BackgroundAlthough COVID-19 vaccines are currently under use in pregnant and postpartum women, there is still lack of evidence regarding safety and effectiveness in these populations. This study aims to describe the safety profile of COVID-19 vaccines in pregnant and postpartum women in the early stage of vaccination campaign in Brazil.MethodsThis is an observational cross-sectional study using data from the Brazilian surveillance information system for adverse events (SI-EAPV) to characterize the safety of COVID-19 vaccines available (Sinovac/Butantan, Pfizer/BioNTech, AstraZeneca and Janssen) in Brazilian pregnant and postpartum women after receiving it from April to August 2021. A descriptive analysis was performed to assess the frequency and incidence rate of the adverse events (AE) for COVID-19 vaccines.ResultsA total of 3,333 adverse events following COVID-19 immunization were reported for the study population in the SIEAPV. The incidence of AE found was 309.4/100,000 doses (95% CI 297.23, 321.51). Regarding the four vaccines available in the country, Sinovac/Butantan had the lowest incidence (74.08/100,000 doses; 95% CI 63.47, 84.69). Systemic events were the most frequent notified for the group (82.07%), followed by local (11.93%) and maternal (4.74%), being most of them classified as non-severe (90.65%).ConclusionA similar pattern of AE as stated in other studies was found, with even better results for non-viral vector vaccines, corroborating to 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.

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.

Objective Our study assessed DATASUS as a potential source for pharmacoepidemiologic studies in rheumatoid arthritis (RA) in the Brazilian population focusing on treatment patterns and determinants of initiating or switching to a novel therapy. Methods Descriptive database study of RA patients with at least one claim of RA and ≥ 2 claims of disease-modifying anti-rheumatic drug (DMARD); conventional synthetic (cs), biologic (b) or targeted synthetic (ts) DMARD with more than < 6 month of follow-up from 01-Jan-to 31-Dec-2020. Analyses were stratified for SUS and non-SUS-exclusive user cohorts. Results We identified 250,251 patients with RA: mean age of 58.4 years, majority female (83%) and white (58%). 62% were SUS-exclusive and 38% non-SUS exclusive. Most common bDMARD was adalimumab and etanercept. Age (adjusted odds ratio 1.78 [50+]; 95% CI 1.57–2.01), SUS exclusive (0.53;0.47–0.59), distance to clinic [160 + km] (0.57;0.45–0.72), and pre-index csDMARD claims (1.23;1.08–1.41) were independent predictors of initiating a novel oral tsDMARD. Switching from bDMARD to tsDMARD, associations were similar, except directionality of SUS exclusive (adjusted hazard ratio 1.10;1.03–1.18), distance to clinic (1.18;1.03–1.35), and number of previous bDMARD (0.15;0.14–0.16). Conclusion DATASUS is a valid source for treatment-related analyses in RA reflecting the public health system in Brazil.

Objectives: To identify and describe the profile of potential transthyretin cardiac amyloidosis (ATTR-CM) cases in the Brazilian public health system (SUS), using a predictive machine learning (ML) model. Methods: This was a retrospective descriptive database study that aimed to estimate the frequency of potential ATTR-CM cases in the Brazilian public health system using a supervised ML model, from January 2015 to December 2021. To build the model, a list of ICD-10 codes and procedures potentially related with ATTR-CM was created based on literature review and validated by experts. Results: From 2015 to 2021, the ML model classified 262 hereditary ATTR-CM (hATTR-CM) and 1,581 wild-type ATTR-CM (wtATTR-CM) potential cases. Overall, the median age of hATTR-CM and wtATTR-CM patients was 66.8 and 59.9 years, respectively. The ICD-10 codes most presented as hATTR-CM and wtATTR-CM were related to heart failure and arrythmias. Regarding the therapeutic itinerary, 13% and 5% of hATTR-CM and wtATTR-CM received treatment with tafamidis meglumine, respectively, while 0% and 29% of hATTR-CM and wtATTR-CM were referred to heart transplant. Conclusion: Our findings may be useful to support the development of health guidelines and policies to improve diagnosis, treatment, and to cover unmet medical needs of patients with ATTR-CM in Brazil.