Abstract
BackgroundGuillain–Barré 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.AimWe assessed the risk of GBS after HPV vaccination through a systematic literature review and meta-analysis.MethodsWe 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).ResultsOf 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.ConclusionsThe 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.
Highlights
Guillain–Barré syndrome (GBS) is a rare autoimmune disease that can follow viral infections and has in a few cases been linked to vaccinations
We planned for inclusion of people aged 9 years and older [14] because the human papillomavirus (HPV) vaccines are approved for people aged 9 years and older
Results of individual studies The reported occurrence of GBS following HPV vaccination is summarised in Table 2 and described by study design and by geographic region
Summary
Guillain–Barré syndrome (GBS) is a rare autoimmune disease that can follow viral infections and has in a few cases been linked to vaccinations. 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. 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. CI: confidence interval; CPRD GOLD: Clinical Practice Research Datalink General Practice Online Database; GBS: Guillain–Barré syndrome; GSK: GlaxoSmithKline; HR: hazard ration; ICD: International Classification of Diseases; IR: incidence rate; MedDRA: Medical Dictionary for Regulatory Activities; NA: not applicable; ND: not done; NP: not possible; NR: not reported; OR: odds ratio; py: person-year; RCT: randomised controlled trial; RI: relative incidence; RR: relative risk; VAERS: Vaccine Adverse Event Reporting System; VDS: Vaccine Safety Datalink.
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