Resumo O objetivo deste artigo é analisar as taxas de coberturas vacinais em crianças menores de um ano durante o período de 2015 a 2020 no estado de Minas Gerais (MG). Estudo ecológico, de série temporal, sobre as coberturas vacinais em crianças menores de 1 ano, considerando-se como unidade de análise as 28 Gerências/Superintendências Regionais de Saúde (GRS/SRS) de MG. Analisaram-se as coberturas vacinais dos seguintes imunobiológicos vacinas: contra o Bacilo de Calmette e Guérin (BCG), contra rotavírus humano, contra pneumococo 10, pentavalente, contra meningococo C, contra febre amarela e contra a poliomielite. Empregou-se o modelo autorregressivo de Prais-Winsten para análise de tendência. Destaca-se o ano de 2020, que apresentou a menor proporção de GRS e SRS que alcançaram as metas preconizadas de cobertura vacinal para os imunobiológicos analisados. Quanto à análise de tendência da cobertura, 8 das 28 GRS/SRS apresentaram tendência decrescente de, pelo menos, 5 dos 7 imunobiológicos avaliados. Observou-se tendência decrescente na cobertura vacinal de pelo menos cinco imunobiológicos em oito das GRS /SRS, com destaque para a vacina Pentavalente, que apresentou tendência decrescente de cobertura vacinal em 60,71% das GRS e SRS.
This scoping review responds to the appeal of the scientific community for collaboration between different entities for pharmacovigilance and active surveillance of coronavirus disease 2019 (COVID-19) vaccines. The objective is to identify, systematically evaluate, and synthesize the best scientific evidence available on the indicators used in pharmacovigilance systems. Our results demonstrate that approximately 50% of the 25 studies used in this review have been carried out in the past 5 years. Of these, only four used the pharmacovigilance indicators proposed by the World Health Organization (WHO). Eighty-seven pharmacovigilance indicators were identified, of which seven (8.0%) related to signal detection. While the WHO advocates signal detection as routine pharmacovigilance, in special situations – such as accelerated clinical studies where adverse events are not yet well known – other indicators related to signal detection appear to be good options for maintaining quality pharmacovigilance and active surveillance in the development of the COVID-19 vaccine. However, the less robust pharmacovigilance systems in low-income countries will necessitate greater involvement of health professionals from public and private sectors, pharmaceutical companies, academic institutions, and the general public, to ensure information security and detection of signals for the COVID-19 vaccine.
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. Following immunization, participants were observed for 30 minutes and they received a participant card to register adverse events information. All safety information registered were checked at a clinical site visit 14 days after immunization and by a telephone contact 42 days after immunization for unsolicited Adverse Events (AE) and Guillain-Barré Syndrome (GBS).
Results
A total of 942 volunteers participated in the two studies: 305 elderly, 109 children, 108 pregnant women, 32 women in the postpartum period, and 388 health workers. Overall, the median number of AR per participant ranged from 1 to 4. The lowest median number of AR per participant was observed among healthcare workers (1 AR per participant) and the highest among pregnant women (4 AR per participant). Overall, local pain (46.6%) was the most frequent solicited local AR. The most frequent systemic ARs were: headache (22.5%) followed by fatigue (16.0%), and malaise (11.0%). The majority of solicited ARs (96%) were mild, Grades 1 or 2), only 3% were Grade 3, and 1% was Grade 4. No serious AEs, including Guillain-Barré Syndrome, were reported up to 42 days postvaccination.
Conclusion
The results from the two studies confirmed that the 2017 and 2018 seasonal trivalent influenza vaccines produced by Instituto Butantan were safe and that active pharmacovigilance studies should be considered, when it is feasible, as an important initiative to monitor vaccine safety in the post-marketing period.
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