University of Minnesota
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6.4.b

Post-marketing assessment

In progress

Identify a framework to address post-marketing assessment of safety and relative effectiveness of broadly protective or universal influenza vaccines compared with conventional seasonal influenza vaccines. 

Progress Highlights

Baylor 2022 identified opportunities for improving the monitoring of safety and effectiveness of new influenza vaccines in the United States.

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Diez-Domingo 2022 assessed the role of public-private partnerships in post-licensure monitoring of vaccine safety and efficacy, based on lessons learned from the European DRIVE (Development of Robust and Innovative Vaccine Effectiveness) project.

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Zuber 2021 recognized that novel vaccine technologies may have different safety profiles requiring adapted pharmacovigilance approaches and highlights the role of the Global Advisory Committee on Vaccine Safety in post-licensure surveillance. 

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Levison 2022 conducted a retrospective nationwide population-based case–control study in Denmark to estimate the magnitude and duration of GBS risk following influenza vaccination, as an example of assessing post-marketing safety.

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Salmon 2021 used vaccine safety case studies to illustrate potential safety issues with new vaccines (including pandemic influenza vaccine) and identify key lessons for evaluating the safety of new vaccines via post-marketing surveillance.

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