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CDC Panel Supports HPV Vaccine for Pre-Teen Girls
  CDC Media Advisory
For Immediate Release
June 29, 2006
CDC's Advisory Committee Recommends Human Papillomavirus Virus Vaccination
CDC's Advisory Committee Recommends Human Papillomavirus Virus Vaccination Vaccine considered highly effective in preventing infections that are the cause of most cervical cancers.
The Advisory Committee on Immunization Practices (ACIP) voted Thursday to recommend that a newly licensed vaccine designed to protect against human papillomavirus virus (HPV) be routinely given to girls when they are 11-12 years old. The ACIP recommendation also allows for vaccination of girls beginning at nine years old as well as vaccination of girls and women 13-26 years old. HPV is the leading cause of cervical cancer in women.
According to the ACIP's recommendation, three doses of the new vaccine should be routinely given to girls when they are 11 or 12 years old. The advisory committee, however, noted that the vaccination series can be started as early as nine years old at the discretion of the physician or health care provider. The recommendation also includes girls and women 13-26 years old because they will benefit from getting the vaccine. The vaccine should be administered before onset of sexual activity (i.e., before women are exposed to the viruses), but females who are sexually active should still be vaccinated.
"This vaccine represents an important medical breakthrough," said Dr. Anne Schuchat, director of CDC's National Center for Immunization and Respiratory Diseases. "As a result, these vaccine recommendations address a major health problem for women and represent a significant advance in women's health. It has been tested in thousands of women around the world and has been found to be safe and effective in providing protection against the two types of HPV that cause most cervical cancers."
Gardasil, manufactured by Merck, is the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to HPV -- `HPV causes genital warts in men and women. The vaccine is highly effective against four types of the HPV virus, including two that cause about 70 percent of cervical cancer. Those who have not acquired HPV would get the full benefits of the vaccine. On average, there are 9,710 new cases and 3,700 deaths from cervical cancer in the United States each year.
HPV is the most common sexually transmitted infection in the United States, More than 20 million men and women in the United States are currently infected with HPV and there are 6.2 million new infections each year. HPV is most common in young women and men who are in their late teens and early 20s. By age 50, at least 80 percent of women will have acquired HPV infection.
"Although an effective vaccine is a major advance in the prevention of genital HPV and cervical cancer, it will not replace other prevention strategies, such as cervical cancer screening for women or protective sexual behaviors," said Dr. Schuchat "Women should continue to get pap tests as a safeguard against cervical cancer."
The ACIP, consisting of 15 members appointed by the Secretary of the Department of Health and Human Services (HHS), advises the director of CDC and Secretary of HHS on control of vaccine-preventable disease and vaccine usage. Recommendations of the ACIP become CDC policy when they are accepted by the director of CDC and are published in CDC's Morbidity and Mortality Weekly Report (MMWR). There are no federal laws requiring the immunization of children. All school and daycare entry laws are state laws and vary from state to state.

CDC Panel Backs Cervical Cancer Vaccine For Pre-Teen Girls
29 Jun 2006 - 10:00am (PDT)
A CDC panel voted today to include Gardasil, an HPV vaccine that protects women from developing cervical cancer, as a routine shot to be given to 11 and 12 year old girls. There are about 4 million 11-12 year-old girls in the USA.
The panel, the Advisory Committee for Immunization Practices, consists of outside specialists. The CDC tends to go along with what the panel advises.
This means pediatricians will adopt Gardasil as standard practice for pre-teen girls, health insurers will have to fund it. Total US sales of Gardasil are expected to reach approximately $3 billion per year for Merck, the makers of the vaccine.
Gardasil protects women from HPV (human papillomavirus), a sexually transmitted virus, which is responsible for the majority of cervical cancers worldwide. Cervical cancer is the second biggest cancer killer of women.
Merck had wanted girls as young as nine to receive Gardasil. The panel decided on a slightly older age, as younger girls are receiving other shots. By vaccinating 11 and 12 year-old girls, the vaccine will be administered before they become sexually active. Gardasil offers protection before a girl is exposed to HPV.
Two HPV strains are responsible for causing 70% of all cervical cancers. Gardasil protects females from these two strains. It also protects against two other strains that are responsible for most genital warts.
The treatment consists of three injections, spread over six months. The whole course costs $120.
About 300,000 women worldwide die of cervical cancer each year. Gardasil could save the lives of 200,000 women each year.
At first, when news of the vaccine's potential came out, there was some opposition. Some people felt that girls would become sexually active at a younger age. However, the opposition ebbed as soon as people realised how many lives could be saved.

Panel Advises HPV Vaccine for Young Girls-
Panel Recommends Routine Vaccination of 11- and 12-Year-Old Girls Against Cervical Cancer

ATLANTA Jun 29, 2006 (AP)\ Taking up a sensitive issue among religious conservatives, an influential government advisory panel Thursday recommended that 11- and 12-year-old girls be routinely vaccinated against the sexually transmitted virus that causes cervical cancer.
The Advisory Committee on Immunization Practices also said the shots can be started for girls as young as 9, at the discretion of their doctors.
The committee's recommendations usually are accepted by federal health officials, and influence insurance coverage for vaccinations.
The recommendation involves Gardasil, which is made by Merck & Co. and is the first vaccine specifically designed to prevent cancer. Approved earlier this month by the Food and Drug Administration for females ages 9 to 26, it protects against strains of the human papilloma virus, or HPV, which causes cervical, vulvar and vaginal cancers and genital warts.
Health officials estimate that more than 50 percent of sexually active women and men will be infected with one or more types of HPV in their lifetimes. Vaccine proponents say it could dramatically reduce the nearly 4,000 cervical cancer deaths in the United States each year.
The vaccine is considered most effective when given to girls before they become sexually active. About 7 percent of children have had sexual intercourse before age 13, and about a quarter of boys and girls have had sex by age 15, according to government surveys.
The committee's vote was unanimous, with two of the 15 members abstaining because of they have worked on Merck-funded studies.
The committee also voted to add the HPV vaccine to the coverage list for the federal Vaccines for Children program, which pays for immunizations for the poor. That could mean $50 million to $100 million in additional spending in the first year, government officials said.
Some health officials had girded themselves for arguments from religious conservatives and others that vaccinating youngsters against the sexually transmitted virus might make them more likely to have sex. But the controversy never materialized in the panel's public meetings.
Merck officials said that in the past 18 months they met with several conservative and religious groups to educate them about the vaccine and the illnesses it is designed to prevent.
Earlier this year, the Family Research Council, a conservative group, did not speak out against giving the HPV shot to young girls. The organization mainly opposes making it one of the vaccines required before youngsters can enroll in school, said the group's policy analyst, Moira Gaul.
Another organization, Colorado-based Focus on the Family, was even stronger in voicing fears that states would require schoolchildren to get HPV shots.
"By giving its highest level of recommendation, the panel has placed strong pressure on state governments to make HPV vaccinations mandatory," Linda Klepacki, a Focus on the Family analyst for sexual health, said in a statement.
"If that happens, state officials, not parents, would become the primary sexual-health decision makers for America's children. That's the way things are done in dictatorships, not democracies."
The government advisory panel did not recommend that the vaccine be required by schools, though some organizations including Planned Parenthood have advocated such a step.
Surveys suggest the shots will have little effect on youngsters' sexual behavior, said Nicole Liddon, a behavioral scientist with the Centers for Disease Control and Prevention. In a recent survey of virgins 15 to 19, only 10 percent of boys and 7 percent of girls cited fear of disease as a reason not to have sex, Liddon said.
The vaccine comes as a $360 series of three shots, and in tests has been highly effective against HPV. The vaccine is formulated to address the subtypes of HPV responsible for 70 percent of cervical cancer cases and 90 percent of genital warts.
In a public comment session at Thursday's meeting, all nine speakers supported recommending the vaccine to females 9 to 26, the broadest possible group under FDA license. The speakers included a state senator from Maryland and the chief medical officer of AmeriChoice, a UnitedHealth Group company that manages state Medicaid programs.
The panel focused on 11- to 12-year-olds in part because children that age already routinely get two other shots.
Several speakers also called for the immunization of boys, as soon as studies are completed on the vaccine's safety and effectiveness for males. HPV has been linked to penile, anal, and head and neck cancers and a tumor-like condition of the respiratory tract.
Merck officials said clinical effectiveness studies in males should be completed by 2008.
Merck officials also said they can provide the more than 19 million doses that health officials expect would be used in the next year.
Also on Thursday, the committee voted to recommend that children get two doses of the vaccine against chickenpox. The first dose would be given at 12 to 15 months of age, and the second at 4 to 6 years. The previous recommendation was for just one shot, but outbreaks have continued to occur among schoolchildren.
The committee also recommended a second dose for children and adults who have had only one shot.
Copyright 2006 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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