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Cited by 34Cervical Cancer and HPV ResearchPharmacovigilance and Adverse Drug ReactionsIntramuscular injections and effects

The association of adverse events with bivalent human papilloma virus vaccination: a nationwide register-based cohort study in Finland.

Open access
Skufca, Jozica, Ollgren, Jukka, Artama, Miia, Ruokokoski, Esa, Nohynek, Hanna, Palmu, Arto A.·2018·Vaccine
DOI 10.1016/j.vaccine.2018.06.074
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Abstract

BACKGROUND: A bivalent HPV vaccine (Cervarix®; HPV2, GlaxoSmithKline) was introduced into the Finnish national vaccination programme (NVP) in November 2013 for girls aged 11-13 years with a catch-up for 14-15 year-olds. We evaluated the association between HPV2 and selected autoimmune diseases and clinical syndromes by conducting a nation-wide retrospective register-based cohort study. METHODS: First life-time occurrences of the relevant ICD-10 codes in girls aged 11-15 years between Nov-2013 and Dec-2016 were obtained from the national hospital discharge register. Population denominators were obtained from the Population Information System and vaccination records from the National Vaccination Register. Registers were linked using unique personal identity codes. Association between HPV2 and 38 selected outcomes were studied using Cox regression, with age as the main time-scale and the first vaccination dose as the time-dependent exposure. The hazard ratios (HR) with 95%CI were assessed according to the time since exposure (entire follow-up, 0-180/181-365/>365 days). RESULTS: Of 240 605 girls eligible for HPV2 vaccination, 134 615 (56%) were vaccinated. After adjustment for geographical area (6 hospital districts), country of origin (Finnish-born/not) and number of hospital contacts from 9 through 10 years of age, HRs ranged from 0.34 (95%CI 0.11-1.05) to 8.37 (95%CI 0.85-82.54) and HPV2 vaccination was not statistically significantly associated with a higher risk of any outcome during the entire follow-up. CONCLUSIONS: This study found no significantly increased risk for the selected outcomes after the HPV vaccination in girls 11-15 years of age. These results provide valid evidence to counterbalance public scepticism, fears of adverse events and possible opposition to HPV vaccination and consequently can contribute to increase HPV vaccination coverage in Finland as well as elsewhere.

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  • A registry-based cohort study in Finland including 134,615 vaccinated females and a review of 6 years of post-licensure VAERS data identified no unexpected safety concerns.

    “This study is consistent with the findings of a registry based cohort study in Finland which included 134,615 vaccinated females and (Skufca et al., 2018) a review of 6 years of post-licensure data in the Vaccine Adverse Event Reporting System (VAERS) which identified no unexpected safety concerns (Arana et al., 2018).”

    From Vaccine Safety: Myths and Misinformation (2020) · cites this paper as Skufca et al., 2018

  • Studies have repeatedly demonstrated that the HPV vaccine is safe and there are strong epidemiologic data refuting claims of an association with autoimmune diseases.

    “Studies have repeatedly demonstrated that this is a safe vaccine and there are strong epidemiologic data refuting claims of an association with AI diseases.”

    From Vaccine Safety: Myths and Misinformation (2020) · cites this paper as Skufca et al., 2018

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Research works printed but not linked: 3

  1. Jacobsen S, Søborg B, Mølbak K. Addressing HPV vaccine hesitancy in Denmark, 2017. ESCAIDE conference, November 2017. Available at: <https://www. escaide.eu/sites/escaide/files/documents/ESCAIDE_2017%20abstract% 20book_final_03.pdf> [Accessed: June 6, 2018]
  2. Brinth L, Theibel AC, Pors K, Mehlsen J. Suspected side effects to the quadrivalent human papilloma vaccine. Dan Med J 2015 62:A5064. Available at: <http://ugeskriftet.dk/danish-medical-journal> [Accessed: June 6, 2018]
  3. World Health Organization (WHO). International Classification of Primary Care, Second edition (ICPC-2). Available at: <http://www.who. int/classifications/icd/adaptations/icpc2/en/> [Accessed: June 6, 2018]

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  • Vaccine Safety: Myths and Misinformation

    Geoghegan, S., O’Callaghan, K. P., & Offit, P. A. (2020) · Frontiers in Microbiology · doi:10.3389/fmicb.2020.00372 · Cited by 275 · see citing works

    “This study is consistent with the findings of a registry based cohort study in Finland which included 134,615 vaccinated females and (Skufca et al., 2018) a review of 6 years of post-licensure data in the Vaccine Adverse Event Reporting Frontiers in Microbiology | www.frontiersin.org 4 March 2020 |…”
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Related

Authors
Skufca, J., Ollgren, J., Artama, M., Ruokokoski, E., Nohynek, H., & Palmu, A. A.
Affiliations
Finnish Institute for Health and Welfare (FI)
Corresponding author
Artama, Miia
ORCID
Venue
Vaccine
Publisher
Elsevier BV
Published
2018-09
Volume
36
Issue
39
Pages
5926-5933
ISSN
0264-410X (ISSN-L)
DOI
10.1016/j.vaccine.2018.06.074
OpenAlex
W2885602640
Cited by
34
References
31
Citations by year
2026: 1 · 2025: 5 · 2024: 4 · 2023: 1 · 2022: 2 · 2021: 5 · 2020: 7 · 2019: 6 · 2018: 3
FWCI
4.12
Type
journal article
Language
en
Open access
Licence
Locations
  • Vaccine (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • STM:n Hallinnonalan avoin julkaisuarkisto (Julkari) (submittedVersion)
  • WOS
Topics
  • Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Emergency Medicine › Intramuscular injections and effects
Keywords
bivalent HPV vaccine, Cervarix, vaccine adverse events, autoimmune disease, clinical syndromes, vaccine safety, national vaccination program, Finland
MeSH terms
Vaccination Coverage, Adolescent, Autoimmune Diseases, Uterine Cervical Neoplasms, Child, Female, Finland, Humans, Registries, Retrospective Studies, Cohort Studies, Proportional Hazards Models, Adverse Drug Reaction Reporting Systems, Immunization Programs, Papillomavirus Infections, Human papillomavirus 18, Human papillomavirus 16, Papillomavirus Vaccines

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