Evidence map›Paper›PMID 27037540›Full record

ArticlePharmacoepidemiology and drug safety2016

Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 seasons.

Rongxia Li, Brock Stewart, Michael M McNeil, Jonathan Duffy, Jennifer Nelson, Alison Tse Kawai, Roger Baxter, Edward A Belongia, Eric Weintraub

Open access · greenAbstract read
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 4 pooled it
4.3field-weighted citation impact, top 6% 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

24 citing papers in PubMed, 4 syntheses or guidelines pooled it, 41 citations in OpenAlex.

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  13. The effect of sex on responses to influenza vaccines.Human vaccines & immunotherapeutics · 2021
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  16. SARS-CoV-2 will constantly sweep its tracks: a vaccine containing CpG motifs in 'lasso' for the multi-faced virus.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2020
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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

9 authors at 6 institutions in 3 countries.

Rongxia LiImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Brock StewartDivision of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Michael M McNeilImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Jonathan DuffyImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Jennifer NelsonGroup Health Research Institute, Seattle, WA, USA.
Alison Tse KawaiDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Roger BaxterKaiser Permanente Vaccine Study Center, Oakland, CA, USA.
Edward A BelongiaMarshfield Clinic Research Foundation, Marshfield, WI, USA.
Eric WeintraubImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Centers for Disease Control and Prevention · USNational Center for Immunization and Respiratory Diseases · USHarvard University · USKaiser Permanente · USKaiser Permanente Washington Health Research Institute · USMarshfield Clinic · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

purposeThe changes in each year in influenza vaccine antigenic components as well as vaccine administration patterns may pose new risks of adverse events following immunization (AEs). To evaluate the safety of influenza vaccines annually administered to people ≥ 6 months, we conducted weekly post licensure surveillance for seven pre-specified adverse events following receipt of influenza vaccines during the 2013-2014 and 2014-2015 seasons in the Vaccine Safety Datalink (VSD).

methodsWe used both a historically-controlled cohort design with the Poisson-based maximized sequential probability ratio test (maxSPRT) and a self-controlled risk interval (SCRI) design with the binomial-based maxSPRT. For each adverse event outcome, we defined the risk interval on the basis of biologic plausibility and prior literature. For the historical cohort design, numbers of expected adverse events were calculated from the prior seven seasons, adjusted for age and site. For the SCRI design, a comparison window was defined either before vaccination or after vaccination, depending on each specific outcome.

resultsAn elevated risk of febrile seizures 0-1 days following trivalent inactivated influenza vaccine (IIV3) was identified in children aged 6-23 months during the 2014-2015 season using the SCRI design. We found the relative risk (RR) of febrile seizures following concomitant administration of IIV3 and PCV13 was 5.3 with a 95% CI 1.87-14.75. Without concomitant PCV 13 administration, the estimated risk decreased and was no longer statistically significant (RR: 1.4; CI: 0.54 - 3.61).

conclusionNo increased risks, other than for febrile seizures, were identified in influenza vaccine safety surveillance during 2013-2014 and 2014-2015 seasons in the VSD. Copyright © 2016 John Wiley & Sons, Ltd.

Indexed as

Adverse Drug Reaction Reporting SystemsProduct Surveillance, PostmarketingAdolescentAdultAgedAge FactorsAntigens, ViralChildChild, PreschoolCohort StudiesFemaleHumansInfantInfluenza VaccinesMaleMiddle AgedAntigens, ViralInfluenza Vaccinesfebrile seizuresPCV13pharmacoepidemiologyvaccine safety

Identifiers

PMID27037540
PMCPMC10878475
OpenAlexW2328728812

What OpenQuestion holds

Textmetadata
LicenceTDM
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.