Evidence map›Paper›PMID 36919537›Full record

ArticleHuman vaccines & immunotherapeutics2023

Enhanced passive safety surveillance of the MF59-adjuvanted quadrivalent influenza vaccine in the elderly during the 2021/22 influenza season.

Daniela Amicizia, Alexander Domnich, Piero Luigi Lai, Andrea Orsi, Giancarlo Icardi, Oksana Tkach-Motulyak, Donatella Panatto

Open access · goldAbstract read
In one paragraph

Article in Human vaccines & immunotherapeutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Enhanced Immune Responses AgainstIndian journal of microbiology · 2024
    Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 4 countries.

Daniela AmiciziaDepartment of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
Alexander DomnichHygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, Genoa, Italy.
Piero Luigi LaiDepartment of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
Andrea OrsiDepartment of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
Giancarlo IcardiDepartment of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
Oksana Tkach-MotulyakCSL Seqirus, Global Clinical Safety & Pharmacovigilance, Maidenhead, UK.
Donatella PanattoDepartment of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.ORCID 0000-0002-2677-0551
Intersil (United States) · USOspedale Policlinico San Martino · ITSeqirus (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In accordance with European directives, each year the enhanced safety surveillance (ESS) of seasonal influenza vaccines should be conducted in order to detect any potential increase in reactogenicity when the vaccine composition is updated or a new formulation becomes available. The objective of this passive ESS (EPSS) was to assess the frequency of spontaneously reported adverse events (AEs) following vaccination with the 2021/22 formulation of the MF59-adjuvanted quadrivalent influenza vaccine (aQIV) among older adults in Italy through the collection of data within a short time period (start of seasonal influenza vaccination) in order to monitor the reactogenicity of aQIV early in the season. All AEs reported within seven days following vaccination were analyzed by type and seriousness. In all, 1,059 vaccination cards were distributed to individuals aged ≥65 years. Only one, non-serious, spontaneous individual case safety report was submitted, yielding an overall rate of 0.9 per 1,000 doses administered. This report consisted of a reactogenic AE of pyrexia. The EPSS confirmed that the reactogenicity profile of aQIV was consistent with the known safety profile of the previous trivalent formulation. These optimal safety data could bolster public confidence in influenza vaccination and help to improve vaccination coverage.

Indexed as

Influenza, HumanInfluenza VaccinesAdjuvants, ImmunologicAgedHumansPolysorbatesSeasonsSqualeneVaccinationVaccines, CombinedAdjuvants, ImmunologicInfluenza VaccinesMF59 oil emulsionPolysorbatesSqualeneVaccines, Combinedenhanced passive safety surveillanceFluad Tetra®Influenzainfluenza vaccinesthe elderly

Identifiers

PMID36919537
PMCPMC10072113
OpenAlexW4324311392

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.