Lakshmi Sukumaran1, Natalie L McCarthy, Elyse O Kharbanda, Eric S Weintraub, Gabriela Vazquez-Benitez, Michael M McNeil, Rongxia Li, Nicola P Klein, Simon J Hambidge, Allison L Naleway, Marlene M Lugg, Michael L Jackson, Jennifer P King, Frank DeStefano, Saad B Omer, Walter A Orenstein. 1. Immunization Safety Office, Centers for Disease Control and Prevention, the Department of Pediatrics, Emory University School of Medicine, and the Rollins School of Public Health and the Emory Vaccine Center, Emory University, Atlanta, Georgia; the HealthPartners Institute for Education and Research, Minneapolis, Minnesota; Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, and the Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California; the Department of Ambulatory Care Services, Denver Health, Institute for Health Research, Kaiser Permanente Colorado, Department of Pediatrics, University of Colorado, Denver, Colorado; the Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon; Group Health Research Institute, Seattle, Washington; and the Marshfield Clinic Research Foundation, Marshfield, Wisconsin.
Abstract
OBJECTIVE: To evaluate the safety of coadministering tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) and influenza vaccines during pregnancy by comparing adverse events after concomitant and sequential vaccination. METHODS: We conducted a retrospective cohort study of pregnant women aged 14-49 years in the Vaccine Safety Datalink from January 1, 2007, to November 15, 2013. We compared medically attended acute events (fever, any acute reaction) and adverse birth outcomes (preterm delivery, low birth weight, small for gestational age) in women receiving concomitant Tdap and influenza vaccination and women receiving sequential vaccination. RESULTS: Among 36,844 pregnancies in which Tdap and influenza vaccines were administered, the vaccines were administered concomitantly in 8,464 (23%) pregnancies and sequentially in 28,380 (77%) pregnancies. Acute adverse events after vaccination were rare. We found no statistically significant increased risk of fever or any medically attended acute adverse event in pregnant women vaccinated concomitantly compared with sequentially. When analyzing women at 20 weeks of gestation or greater during periods of influenza vaccine administration, there were no differences in preterm delivery, low-birth-weight, or small-for-gestational-age neonates between women vaccinated concomitantly compared with sequentially in pregnancy. CONCLUSION: Concomitant administration of Tdap and influenza vaccines during pregnancy was not associated with a higher risk of medically attended adverse acute outcomes or birth outcomes compared with sequential vaccination. LEVEL OF EVIDENCE: II.
OBJECTIVE: To evaluate the safety of coadministering tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) and influenza vaccines during pregnancy by comparing adverse events after concomitant and sequential vaccination. METHODS: We conducted a retrospective cohort study of pregnant women aged 14-49 years in the Vaccine Safety Datalink from January 1, 2007, to November 15, 2013. We compared medically attended acute events (fever, any acute reaction) and adverse birth outcomes (preterm delivery, low birth weight, small for gestational age) in women receiving concomitant Tdap and influenza vaccination and women receiving sequential vaccination. RESULTS: Among 36,844 pregnancies in which Tdap and influenza vaccines were administered, the vaccines were administered concomitantly in 8,464 (23%) pregnancies and sequentially in 28,380 (77%) pregnancies. Acute adverse events after vaccination were rare. We found no statistically significant increased risk of fever or any medically attended acute adverse event in pregnant women vaccinated concomitantly compared with sequentially. When analyzing women at 20 weeks of gestation or greater during periods of influenza vaccine administration, there were no differences in preterm delivery, low-birth-weight, or small-for-gestational-age neonates between women vaccinated concomitantly compared with sequentially in pregnancy. CONCLUSION: Concomitant administration of Tdap and influenza vaccines during pregnancy was not associated with a higher risk of medically attended adverse acute outcomes or birth outcomes compared with sequential vaccination. LEVEL OF EVIDENCE: II.
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