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Peer reviewedOpen accessInfluenzaSARSCOVID-19

Passive enhanced safety surveillance for Vaxigrip and Intanza 15 µg in the United Kingdom and Finland during the northern hemisphere influenza season 2015/16

Eurosurveillance·

Hélène Bricout, Anne Laure Chabanon, Audrey Souverain, Christine Sadorge, Timo Vesikari, Timothy David Caroe

DOI
10.2807/1560-7917.es.2017.22.18.30527
PMID
28494843
PMCID
PMC5434878
OpenAlex
W2613574596
Study type
Journal article
Publisher
European Centre for Disease Control and Prevention (ECDC)
Article type
journal-article
Integrity
current

Why this research matters now

The passive enhanced safety surveillance demonstrated improved data reporting and showed suitability to health authority requirements for near real-time detection of potential increases in vaccine reactogenicity following annual influenza strain updates.

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Structured evidence summary

Research question

The study aimed to estimate reporting rates of suspected adverse reactions occurring within 7 days following vaccination with Vaxigrip and Intanza 15 µg during the 2015/16 influenza season in the UK and Finland.

Study design

This was a pilot passive enhanced safety surveillance study conducted in two countries during the northern hemisphere 2015/16 influenza season. The approach facilitated spontaneous vaccinee reports and estimated near real-time vaccinee exposure.

Population and setting

The study enrolled 1,012 Vaxigrip vaccinees and 1,017 Intanza 15 µg vaccinees in the United Kingdom and Finland during the 2015/16 influenza season.

Main findings

Among Vaxigrip vaccinees, 3.2% reported 122 suspected adverse reactions, with 110 occurring within 7 days post-vaccination. Among Intanza 15 µg vaccinees, 3.0% reported 114 suspected adverse reactions, with 99 occurring within 7 days. The results were consistent with the known safety profile and showed no change in reactogenicity or safety concerns.

Public-health relevance

The passive enhanced safety surveillance demonstrated improved data reporting and showed suitability to health authority requirements for near real-time detection of potential increases in vaccine reactogenicity following annual influenza strain updates.

Important limitations

This summary is limited to the supplied single-article abstract and metadata. The abstract notes that further fine tuning of the methodology is under discussion between stakeholders. Full interpretation requires access to the original paper.

GIDS interpretation

This article was classified under Influenza, Vaccination, and Surveillance topics with linkage to Finland and United Kingdom. The article addresses enhanced safety monitoring methodology for seasonal influenza vaccines and may be discoverable through surveillance-related queries, though it reports on a specific pilot study rather than ongoing surveillance signals.

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Related GIDS surveillance

Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.

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Evidence relationships

This article has 13 auditable classifier relationships to diseases, places, topics, and study design.

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