title: Safety of hepatitis B, pneumococcal polysaccharide and meningococcal polysaccharide vaccines in pregnancy: a systematic review.
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.
authors.affiliation: Alfa Institute of Biomedical Sciences (AIBS), Athens, Greece.
authors.forename: Marinos C
authors.initials: MC
authors.lastname: Makris
authors.forename: Konstantinos A
authors.initials: KA
authors.lastname: Polyzos
authors.forename: Michael N
authors.initials: MN
authors.lastname: Mavros
authors.forename: Stavros
authors.initials: S
authors.lastname: Athanasiou
authors.forename: Petros I
authors.initials: PI
authors.lastname: Rafailidis
authors.forename: Matthew E
authors.initials: ME
authors.lastname: Falagas
mesh_terms: D001424:Bacterial Infections / Q000517:prevention & control*; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000009:adverse effects*; D006801:Humans; D008589:Meningococcal Infections / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000009:adverse effects*; D011008:Pneumococcal Infections / Q000517:prevention & control; D022242:Pneumococcal Vaccines / Q000009:adverse effects*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious
chemical_list: D017325:Hepatitis B Vaccines; D022401:Meningococcal Vaccines; D022242:Pneumococcal Vaccines