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

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dc.contributorCentro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributorHVB - Hospital Vital Brazilpt_BR
dc.contributor.authorGattás, Vera Lúciapt_BR
dc.contributor.authorBraga, Patrícia Emíliapt_BR
dc.contributor.authorKoike, Marcelo Eijipt_BR
dc.contributor.authorLucchesi, Maria Beatriz Bastospt_BR
dc.contributor.authorOliveira, Mayra Martho Moura dept_BR
dc.contributor.authorPiorelli, Roberta de Oliveirapt_BR
dc.contributor.authorQueiroz, Vivianpt_BR
dc.contributor.authorPrecioso, Alexander Robertopt_BR
dc.identifier.citationGattás VL, Braga PE, Koike ME, Lucchesi MBB, Oliveira MMM, Piorelli RO, et al. Safety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017. Rev. Inst. Med. trop. S. Paulo. 2019 Jan;61:e4. doi:10.1590/s1678-9946201961004.pt_BR
dc.description.abstractVaccination 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 (c)). 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-Barre 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.pt_BR
dc.relation.ispartofRevista do Instituto de Medicina Tropical de São Paulopt_BR
dc.rightsOpen accesspt_BR
dc.titleSafety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017pt_BR
dc.rights.licenseCC BY-NCpt_BR
dc.subject.keywordinfluenza vaccinept_BR
dc.subject.keywordAdverse events following immunization (AEFI)pt_BR
dc.subject.keywordSafety vaccinespt_BR
dc.subject.keywordInstituto Butantanpt_BR
dc.relation.ispartofabbreviatedRev Inst Med trop S Paulopt_BR
dc.identifier.citationabntv. 61, e4, jan. 2019pt_BR
dc.identifier.citationvancouver2019 Jan;61:e4pt_BR
dc.contributor.butantanGattás, Vera Lúcia|:Pesquisador|:Centro de Ensaios Clínicos e Farmacovigilância|:PrimeiroAutor:Autor de correspondênciapt_BR
dc.contributor.butantanPiorelli, Roberta de Oliveira|:Pesquisador|:Centro de Ensaios Clínicos e Farmacovigilância:HBV - Hospital Vital Brazil|:pt_BR
dc.contributor.butantanBraga, Patrícia Emília|:Pesquisador|:Centro de Ensaios Clínicos e Farmacovigilância|:pt_BR
dc.contributor.butantanKoike, Marcelo Eiji|:Técnico|:Centro de Ensaios Clínicos e Farmacovigilância|:pt_BR
dc.contributor.butantanLucchesi, Maria Beatriz Bastos|:Pesquisador|:Centro de Ensaios Clínicos e Farmacovigilância|:pt_BR
dc.contributor.butantanOliveira, Mayra Martho Moura de|:Técnico|:Centro de Ensaios Clínicos e Farmacovigilância|:pt_BR
dc.contributor.butantanQueiroz, Vivian|:Técnico|:Centro de Ensaios Clínicos e Farmacovigilância|:pt_BR
dc.contributor.butantanPrecioso, Alexander Roberto|:Pesquisador|:Centro de Ensaios Clínicos e Farmacovigilância|:pt_BR
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