ArticleJournal of pharmaceutical policy and practice2025
Perspectives on the impact of regulatory measures on national COVID-19 vaccination programs: a qualitative study from six EU member states.
Article in Journal of pharmaceutical policy and practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The European Medicines Agency (EMA) issued regulatory recommendations and communications in 2021 about the risk of thrombosis with thrombocytopenia syndrome (TTS) associated with COVID-19 adenoviral vector vaccines Vaxzevria and Jcovden. Little is known about how such measures impacted on national vaccination strategies and how they influenced decision-making processes of policy-makers and experts. The aim of this study was to evaluate the impact of regulatory actions for Vaxzevria and Jcovden on national vaccination strategies following the EMA's 2021 review on safety measures on TTS. Methods: A grey literature review was performed to gather information on EMA's actions as well as changes to national vaccination strategies in Denmark, Greece, Latvia, the Netherlands, Portugal and Slovenia. Semi-structured interviews were held with experts who had either advisory or decision roles in national vaccination programmes to contextualise the results of the grey literature review and discuss their experiences. Interviews were coded and analysed on national levels. Results: EMA made various adaptations to product information and released safety warnings and other regulatory communications for both vaccines relating to TTS risk. Countries varied widely in changes made to national vaccination policies. Interviews revealed that experts relied mainly on their professional networks and information sources, other than the EMA, to inform their recommendations and/or decision-making. Conclusion: EMA's regulatory actions were not the main source informing adaptations to national vaccination strategies. National decision-makers country reverted to their preferred sources. The use of varying sources explains some of the variations in the vaccination strategies.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.