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Mike Ferrara
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Safety Questions Surround Merck’s Gardasil Expansion

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As Merck seeks FDA approval to expand the use of the HPV vaccine Gardasil in women ages 27-45 (so far it is approved only for use in females ages 9-26 to prevent HPV, and for use in males ages 9-26 to prevent genital warts), it’s important that anyone considering getting this vaccine or having a child vaccinated learn more about its history and is potential risks.

The FDA was uncharacteristically eager to approve and recommend Gardasil. Unlike other vaccines, which usually take three years to be FDA-approved after the conclusion of clinical testing, Gardasil sped through the system in a mere six months. With similar alacrity, only a few weeks after FDA approval, the CDC recommended Gardasil for universal use among girls and women 9-26. Typically, it takes vaccines from 5 to 10 years to achieve this kind of universal status.

Typically, the grace period between the time a vaccine enters the market and the time it is universally adopted allows for adverse reactions, side-effects and other problems to be found before they have an impact on a huge population. Gardasil has not had this grace period. As of June 1, 2009, 25 million doses of the vaccine had been distributed in the United States. There had also been 14,072 official reports of adverse events occurring after Gardasil vaccination in the United States. Ninety three percent were not serious, and ranged from arm pain to fainting, but seven percent were extremely serious, and included paralysis, blood clots, and more than 40 deaths (26 of which have been confirmed).

The worst reactions, as well as any and all long-term complications, may be still to come. Because the duration of Gardasil clinical trials was only five years, it is also not clear how long the vaccine offers protection against some strains of HPV. (It only offers 70% protection against HPV at full strength to begin with.) Some of Merck’s own clinical trials suggested that HPV protection wears off in some girls as early as three years after receiving Gardasil…which will probably translate into the need for girls and women to get booster shots every few years, ad infinitum.

The available information on this vaccine’s adverse effects strongly suggests that the FDA and CDC need to curb the use of Gardasil and re-evaluate its safety, both in the short term and in the long term. The last thing we need is an expansion of a potentially dangerous vaccine to an even larger population.