Vanni Tazio, Thomé Beatriz da Costa, Oliveira Mayra Martho Moura de, Gattás Vera Lúcia, Salomão Maria da Graça, Koike Marcelo Eiji, Lucchesi Maria Beatriz Bastos, Braga Patrícia Emília, Piorelli Roberta de Oliveira, Viscondi Juliana Yukari Koidara, Mondini Gabriella, da Silva Anderson, Espínola Heloísa Maximo, Santos Joane do Prado, Dias de Nóvoa Rocha Samanta Hosokawa, Weckx Lily Yin, Menang Olga, Soquet Muriel, Precioso Alexander Roberto
Clinical Safety and Risk Management Centre, Instituto Butantan, São Paulo, São Paulo, Brazil.
Federal University of São Paulo, São Paulo, São Paulo, Brazil.
PLoS One. 2021 Feb 11;16(2):e0246540. doi: 10.1371/journal.pone.0246540. eCollection 2021.
Active pharmacovigilance studies are pivotal to better characterize vaccine safety.
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).
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.
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.
主动药物警戒研究对于更好地描述疫苗安全性至关重要。
这些是多中心前瞻性队列研究，旨在通过主动药物警戒实践评估布坦坦研究所生产的2017年和2018年季节性三价流感疫苗（TIV）的安全性。在2017年和2018年巴西全国季节性流感疫苗接种活动期间，邀请了老年人、儿童、医护人员、孕妇和产褥期妇女参与研究。免疫接种后，对参与者观察30分钟，并发放一张参与者卡片以记录不良事件信息。在免疫接种后14天进行临床现场访视，并在免疫接种后42天通过电话联系检查所有登记的安全信息，以了解自发不良事件（AE）和格林-巴利综合征（GBS）情况。
共有942名志愿者参与了这两项研究：305名老年人、109名儿童、108名孕妇、32名产后妇女和388名医护人员。总体而言，每位参与者的不良事件中位数为1至4起。每位参与者不良事件中位数最低的是医护人员（每位参与者1起不良事件），最高的是孕妇（每位参与者4起不良事件）。总体而言，局部疼痛（46.6%）是最常见的自发局部不良事件。最常见的全身不良事件依次为：头痛（22.5%）、疲劳（16.0%）和不适（11.0%）。大多数自发不良事件（96%）为轻度（1级或2级），只有3%为3级，1%为4级。接种疫苗后42天内未报告包括格林-巴利综合征在内的严重不良事件。
两项研究结果证实，布坦坦研究所生产的2017年和2018年季节性三价流感疫苗是安全的，并且在可行的情况下，主动药物警戒研究应被视为上市后监测疫苗安全性的一项重要举措。
