Safety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017

• Published in: Revista do Instituto de Medicina Tropical de São Paulo
• Main Authors: Vera Lúcia Gattás, Patrícia Emília Braga, Marcelo Eiji Koike, Maria Beatriz Bastos Lucchesi, Mayra Martho Moura de Oliveira, Roberta de Oliveira Piorelli, Vivian Queiroz, Alexander Roberto Precioso
• Format: Article in Journal/Newspaper
• Language: English
• Published: Universidade de São Paulo (USP) 2018
• Subjects: Influenza vaccine; Adverse events following immunization (AEFI); Safety vaccines; Surveillance; Instituto Butantan; Arctic medicine. Tropical medicine; RC955-962; Infectious and parasitic diseases; RC109-216; Arctic; Barré
• Online Access: https://doi.org/10.1590/s1678-9946201961004; https://doaj.org/article/b434828bc7ff4f2cb1192d288b5f0c35

ABSTRACT 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.