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Tuesday, March 6, 2007 - 2:05 PM
38

Quadrivalent Human Papillomavirus Vaccine Adverse Events

Elaine Rich Miller1, Claudia Vellozzi2, Scott Campbell3, Lauri Markowitz4, Emily J. Woo5, and Hector S. Izurieta5. (1) Immunization Safety Branch, Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop D-26, Atlanta, GA, USA, (2) Immunization Safety Office, Office of the Chief Science Officer, Office of the Director, CDC, Centers for Disease Control and Prevention, 1600 Clifton Rd, MS D-26, Atlanta, GA, USA, (3) Immunization Safety Office, Center for Disease Control and Prevention, 1600 Clifton Road, NE, Mailstop D-26, Atlanta, GA, USA, (4) Division of STD Prevention, Centers for Disease Control and Prevention, 1600 Clifton Rd, Mail Stop E-02, Atlanta, GA, (5) CBER, Food and drug administration, 1401 Rockville PIke, HFM 222, Rockville, MD, USA


Learning Objectives for this Presentation:
By the end of this presentation, participants will be able to describe adverse events (AEs) most commonly reported to the Vaccine Adverse Event Reporting System (VAERS) following quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recombinant vaccine.

Background:
HPV vaccine was licensed June 8, 2006 for females aged 9-26 years to prevent cervical cancer, genital warts, and precancerous and dysplastic lesions caused by HPV types 6. 11, 16 and 18. VAERS is a passive surveillance system, federally mandated to provide postlicensure vaccine safety surveillance. However, it is subject to underreporting, reporting of unverified diagnoses, and incomplete information.

Objectives:
To describe AEs reported to VAERS after HPV vaccine.

Methods:
We reviewed VAERS data to determine AE reports after HPV vaccine. We compared the proportion of the most common AEs reported following HPV vaccine to the proportion of the same AEs reported following hepatitis B (HepB) and meningococcal conjugate (MCV4) vaccines among females aged 9-26 years.

Results:
As of October 16, 2006 VAERS had received 74 AE reports after HPV vaccine. The most commonly reported AEs were syncope (23%), rash (19%) and injection-site pain (18%). The proportions of syncope and injection-site pain reports were higher after HPV than HepB or MCV4 vaccines. The proportion of rash reports was higher after HPV than MCV4 vaccine.

Conclusions:
Syncope, rash and injection-site pain are the most frequently reported AEs following HPV vaccine among the small number of VAERS reports received to date. However, proportions of VAERS reports should not be interpreted as incidence rates, and differences in proportions would require further investigation in settings other than VAERS. In clinical trials, only injection-site pain occurred significantly more frequently among vaccine than placebo recipients. Healthcare personnel who administer HPV and other vaccines to adolescents are encouraged to follow recommendations regarding syncope and vaccine administration technique and to submit VAERS reports after AEs.

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