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. 2015 Oct 20;314(15):1581-7.
doi: 10.1001/jama.2015.12790.

Association of Tdap Vaccination With Acute Events and Adverse Birth Outcomes Among Pregnant Women With Prior Tetanus-Containing Immunizations

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Association of Tdap Vaccination With Acute Events and Adverse Birth Outcomes Among Pregnant Women With Prior Tetanus-Containing Immunizations

Lakshmi Sukumaran et al. JAMA. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Sukumaran reports receiving research support from the National Institutes of Health. Dr Naleway reports receiving research support from GlaxoSmithKline and Pfizer. Dr Klein reports receiving research support from GlaxoSmithKline, Sanofi Pasteur, Merck, Pfizer, Nuron Biotech, MedImmune, Novartis, and Protein Science. The Vaccine Safety Datalink Project is funded by the Centers for Disease Control and Prevention.

Figures

Figure.
Figure.. Tdap Vaccinations Received During Pregnancy From January 1, 2007, Through November 15, 2013, Recorded in 7 Vaccine Safety Datalink Sites
Tdap indicates tetanus, diphtheria, and acellular pertussis. a Singleton pregnancies. b Not live birth includes stillbirth, spontaneous abortion, therapeutic abortion, trophoblastic disease, ectopic pregnancy, and unknown outcomes.

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