Evidence map›Paper›PMID 34510402›Full record

ArticleDrugs - real world outcomes2022

Human Papillomavirus Vaccination and Premature Ovarian Failure: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System.

Collins Tatang, Teigna Arredondo Bisonó, Aurore Bergamasco, Francesco Salvo, Sue Ann Costa Clemens, Yola Moride

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Drugs - real world outcomes, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05838157 (Research for the Effect of HPV Vaccine on Menstrual Cycle in Women of Reproductive Age), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 17% 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.

NCT05838157 unknown statusnot on this mapstarted 2023, after this paper: background citation

Research for the Effect of HPV Vaccine on Menstrual Cycle in Women of Reproductive Age

TypeobservationalSponsorSun Yat-sen UniversityRan2023 to 2024Enrolled600ConditionsMenstrual Disorder, Premature Ovarian FailureArmsprophylactic HPV vaccine(bivalent HPV、quadrivalent HPV、9-valent HPV)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 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

6 authors at 3 institutions in 4 countries.

Collins TatangMaster Program in Vaccinology, University of Siena, Siena, Italy.
Teigna Arredondo BisonóYOLARX Consultants, Paris, France.
Aurore BergamascoYOLARX Consultants, Paris, France.
Francesco SalvoService de Pharmacologie Médicale, CHU de Bordeaux, Bordeaux, France.
Sue Ann Costa ClemensPediatric Infectious Diseases and Institute for Global Health, University of Siena, Siena, Italy.
Yola MorideYOLARX Consultants, Paris, France. yola.moride@umontreal.ca.ORCID http://orcid.org/0000-0002-8753-2274
University of Siena · ITRutgers, The State University of New Jersey · USUniversité de Bordeaux · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThere have been public health concerns about a potential association between human papillomavirus (HPV) vaccines and premature ovarian failure (POF) in young women.

objectiveTo identify a potential safety signal of POF after HPV vaccination using the United States (US) Vaccine Adverse Event Reporting System (VAERS) database.

methodsWe manually selected relevant MedDRA preferred terms related to POF and identified in VAERS all POF reports in women less than 40 years of age between 2 July 1990 and 14 May 2018, followed by a review of narratives to confirm the cases. We conducted descriptive analyses on age, POF type, HPV vaccine type (HPV2, HPV4, HPV9), time to onset of POF, and dose rank. We described trends in reporting over time and assessed a potential safety signal using the proportional reporting ratio (PRR).

resultsOf the 228,341 eligible POF reports, 281 (0.1%) were suspected to be associated with HPV vaccines. Median patient age was 15 years (range 11-39 years). POF events consisted mainly of amenorrhea (80.4%) and premature menopause (15.3%). Mean number of reported POF events significantly increased after the first HPV vaccine launch in 2006 with 22.2 POF cases/year up from 1.4 POF cases/year before the launch. PRR was 46.1 (95% confidence interval: 31.7-67.2) and sensitivity analyses yielded similar estimates.

conclusionOur study suggests the presence of a potential safety signal of POF associated with HPV vaccination, which may only be partly attributed to notoriety bias. Due to the well-known limitations of spontaneous reporting data, further investigations are warranted.

Identifiers

PMID34510402
PMCPMC8844335
OpenAlexW3200732477

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.