A/H1N1 pandemic influenza vaccination: A retrospective evaluation of adverse maternal, fetal and neonatal outcomes in a cohort of pregnant women in Italy

Fabiani, Massimo; Bella, Antonino; Rota, Maria Cristina; Clagnan, Elena; Gallo, Tolinda; D'Amato, M; Pezzotti, Patrizio; Ferrara, Lorenza; Demicheli, Vittorio; Martinelli, Domenico; Prato, Rosa; Rizzo, Caterina

doi:10.1016/j.vaccine.2015.03.041

Cited by 41 publications

(37 citation statements)

References 27 publications

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“…15,20,[23][24][25][26] Two of these studies reported significant effect measures < 1, 20,25 and the other five reported nonsignificant effect measures. 15,20,23,24,26,31 In the meta-analysis A/H1N1pdm09 monovalent vaccination had a protective effect against LBW with a pooled effect of 0.88 (95% CI: 0.79, 0.98) and substantial heterogeneity among the chosen studies (I 2 ¼ 61.6%, p ¼ 0.016), ►Fig. 7.…”

Section: Low Birth Weightmentioning

confidence: 99%

“…Only a few studies identified the precise gestational age at which vaccination occurred and applied time-dependent analyses from time of exposure to outcome. 15,24,26,30,31 Another consideration that most of the studies did not address was the timing of pregnancy in relation to exposure to the influenza virus. The direct effect of maternal vaccination on birth outcomes is expected to be observed only in pregnancies in which the vulnerable period for the outcome of interest overlaps with the influenza season.…”

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confidence: 99%

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The Effects of Influenza Vaccination during Pregnancy on Birth Outcomes: A Systematic Review and Meta-Analysis

et al. 2016

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Objective Numerous observational studies have evaluated the relationship between influenza vaccination during pregnancy and birth outcomes. The number of studies on this subject has increased, especially after the 2009 A/H1N1 pandemic (A/H1N1pdm09). This meta-analysis aims to determine the impact of maternal vaccination with either seasonal trivalent inactivated influenza vaccines (IIV) or A/H1N1pdm09 monovalent vaccines on the rates of preterm (PTB), small for gestational age (SGA), and low birth weight (LBW) births. Methods English language randomized controlled trials and observational studies assessing the proposed outcomes after administration of influenza vaccine during pregnancy were screened. Observational studies were included if they presented adjusted measures and if the total number of women evaluated reached predefined thresholds. Sensitivity analyses were performed, including all published observational studies irrespectively of the sample size. Results A total of 5 and 13 publications that assessed the impact of IIV and monovalent A/H1N1pdm09 vaccines, respectively, fulfilled the inclusion criteria for the main analyses. The rate of PTB and LBW was lower in women who received IIV during pregnancy compared with nonvaccinated women (odds ratio Ã Contributed equally to this article.[

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Section: Low Birth Weightmentioning

confidence: 99%

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confidence: 99%

The Effects of Influenza Vaccination during Pregnancy on Birth Outcomes: A Systematic Review and Meta-Analysis

et al. 2016

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“…Studies published since these reviews have been consistent with these findings. [54][55][56][57] Studies that investigated outcomes for women immunized during their first trimester generally had lower statistical power due to the smaller number of women immunized during this period. Only a small number of studies have investigated the most important first trimester outcomes of spontaneous abortion and congenital anomalies.…”

Section: Safety Of Vaccines For Pregnant Womenmentioning

confidence: 99%

Vaccines in pregnancy: The dual benefit for pregnant women and infants

Marshall

McMillan

Andrews

et al. 2016

Human Vaccines & Immunotherapeutics

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Maternal immunization has the potential to reduce the burden of infectious diseases in the pregnant woman and her infant. Many countries now recommend immunization against influenza at any stage of pregnancy and against pertussis in the third trimester. Despite evidence of the safety and effectiveness of these vaccines when administered during pregnancy, uptake generally remains low for influenza and moderate for pertussis vaccine. Enhancing confidence in both immunization providers and pregnant women by increasing the evidence-base for the safety and effectiveness of vaccines during pregnancy, improving communication and access by incorporating immunization into standard models of antenatal care are likely to improve uptake. Developing a framework for implementation of vaccines for pregnant women which is cognizant of local and national cultural, epidemiological, behavioral and societal factors will enable a smooth transition and high uptake for new vaccines currently in development for pregnant women.

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“…[37][38][39][40] While one retrospective study in pregnant women suggested a trend to increased gestational diabetes and eclampsia in those that received MF59-adjuvanted influenza vaccine, 41 other studies have not reported similar effects during pregnancy. [42][43][44][45] A randomized controlled clinical trial comparing MF59-adjuvanted vaccine (Focetria Ò ) in pregnant and non-pregnant women found that a non-significant trend to a lower antibody response in pregnant women; 72% of the women reported adverse reactions, with 64% experiencing local reactions and 26% systemic reactions with malaise as the most common symptom. 25 …”

Section: Adjuvanted Influenza Vaccines In Pregnancymentioning

confidence: 99%