Segurança e imunogenicidade da vacina trivalente inativada contra influenza durante a gravidez: uma revisão sistemática de estudos observacionais e randomizados

Abstract

Seasonal influenza vaccination in pregnant women presents a unique challenge: it is known that influenza infection in pregnancy can cause severe morbidity, yet the benefits of maternal vaccination remain unclear. This study aims to conduct a systematic literature review synthesising available knowledge on the safety and immunogenicity of seasonal trivalent fragmented inactivated influenza (TIV) vaccine in pregnant women, and on the transmission and duration of maternal antibodies in the newborn. The search strategies were based on the defined acronym PICOS: (Participant) pregnant women; (Intervention) TIV vaccination; (Comparator) according to studies found in the review; (Outcomes) local and systemic adverse event/reaction, significant immunogenic improvement and maternally acquired immunity to influenza; (Study design) all types without restrictions. The following databases were searched: Web of Science (WoS), Medline (via PubMed), Embase, LILACS/VHL and CINAHL, from database inception until July 2018. Titles and abstracts were screened to identify potentially-relevant studies, which were then read in full. Data was extracted using a standardized form; the most relevant findings were summarized in a narrative synthesis. Methodological validity and quality will be assessed by standardized critical assessment tools, based on the Evaluation, Development and Rating Classification (GRADE) guidelines. The Electronic research found 133 articles at WoS, 1442 at Medline, 2157 at Embase, 1017 at LILACS/VHL and 391 at CINAHL. The selection of titles and abstracts resulted in 118 observational studies and 5 RCTs. After the examination of the full texts, 21 articles were excluded because they did not include the full scope of the study. The observational studies (97) included 41 cross-sectional studies and 3 case controls. Eight studies reported local and systemic adverse events. The most reported events in pregnant women were: Local pain, skin eruption, muscle pain, fever, malaise and headache. In newborns: Meningitis, Low weight, Influenza like and Fetal death. Regarding immunogenicity data, they showed that pregnant women have the ability to produce rates within or above the recommended standard. According to the survey of data and reports from the studies analyzed, it is possible to say that the inactivated trivalent vaccine against influenza is beneficial for pregnant women.