Safety of Hepatitis B, Pneumococcal Polysaccharide and Meningococcal Polysaccharide Vaccines in Pregnancy: A Systematic Review

• Published in: Drug safety 2012, Vol.35 (1), p.1-14
• Main Authors: Makris, Marinos C., Polyzos, Konstantinos A., Mavros, Michael N., Athanasiou, Stavros, Rafailidis, Petros I., Falagas, Matthew E.
• Format: Article
• Language: English
• Subjects: Abortion; Bacterial diseases; Bacterial diseases of the nervous system. Bacterial myositis; Biological and medical sciences; Clinical trial. Drug monitoring; Clinical trials; Data processing; Drug Safety and Pharmacovigilance; Drug toxicity and drugs side effects treatment; Drugs; Fetuses; General pharmacology; Hepatitis B; Human bacterial diseases; Human viral diseases; Immunization; Infectious diseases; Medical sciences; Medicine; Medicine & Public Health; Miscellaneous (drug allergy, mutagens, teratogens...); Neisseria meningitidis; Neonates; Pharmacology. Drug treatments; Pharmacology/Toxicology; Polysaccharides; Pregnancy; Review Article; Reviews; Side effects; Statistics; Streptococcus pneumoniae; Teratogenicity; Vaccines; Viral diseases; Viral hepatitis
• ISSN: 0114-5916; 1179-1942
• DOI: 10.2165/11595670-000000000-00000

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.