Maternal Safety of Trivalent Inactivated Influenza Vaccine in Pregnant Women
Objective: To estimate the risks for medically attended events occurring within 42 days of receiving trivalent inactivated influenza vaccine and to evaluate specific risks of first-trimester vaccination. Methods: This retrospective observational cohort study compared rates of medically attended adverse events in trivalent inactivated influenza-vaccinated and unvaccinated pregnant women in the Vaccine Safety Datalink. Using a Poisson distribution and log link, we calculated maternal adjusted incident rate ratios for composite safety outcomes for the full cohort and the subset vaccinated during the first trimester. Results: The cohort included 75,906 vaccinated (28.4% in the first trimester) and 147,992 unvaccinated women matched by age, site, and pregnancy start date. In the first 3 days after vaccination, trivalent inactivated influenza vaccine was not associated with increased risk of specified medically attended events, including allergic reactions, cellulitis, and seizures (full cohort adjusted incident rate ratio 1.12, 95% confidence interval [CI] 0.81-1.55; P=.48; first-trimester adjusted incident rate ratio .97, 95% CI 0.53-1.78; P=.93). In the first 42 days, no incident cases of Guillain-Barré syndrome, optic neuritis, transverse myelitis, or Bells palsy were identified. Trivalent inactivated influenza vaccine was not associated with thrombocytopenia (full cohort adjusted incident rate ratio 0.90, 95% CI 0.68--1.19; P=.45; first-trimester adjusted incident rate ratio 0.56, 95% CI 0.22-1.39; P=.21) or an acute neurologic event (full cohort adjusted incident rate ratio 0.92, 95% CI 0.54-1.6; P=.75; first-trimester adjusted incident rate ratio 1.05, 95% CI 0.46-2.38; P=.91). Conclusions: Receipt of trivalent inactivated influenza vaccine during pregnancy was not associated with increased risk of adverse events in the 42 days after vaccination, supporting its safety for the mother.
[Show abstract] [Hide abstract] ABSTRACT: Introduction: Since October 2012, the combined tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine (Tdap) has been recommended in the United States during every pregnancy. Methods: In this observational study from the Vaccine Safety Datalink, we describe receipt of Tdap during pregnancy among insured women with live births across seven health systems. Using a retrospective matched cohort, we evaluated risks for selected medically attended adverse events in pregnant women, occurring within 42 days of vaccination. Using a generalized estimating equation, we calculated adjusted incident rate ratios (AIRR). Results: Our vaccine coverage cohort included 438,487 live births between January 1, 2007 and November 15, 2013. Across the coverage cohort, 14% received Tdap during pregnancy. By 2013, Tdap was administered during pregnancy in 41.7% of live births, primarily in the 3rd trimester. Our vaccine safety cohort included 53,885 vaccinated and 109,253 matched unvaccinated pregnant women. There was no increased risk for a composite outcome of medically attended acute adverse events within 3 days of vaccination. Similarly, across the safety cohort, over a 42 day window, incident neurologic events, thrombotic events, and new onset proteinuria did not differ by maternal receipt of Tdap. Among women receiving Tdap at 20 weeks gestation or later, as compared to their matched controls, there was no increased risk for gestational diabetes or cardiac events while venous thromboembolic events and thrombocytopenia were diagnosed within 42 days of vaccination at slightly decreased rates. Conclusion: Tdap coverage during pregnancy increased from 2007 through 2013, but was still below 50%. No acute maternal safety signals were detected in this large cohort.0Comments 0Citations
- "In the current study we detected only one myocarditis and two pericarditis cases following maternal Tdap and 9 myocarditis cases among pregnant women who did not receive Tdap, with no consistent pattern of increased incidence following vaccination. Consistent with our prior studies of maternal influenza vaccination and a recent study on risks of concomitant maternal Tdap and influenza vaccination, we did not observe an increased risk for a composite outcome of 0–3 day events that included fever, malaise, allergic, local and other reactions following maternal Tdap[25,30,38]. Medically attended fever within 3 days of vaccination/index date was more common in vaccinated than unvaccinated, with rates of 2.8 per 10,000 versus <1 per 10,000, respectively, with an AIRR of 5.4 (95% CI: 2.1–13.9). However, in both groups rates for medically attended fever were quite low. "
[Show abstract] [Hide abstract] ABSTRACT: BACKGROUND Infections remain one of the leading causes of morbidity in pregnant women and newborns, with vaccine-preventable infections contributing significantly to the burden of disease. In the past decade, maternal vaccination has emerged as a promising public health strategy to prevent and combat maternal, fetal and neonatal infections. Despite a number of universally recommended maternal vaccines, the development and evaluation of safe and effective maternal vaccines and their wide acceptance are hampered by the lack of thorough understanding of the efficacy and safety in the pregnant women and the offspring.0Comments 10Citations
- "In the case of influenza, the long-standing observation of its heightened severity on the mother and the fetus from across the world (Callaghan et al., 2010; Liu et al., 2011; Beigi, 2012; Hansen et al., 2012; Soydinc et al., 2012; Beau et al., 2014 ) and the dramatic disease morbidity and mortality in pregnant women during the 2009 H1N1 pandemic (Creanga et al., 2010 ) have underscored the importance of maternal vaccination and promoted the ACIP recommendation . Several wide-ranging surveillance studies in North America, Europe, Asia, Australia and Latin America all found no evidence to suggest that the IIV vaccine posed significant risk to either the mother or the fetus (Lim et al., 2010; Moro et al., 2011; Omon et al., 2011; Fell et al., 2012; Mackenzie et al., 2012; Oppermann et al., 2012; Pasternak et al., 2012; Carcione et al., 2013; Conlin et al., 2013; Irving et al., 2013; Louik et al., 2013; Nazareth et al., 2013; Nordin et al., 2013). In terms of hepatitis vaccination, there appears to be little or no data evaluating the effectiveness of the inactivated hepatitis vaccines in perinatal contexts . "
[Show abstract] [Hide abstract] ABSTRACT: Objective. To assess the effects of the inactivated influenza virus vaccine on influenza outcomes in pregnant women and their infants. Methods. We performed a systematic review of the literature. We searched for randomized controlled trials and cohort studies in the MEDLINE, Embase, and other relevant databases (inception to September 2013). Two researchers selected studies and extracted the data independently. We used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to assess the quality of the evidence. Results. We included eight studies out of 1,967 retrieved records. Influenza vaccination in pregnant women significantly reduced the incidence of influenza-like illness in mothers and their infants when compared with control groups (high-quality evidence) and reduced the incidence of laboratory-confirmed influenza in infants (moderate-quality evidence). No difference was found with regard to influenza-like illness with fever higher than 38°C (moderate-quality evidence) or upper respiratory infection (very-low-quality evidence) in mothers and infants. Conclusions. Maternal vaccination against influenza was shown to prevent influenza-like illness in women and infants; no differences were found for other outcomes. As the quality of evidence was not high overall, further research is needed to increase confidence and could possibly change these estimates.0Comments 2Citations
- "Adverse reactions were not systematically assessed across the studies, but there was no evidence of increase in clinically relevant risk related to influenza vaccination during pregnancy. A big cohort study that focused on the safety of trivalent inactivated influenza vaccine, however, did not find any increased risk of adverse events and adverse obstetric events in the vaccinated mothers, when compared to unvaccinated pregnant women [43, 44]. Other factors can prevent influenza in infants such as the effect of breast-feeding  and immunization of all the infant's close contacts, also known as cocooning . "