Evidence map›Paper›PMID 36577134›Full record

Observational studyHuman vaccines & immunotherapeutics2022

Extended surveillance to assess safety of 9-valent human papillomavirus vaccine.

Maria E Sundaram, Burney A Kieke, Kayla E Hanson, Edward A Belongia, Eric S Weintraub, Matthew F Daley, Rulin C Hechter, Nicola P Klein, Edwin M Lewis, Allison L Naleway and 2 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in Human vaccines & immunotherapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 15% 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
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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

12 authors at 5 institutions in 1 country.

Maria E SundaramCenter for Clinical Epidemiology and Population Health, Marshfield Clinic Research Institute, Marshfield, Wisconsin, USA.
Burney A KiekeCenter for Clinical Epidemiology and Population Health, Marshfield Clinic Research Institute, Marshfield, Wisconsin, USA.
Kayla E HansonCenter for Clinical Epidemiology and Population Health, Marshfield Clinic Research Institute, Marshfield, Wisconsin, USA.
Edward A BelongiaCenter for Clinical Epidemiology and Population Health, Marshfield Clinic Research Institute, Marshfield, Wisconsin, USA.
Eric S WeintraubImmunization Safety Office, US Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Matthew F DaleyInstitute for Health Research, Kaiser Permanente Colorado, Aurora, Colorado, USA.
Rulin C HechterDepartment of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California, USA.
Nicola P KleinDivision of Research, and Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, California, USA.
Edwin M LewisDivision of Research, and Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, California, USA.
Allison L NalewayCenter for Health Research,Kaiser Permanente Northwest, Portland, Oregon, USA.
Jennifer C NelsonBiostatistics Unit, Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.
James G DonahueCenter for Clinical Epidemiology and Population Health, Marshfield Clinic Research Institute, Marshfield, Wisconsin, USA.
Marshfield Clinic · USKaiser Permanente · USCenters for Disease Control and Prevention · USKaiser Permanente Center for Health Research · USKaiser Permanente Washington Health Research Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The safety of 9-valent HPV vaccine (9vHPV) has been established with regard to common and uncommon adverse events. However, investigation of rare and severe adverse events requires extended study periods to capture rare outcomes. This observational cohort study investigated the occurrence of three rare and serious adverse events following 9-valent human papillomavirus (9vHPV) vaccination compared to other vaccinations, in US individuals 9-26 years old, using electronic health record data from the Vaccine Safety Datalink (VSD). We searched for occurrences of Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), and stroke following 9vHPV vaccination from October 4, 2015, through January 2, 2021. We compared the risks of GBS, CIDP, and stroke following 9vHPV vaccination to risks of those outcomes following comparator vaccines commonly given to this age group (Td, Tdap, MenACWY, hepatitis A, and varicella vaccines) from January 1, 2007, through January 2, 2021. We observed 1.2 cases of stroke, 0.3 cases of GBS, and 0.1 cases of CIDP per 100,000 doses of 9vHPV vaccine. After observing more than 1.8 million doses of 9vHPV, we identified no statistically significant increase in risks associated with 9vHPV vaccination for any of these adverse events, either combined or stratified by age (9-17 years of age vs. 18-26 years of age) and sex (males vs. females). Our findings provide additional evidence supporting 9vHPV vaccine safety, over longer time frames and for more serious and rare adverse events.

Indexed as

Papillomavirus InfectionsPapillomavirus VaccinesPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingAdolescentAdultChildFemaleHuman Papillomavirus VirusesHumansMaleVaccinationYoung AdultPapillomavirus Vaccineschronic inflammatory demyelinating polyneuropathyGuillain-Barré syndromeHuman papillomavirus vaccinestrokevaccine safety

Identifiers

PMID36577134
PMCPMC9891676
OpenAlexW4313212489

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.