FDA Pressured to Consider Expanding HPV Vaccines to “Older” Women

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North Hollywood, CA, October 11, 2010 — Merck Pharmaceutical Co. will attempt to gain approval to expand the market for Gardasil before the end of the year, after three previous rejections by the FDA.  Currently the vaccine is approved for use for adolescent girl’s ages 9 to 26. Merck proposes to extend the market to women ages 27 to 55.

S.A.N.E Vax.org is concerned that extending the market for vaccination before independent studies on the safety and efficacy of Gardasil is dangerous – and not in women’s best interest.  First, whether or not the vaccine will actually affect cervical cancer rates will not be known for 20 years.  Secondly, the true number of adverse reactions and deaths have not yet even been tallied and accounted for – and this should be unacceptable to the FDA and the American public.

Another concern is that the older women get – and the more sexually active they become, their chances of being exposed to the Human Papillomavirus increase.  It is already documented in the May 2006 FDA VRBPAC reports that if a woman is exposed to HPV and receives the vaccine her chances of getting cervical cancer increase by 44.6% after inoculation with Gardasil and 32.5% after Cervarix.  Why should older women play Russian roulette with their gynecological health?

Even though incidences of cervical cancer do not occur in most women until their 40’s and 50’s – the persistent infection leading to the cancerous cells is already present and done damage to a woman’s health.  Only annual Pap screening will determine cellular changes and that has been and always will be a sufficient tool to for cervical cancer prevention.

The demographics of women currently being inoculated with Gardasil and the proposed older market also needs to be taken into consideration.

Ages 9 to 26: Girls in puberty, menarche and in their teen years are at the most fragile times of their lives.  Their endocrine systems are developing and they are very susceptible to external influences like a vaccination with histamine such as Gardasil. Many of the girls who have been adversely injured from the vaccines have had a prior history of allergies – acerbated by the yeast in the vaccine and auto-immune diseases – (histamine influencing the immune system to attack itself.)  Irregular hormone fluctuations during this time also add to the mix – since it is documented that immunity is lower during the paramenstrum.

Ages 27 to 55: Not only do women in this age group also run the risk of prior exposure to HPV, use of birth control pills and other hormonal influences found to increase cervical cancer rates. In addition, the older a woman gets, the more run down her immune and endocrine systems become due to external influences and lack of nutrition.  Women in their 40’s and 50’s are also subject peri-menopause and menopause and erratic and irregular hormone cycles – placing them in the same fragile category as girls entering menarche.

S.AN.E. Vax is demanding that independent studies on the safety and efficacy of the HPV vaccines be conducted prior to approval for expanded use. Those studies need to include – women of all ages and risk groups.

If that is done – and if those independents studies conclude without a doubt that HPV vaccines pose no risk to women’s health – only then should the FDA grant approval for expanding the HPV vaccine market.

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