On the relationship between human papilloma virus vaccine and autoimmune diseases.
The human papilloma virus (HPV) vaccines were introduced to reduce the incidence of cervical cancer. The bivalent vaccine is effective against HPV-16, -18, -31, -33 and -45 while the quadrivalent vaccine is effective against HPV-16, 18, 31, 6 and 11 types. The immunisation, recommended for adolescent females, has led to high vaccine coverage in many countries. Along with the introduction of the HPV vaccines, several cases of onset or exacerbations of autoimmune diseases following the vaccine shot have been reported in the literature and pharmacovigilance databases, triggering concerns about its safety. This vaccination programme, however, has been introduced in a population that is at high risk for the onset of autoimmune diseases, making it difficult to assess the role of HPV vaccine in these cases and no conclusive studies have been reported thus far. We have thus analysed and reviewed comprehensively all case reports and studies dealing with either the onset of an autoimmune disease in vaccinated subject or the safety in patients with autoimmune diseases to define the role of the HPV vaccines in these diseases and hence its safety. A solid evidence of causal relationship was provided in few cases in the examined studies, and the risk vs. benefit of vaccination is still to be solved. The on-going vigilance for the safety of this vaccine remains thus of paramount importance.
Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital "Luigi Sacco", Università di Milano, 20157 Milan, Italy.
Paolo
P
Pellegrino
Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital "Luigi Sacco", Università di Milano, 20157 Milan, Italy.
Carla
C
Carnovale
Scientific Institute, IRCCS E. Medea, 23842 Bosisio Parini, Lecco, Italy.
Marco
M
Pozzi
IRCCS Foundation Ca' Granda Ospedale Maggiore Policlinico, Milan 20122, Italy.
Stefania
S
Antoniazzi
Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital "Luigi Sacco", Università di Milano, 20157 Milan, Italy.
Valentina
V
Perrone
Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital "Luigi Sacco", Università di Milano, 20157 Milan, Italy.
Dionigi
D
Salvati
Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital "Luigi Sacco", Università di Milano, 20157 Milan, Italy.
Marta
M
Gentili
Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital "Luigi Sacco", Università di Milano, 20157 Milan, Italy.
Tatiana
T
Brusadelli
Scientific Institute, IRCCS E. Medea, 23842 Bosisio Parini, Lecco, Italy; Unit of Clinical Pharmacology, Consiglio Nazionale delle Ricerche Institute of Neuroscience, Department of Biomedical and Clinical Sciences, University Hospital "Luigi Sacco", Università di Milano, 20157 Milan, Italy. Electronic address: emilio.clementi@unimi.it.
Emilio
E
Clementi
Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital "Luigi Sacco", Università di Milano, 20157 Milan, Italy.
Sonia
S
Radice
D001327:Autoimmune Diseases / Q000453:epidemiology / Q000209:etiology*; D005260:Female; D006801:Humans; D015994:Incidence; D030361:Papillomavirus Infections / Q000517:prevention & control; D053918:Papillomavirus Vaccines / Q000009:adverse effects / Q000276:immunology*; D014611:Vaccination / Q000009:adverse effects
D053918:Papillomavirus Vaccines
Acute disseminated encephalomyelitis; Autoimmunity diseases; Human papilloma virus vaccine; Juvenile idiopathic arthritis; Multiple sclerosis; Rheumatoid arthritis