Pharmacovigilance capacity strengthening for WHO prequalification: The case of the trivalent influenza vaccine manufactured by Instituto Butantan

Koike, Marcelo Eiji; Gattás, Vera Lúcia; Lucchesi, Maria Beatriz Bastos; Oliveira, Mayra Martho Moura de; Vanni, Tázio; Thomé, Beatriz; Menang, Olga; Socquet, Muriel; Precioso, Alexander Roberto

doi:10.1016/j.vaccine.2019.09.082

Cited by 4 publications

(2 citation statements)

References 3 publications

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“…Instituto Butantan has been conducting routine pharmacovigilance activities for its TIV using a passive method of surveillance. As part of the preparedness for the WHO pre-qualification inspection of the seasonal influenza vaccine [6], we conducted active pharmacovigilance studies in 2017 and 2018. Therefore, the objective of those studies were to perform active surveillance of Adverse Events Following Immunization (AEFI) in the following five target groups from the 2017 and 2018 annual influenza immunization campaigns in Brazil: elderly, children, healthcare workers, pregnant women, and women in the post-partum period.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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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.

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Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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“…While the pharmacovigilance system met local regulations, improvements were required for WHO prequalification. Among other notes, the need to build performance indicators to assess the IB pharmacovigilance system was evidenced, and based on this finding, it was recommended that the IB pharmacovigilance implements an assessment system through performance indicators, also taking into account the Guideline on Good Pharmacovigilance Practices (GVP) (set of measures drawn up to facilitate the performance of pharmacovigilance) regarding performance indicators as a fundamental way of maintaining the quality of service (4,7).…”

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Pharmacovigilance quality system for vaccine monitoring (COVID-19) using quality indicators: a scoping review

Oliveira

Wagner

Gattás

et al. 2021

IJIC

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This scoping review responds to the appeal of the scientific community for collaboration between different entities for pharmacovigilance and active surveillance of coronavirus disease 2019 (COVID-19) vaccines. The objective is to identify, systematically evaluate, and synthesize the best scientific evidence available on the indicators used in pharmacovigilance systems. Our results demonstrate that approximately 50% of the 25 studies used in this review have been carried out in the past 5 years. Of these, only four used the pharmacovigilance indicators proposed by the World Health Organization (WHO). Eighty-seven pharmacovigilance indicators were identified, of which seven (8.0%) related to signal detection. While the WHO advocates signal detection as routine pharmacovigilance, in special situations – such as accelerated clinical studies where adverse events are not yet well known – other indicators related to signal detection appear to be good options for maintaining quality pharmacovigilance and active surveillance in the development of the COVID-19 vaccine. However, the less robust pharmacovigilance systems in low-income countries will necessitate greater involvement of health professionals from public and private sectors, pharmaceutical companies, academic institutions, and the general public, to ensure information security and detection of signals for the COVID-19 vaccine.

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A randomized, double-blind, non-inferiority trial comparing the immunogenicity and safety of two seasonal inactivated influenza vaccines in adults

Vanni

Salomão

Viscondi

et al. 2023

Vaccine

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Pharmacovigilance capacity strengthening for WHO prequalification: The case of the trivalent influenza vaccine manufactured by Instituto Butantan

Cited by 4 publications

References 3 publications

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

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

Pharmacovigilance quality system for vaccine monitoring (COVID-19) using quality indicators: a scoping review

A randomized, double-blind, non-inferiority trial comparing the immunogenicity and safety of two seasonal inactivated influenza vaccines in adults

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