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

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.

Active pharmacovigilance of the seasonal trivalent influenza vaccine produced by Instituto Butantan: A prospective cohort study of five target groups

“…And healthcare workers. The safety profiles described in our study are in accordance with those from other studies evaluating seasonal trivalent influenza vaccine produced by Instituto Butantan [32,33], and with from other studies available in the literature which evaluated similar vaccines such as Vaxigrip [34] and Fluarix [35] and Fluad [36]. This study confirmed the capability of Instituto Butantan to perform active pharmacovigilance studies for its seasonal TIV and it will contribute to the preparedness of Instituto Butantan for the WHO pre-qualification of the seasonal TIV.…”

Antigenic Variability a Potential Factor in Assessing Relationship Between Guillain Barré Syndrome and Influenza Vaccine – Up to Date Literature Review

“…Out of 26 articles, eight articles were observational studies focusing on post-vaccine-surveillance data from the adverse event reporting system established by regulatory agencies [6,[9][10][11][12][13][14][15]. There were four systematic literature reviews with one emphasizing the etiologies of GBS while three were focused on the association between influenza vaccine and development of GBS [2,3,5,16].…”

“…They are believed to be the greatest success in the field of medicine. Because of successful vaccination programs, the medical community has been focusing on adverse events of vaccines rather than disease prevention in recent years [9]. Several studies have been performed to investigate the safety of vaccines.…”

“…There were seven cases of GBS reported during this time, supporting the relationship between GBS and the seasonal trivalent influenza vaccine. However, causality could not be determined because of a lack of sufficient medical information [9]. There was another noteworthy study in Korea, focusing on the clinical presentation of post-vaccination GBS provided comparative data on a specific type of influenza vaccine.…”

Challenges facing drug utilization research in the Latin American region

“…17 DUR may also provide a proxy of denominators in pharmacovigilance, 3 as in the Gattas' study where the Instituto Butantan in Brazil used doses of triple influenza vaccine as denominator to estimate the incidence rates of adverse events following immunization. 18 Despite many advances in DUR methodologies, moving from merely descriptive studies to analytic studies with the inclusion of quality indicators, and lately drug use as indicators of the quality of the healthcare system, in some regions, such as Latin America (-LatAm), these advances have been slow. [19][20][21] This region faces particular challenges because of fewer resources, and/or fragmented or not fully integrated healthcare systems with limited access to electronic health records, registries, and computerized decision-support systems.…”