Research ethics and resource allocation in times of covid-19 / Ética de investigación y asignación de recursos en tiempos de covid-19 / Ética em pesquisa e alocação de recursos em tempos de covid-19

Abstract The purpose of this reflection is to include ethical principles in the discussion on resource allocation in times of covid-19. This study presents recent news and documents on the use of resources in the pandemic and principles such as justice, autonomy and beneficence. The comprehension that all human beings are worthy of respect, solidarity and protection can help pave the way for accelerating pandemic control for all.

Resumen El propósito de esta reflexión es incluir principios éticos en la discusión sobre la asignación de recursos en tiempos de covid-19. Se trata de un estudio que presenta noticias y documentos recientes sobre el uso de recursos en la pandemia y sobre principios como justicia, autonomía y beneficencia. La comprensión de que todos los seres humanos son dignos de respeto, solidaridad y protección puede ayudar a allanar el camino para acelerar el control de la pandemia para todos.

Resumo O objetivo desta reflexão é incluir princípios éticos na discussão sobre alocação de recursos em tempos de covid-19. Este estudo apresenta notícias e documentos recentes sobre uso de recursos na pandemia, e princípios como justiça, autonomia e beneficência. A compreensão de que todos os seres humanos merecem respeito, solidariedade e proteção pode ajudar a trilhar caminhos que acelerem o controle da pandemia para todos.

Pharmacovigilance capacity strengthening for WHO prequalification: the case of the trivalent influenza vaccine manufactured by Instituto Butantan

Instituto Butantan is a biomedical research center and vaccine manufacturer affiliated with the São Paulo State Secretary of Health in Brazil. In 2013, Instituto Butantan successfully licensed its trivalent influenza vaccine, in order to support the Brazilian National Immunization Program's influenza vaccination strategy, which was introduced in 1999. In order to respond to the increasing influenza vaccine demand worldwide, Instituto Butantan is undergoing prequalification of its trivalent influenza vaccine by the World Health Organization (WHO). A key requirement of the prequalification review was the submission of a pharmacovigilance plan, including an active surveillance evaluation, for the trivalent influenza vaccine, and proof of a functional pharmacovigilance system at Instituto Butantan. The aim of this paper is to describe the capacity strengthening process of the pharmacovigilance system at Instituto Butantan for the WHO prequalification of the trivalent influenza vaccine. This process was supported by PATH and the U.S. Federal Government Biomedical Advanced Research and Development Authority (BARDA). The key strategic axes for this capacity strengthening process included the improvement of organizational structure, human resources training, internal processes and procedures, appropriate documentation, and acquisition of an E2B compliant pharmacovigilance database. The project led to the establishment of a functional pharmacovigilance system compliant with international regulatory requirements.