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

Gattás, Vera Lúcia; Braga, Patrícia Emília; Koike, Marcelo Eiji; Lucchesi, Maria Beatriz Bastos; Oliveira, Mayra Martho Moura de; Piorelli, Roberta de Oliveira; Queiroz, Vivian; Precioso, Alexander Roberto

doi:10.1590/S1678-9946201961004

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Review • Rev. Inst. Med. trop. S. Paulo 61 • 2019 • https://doi.org/10.1590/S1678-9946201961004 copy

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

Authorship SCIMAGO INSTITUTIONS RANKINGS

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 1^st 2013 to December the 31^st 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.

KEYWORDS:
Influenza vaccine; Adverse events following immunization (AEFI); Safety vaccines; Surveillance; Instituto Butantan

Characteristics		Year of vaccination
		2013 (n=222)		2014 (n=247)		2015 (n=708)		2016 (n=71)		2017 (n=167)		Total (n=1,415)
		n	%	n	%	n	%	n	%	n	%	n	%
Source
	Spontaneous	56	25.2	63	25.5	30	4.2	60	84.5	58	34.7	267	18.9
	NIP^‡ ‡ NIP: National Immunization Program;	166	74.8	184	74.5	678	95.8	11	15.5	3	1.8	1,042	73.6
	Active PV^# # PV: Pharmacovigilance;	0	0	0	0	0	0	0	0	106	63.5	106	7.5
Reporter type
	HCP^§ § HCP: Health Care Professional	194	87.4	199	80.6	697	98.4	51	71.8	135	80.8	1,276	90.2
	Non-HCP^§ § HCP: Health Care Professional	24	10.8	45	18.2	9	1.3	16	22.5	21	12.6	115	8.1
	Not informed	4	1.8	3	1.2	2	0.3	4	5.6	11	6.6	24	1.7
Sex
	Female	126	56.8	160	64.8	413	58.3	38	53.5	138	82.6	875	61.8
	Male	90	40.5	78	31.6	293	41.4	31	43.7	23	13.8	515	36.4
	Not informed	6	2.7	9	3.6	2	0.3	2	2.8	6	3.6	25	1.8
Age (years)
	0 – 4	66	29.7	108	43.7	305	43.1	36	50.7	11	6.6	526	37.2
	5 – 9	14	6.3	14	5.7	137	19.4	0	0	4	2.4	169	11.9
	10 – 19	6	2.7	6	2.4	25	3.5	2	2.8	12	7.2	51	3.6
	20 – 29	17	7.7	13	5.3	37	5.2	4	5.6	80	47.9	151	10.7
	30 – 39	28	12.6	17	6.9	49	6.9	8	11.3	25	15.0	127	9.0
	40 – 49	19	8.6	15	6.1	39	5.5	4	5.6	8	4.8	85	6.0
	50 – 59	24	10.8	7	2.8	37	5.2	5	7.0	3	1.8	76	5.4
	60 – 69	25	11.3	10	4.0	42	5.9	3	4.2	8	4.8	88	6.2
	≥70	10	4.5	12	4.9	33	4.7	2	2.8	6	3.6	63	4.5
	Not informed	13	5.9	45	18.2	4	0.6	7	9.9	10	6.0	79	5.6

AEFI^† † AEFI: Adverse Event Following Immunization;	Year of vaccination
	2013		2014		2015		2016		2017		Total
	(n=487)		(n=839)		(n=2,384)		(n=198)		(n=232)		(n=4,140)
	n	IR^‡ ‡ IR: Incidence Rate per 100.000 doses of Instituto Butantan TIV (#AEFI / # doses)	n	IR^‡ ‡ IR: Incidence Rate per 100.000 doses of Instituto Butantan TIV (#AEFI / # doses)	n	IR^‡ ‡ IR: Incidence Rate per 100.000 doses of Instituto Butantan TIV (#AEFI / # doses)	n	IR^‡ ‡ IR: Incidence Rate per 100.000 doses of Instituto Butantan TIV (#AEFI / # doses)	n	IR^‡ ‡ IR: Incidence Rate per 100.000 doses of Instituto Butantan TIV (#AEFI / # doses)	n	IR^‡ ‡ IR: Incidence Rate per 100.000 doses of Instituto Butantan TIV (#AEFI / # doses)
Local pain	65	1.06	60	0.58	305	0.66	14	0.03	7	0.02	451	0.28
Local erythema	53	0.86	44	0.43	250	0.54	9	0.02	14	0.03	370	0.23
Local warmth	53	0.86	43	0.42	247	0.53	5	0.01	4	0.01	352	0.22
Local swelling	3	0.05	46	0.45	259	0.56	4	0.01	5	0.01	317	0.20
Fever	48	0.78	66	0.64	156	0.34	19	0.04	9	0.02	298	0.19
Headache	19	0.31	30	0.29	72	0.16	8	0.02	3	0.01	132	0.08
Rash	7	0.11	12	0.12	84	0.18	5	0.01	1	0.00	109	0.07
Vomiting	6	0.10	18	0.18	50	0.11	5	0.01	5	0.01	84	0.05
Pain	4	0.07	29	0.28	34	0.07	12	0.02	4	0.01	83	0.05
Cough	6	0.10	22	0.21	35	0.08	7	0.01	4	0.01	74	0.05
Local abscess	5	0.08	15	0.15	52	0.11	0	0.00	1	0.00	73	0.05
Hypersensitivity	22	0.36	10	0.10	26	0.06	1	0.00	3	0.01	62	0.04
Edema	1	0.02	29	0.28	28	0.06	0	0.00	2	0.00	60	0.04
Myalgia	7	0.11	10	0.10	35	0.08	2	0.00	2	0.00	56	0.04
Pruritus	1	0.02	4	0.04	45	0.10	5	0.01	0	0.00	55	0.03
Local pruritus	1	0.02	5	0.05	40	0.09	6	0.01	2	0.00	54	0.03
Influenza like illness	11	0.18	29	0.28	5	0.01	6	0.01	1	0.00	52	0.03
Local induration	30	0.49	14	0.14	4	0.01	1	0.00	3	0.01	52	0.03
Nausea	1	0.02	15	0.15	28	0.06	1	0.00	6	0.01	51	0.03
Local nodule	1	0.02	5	0.05	45	0.10	0	0.00	0	0.00	51	0.03
Dyspnea	3	0.05	12	0.12	30	0.06	4	0.01	1	0.00	50	0.03

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[1] Correspondence to: Vera Lúcia Gattás instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, Av. Vital Brazil, 1500, CEP 05503-900, São Paulo, SP, Brazil Tel: +55 11 3723-2126E-mail:vera.gattas@butantan.gov.br