Lakshmi Sukumaran1, Natalie L McCarthy2, Elyse O Kharbanda3, Michael M McNeil2, Allison L Naleway4, Nicola P Klein5, Michael L Jackson6, Simon J Hambidge7, Marlene M Lugg8, Rongxia Li2, Eric S Weintraub2, Robert A Bednarczyk9, Jennifer P King10, Frank DeStefano2, Walter A Orenstein11, Saad B Omer12. 1. Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia2Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia. 2. Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia. 3. HealthPartners Institute for Education and Research, Minneapolis, Minnesota. 4. The Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon. 5. Kaiser Permanente Vaccine Study Center, Oakland, California. 6. Group Health Research Institute, Seattle, Washington. 7. Department of Ambulatory Care Services, Denver Health, Denver, Colorado 8Institute for Health Research, Kaiser Permanente Colorado, Denver9Department of Pediatrics, University of Colorado, Denver. 8. Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena. 9. Rollins School of Public Health, Emory University, Atlanta, Georgia. 10. Marshfield Clinic Research Foundation, Marshfield, Wisconsin. 11. Emory Vaccine Center, Emory University, Atlanta, Georgia. 12. Rollins School of Public Health, Emory University, Atlanta, Georgia13Emory Vaccine Center, Emory University, Atlanta, Georgia.
Abstract
IMPORTANCE: The Advisory Committee on Immunization Practices (ACIP) recommends the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine for pregnant women during each pregnancy, regardless of prior immunization status. However, safety data on repeated Tdap vaccination in pregnancy is lacking. OBJECTIVE: To determine whether receipt of Tdap vaccine during pregnancy administered in close intervals from prior tetanus-containing vaccinations is associated with acute adverse events in mothers and adverse birth outcomes in neonates. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study in 29,155 pregnant women aged 14 through 49 years from January 1, 2007, through November 15, 2013, using data from 7 Vaccine Safety Datalink sites in California, Colorado, Minnesota, Oregon, Washington, and Wisconsin. EXPOSURES: Women who received Tdap in pregnancy following a prior tetanus-containing vaccine less than 2 years before, 2 to 5 years before, and more than 5 years before. MAIN OUTCOMES AND MEASURES: Acute adverse events (fever, allergy, and local reactions) and adverse birth outcomes (small for gestational age, preterm delivery, and low birth weight) were evaluated. Women who were vaccinated with Tdap in pregnancy and had a prior tetanus-containing vaccine more than 5 years before served as controls. RESULTS: There were no statistically significant differences in rates of medically attended acute adverse events or adverse birth outcomes related to timing since prior tetanus-containing vaccination. [table: see text]. CONCLUSIONS AND RELEVANCE: Among women who received Tdap vaccination during pregnancy, there was no increased risk of acute adverse events or adverse birth outcomes for those who had been previously vaccinated less than 2 years before or 2 to 5 years before compared with those who had been vaccinated more than 5 years before. These findings suggest that relatively recent receipt of a prior tetanus-containing vaccination does not increase risk after Tdap vaccination in pregnancy.
IMPORTANCE: The Advisory Committee on Immunization Practices (ACIP) recommends the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine for pregnant women during each pregnancy, regardless of prior immunization status. However, safety data on repeated Tdap vaccination in pregnancy is lacking. OBJECTIVE: To determine whether receipt of Tdap vaccine during pregnancy administered in close intervals from prior tetanus-containing vaccinations is associated with acute adverse events in mothers and adverse birth outcomes in neonates. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study in 29,155 pregnant women aged 14 through 49 years from January 1, 2007, through November 15, 2013, using data from 7 Vaccine Safety Datalink sites in California, Colorado, Minnesota, Oregon, Washington, and Wisconsin. EXPOSURES: Women who received Tdap in pregnancy following a prior tetanus-containing vaccine less than 2 years before, 2 to 5 years before, and more than 5 years before. MAIN OUTCOMES AND MEASURES: Acute adverse events (fever, allergy, and local reactions) and adverse birth outcomes (small for gestational age, preterm delivery, and low birth weight) were evaluated. Women who were vaccinated with Tdap in pregnancy and had a prior tetanus-containing vaccine more than 5 years before served as controls. RESULTS: There were no statistically significant differences in rates of medically attended acute adverse events or adverse birth outcomes related to timing since prior tetanus-containing vaccination. [table: see text]. CONCLUSIONS AND RELEVANCE: Among women who received Tdap vaccination during pregnancy, there was no increased risk of acute adverse events or adverse birth outcomes for those who had been previously vaccinated less than 2 years before or 2 to 5 years before compared with those who had been vaccinated more than 5 years before. These findings suggest that relatively recent receipt of a prior tetanus-containing vaccination does not increase risk after Tdap vaccination in pregnancy.
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