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Observational Study
. 2023 Jan 13;18(1):e0280284.
doi: 10.1371/journal.pone.0280284. eCollection 2023.

Adverse events of COVID-19 vaccines in pregnant and postpartum women in Brazil: A cross-sectional study

Dimas Tadeu Covas  1 , Ariane de Jesus Lopes de Abreu  2 , Carolina Zampirolli Dias  2 , Rafaela Vansan Ferreira  2 , Ramon Gonçalves Pereira  2 , Guilherme Silva Julian  2
Affiliations
Observational Study

Adverse events of COVID-19 vaccines in pregnant and postpartum women in Brazil: A cross-sectional study

Dimas Tadeu Covas et al. PLoS One. .

Abstract

Background: By the fact that pregnant and postpartum women are currently using COVID-19 vaccines, ensure their safety is critical. So, more safety evidence is crucial to include this new technology to their vaccine's calendar and to develop public policies regarding the support and training of Health Care Personnel. This study aims to describe the adverse events (AE) of COVID-19 vaccines in pregnant and postpartum women in the early stage of vaccination campaign in Brazil.

Methods: An observational cross-sectional study using data from the Brazilian surveillance information system to characterize the AE of COVID-19 vaccines (Sinovac/Butantan, Pfizer/BioNTech, AstraZeneca and Janssen) in Brazilian pregnant and postpartum women from April to August 2021. Frequency and incidence rate of AE for COVID-19 vaccines were assessed.

Results: 3,333 AE following immunization were reported for the study population. AE incidence was 309.4/100,000 doses (95% CI 297.23, 321.51). Within the vaccines available, Sinovac/Butantan had the lowest incidence (74.08/100,000 doses; 95% CI 63.47, 84.69). Systemic events were the most frequent notified (82.07%), followed by local (11.93%) and maternal (4.74%), being most of them classified as non-severe (90.65%).

Conclusion: Our results corroborate the recommendation of vaccination for these groups. Even though, further studies appraising a longer observation time are still needed to provide a broader safety aspect for the vaccines currently under use for this population.

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Conflict of interest statement

All authors have contributed significantly and agree with the content of the manuscript. They declare the following financial interests/personal relationships which may be considered as potential competing interests: DTC is director of Instituto Butantan. RGP, RVF and CZD are employees of IQVIA Brazil which was contracted by Sinovac Life Sciences to conduct the study. GSJ and AJLA were employees of IQVIA Brazil during the study conduction and currently are employees of Pfizer Brazil. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

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Fig 1. Attrition diagram.
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