HPV Vaccine Safe in Females With Autoimmune Disease

Pam Harrison

August 02, 2016

Concerns that females with an autoimmune disease might be predisposed to develop a second autoimmune disorder if exposed to the human papilloma virus (HPV) vaccine are unfounded, because girls and women who receive the vaccine are slightly less likely than unvaccinated persons to do so, a large population-based study indicates.

"It has been suggested that, similar to viral infections, vaccines could act as a trigger of autoimmune disease," comment lead author Olof Grönlund, a doctoral candidate at the Karolinska Institute, in Stockholm, Sweden, and colleagues.

"But we did not observe an increased risk of new-onset autoimmune disease in girls and women with pre-existing autoimmune disease after qHPV [quadrivalent HPV] vaccination," they note.

"Our results may be of relevance for clinicians and policymakers considering vaccination safety in this population," the researchers comment.

The study was published online July 31 in the Journal of Internal Medicine.

The observational, register-based cohort study included all girls and women between the ages of 10 and 30 years with a diagnosis of at least one autoimmune disease living in Sweden between October 2006 and December 2012.

Of this large cohort, 70,265 girls and women had at least 1 of 49 predefined autoimmune diseases and were included in the study cohort.

Patients received either the qHPV vaccine (Gardasil, Sanofi Pasteur, MSD, SNC) or the bivalent HPV vaccine (Cervarix, GlaxoSmithKline Biologicals).

Of the cohort, 63% were fully vaccinated, and more than one quarter received two doses.

Control participants included women who had not received any HPV vaccine. This cohort contributed 245,807 person-years of follow-up during the study interval.

Women who had been exposed to at least one dose of the qHPV vaccine contributed 7848 person-years of follow-up during a predefined risk period of up to 180 days following receipt of any dose of the qHPV vaccine.

In this vaccine-exposed cohort, 124 new-onset cases of autoimmune disease were documented during the 180-day risk period, for a rate of 15.8 new events per 1000 person-years.

In comparison, the rate of new diagnoses among unvaccinated females was 22.1 new diagnoses per 1000 person-years.

After adjusting for a number of confounding variables, the difference in new-onset autoimmune disease was 23% lower among the vaccine-exposed group compared with the unexposed group, a difference that was not statistically significant.

"Since the regulatory approval of qHPV, no serious adverse events have been found in healthy individuals in several large population-based studies," Grönlund observes.

"Our results strengthen the existing evidence base on qHPV safety and provide information for those considering qHPV vaccination in this vulnerable population," he adds.

Olaf Grönlund has disclosed no relevant financial relationships. Several coauthors have reported relationships with industry, which are listed in the original article.

J Intern Med. Published online July 31, 2016. Abstract

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