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

Jozica Skufca; Jukka Ollgren; Miia Artama; Esa Ruokokoski; Hanna Nohynek; Arto A. Palmu

doi:10.1016/j.vaccine.2018.06.074

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

Jozica Skufca, Jukka Ollgren, Miia Artama, Esa Ruokokoski, Hanna Nohynek, Arto A. Palmu

Research output: Contribution to journal › Article › Scientific › peer-review

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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.

Original language	English
Pages (from-to)	5926-5933
Number of pages	8
Journal	Vaccine
Volume	36
Issue number	39
DOIs	https://doi.org/10.1016/j.vaccine.2018.06.074
Publication status	Published - 18 Sept 2018
Publication type	A1 Journal article-refereed

Keywords

Adverse events following immunization
HPV2
Human papillomavirus vaccine
Register-based cohort study
Vaccine safety

ASJC Scopus subject areas

Molecular Medicine
General Immunology and Microbiology
General Veterinary
Public Health, Environmental and Occupational Health
Infectious Diseases

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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1-s2.0-S0264410X18309253-mainFinal published version, 1.18 MBLicence: CC BY-NC-ND

https://urn.fi/URN:NBN:fi:tuni-202304133683Licence: CC BY-NC-ND

Cite this

@article{fa096afde5d64b459a0739213b003fff,

title = "The association of adverse events with bivalent human papilloma virus vaccination: A nationwide register-based cohort study in Finland",

abstract = "Background: A bivalent HPV vaccine (Cervarix{\textregistered}; 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.",

keywords = "Adverse events following immunization, HPV2, Human papillomavirus vaccine, Register-based cohort study, Vaccine safety",

author = "Jozica Skufca and Jukka Ollgren and Miia Artama and Esa Ruokokoski and Hanna Nohynek and Palmu, {Arto A.}",

note = "Funding Information: Authors are employed by National Institute for Health and Welfare which has received research funding from GlaxoSmithKline and Pfizer, Inc. AAP and ER are co-investigators in these studies. Publisher Copyright: {\textcopyright} 2018 The Author(s)",

year = "2018",

month = sep,

day = "18",

doi = "10.1016/j.vaccine.2018.06.074",

language = "English",

volume = "36",

pages = "5926--5933",

number = "39",

}

TY - JOUR

T1 - The association of adverse events with bivalent human papilloma virus vaccination

T2 - A nationwide register-based cohort study in Finland

AU - Skufca, Jozica

AU - Ollgren, Jukka

AU - Artama, Miia

AU - Ruokokoski, Esa

AU - Nohynek, Hanna

AU - Palmu, Arto A.

N1 - Funding Information: Authors are employed by National Institute for Health and Welfare which has received research funding from GlaxoSmithKline and Pfizer, Inc. AAP and ER are co-investigators in these studies. Publisher Copyright: © 2018 The Author(s)

PY - 2018/9/18

Y1 - 2018/9/18

N2 - 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.

AB - 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.

KW - Adverse events following immunization

KW - HPV2

KW - Human papillomavirus vaccine

KW - Register-based cohort study

KW - Vaccine safety

U2 - 10.1016/j.vaccine.2018.06.074

DO - 10.1016/j.vaccine.2018.06.074

M3 - Article

C2 - 30115524

AN - SCOPUS:85053839294

SN - 0264-410X

VL - 36

SP - 5926

EP - 5933

JO - Vaccine

JF - Vaccine

IS - 39

ER -

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

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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