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Second HPV Vaccine Gets Green Light


 

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended a bivalent human papillomavirus vaccine as an alternative to the quadrivalent vaccine for the prevention of cervical cancer and related precancerous conditions in women and girls aged 9-26 years.

ACIP made the recommendation at its annual fall meeting

The bivalent human papillomavirus (HPV) vaccine (GlaxoSmithKline's Cervarix) was recently approved by the Food and Drug Administration. The vaccine provides clinicians with another option to vaccinate adolescent girls and young women against diseases caused by HPV types 16 and 18. But unlike the quadrivalent vaccine, the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC, who presented the ACIP recommendations.

The quadrivalent vaccine (Merck & Co.'s Gardasil) protects against genital warts associated with HPV types 6 and 11, in addition to protecting against diseases caused by HPV types 16 and 18.

ACIP recommended against a statement of no preference between the bivalent and quadrivalent vaccines after a lively debate. Instead, the recommendations will present the information about the two vaccines without a statement of preference or a statement of nonpreference.

The recommendations state that the two vaccines can be used interchangeably to complete the three-dose series, but that using the same vaccine for the entire series is preferable. The bivalent vaccine, like the quadrivalent vaccine, is not a live vaccine, and it can be given simultaneously with other vaccines.

ACIP also voted to harmonize the age ranges for the two vaccines, with first doses given at ages 11-12 years and recommended second and third doses at 1-2 months and 6 months after the first dose. The recommended minimum dosing intervals remained as 4 weeks between the first and second dose and 12 weeks between the second and third doses. The vaccine can be initiated as young as 9 years, and catch-up vaccination is recommended for females aged 13-26 years.

In addition, ACIP voted to move information about pregnancy to the precautions section. Pregnancy is not currently a contraindication for the vaccine. But Dr. Frank DeStefano of the CDC's immunization safety office said that post-marketing safety surveillance studies would be conducted on the bivalent HPV vaccine using the Vaccine Adverse Event Reporting System (VAERS).

The committee voted to add the bivalent vaccine to the CDC's Vaccines for Children program.

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