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Safety of Hepatitis B, Pneumococcal Polysaccharide and Meningococcal Polysaccharide Vaccines in Pregnancy

A Systematic Review

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Abstract

Immunization during pregnancy has the potential to protect the mother and the newborn from preventable diseases. Current recommendations suggest that inactivated vaccines might be considered during pregnancy when the benefits outweigh the risks.

In this review, we aimed to evaluate the safety of hepatitis B (HB) vaccine, pneumococcal polysaccharide vaccine (PPSV) and meningococcal polysaccharide vaccine (MPSV) administration during pregnancy by systematically reviewing the available evidence in PubMed and Scopus databases, as well as postmarketing surveillance data (including the Vaccine Adverse Event Reporting System [VAERS] database). A total of 18 studies were eligible for inclusion in the review. Six studies provided data on HB vaccine, six on PPSV and three on MPSV; three additional studies compared PPSV with MPSV. Additionally, 91 reports on vaccinations of pregnant women were identified from postmarketing surveillance data (88 on HB vaccine, 2 on PPSV, 1 on MPSV). The most common complaints were local reactions, including tenderness and swelling. Overall, immunization during pregnancy did not seem to be associated with a teratogenic effect on the fetus, preterm labour or spontaneous abortion. However, the lack of randomized, placebo-controlled trials, or even large cohort studies, in addition to the inherent limitations of the reviewed observational studies with small statistical power, precluded safe conclusions. Large, prospective, population-based cohort studies are needed to elucidate this issue.

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Acknowledgements

No sources of funding were used to prepare this manuscript. The authors have no conflicts of interest that are directly relevant to the content of this review.

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Authors and Affiliations

  1. Alfa Institute of Biomedical Sciences (AIBS), 9 Neapoleos Street, 151 23, Marousi, Athens, Greece

    Marinos C. Makris, Konstantinos A. Polyzos, Michael N. Mavros, Stavros Athanasiou, Petros I. Rafailidis &  Matthew E. Falagas

  2. Department of Obstetrics and Gynecology, Athens University School of Medicine, Athens, Greece

    Stavros Athanasiou

  3. Department of Medicine, Henry Dunant Hospital, Athens, Greece

    Petros I. Rafailidis &  Matthew E. Falagas

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  1. Marinos C. Makris
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  2. Konstantinos A. Polyzos
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  6. Matthew E. Falagas
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Correspondence to Matthew E. Falagas.

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Makris, M.C., Polyzos, K.A., Mavros, M.N. et al. Safety of Hepatitis B, Pneumococcal Polysaccharide and Meningococcal Polysaccharide Vaccines in Pregnancy. Drug Saf 35, 1–14 (2012). https://doi.org/10.2165/11595670-000000000-00000

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