A study of nearly 4 million women indicates that there is no causal relationship between the quadrivalent human papillomavirus (qHPV) vaccination and the risk of multiple sclerosis (MS) or other demyelinating diseases.
A study of nearly 4 million women indicates that there is no causal relationship between the quadrivalent human papillomavirus (qHPV) vaccination and the risk of multiple sclerosis (MS) or other demyelinating diseases.
Swedish and Danish researchers used nationwide registers to create a cohort of all females aged 10 to 44 years in Denmark and Sweden, who were followed from 2006 to 2013. Information on qHPV vaccination and data on incident diagnoses of MS and other demyelinating diseases were also identified using the registers. A primary analysis used a cohort design with unvaccinated and vaccinated study participants; a secondary analysis had a self-controlled case-series design that included only cases. A 2-year risk period following vaccination was used for both analyses.
The study involved 3,983,824 women, of whom 789,082 received 1,927,581 qHPV doses. Over the course of follow-up, 4322 cases of MS and 3300 cases of other demyelinating diseases were identified. Seventy-three of the MS cases and 90 of the other demyelinating disease cases were diagnosed during the risk period. Cohort analysis showed no increased risk of MS (crude incidence rates, 6.12 events/100,000 person-years [95% confidence interval {CI}, 4.86-7.69] and 21.54 events/100,000 person-years [95% CI, 20.90-22.20] for the vaccinated and unvaccinated periods; adjusted rate ratio [aOR], 0.90 [95% CI, 0.70-1.15]) and other demyelinating diseases (crude incidence rates, 7.54 events/100 000 person-years [95% CI, 6.13-9.27] and 16.14 events/100 000 person-years [95% CI, 15.58-16.71]; aOR, 1.00 [95% CI, 0.80-1.26]) in association with the qHPV vaccine.
No association was found with the self-controlled case-series design either (MS: incidence ratio, 1.05 [95% CI, 0.79-1.38]; other demyelinating diseases: incidence ratio, 1.14 [95% CI, 0.88-1.47]).
The investigators concluded that the qHPV vaccine showed no association with the development of MS and other demyelinating diseases.
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