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Updated guidance issued on use of HPV vaccines
Add current data to your clinical knowledge base: the Advisory Committee on Immunization Practices (ACIP) has issued updated recommendations for routine and catch-up vaccination of females with the bivalent or quadrivalent human papillomavirus vaccines (HPV2, HPV4), as well as published its policy statement and summarized background data on use of the HPV4 vaccine in males.1-2
There are no major changes in the recommendations for use of HPV vaccines in females, says Lauri Markowitz, MD, medical epidemiologist at the Centers for Disease Control and Prevention. The recommendations now state that either vaccine can be used, she notes.
"The main purpose [of the publication] is to provide some basic information about the bivalent vaccine and to reiterate the recommendations for either vaccine," she states.
The Food and Drug Administration (FDA) approved GlaxoSmithKline's Cervarix bivalent vaccine for use in the prevention of cervical pre-cancers and cervical cancer associated with oncogenic HPV types 16 and 18 for use in girls and young women ages 10-25 in October 2009. At the same time, it issued approval of the Merck and Co. quadrivalent vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to HPV types 6 and 11 in boys and men, ages 9-26.
Review the guidance
The dosing and administration schedules in females are the same for the HPV4 and HPV2.1 Each dose is 0.5 ml, administered intramuscularly, preferably in a deltoid muscle. The vaccines are administered in a three-dose schedule, with the second dose administered 1-2 months after the first dose, and the third dose given six months after the first dose.
ACIP recommends routine vaccination of females ages 11 or 12 with three doses of either vaccine; the vaccination series can be started as early as age 9. Recommendations call for vaccination of females ages 13-26 who have not been vaccinated previously or who have not completed the three-dose series. If a female reaches age 26 before the series is complete, remaining doses can be administered after she passes that age. Ideally, vaccine should be administered before potential exposure to HPV through sexual contact, the guidance states.1
Whenever feasible, the same HPV vaccine should be used for the entire vaccination series, the publication states. While no studies have addressed interchangeability of HPV vaccines, either HPV vaccine can be used to complete the series to provide protection against HPV 16 and 18 if the vaccine provider does not know or have available the HPV vaccine product previously administered.1
Both HPV vaccines are contraindicated for persons with a history of immediate hypersensitivity to any vaccine component. HPV4 is produced in Saccharomyces cerevisiae (baker's yeast), so it should not be used for persons with a history of immediate hypersensitivity to yeast. Prefilled syringes of HPV2 have latex in the rubber stopper and should not be used in persons with anaphylactic latex allergy; HPV2 single dose vials contain no latex.1
Studies suggest that increased fainting occurs among females 13 years and older after receiving any vaccine.3 To avoid serious injury related to a syncopal episode, vaccine providers should consider observing patients for 15 minutes after they are vaccinated.1
Former Argentina President Juan Perón's wife, Eva Perón, died of cervical cancer, and so did Juan Perón's first wife, points out Robert Hatcher, MD, MPH, professor of gynecology and obstetrics at Emory University School of Medicine in Atlanta.
"Men infect women with the viruses that cause cervical cancer. Cervical cancer is an infectious disease caused by certain types of the human papillomavirus," states Hatcher. "Finally, the guidelines for the use of Gardasil [HPV4] are taking this basic fact of life into consideration."
The new guidance states that the HPV4 vaccine should be administered to males ages 9-26 in a three-dose schedule.2 The second dose is administered one to two months after the first dose, with the third dose given six months after the first dose. The minimum interval between the first and second dose of vaccine is four weeks, and the minimum interval between the second and third dose is 12 weeks. The minimum interval between the first and third dose is 24 weeks. Doses received after a dosing interval that is shorter than recommended should be readministered, the guidance advises. If the HPV vaccine schedule is interrupted, the vaccine series does not need to be restarted. Males who receive the vaccine also should be observed for 15 minutes after vaccine administration for possible fainting, the guidance states.
How many young women are getting the HPV vaccine? A new report published by researchers at Washington University School of Medicine in St. Louis indicates only about one in three young women has received the shot.4
To conduct the study, researchers tracked rates of HPV vaccination in Delaware, New York, Oklahoma, Pennsylvania, Texas, and West Virginia, analyzing data from 1,709 girls in 274 counties. Just 34% of girls ages 13 to 17 were vaccinated in the six states surveyed, data show.4 Results of the study suggest geographic disparity in HPV vaccination.