Adverse Events Analyzed for Human Papillomavirus Vaccine

CDC study finds adverse events consistent with other vaccines, except for syncope and embolism

TUESDAY, Aug. 18 (HealthDay News) -- Most adverse events from the human papillomavirus vaccine do not exceed background rates for other vaccines, but syncope and venous thromboembolic events were disproportionately reported, according to a study in the Aug. 19 issue of the Journal of the American Medical Association.

Barbara A. Slade, M.D., of the Centers for Disease Control and Prevention in Atlanta, and colleagues reviewed data on adverse events following immunization (AEFIs) with the quadrivalent human papillomavirus recombinant vaccine (qHPV) as reported to the Vaccine Adverse Event Reporting System (VAERS) from 2006 to 2008. The researchers further analyzed AEFIs in vaccine pre-licensure trials, the more severe adverse events, and those that got public attention.

The researchers analyzed 12,424 reports of AEFIs, a rate of 53.9 reports per 100,000 doses. There were 772 reports of serious AEFIs, including 32 deaths. The AEFI rates (reports per 100,000 doses) were as follows: 8.2 for syncope; 7.5 for injection site reaction; 6.8 for dizziness; 5.0 for nausea; 4.1 for headache; 3.1 for hypersensitivity reactions; 2.6 for urticaria; 0.2 for venous thromboembolic events, autoimmune disorders and Guillain-Barre syndrome; 0.1 for anaphylaxis and death; 0.04 for transverse myelitis and pancreatitis; and 0.009 for motor neuron disease.

"The post-licensure safety profile presented here is broadly consistent with safety data from pre-licensure trials. Because VAERS data must be interpreted cautiously and cannot generally be used to infer causal associations between vaccines and AEFIs, post-licensure monitoring will continue, and identified signals may be evaluated using epidemiologic observational studies," the authors write.

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