Evaluating the safety profile of the CoronaVac in adult and older adult populations: A phase IV prospective observational study in Brazil.

This Phase IV prospective observational study aimed to evaluate the frequency of solicited and unsolicited adverse reactions within seven days following the administration of each dose of CoronaVac (14-day interval) by age group (18-59 years and ≥60 years). Participants (n = 538; 487 adults and 51 older adults) were enrolled from three public health centers in São Paulo, Brazil from May 2021 to January 2022. The study involved a two-dose vaccination regimen administered 14 days apart.

Active vaccine safety surveillance in low- and middle-income countries: Challenges for vaccine manufacturers from emerging countries.

Developing Countries Vaccine Manufacturers Network (DCVMN) is an alliance of vaccine developers, manufacturers, and marketing authorization holders (MAHs) from low- and middle-income countries (LMICs) that plays a vital role in ensuring equitable, inclusive, accountable, and timely access to affordable, high-quality vaccines in these countries. Besides research and development, this network promotes manufacturing and global supply chains for effective strengthening of regulatory and pharmacovigilance activities. Traditionally, vaccine safety surveillance systems in LMICs rely on spontaneous reporting.

A randomized, double-blind, non-inferiority trial comparing the immunogenicity and safety of two seasonal inactivated influenza vaccines in adults.

Background: To enhance the production and availability of influenza vaccines in different regions of the world is paramount to mitigate the global burden of this disease. Instituto Butantan developed and manufactured an embryonated egg-based inactivated split-virion trivalent seasonal influenza vaccine as part of a technology transfer partnership with Sanofi Pasteur.

Methods: This is a phase IV, randomized, double-blind, active-controlled, multicenter clinical trial including adults 18-60 and > 60 years recruited during the 2019 southern hemisphere influenza season.

Relationship between short and long-term glycemic variability and oxidative stress in type 1 diabetes mellitus under daily life insulin treatment.

Objective: The purpose of this study was to investigate the heterogeneity of the association between glycemic variability and oxidative stress markers in T1DM patients under daily life insulin treatment.

Methods: We studied, in a cross-sectional analysis, 76 T1DM patients without clinical chronic diabetes complications and 22 healthy individuals. Were evaluated the short-term glycemic variability (STGV), long-term glycemic variability (LTGV), oxidative stress markers [8-isoprostaglandin-F2α (Ur-8-iso-PGF2α), nitric oxide (NO), thiobarbituric acid reactive substances (TBARS) and erythrocytes reduced/oxidized glutathione (GSH/GSSG)] and biochemical dosages (glycaemia, HbA1c, lipidogram, albuminuria).

Active pharmacovigilance of the seasonal trivalent influenza vaccine produced by Instituto Butantan: A prospective cohort study of five target groups.

Introduction: Active pharmacovigilance studies are pivotal to better characterize vaccine safety.

Methods: These are multicenter prospective cohort studies to evaluate the safety of the 2017 and 2018 seasonal trivalent influenza vaccines (TIVs) manufactured by Instituto Butantan, by means of active pharmacovigilance practices. Elderly, children, healthcare workers, pregnant women, and women in the puerperium period were invited to participate in the study during the 2017 and 2018 Brazilian national seasonal influenza vaccination campaigns.

Safety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017.

Vaccination has been a successful strategy in influenza prevention. However, despite the safety and efficacy of the vaccines, they can cause adverse events following immunization (AEFI). Moreover, due to the vaccination success, most of vaccine-preventable diseases (VPD) have become rare, and public attention has been shifted from VPD to the AEFI associated with vaccination.

Protocol to refine intestinal motility test in mice.

We propose a new protocol intended to conform to the 3Rs (replacement, reduction, and refinement) principle, using animals fasted for 3 h to control intestinal motility, which reduced stress in the animals. In this new protocol, mice are deprived of food for a short time (3 h) and are not killed. The mice are observed until evacuation containing charcoal is observed, and the experimental results are based on the charcoal evacuation time.