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

• Published in: JAMA : the journal of the American Medical Association Vol. 314; no. 15; pp. 1581 - 1587
• Main Authors: Sukumaran, Lakshmi, McCarthy, Natalie L, Kharbanda, Elyse O, McNeil, Michael M, Naleway, Allison L, Klein, Nicola P, Jackson, Michael L, Hambidge, Simon J, Lugg, Marlene M, Li, Rongxia, Weintraub, Eric S, Bednarczyk, Robert A, King, Jennifer P, DeStefano, Frank, Orenstein, Walter A, Omer, Saad B
• Format: Journal Article
• Language: English
• Published: United States American Medical Association 20.10.2015
• Subjects: Adolescent; Adult; Cohort Studies; Diphtheria-Tetanus-acellular Pertussis Vaccines - administration & dosage; Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects; Female; Humans; Infant, Newborn; Infant, Small for Gestational Age; Medical research; Middle Aged; Pregnancy; Premature Birth; Prenatal Care - standards; Retrospective Studies; Risk; Risk factors; Tetanus; Tetanus Toxoid - administration & dosage; Time Factors; Vaccination - methods; Vaccines; Young Adult
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.2015.12790

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. For example, local reactions occurred at a rate (per 10 000 women) of 4.2 in those who received Tdap in pregnancy less than 2 years before (adjusted risk ratio [RR], 0.49 [95% CI, 0.11-2.20]; P = .35) and 7.0 two to 5 years before (adjusted RR, 0.77 [95% CI, 0.31-1.95]; P = .59) a prior tetanus-containing vaccine compared with 11.2 in controls. Preterm delivery occurred in 6.6% of women receiving Tdap in pregnancy less than 2 years before (adjusted RR, 1.15 [95% CI, 0.98-1.34]; P = .08) and 6.4% two to 5 years before (adjusted RR, 1.06 [95% CI, 0.94-1.19]; P = .33) a prior tetanus-containing vaccine compared with 6.8% of controls. Small for gestational age delivery occurred in 9.0% of women less than 2 years before (adjusted RR, 0.99 [95% CI, 0.87-1.13]; P = .88) and 8.7% of women 2 to 5 years before (adjusted RR, 0.96 [95% CI, 0.87-1.06]; P = .45) a prior tetanus-containing vaccine compared with 9.1% of controls. 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.