In:
PLOS ONE, Public Library of Science (PLoS), Vol. 16, No. 2 ( 2021-2-11), p. e0246540-
Abstract:
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.
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0246540
DOI:
10.1371/journal.pone.0246540.g001
DOI:
10.1371/journal.pone.0246540.t001
DOI:
10.1371/journal.pone.0246540.t002
DOI:
10.1371/journal.pone.0246540.t003
DOI:
10.1371/journal.pone.0246540.t004
DOI:
10.1371/journal.pone.0246540.t005
DOI:
10.1371/journal.pone.0246540.t006
DOI:
10.1371/journal.pone.0246540.t007
DOI:
10.1371/journal.pone.0246540.t008
DOI:
10.1371/journal.pone.0246540.s001
DOI:
10.1371/journal.pone.0246540.s002
DOI:
10.1371/journal.pone.0246540.s003
DOI:
10.1371/journal.pone.0246540.r001
DOI:
10.1371/journal.pone.0246540.r002
DOI:
10.1371/journal.pone.0246540.r003
DOI:
10.1371/journal.pone.0246540.r004
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2021
detail.hit.zdb_id:
2267670-3
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