Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis and Influenza Vaccinations in Pregnancy

Abstract

Objective To evaluate the safety of co-administering 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 to 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 infants 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 to sequential vaccination.

The safety of maternal immunization

“…Another observational study of 36,844 pregnancies in the US showed that acute adverse events were rare following concomitant vaccination and there was no difference in preterm delivery, low birth weight, or SGA births among women who received pertussis and seasonal influenza vaccine concomitantly. 40 These studies suggest concomitant vaccination is safe; however, additional research is needed, particularly with regards to pregnancy outcomes.…”

“…[39][40][41][42] Between 1-11% of pregnant women report pain or swelling at the injection site, and between 2-3% of women report a fever following vaccination. 39,42,43 However, one prospective study reported as many as 79% of pregnant women experiencing pain or swelling at the injection site.…”

“…44 The authors suggested IIV could be more pyrogenic in comparison to pertussis-containing vaccine; however, other studies in pregnant women do not support this. 50 While one study has shown the co-administration of IIV and pertussis-containing vaccines is safe to the fetus, 40 the safety of concomitant vaccination of pertussis vaccines with IIV should be further explored.…”

Vacunación con pertussis en el embarazo: una estrategia segura y efectiva para proteger al lactante menor

“…The occurrence of adverse effects of vaccination and obstetric adverse effects were evaluated, concluding that coadministration of vaccines had no higher incidence of severe adverse events in vaccination or in the development of preterm delivery, small for gestational age, versus patients who received administration sequentially 29 . A retrospective study of same authors measured the risk of acute adverse events and adverse events at birth in women receiving Tdap vaccine during pregnancy, and who had previously received tetanus vaccine.…”

Immunisation and pregnancy: who, what, when and why?

“…The safety of influenza and pertussis vaccines is very good, and they can be administered at the same consultation. 3 Close household contacts and carers such as siblings, partners and grandparents should also be up to date with all of their age-appropriate immunisations, such as rotavirus, varicella and MMR (measles-mumpsrubella) and particularly pertussis vaccine.…”