Epidemiologia dos eventos supostamente atribuíveis às vacinas covid-19 durante o primeiro ano da vacinação em Minas Gerais, Brasil

Abstract

Introduction: Coronavirus disease (COVID-19), caused by SARS-CoV-2, is characterized by an acute, potentially serious respiratory infection. In March 2020, the World Health Organization (WHO) declared it a pandemic and even considered it a syndemic. Given the recent accelerated introduction of COVID-19 vaccines, which employ various production technologies and will be administered to millions of individuals, there may be a significant increase in reports of Events Supposedly Attributable to Vaccination or Immunization (ESAVI). Therefore, pharmacovigilance studies on ESAVI are of utmost importance. Objective: To estimate and describe the occurrence of ESAVI reported in Minas Gerais (MG), Brazil, associated with COVID-19 vaccines. Method: This was an epidemiological, descriptive study using secondary dataon ESAVI in the state of MG from January 18, 2021, to January 21, 2022. The frequencyof all ESAVI cases temporally associated with COVID-19 vaccines (AstraZeneca/Fiocruz, Sinovac/Butantan, Pfizer/Wyeth, and Janssen) notified in the system, available during that timefor application in Brazil through the National Immunization Program (PNI) was examined. The incidence rate (IR) of adverse events per 100,000 doses administered in the state was also calculated. Microsoft Office Excel (version 2016) and Stata (version 17.0) were used for data analysis. ESAVI cases were presented as proportions (%) based on the administered immunobiological, dose, age group, gender, type of event, and causality classification. Results: During the study period, a total of 34,307,831 doses of COVID-19 vaccines were administered. A total of 34,971 cases of ESAVI were reported, with 31,544 (91.7%) being adverse events, with an incidence rate (IR) of 91.9 cases per 100,000 doses administered, and 2,838 (8.2%) were immunization errors (IE), with an IR of 8.3 cases per 100,000 doses administered. Regarding the severity classification of adverse events, 29,093 (92.2%) of the ESAVI were classified as non-serious adverse events (IR = 84.8). Serious adverse events accounted for 7.8% of ESAVI (IR = 7.1), and deaths accounted for 2.9% of all ESAVI (IR = 2.7). The main signs and symptoms for non-serious events were chills, headache, and local pain at the injection site, while for serious events, considering the System Organ Class (SOC), respiratory, thoracic, and mediastinal disorders were prominent, with higher incidences for the Sinovac/Butantan and AstraZeneca/Fiocruz vaccines (IR = 7.2 and 5.6 cases per thousand doses administered, respectively). Regarding the causality of closed deaths, 85.2% were classified as coincidental or inconsistent reactions, and two (2) deaths were classified as product-related reactions. Conclusion: In this study, although ESAVIs from COVID-19 vaccines in the state of Minas Gerais were frequent, most of them were non-serious. It can be concluded, therefore, that COVID-19 vaccines have shown to be positive and effective in combating the virus, significantly reducing morbidity and mortality cases, in addition to being safe and competent reducing cases of morbidity and mortality, in addition to being safe and competent.