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See Latest ArticlesPostlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine
JAMA, 08/24/09
Slade BA et al. – Study reports that most of the adverse events following immunization (AEFI) rates upon administration of quadrivalent human papillomavirus recombinant vaccine (qHPV) were not greater than the background rates compared with other vaccines, but there was disproportional reporting of syncope and venous thromboembolic events.
Methods- A summarization of reports to the Vaccine Adverse Event Reporting System (VAERS) following receipt of qHPV
- AEFIs were reported to VAERS, a national, voluntary, passive surveillance system, from June 1, 2006, through Dec 31, 2008
- Additional analyses were performed for some AEFIs in prelicensure trials: those of unusual severity, or those that had received public attention
- Statistical data mining, including proportional reporting ratios (PRRs) and empirical Bayesian geometric mean methods to detect disproportionality in reporting
- Main outcome measures:
- Numbers of reported AEFIs
- Reporting rates, and
- Comparisons with expected background rates
- VAERS received 12,424 reports of AEFIs following qHPV distribution- a rate of 53.9 reports per 100,000 doses distributed
- 6.2% described serious AEFIs, including 32 reports of death
- Reporting rates per 100,000 qHPV doses distributed were:
- 8.2 for syncope; 7.5 for local site reactions
- 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-Barré syndrome
- 0.1 for anaphylaxis and death
- 0.04 for transverse myelitis and pancreatitis, and
- 0.009 for motor neuron disease
- Disproportional reporting of syncope and venous thromboembolic events was noted with data mining methods
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