Infante Vanessa, Cintra Monica Akissue de Camargo Teixeira, Fernandes Eder Gatti, Loch Ana Paula, Ragiotto Lucas, Braga Patrícia Emília, Salomão Maria da Graça, Lucchesi Maria Beatriz Bastos, de Oliveira Mayra Martho Moura, Gattás Vera Lúcia, da Silva Anderson Soares, Boas Paulo José Fortes Villas, Lopes Marta Heloisa, Moreira José, Boulos Fernanda Castro
Clinical Trials and Pharmacovigilance Center, Instituto Butantan, São Paulo, Brazil.
Centro de Saúde Escola da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP-USP) Dr. Joel Domingos Machado, São Paulo, Brazil.
PLOS Glob Public Health. 2025 Feb 25;5(2):e0004069. doi: 10.1371/journal.pgph.0004069. eCollection 2025.
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. Solicited and unsolicited adverse reactions (ARs) were assessed within seven days after each dose, and medically attended adverse events following immunization (AEFI) were monitored for 42 days. Safety data were collected through participant diary cards, telephone follow-ups, and on-site visits. Among adults, the most frequently reported local AR after the first and second doses was pain (256 [52.6%] and 129 [29.5%], respectively), while the most common systemic AR was headache (158 [34.5%] and 51 [11.6%], respectively). Most local and systemic solicited ARs were of Grade 1 or 2 severity, with ARs being more prevalent in adults following the first dose. One serious adverse event related to the vaccine was reported in adults, with no fatalities. Nine adult participants experienced adverse events of special interest, including five cases of COVID-19. These findings support the overall safety profile of CoronaVac in adults and older adult individuals, with adverse events being generally mild and self-limited.
这项IV期前瞻性观察性研究旨在按年龄组（18至59岁和≥60岁）评估每剂科兴新冠疫苗（间隔14天）接种后7天内发生的预期和非预期不良反应的频率。2021年5月至2022年1月期间，从巴西圣保罗的三个公共卫生中心招募了参与者（n = 538；487名成年人和51名老年人）。该研究采用两剂接种方案，间隔14天。在每剂接种后7天内评估预期和非预期不良反应（ARs），并对免疫后需就医的不良事件（AEFI）进行42天的监测。通过参与者日记卡、电话随访和现场访视收集安全性数据。在成年人中，第一剂和第二剂接种后最常报告的局部AR是疼痛（分别为256例[52.6%]和129例[29.5%]），而最常见的全身AR是头痛（分别为158例[34.5%]和51例[11.6%]）。大多数局部和全身预期AR的严重程度为1级或2级，第一剂接种后AR在成年人中更为普遍。在成年人中报告了1例与疫苗相关的严重不良事件，无死亡病例。9名成年参与者经历了特殊关注的不良事件，包括5例COVID-19病例。这些发现支持了科兴新冠疫苗在成年人和老年个体中的总体安全性，不良事件通常为轻度且具有自限性。
