L Henninger; De-Kun Li; Pat Shifflett; Sarah Ball; Jennifer L Williams; Janet Cragan; Julianne Gee; Mark G Thompson Journal: Vaccine Date: 2014-04-14 Impact factor: 3.641
Authors: Kari R Gillmeyer; Seppo T Rinne; Mark E Glickman; Kyung Min Lee; Qing Shao; Shirley X Qian; Elizabeth S Klings; Bradley A Maron; Joseph T Hanlon; Donald R Miller; Renda Soylemez Wiener Journal: Circ Cardiovasc Qual Outcomes Date: 2020-05-12