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HPV vaccination did not increase MS risk in females
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Despite case reports suggesting a link between HPV vaccination and the development of multiple sclerosis and other demyelinating diseases, a research team in Scandinavia found no such risk in vaccinated girls and women, according to study data published in JAMA.
“In this the largest and most comprehensive study to date, there was no support for this particular safety concern,” Anders Hviid, MSc, DMedSc, senior investigator at Statens Serum Institut in Copenhagen, Denmark, told Infectious Disease News. “The current evidence suggests that clinicians and patients should not fear demyelinating diseases as a result of HPV vaccination.”
Since the quadrivalent HPV vaccine (Gardasil, Merck) was licensed in 2006 and the bivalent HPV vaccine (Cervarix, GlaxoSmithKline) in 2009, more than 175 million doses have been distributed globally, the researchers wrote. Large-scale HPV vaccination has spurred safety concerns, including the development of multiple sclerosis (MS), which has undermined public confidence in the vaccines.
Hviid, Nikolai Madrid Scheller, MB, and colleagues investigated the risk for MS and other diseases after administration of the quadrivalent HPV vaccine in a cohort of females aged 10 to 44 years in Denmark and Sweden. The cohort was identified through nationwide registers, and included almost 4 million females. The study’s primary outcome was MS and a composite of demyelinating diseases. The researchers compared rates of these diseases in the 2 years after vaccination with unvaccinated time periods. A 2-year risk period was similarly used in an investigation of MS and hepatitis B vaccination in 2001 (Ascherio and colleagues).
Of the entire cohort, 789,082 females received 1,927,581 vaccine doses. Between 2006 and 2013, 4,322 MS cases and 3,300 cases of other demyelinating diseases were identified. Of these, 73 MS cases and 90 cases of other demyelinating diseases occurred during the risk period.
In the cohort analysis, the researchers discovered no increased risk for MS (adjusted RR=0.9; 95% CI, 0.7-1.15) or other diseases of the central nervous system (adjusted RR=1; 95% CI, 0.8-1.26) associated with HPV vaccination, and no risk was observed using a self-controlled case-series study design.
“Our study adds to the body of data that support a favorable overall safety profile of the [quadrivalent HPV] vaccine and expands on this knowledge by providing comprehensive analyses of multiple sclerosis and other demyelinating diseases,” the researchers wrote. “The size of the study … and the use of nationwide registry data of unselected populations from Denmark and Sweden allowed adequately powered analyses that are likely generalizable.” — John Schoen
For more information:
Ascherio A. N Engl J Med. 2001;344:327-332.
Scheller NM. JAMA. 2015;313:54-61.
Disclosure: One of the researchers reported receiving grants from GlaxoSmithKline, Merck and Sanofi Pasteur. Another researcher reported receiving travel support from Biogen Idec. A third researcher reported receiving a grant from the Novo Nordisk Foundation. No other researchers reported relevant financial disclosures.