Risk of Guillain-Barré syndrome after vaccination against human papillomavirus: A systematic review and meta-analysis, 1 January 2000 to 4 April 2020

T. Sonia Boender; Barbara Bartmeyer; Louise Coole; Ole Wichmann; Thomas Harder

doi:10.2807/1560-7917.ES.2022.27.4.2001619

Risk of Guillain-Barré syndrome after vaccination against human papillomavirus: A systematic review and meta-analysis, 1 January 2000 to 4 April 2020

T. Sonia Boender, Barbara Bartmeyer, Louise Coole, Ole Wichmann, Thomas Harder

UK Health Security Agency

Research output: Contribution to journal › Review article › peer-review

5 Citations (Scopus)

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Abstract

Background: Guillain-Barre syndrome (GBS) is a rare autoimmune disease that can follow viral infections and has in a few cases been linked to vaccinations. Pre-licensure clinical trials did not observe an association between human papillomavirus (HPV) vaccination and GBS, a post-marketing study from 2017 reported an increased relative risk.

Aim: We assessed the risk of GBS after HPV vaccination through a systematic literature review and meta-analysis.

Methods: We searched Embase, MEDLINE and Cochrane for studies reporting on the risk of GBS after HPV vaccination in individuals aged ≥ 9 years, published between 1 January 2000 and 4 April 2020, excluding studies without a comparator group. Seven studies reporting relative effect sizes were pooled using random-effects meta-analysis. We assessed quality of evidence using the GRADE approach. Study protocol was registered (PROSPERO No. #CRD42019123533).

Results: Of 602 identified records, we included 25 studies. Based on over 10 million reports, cases of GBS were rare. In 22 studies no increased risk was observed, while in three studies a signal of increased risk of GBS after HPV vaccination was identified. Meta-analysis yielded a pooled random-effects ratio of 1.21 (95% CI: 0.60-2.43); I2 = 72% (95% CI: 36-88). This translates to a number needed to harm of one million to be vaccinated to generate one GBS case. Quality of evidence was very low.

Conclusions: The absolute and relative risk of GBS after HPV vaccination is very low and lacks statistical significance. This is reassuring for the already implemented vaccination programmes and should be used in respective communication activities.

Original language	English
Journal	Eurosurveillance
Volume	27
Issue number	4
DOIs	https://doi.org/10.2807/1560-7917.ES.2022.27.4.2001619
Publication status	Published - 27 Jan 2022

Bibliographical note

Funding Information: TSB is a fellow of the Centre for Disease Prevention and Control (ECDC) Fellowship Programme, supported financially by ECDC. The views and opinions expressed herein do not state or reflect those of ECDC. ECDC is not responsible for the data, information collation and analysis and cannot be held liable for conclusions or opinions drawn.

Open Access: This is an open-access article distributed under the terms of the Creative Commons Attribution (CC BY 4.0) Licence. You may share and adapt the material, but must give appropriate credit to the source, provide a link to the licence and indicate if changes were made.

Publisher Copyright: This article is copyright of the authors or their affiliated institutions, 2022.

Citation: Boender T Sonia, Bartmeyer Barbara, Coole Louise, Wichmann Ole, Harder Thomas. Risk of Guillain–Barré syndrome after vaccination against human
papillomavirus: a systematic review and meta-analysis, 1 January 2000 to 4 April 2020. Euro Surveill. 2022;27(4):pii=2001619.

DOI: https://doi.org/10.2807/1560-7917.ES.2022.27.4.2001619

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Cite this

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title = "Risk of Guillain-Barr{\'e} syndrome after vaccination against human papillomavirus: A systematic review and meta-analysis, 1 January 2000 to 4 April 2020",

abstract = "Background: Guillain-Barre syndrome (GBS) is a rare autoimmune disease that can follow viral infections and has in a few cases been linked to vaccinations. Pre-licensure clinical trials did not observe an association between human papillomavirus (HPV) vaccination and GBS, a post-marketing study from 2017 reported an increased relative risk. Aim: We assessed the risk of GBS after HPV vaccination through a systematic literature review and meta-analysis. Methods: We searched Embase, MEDLINE and Cochrane for studies reporting on the risk of GBS after HPV vaccination in individuals aged ≥ 9 years, published between 1 January 2000 and 4 April 2020, excluding studies without a comparator group. Seven studies reporting relative effect sizes were pooled using random-effects meta-analysis. We assessed quality of evidence using the GRADE approach. Study protocol was registered (PROSPERO No. #CRD42019123533). Results: Of 602 identified records, we included 25 studies. Based on over 10 million reports, cases of GBS were rare. In 22 studies no increased risk was observed, while in three studies a signal of increased risk of GBS after HPV vaccination was identified. Meta-analysis yielded a pooled random-effects ratio of 1.21 (95% CI: 0.60-2.43); I2 = 72% (95% CI: 36-88). This translates to a number needed to harm of one million to be vaccinated to generate one GBS case. Quality of evidence was very low. Conclusions: The absolute and relative risk of GBS after HPV vaccination is very low and lacks statistical significance. This is reassuring for the already implemented vaccination programmes and should be used in respective communication activities.",

author = "Boender, {T. Sonia} and Barbara Bartmeyer and Louise Coole and Ole Wichmann and Thomas Harder",

note = "Funding Information: TSB is a fellow of the Centre for Disease Prevention and Control (ECDC) Fellowship Programme, supported financially by ECDC. The views and opinions expressed herein do not state or reflect those of ECDC. ECDC is not responsible for the data, information collation and analysis and cannot be held liable for conclusions or opinions drawn. Open Access: This is an open-access article distributed under the terms of the Creative Commons Attribution (CC BY 4.0) Licence. You may share and adapt the material, but must give appropriate credit to the source, provide a link to the licence and indicate if changes were made. Publisher Copyright: This article is copyright of the authors or their affiliated institutions, 2022. Citation: Boender T Sonia, Bartmeyer Barbara, Coole Louise, Wichmann Ole, Harder Thomas. Risk of Guillain–Barr{\'e} syndrome after vaccination against human papillomavirus: a systematic review and meta-analysis, 1 January 2000 to 4 April 2020. Euro Surveill. 2022;27(4):pii=2001619. DOI: https://doi.org/10.2807/1560-7917.ES.2022.27.4.2001619",

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T2 - A systematic review and meta-analysis, 1 January 2000 to 4 April 2020

AU - Boender, T. Sonia

AU - Bartmeyer, Barbara

AU - Coole, Louise

AU - Wichmann, Ole

AU - Harder, Thomas

N1 - Funding Information: TSB is a fellow of the Centre for Disease Prevention and Control (ECDC) Fellowship Programme, supported financially by ECDC. The views and opinions expressed herein do not state or reflect those of ECDC. ECDC is not responsible for the data, information collation and analysis and cannot be held liable for conclusions or opinions drawn. Open Access: This is an open-access article distributed under the terms of the Creative Commons Attribution (CC BY 4.0) Licence. You may share and adapt the material, but must give appropriate credit to the source, provide a link to the licence and indicate if changes were made. Publisher Copyright: This article is copyright of the authors or their affiliated institutions, 2022. Citation: Boender T Sonia, Bartmeyer Barbara, Coole Louise, Wichmann Ole, Harder Thomas. Risk of Guillain–Barré syndrome after vaccination against human papillomavirus: a systematic review and meta-analysis, 1 January 2000 to 4 April 2020. Euro Surveill. 2022;27(4):pii=2001619. DOI: https://doi.org/10.2807/1560-7917.ES.2022.27.4.2001619

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N2 - Background: Guillain-Barre syndrome (GBS) is a rare autoimmune disease that can follow viral infections and has in a few cases been linked to vaccinations. Pre-licensure clinical trials did not observe an association between human papillomavirus (HPV) vaccination and GBS, a post-marketing study from 2017 reported an increased relative risk. Aim: We assessed the risk of GBS after HPV vaccination through a systematic literature review and meta-analysis. Methods: We searched Embase, MEDLINE and Cochrane for studies reporting on the risk of GBS after HPV vaccination in individuals aged ≥ 9 years, published between 1 January 2000 and 4 April 2020, excluding studies without a comparator group. Seven studies reporting relative effect sizes were pooled using random-effects meta-analysis. We assessed quality of evidence using the GRADE approach. Study protocol was registered (PROSPERO No. #CRD42019123533). Results: Of 602 identified records, we included 25 studies. Based on over 10 million reports, cases of GBS were rare. In 22 studies no increased risk was observed, while in three studies a signal of increased risk of GBS after HPV vaccination was identified. Meta-analysis yielded a pooled random-effects ratio of 1.21 (95% CI: 0.60-2.43); I2 = 72% (95% CI: 36-88). This translates to a number needed to harm of one million to be vaccinated to generate one GBS case. Quality of evidence was very low. Conclusions: The absolute and relative risk of GBS after HPV vaccination is very low and lacks statistical significance. This is reassuring for the already implemented vaccination programmes and should be used in respective communication activities.

AB - Background: Guillain-Barre syndrome (GBS) is a rare autoimmune disease that can follow viral infections and has in a few cases been linked to vaccinations. Pre-licensure clinical trials did not observe an association between human papillomavirus (HPV) vaccination and GBS, a post-marketing study from 2017 reported an increased relative risk. Aim: We assessed the risk of GBS after HPV vaccination through a systematic literature review and meta-analysis. Methods: We searched Embase, MEDLINE and Cochrane for studies reporting on the risk of GBS after HPV vaccination in individuals aged ≥ 9 years, published between 1 January 2000 and 4 April 2020, excluding studies without a comparator group. Seven studies reporting relative effect sizes were pooled using random-effects meta-analysis. We assessed quality of evidence using the GRADE approach. Study protocol was registered (PROSPERO No. #CRD42019123533). Results: Of 602 identified records, we included 25 studies. Based on over 10 million reports, cases of GBS were rare. In 22 studies no increased risk was observed, while in three studies a signal of increased risk of GBS after HPV vaccination was identified. Meta-analysis yielded a pooled random-effects ratio of 1.21 (95% CI: 0.60-2.43); I2 = 72% (95% CI: 36-88). This translates to a number needed to harm of one million to be vaccinated to generate one GBS case. Quality of evidence was very low. Conclusions: The absolute and relative risk of GBS after HPV vaccination is very low and lacks statistical significance. This is reassuring for the already implemented vaccination programmes and should be used in respective communication activities.

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Risk of Guillain-Barré syndrome after vaccination against human papillomavirus: A systematic review and meta-analysis, 1 January 2000 to 4 April 2020

Abstract

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