Maternal Safety of Trivalent Inactivated Influenza Vaccine in Pregnant Women
ABSTRACT 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. LEVEL OF EVIDENCE:: II.
- Obstetrics and Gynecology 03/2013; 121(3):503-4. DOI:10.1097/AOG.0b013e318285cf61 · 4.37 Impact Factor
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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.11/2013; 2013:879493. DOI:10.5402/2013/879493
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ABSTRACT: We explored the attitudes, opinions, and concerns of African American women regarding influenza vaccination during pregnancy. As influenza immunization coverage rates remain suboptimal in the United States among this population, we elicited message framing strategies for multicomponent interventions aimed at decreasing future incident cases of maternal and neonatal influenza. Semi-structured in-depth interviews (N = 21) were conducted with pregnant African American women at urban OB/GYN clinics who had not received an influenza vaccine. Interviews were transcribed, subjected to intercoder reliability assessment, and content analyzed to identify common thematic factors related to acceptance of the influenza vaccine and health communication message preferences. Four major themes were identified. These were communication approaches, normal vaccine behavior, pregnancy vaccination, and positive versus negative framing. Two strong themes emerged: positively-framed messages were preferred over negatively-framed messages and those emphasizing the health of the infant. Additionally, previous immunization, message source, and vaccine misperceptions also played important roles in decision-making. The majority of women indicated that positively framed messages focusing on the infant's health would encourage them to receive an influenza vaccine. Messages emphasizing immunization benefits such as protection against preterm birth and low birth weight outcomes have potential to overcome widespread negative community perceptions and cultural beliefs. Additionally, messages transmitted via interpersonal networks and social media strongly influence motivation to obtain vaccination during pregnancy. The findings of this study will assist in developing tailored messages that change pregnant African American women's influenza vaccination decision-making to achieve improved coverage.Maternal and Child Health Journal 12/2013; 18(7). DOI:10.1007/s10995-013-1404-9 · 2.24 Impact Factor