PANEL: HPV VACCINE FOR YOUNG GIRLS

ADVISORY COMMITTEE WANTS GIRLS AGE 11 AND UP
TO GET NEW CERVICAL CANCER VACCINE

By Todd Zwillich
WebMD Medical News
Reviewed By Louise Chang, MD
Thursday, June 29, 2006

Original Link

A government panel today recommended that girls as young as 11 routinely get a new vaccine against cervical cancer.

The Advisory Committee on Immunization Practices, which advises the government on vaccine policies, unanimously backed widespread use of the vaccine in preadolescent girls in hopes of protecting them before most become sexually active.

The vaccine, known as Gardasil, prevents infection with human papillomavirus (HPV), a sexually transmitted virus known to cause most cervical cancers and genital wartsgenital warts.

If the panel's recommendation is approved by the Bush administration, Gardasil would join vaccines against measles, whooping cough, chicken pox, and other diseases on the list of routine shots for all American children.

Such approval would also qualify Gardasil for inclusion in a federal program that provides free vaccines for low-income children.

"This is a huge breakthrough for women's health and for prevention and for cancer prevention," said Anne Schuchat, MD, director of the National Center for Infectious Diseases at the CDC.

The vaccine received the unanimous consent of an FDA panel earlier this month after the drug company Merck showed it was nearly 100% effective in preventing HPV infections.

Early Vaccinations

But the vaccine is only effective in preventing -- not treating -- HPV infections in women, which are highly common. Public health experts urged early vaccinations, before girls become sexually active, to maximize its benefits.

"It was important for the committee that their recommendations offer the vaccine before most girls would have the onset of sexual activity," Schuchat said. "To have the maximum preventative impact, the decision was to target 11- and 12-year-olds."

The committee said the vaccine could be safely given to girls as young as 9, at the discretion of parents and doctors.

Invasive cervical cancer is expected to be diagnosed in more than 9,700 American women this year, and to kill roughly 3,700, according to the American Cancer Society.

Today's recommendation met with praise from women's health groups.

But early vaccination troubles some conservative groups, who worry it might encourage girls to become sexually active.

Charmaine Yoest, a spokeswoman for the conservative Family Research Council, says the group "welcomes" today's vote. But she also says the group opposes putting Gardasil on the list of childhood vaccines required as a condition of attending school.

"This isn't something you get from a sneeze in a classroom, so there is no need to make it mandatory," she tells WebMD.

Pricing Worries

The vaccine contains four HPV subtypes. Two cause most cervical cancers; the other two cause most genital wartswarts. It's designed to be given in a series of three shots.

Multiple vaccine shots are not uncommon, but some health experts worry the vaccine's $120-per-shot cost could limit widespread access.

"Vaccine financing is an enormous issue," Schuchat said.

Inclusion on CDC's routine immunization schedule would qualify Gardasil for the federal Vaccines for Children Program, which provides free vaccines to youngsters who are uninsured or who are Medicaid recipients, Native Americans, or Alaska Natives.

Most, but not all, private insurance companies also use the CDC schedule to decide which vaccines they will cover.

Emily Stewart, a policy analyst with the Planned Parenthood Federation of American, praised the vaccine in a statement before the committee today. She called the panel's recommendation critical to guaranteeing coverage by insurance companies and the government.

"Access to the vaccine should be a public health priority," she said.

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MERCK'S GARDASIL VACCINE NOT PROVEN SAFE FOR LITTLE GIRLS

NATIONAL VACCINE INFORMATION CENTER CRITICIZES FDA
FOR FAST TRACKING LICENSURE

June 27, 2006
PRNewswire

Original Link

WASHINGTON - The National Vaccine Information Center (NVIC) is calling on the CDC's Advisory Committee on Immunization Practices (ACIP) to just say "no" on June 29 to recommending "universal use" of Merck's Gardasil vaccine in all pre-adolescent girls. NVIC maintains that Merck's clinical trials did not prove the human papillomavirus (HPV) vaccine designed to prevent cervical cancer and genital warts is safe to give to young girls.

"Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials," said NVIC president Barbara Loe Fisher. "Merck's pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls."

The FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for most trial participants, rather than a non-reactive saline solution placebo. A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo.

Animal and human studies have shown that aluminum adjuvants can cause brain cell death and that vaccine aluminum adjuvants can allow aluminum to enter the brain, as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue. Nearly 90 percent of all Gardasil recipients and 85 percent of aluminum placebo recipients reported one or more adverse events within 15 days of vaccination, particularly at the injection site. Pain and swelling at injection site and fever occurred in approximately 83 percent of Gardasil and 73 percent of aluminum placebo recipients. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.

"Merck and the FDA do not reveal in public documents exactly how many 9 to 15 year old girls were in the clinical trials, how many of them received hepatitis B vaccine and Gardasil simultaneously, and how many of them had serious adverse events after being injected with Gardasil or the aluminum placebo. For example, if there were fewer than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis."

According to the Merck product manufacturer insert, there was 1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis, and 1 case of reactive arthritis in 11,813 Gardasil recipients plus 1 case of lupus and 2 cases of arthritis out of 9,701 participants primarily receiving an aluminum containing placebo. Clinical trial investigators dismissed most of the 102 Gardasil and placebo associated serious adverse events, including 17 deaths, that occurred in the clinical trials as unrelated.

"There is too little long term safety and efficacy data, especially in young girls, and too little labeling information on contraindications for the CDC to recommend Gardasil for universal use, which is a signal for states to mandate it," said Fisher. "Nobody at Merck, the CDC or FDA know if the injection of Gardasil into all pre-teen girls -- especially simultaneously with hepatitis B vaccine -- will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults. With cervical cancer causing about one percent of all cancer deaths in American women due to routine pap screening, it was inappropriate for the FDA to fast track Gardasil. It is way too early to direct all young girls to get three doses of a vaccine that has not been proven safe or effective in their age group."

The National Vaccine Information Center (NVIC), founded in 1982 by parents of vaccine injured children, has been a leading critic of one-size-fits-all mass vaccination policies and the lack of basic science research into biological mechanisms and high risk factors for vaccine-induced brain and immune system dysfunction. As a member of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC), Barbara Loe Fisher urged trials include adequate safety data on pre-adolescent children and warned against fast tracking Gardasil at the November 28-29, 2001 VRBPAC meeting.

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