Adverse events associated with the use of recommended vaccines during pregnancy: An overview of systematic reviews

•Definite risks were not identified for any vaccine and outcome.•Influenza and pertussis vaccination monopolized most of the available evidence.•Much of the evidence was based on observational studies with a high degree of overlap.•LBW, microcephaly, maternal death, chorioamnionitis were rarely cons...

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Veröffentlicht in:Vaccine 2021-07, Vol.39, p.B12-B26
Hauptverfasser: Macias Saint-Gerons, Diego, Solà Arnau, Iván, De Mucio, Bremen, Arévalo-Rodríguez, Ingrid, Alemán, Alicia, Castro, José Luis, Ropero Álvarez, Alba María
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Sprache:eng
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Zusammenfassung:•Definite risks were not identified for any vaccine and outcome.•Influenza and pertussis vaccination monopolized most of the available evidence.•Much of the evidence was based on observational studies with a high degree of overlap.•LBW, microcephaly, maternal death, chorioamnionitis were rarely considered/reported. Maternal immunization is aimed at reducing morbidity and mortality in pregnant women and their newborns. Updated evidence synthesis of maternal-fetal outcomes is constantly needed to ensure that the risk-benefit of vaccination during pregnancy remains positive. An overview of systematic reviews (OoSRs) was performed. We searched The Cochrane Library, MEDLINE and EMBASE for SRs including recommended vaccines for maternal immunization reporting the following: abortion, stillbirth, chorioamnionitis, congenital anomalies, microcephaly, neonatal death, neonatal infection, preterm birth (PTB), low birth weight (LBW), maternal death and small for gestational age (SGA) from 2010 to April 2019. Quality and overlap of SRs was assessed. Seventeen SRs were identified, eight of them included meta-analysis; quality was high in three SRs, moderate in six SRs, low in two SRs, and critically low in six SRs. Stillbirth and PTB were the most frequently reported outcomes by 15 and 13 SRs, respectively, followed by abortion (9 SRs), congenital anomalies (9 SRs), SGA (8 SRs), neonatal death (8 SRs), LBW (4 SRs), chorioamnionitis (3 SRs), maternal death (1 SR). SRs included mainly observational evidence for influenza and Tdap vaccines (11 SRs and 4 SRs, respectively); limited evidence was found for hepatitis (1 SR), yellow fever (1 SR), and meningococcal (1 SR) vaccines. Most of the SRs found no effect. Eight SRs found benefit/protection of influenza vaccine (for stillbirth, neonatal death, preterm birth, LBW), or Tdap vaccine (for preterm birth and SGA); one found a probable risk (chorioamnionitis/Tdap). The SRs for Hepatitis B, meningococcal and yellow fever vaccines were inconclusive. Definite risks were not identified for any vaccine and outcome; however better evidence is needed for all outcomes and vaccines. The available evidence in the SRs to support vaccine safety was based mainly on observational data. More RCTs with adequate reporting of maternal-fetal outcomes and larger high-quality observational studies are needed.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2020.07.048