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

Autor: Patrícia Emília Braga, Juliana Yukari Koidara Viscondi, Maria Beatriz Bastos Lucchesi, Lily Yin Weckx, Vera Lúcia Gattás, Heloisa Maxímo Espinola, Maria da Graça Salomão, Beatriz Thomé, Muriel Soquet, Gabriella Mondini, Roberta de Oliveira Piorelli, Mayra Martho Moura de Oliveira, Tazio Vanni, Samanta Hosokawa Dias de Nóvoa Rocha, Anderson da Silva, Alexander Roberto Precioso, Marcelo Eiji Koike, Joane do Prado Santos, Olga Menang
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Male
Viral Diseases
Maternal Health
Pharmacovigilance
Medical Conditions
Pregnancy
Medicine and Health Sciences
Public and Occupational Health
Child
Prospective cohort study
Vaccines
Multidisciplinary
Obstetrics and Gynecology
Vaccination and Immunization
Infectious Diseases
Instituto Butantan
Research Design
Influenza Vaccines
Child
Preschool
Medicine
Female
Brazil
Research Article
Trivalent influenza vaccine
medicine.medical_specialty
Drug Research and Development
Infectious Disease Control
Clinical Research Design
Health Personnel
Science
Immunology
Research and Analysis Methods
Adverse Reactions
Drug Safety
Internal medicine
medicine
Humans
Adverse effect
Aged
Pharmacology
business.industry
Biology and Life Sciences
Infant
medicine.disease
Influenza
Health Care
Immunization
Women's Health
Adverse Events
Preventive Medicine
Geriatric Care
Pregnant Women
business
Postpartum period
Zdroj: PLoS ONE, Vol 16, Iss 2, p e0246540 (2021)
PLoS ONE
ISSN: 1932-6203
Popis: Introduction Active pharmacovigilance studies are pivotal to better characterize vaccine safety. Methods 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). Results 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. Conclusion 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.
Databáze: OpenAIRE
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