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CC BY 4.0 · Rev Bras Ginecol Obstet 2022; 44(09): 821-829
DOI: 10.1055/s-0042-1755461
Original Article
Obstetrics

Adverse Events Related to COVID-19 Vaccines Reported in Pregnant Women in Brazil

Eventos adversos pós-vacina contra COVID-19 em gestantes no Brasil
Carla Dinamerica Kobayashi 
1   General Coordination of the National Immunization Program, Ministério da Saúde, Brasília, DF, Brazil
,
Victor Bertollo Gomes Porto 
1   General Coordination of the National Immunization Program, Ministério da Saúde, Brasília, DF, Brazil
,
Martha Elizabeth Brasil da Nóbrega 
1   General Coordination of the National Immunization Program, Ministério da Saúde, Brasília, DF, Brazil
,
Cibelle Mendes Cabral 
1   General Coordination of the National Immunization Program, Ministério da Saúde, Brasília, DF, Brazil
,
Tiago Dahrug Barros 
1   General Coordination of the National Immunization Program, Ministério da Saúde, Brasília, DF, Brazil
,
Cecília Maria Roteli Martins 
2   Centro Universitário Faculdade de Medicina do ABC, Santo André, SP, Brazil
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Abstract

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.

Resumo

As determinações vacinação nas gestantes foram estabelecidas em março de 2021, no Brasil. Apesar da ausência de dados robustos na literatura da vacinação contra coronavirus disease 2019 (COVID-19) nesse grupo, entende-se que a relação de benefício versus risco tende a ser favorável considerando a situação pandêmica e a elevada carga de doença, tendo justificado o uso dessas vacinas em ampla escala nas gestantes de todo o mundo. Entretanto, o monitoramento dos eventos adversos pós vacinação (EAPVs) torna-se ainda mais importante para traçar um perfil de segurança das diferentes plataformas nas gestantes e puérperas. O presente estudo tem como objetivo descrever as principais características dos EAPVs contra COVID-19 ocorridos nas gestantes nos primeiros meses de campanha da vacinação no Brasil. Foram identificadas 1.674 notificações em gestantes, com a inclusão de 582 EAPVs analisados. Dos 582 EAPVs identificados, 481 (82%) foram classificados como eventos adversos não-graves e 101 (17%) como eventos adversos graves, sendo 10 (9,9%) destes referentes aos óbitos. Apenas um caso de óbito materno teve relação causal com a vacinação comprovada (causalidade A1), e foi secundário à síndrome trombocitopênica trombótica (TTS) após a vacina AstraZeneca/Fiocruz. Os outros nove óbitos maternos tiveram causalidade C, ou seja, sem relação causal com a vacina, e a maioria por complicações inerentes à gravidez, como a doença hipertensiva específica da gestação (DHEG) e COVID-19. Apesar de algumas limitações em nosso estudo, acreditamos que ele traz dados importantes sobre as vacinas COVID-19 neste grupo aumentando as evidências disponíveis.

Keywords

COVID-19 vaccines - adverse event - vaccine-preventable diseases - pregnant women - Brazil

Palavras-chave

vacinas contra COVID-19 - evento adverso - doenças preveníveis por vacina - gestantes - Brasil

Contributions

All authors contributed to the design of the study, were involved in the data collection, data analysis and/or interpretation. Also, all authors contributed to the writing/substantive editing and review of the manuscript and approved the final draft of the manuscript.




Publication History

Received: 08 February 2022

Accepted: 18 May 2022

Article published online:
06 September 2022

© 2022. Federação Brasileira de Ginecologia e Obstetrícia. This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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