General Coordination of the National Immunization Program, Ministério da Saúde, Brasília, DF, Brazil.
Centro Universitário Faculdade de Medicina do ABC, Santo André, SP, Brazil.
Rev Bras Ginecol Obstet. 2022 Sep;44(9):821-829. doi: 10.1055/s-0042-1755461. Epub 2022 Sep 6.
Regulations for the vaccination of pregnant women in Brazil occurred in March 2021. Despite the absence of robust data in the literature on the coronavirus disease 2019 (COVID-19) vaccinations in pregnant women, it is understood that the benefit-risk ratio tends to be favorable when considering the pandemic and the high burden of the disease. However, it is still important to monitor for Events Supposedly Attributable to Vaccination or Immunization (ESAVI) and to draw safety profiles of the different platforms used in pregnant and postpartum women. The present study aims to describe the main characteristics of ESAVIs related to COVID-19 vaccines occurring in pregnant women in the first months of the vaccination campaign in Brazil. During the evaluation period, 1,674 notifications of ESAVIs in pregnant women were recorded, and 582 notifications were included for the analysis. Of the 582 ESAVIs identified, 481 (82%) were classified as non-serious adverse events and 101 (17%) as serious adverse events. Ten deaths were identified, including one death which was considered to be causally related to the vaccine. The other nine maternal deaths had causality C, that is, without causal relationship with the vaccine, and most were due to complications inherent to pregnancy, such as pregnancy-specific hypertensive disorder (PSHD) in 4 cases and 3 due to COVID-19. Despite some limitations in our study, we believe it brings new insights into COVID-19 vaccines in this group and will add to the available evidence.
巴西对孕妇接种疫苗的规定于 2021 年 3 月出台。尽管在有关孕妇接种新型冠状病毒病（COVID-19）疫苗的文献中缺乏有力数据，但考虑到大流行和疾病的高负担，风险效益比倾向于有利。然而，监测与疫苗接种有关的疑似不良事件（ESAVI）以及绘制在孕妇和产后妇女中使用的不同平台的安全性概况仍然很重要。本研究旨在描述巴西疫苗接种运动开始后的头几个月内，与 COVID-19 疫苗相关的孕妇中 ESAVI 的主要特征。在评估期间，记录了 1674 例孕妇的 ESAVI 通知，其中 582 例纳入分析。在所确定的 582 例 ESAVI 中，481 例（82%）被归类为非严重不良事件，101 例（17%）为严重不良事件。确定了 10 例死亡病例，其中 1 例被认为与疫苗有因果关系。其他 9 例产妇死亡病例因果关系为 C，即与疫苗无因果关系，大多数死亡是由于妊娠固有并发症所致，例如 4 例妊娠特定高血压疾病（PSHD）和 3 例因 COVID-19 引起。尽管我们的研究存在一些局限性，但我们认为它为该群体的 COVID-19 疫苗提供了新的见解，并将为现有证据增添内容。
