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Cercical cancer vaccine, Gardasil. Is it safe to give to young girls?

richard

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Cercical cancer vaccine, Gardasil. Is it safe to give to young girls?
Posted: 28 Jun 06 10:32 AM

June 27, 2006

MERCK’S GARDASIL VACCINE NOT PROVEN SAFE FOR LITTLE GIRLS National Vaccine Information Center Criticizes FDA for Fast Tracking Licensure

Washington, D.C. – 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 http://www.fda.gov/ohrms/dockets/ac/cber01.htm#

Vaccines & Related Biological

For references and more information, go to www.nvic.org.

richard

55 posts

Re: Cercical cancer vaccine, Gardasil. Is it safe to give to young girls?
Posted: 17 Jun 07 9:22 AM

From The Sunday Times

June 17, 2007

Girls to get sex virus vaccine

Sarah-Kate Templeton, Health Correspondent

GIRLS aged 12 are to be vaccinated against a sexually transmitted virus that causes cervical cancer under plans to be approved this week by a government committee.

The Joint Committee on Vaccination and Immunisation is expected to recommend that all girls should be given the jab in the first year of secondary school to protect them against the human papilloma virus (HPV).

The committee, which comprises senior health specialists, is also expected to recommend a catchup campaign to vaccinate all girls aged 12-16.

The final decision about who will receive the vaccine, which costs more than £300 for a series of three doses, rests with the Department of Health. However, it is intended the programme should start in September 2008.

Ministers are known to be in favour although vaccinating girls against HPV will cost more than all the other childhood vaccinations put together. By comparison, the measles, mumps and rubella (MMR) vaccine costs about £12 for two doses.

The committee believes the expense is justified. The vaccine has been shown to be effective if it is administered before girls are sexually active. If all 12-year-olds were immunised, which would cost more than £100m a year, the committee believes death rates from cervical cancer could be slashed. The virus accounts for 70% of cases of the disease.

There may, however, be concerns among parents about children being overloaded with vaccinations. Children already receive at least seven jabs by the age of 12. As with the MMR vaccine, parents would be free to decide whether their children had the HPV jab.

In America, where the jab has been introduced in several states, there has also been criticism from religious groups that the vaccines can encourage girls to have unprotected sex and that it sends out confused messages about when it is right for girls to lose their virginity.

However, Dr Syed Ahmed, a committee member, said: “Surveys show the vast majority of parents are in favour of the vaccine. I don’t think girls are thinking about cancer when they decide whether or not to have sex. They are more concerned about becoming pregnant or catching chlamydia or gonorrhoea.”

The committee also says there is little evidence of any side effects, which are far outweighed by the benefits. Cervical cancer affects about 3,000 British women each year, some of whom can be in their twenties. About 1,000 women die from the disease every year.

Last week a report by the government’s Independent Advisory Group on Sexual Health and HIV gave a warning about the explosion of sexually transmitted diseases in young people.

The report warned that teenagers are having sex at a younger age and are having a higher number of partners.

And according to a study by the United Nations International Children’s Fund, more teenagers in Britain have had sex by the age of 15 than in any other European country. The figures showed 38% of children have had sex by 15 compared with 22% in France and 16% in Spain.

Germany, France, Italy, Austria, Luxembourg and Norway have all recommended that the HPV vaccine is given to girls and young women.

The Australian government has also recommended that all girls are vaccinated from the age of 12.

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