Evidence map›Paper›PMID 29356318›Full record

ReviewInfluenza and other respiratory viruses2018

Standardisation of inactivated influenza vaccines-Learning from history.

John M Wood, Jerry P Weir

Abstract readHistorical ArticleReview
In one paragraph

Review in Influenza and other respiratory viruses, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
–field-weighted citation impact
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

21 citing papers in PubMed.

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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

2 authors.

John M WoodFormerly National Institute for Biological Standards and Control, Potters Bar, Bushey, Herts, UK.
Jerry P WeirDivision of Viral Products, Center for Biologics Evaluations and Research, Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-0260-0996

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The single radial immunodiffusion assay has been the accepted method for determining the potency of inactivated influenza vaccines since 1978. The worldwide adoption of this assay for vaccine standardisation was facilitated through collaborative studies that demonstrated a high level of reproducibility and its applicability to the different types of influenza vaccine being produced at that time. Clinical evidence indicated the relevance of SRID as a potency assay. Unique features of the SRID assay are likely responsible for its longevity even as newer technologies for vaccine characterisation have been developed and refined. Nevertheless, there are significant limitations to the SRID assay that indicate the need for improvement, and there has been a substantial amount of work undertaken in recent years to develop and evaluate alternative potency assays, including collaborative studies involving research laboratories, regulatory agencies and vaccine manufacturers. Here, we provide an overview of the history of inactivated influenza vaccine potency testing, the current state of alternative assay development and the some of the major challenges to be overcome before implementation of new assays for potency determination.

Indexed as

Vaccine PotencyHistory, 20th CenturyHistory, 21st CenturyHumansInfluenza VaccinesReproducibility of ResultsSensitivity and SpecificityTechnology, PharmaceuticalInfluenza Vaccinesinfluenza vaccinepotencySRID

Identifiers

PMID29356318
PMCPMC5820418

What OpenQuestion holds

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Registered trials

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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.