Evidence map›Paper›PMID 34777351›Full record

SynthesisFrontiers in immunology2021

Safety of Influenza A H1N1pdm09 Vaccines: An Overview of Systematic Reviews.

Lene Kristine Juvet, Anna Hayman Robertson, Ida Laake, Siri Mjaaland, Lill Trogstad

Open access · goldAbstract readSystematic Review
In one paragraph

Synthesis in Frontiers in immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 16% 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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Appraisal of umbrella reviews on vaccines.Communications medicine · 2024
    Review
  5. Review
  6. Zoonosis and zooanthroponosis of emerging respiratory viruses.Frontiers in cellular and infection microbiology · 2023
    Review
  7. 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

5 authors at 1 institution in 1 country.

Lene Kristine JuvetDivision of Infection Control and Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.
Anna Hayman RobertsonDivision of Infection Control and Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.
Ida LaakeDivision of Infection Control and Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.
Siri MjaalandDivision of Infection Control and Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.
Lill TrogstadDivision of Infection Control and Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.
Norwegian Institute of Public Health · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: In 2009, a new influenza A H1N1 virus emerged causing a global pandemic. A range of monovalent influenza A H1N1pdm09 vaccines with or without adjuvants were developed. After the mass vaccination campaigns safety concerns related to H1N1pdm09 vaccines were reported. More than a decade later, reported AEFIs are still under scrutiny. We performed a systematic review aiming to synthesize the evidence on the safety of the H1N1pdm09 vaccines on reported outcomes from existing systematic reviews. Methods: Four electronic databases, PubMed, EMBASE, Epistimonikos and the Cochrane Database of Systematic Reviews were searched for articles on H1N1pdm09 vaccination published from 2009 to January 2021. Systematic reviews assessing short- or long-term adverse events after H1N1pdm09 vaccination were considered for inclusion. Data was extracted from all selected reviews. Outcomes were grouped and results from each included review were presented narratively and in tables. Results: 16 systematic reviews met the inclusion criteria. Reported outcomes were short-term events (3 reviews), fetal/pregnancy outcomes (8 reviews), Guillain-Barré syndrome (GBS) (4 reviews), narcolepsy (2 reviews) demyelinating diseases (1 review based on one study only) and inflammatory bowel disease (IBD) (1 review). Short-term serious adverse events were rare, 3 cases amongst 16725 subjects in 18 randomized controlled trials (0.018%). No deaths were reported. The risks of local events were generally higher for adjuvanted vaccines as compared to unadjuvanted vaccines. Maternal H1N1pdm09 vaccination in any trimester was not associated with an increase in preterm birth, small for gestational age, congenital malformations or fetal death. For GBS, results were conflicting. The main systematic review on narcolepsy found a 5-14-fold increased risk in children, and a 2-7- fold increased risk in adults after vaccination with Pandemrix. The attributable risk of narcolepsy one year after vaccination was 1 case per 18 400 vaccine doses in children/adolescents, and 1 case per 181 000 vaccine doses in adults. Conclusion: Adjuvanted vaccines had more local but not serious adverse events compared to unadjuvanted vaccines. Vaccination with Pandemrix was strongly associated with narcolepsy, particularly in children. No increased risks of pregnancy outcomes were seen after pandemic vaccination. The findings on GBS were inconclusive.

Indexed as

ChildFemaleGuillain-Barre SyndromeHumansInfluenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesMass VaccinationNarcolepsyPregnancyPremature BirthSystematic Reviews as TopicInfluenza Vaccinespandemrixadverse eventsH1N1pdm09 vaccinationinfluenza vaccinespandemic vaccinessafety

Identifiers

PMID34777351
PMCPMC8581668
OpenAlexW3210560023

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.