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 Vol. 22 No. 5, November 2009
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AAP Grand Rounds 22:51 (2009)
© 2009 American Academy of Pediatrics

INFECTIOUS DISEASES

HPV Vaccine: Postlicensure Safety Data

Source: Slade BA, Leidel L, Vellozzi C, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant (HPV) vaccine. JAMA. 2009;302(2):750–757; doi:10.1001/jama.2009.1201[Abstract/Free Full Text]

The first 20% of the full text of this article appears below.


PICO

Question: Among recipients of the HPV vaccine, what are the reported adverse events?

Question type: Description

Study design: Retrospective review

 

Investigators from the CDC and the Food and Drug Administration analyzed US reports to the Vaccine Adverse Events Reporting System (VAERS) from June 1, 2006, through December 31, 2008 regarding reactions by patients to the quadrivalent human papillomavirus vaccine (qHPV).

During the 2.5-year study period 23,051,336 doses of qHPV vaccine were distributed and 12,424 reports were made to VAERS, for a rate of 53.9 reports/100,000 doses distributed. Sixty-eight percent (8,471) of the reports were submitted by the manufacturer. Of the manufacturer reports for qHPV adverse events (AE) following immunization, 7,561 (89%) had insufficient identifying information to permit clinical follow-up or review.

In 80% of the reports, qHPV was the only vaccine used. Forty percent of the AEs occurred on the day of the vaccination, 61% after the first dose, 25% after the second, and 13% after the third. A total of 772 (6.2%) AEs were serious including 32 reports . . . [Full Text of this Article]

Mobeen H. Rathore, MD, CPE, FAAP
University of Florida and Wolfson Children’s Hospital, Pediatric Infectious Diseases and Immunology, Jacksonville, FL