Large Scandinavian Study Shows No Increase in MS Risk after HPV Vaccination
January 13, 2015
A study of nearly four million girls and women identified in nationwide patient registries in Denmark and Sweden found no increased risk of developing MS among nearly 800,000 who received quadrivalent human papillomavirus vaccine (Gardasil®), designed to prevent cervical cancer. Nikolai Madrid Scheller, Dr. Anders Hviid (Statens Serum Institut, Copenhagen) and colleagues in Denmark and Sweden report these findings in JAMA (2015;313:54-61). The study was funded by the Swedish Foundation for Strategic Research, Novo Nordisk Foundation, and The Danish Medical Research Council.
Background: Quadrivalent HPV vaccine (Gardasil®) is designed to prevent certain types of cervical cancer and similar disease in girls and women ages 9 to 26. Cases have been described of people developing demyelinating disease (disorders, including multiple sclerosis, in which nerve-insulating myelin is damaged) following vaccination, leading to concerns about vaccine safety. This study approaches the issue by conducting an epidemiology study using large, nationwide patient registries. This study specifically investigated vaccination with Gardasil because insufficient numbers of patients had received vaccination with another available HPV vaccine called bivalent HPV vaccine (Cervarix®).
The Study: Investigators reviewed data in nationwide patient registries on all Danish girls and women aged 10 to 44 years October 1, 2006, to July 1, 2013, and all Swedish girls and women aged 10 to 44 years from October 1, 2006, until December 31, 2012. They evaluated two outcomes: a diagnosis of MS, and an outcome comprising other demyelinating diseases such as optic neuritis, neuromyelitis optica, transverse myelitis, and acute disseminated encephalomyelitis.
Of almost four million girls and women, nearly 800,000 received the HPV vaccination. The investigators found no increased risk of MS or other demyelinating diseases following HPV vaccination.
Comment: This comprehensive study adds important information to our knowledge of vaccine safety in MS. Use of Gardasil should be preceded by a thorough discussion between patient and physician of the possible benefits and risks. Read more about vaccine use and safety in MS.
Gardasil is a registered trademark of Merck Sharp & Dohme Corp.
Cervarix is a registered trademark of the GlaxoSmithKline group of companies.