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.

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. This manuscript describes the safety of Instituto Butantan (IB) seasonal trivalent influenza vaccine (TIV) from 2013 to 2017. AEFI data were received by the Department of Pharmacovigilance of IB (PV-IB), from January the 1st 2013 to December the 31st 2017, and were recorded in an electronic database (OpenClinica©). PV-IB received 1,415 Individual Case Safety Reports (ICSR) associated with the TIV; 1,253 ICSR with at least one AEFI were analyzed and 4,140 AEFI were identified. The other 162 (11.4%) cases did not present any symptom. Among the total of AEFI, 405 (9.8%) were classified as serious. AEFI with the highest incidence rates per 100,000 doses of TIV were: “local pain” (0.28), “local erythema” (0.23), “local warmth” (0.22), “local swelling” (0.20) and “fever” (0.19). PV-IB received 175 (4.2%) occurrences of SAE of special interest, of which 75 (1.8%) anaphylaxis/anaphylactic reactions, 56 (1.4%) neurological syndromes (including seven Guillain-Barré Syndrome) and 44 (1.1%) convulsion/febrile convulsion. The results of this manuscript suggested that Instituto Butantan trivalent influenza vaccine (IB-TIV) is safe, as most of the reported AEFI were classified as non-serious. AEFI described for the IB-TIV are in agreement with the ones described in the literature for similar vaccines.

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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.

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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.

The emergence of potentially pandemic viruses has resulted in preparedness efforts to develop candidate vaccines and adjuvant formulations. We evaluated the dose-sparing effect and safety of two distinct squalene-based oil-in-water adjuvant emulsion formulations (IB160 and SE) with influenza A/H7N9 antigen. This phase I, randomized, double-blind, placebo-controlled, dose-finding trial (NCT03330899), enrolled 432 healthy volunteers aged 18 to 59. Participants were randomly allocated to 8 groups: 1A) IB160 + 15μg H7N9, 1B) IB160 + 7.5μg H7N9, 1C) IB160 + 3.75μg H7N9, 2A) SE + 15μg H7N9, 2B) SE + 7.5μg H7N9, 2C) SE + 3.75μg H7N9, 3) unadjuvanted vaccine 15μg H7N9 and 4) placebo. Immunogenicity was evaluated through haemagglutination inhibition (HI) and microneutralization (MN) tests. Safety was evaluated by monitoring local and systemic, solicited and unsolicited adverse events (AE) and reactions (AR) 7 and 28 days after each study injection, respectively, whereas serious adverse events (SAE) were monitored up to 194 days post-second dose. A greater increase in antibody geometric mean titers (GMT) was observed in groups receiving adjuvanted vaccines. Vaccinees receiving IB160-adjuvanted formulations showed the greatest response in group 1B, which induced an HI GMT increase of 4.7 times, HI titers ≥40 in 45.2% of participants (MN titers ≥40 in 80.8%). Vaccinees receiving SE-adjuvanted vaccines showed the greatest response in group 2A, with an HI GMT increase of 2.5 times, HI titers ≥40 in 22.9% of participants (MN titers ≥40 in 65.7%). Frequencies of AE and AR were similar among groups. Pain at the administration site and headache were the most frequent local and systemic solicited ARs. The vaccine candidates were safe and the adjuvanted formulations have a potential dose-sparing effect on immunogenicity against influenza A/H7N9. The magnitude of this effect could be further explored.