Controversial Vaccine Defended by FDA

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Controversial Vaccine Defended by FDA

Special Report - August 25, 2009
A new government study found that the Gardasil vaccine—which helps to protect against genital warts and certain cancers that are caused by the Human Papilloma Virus (HPV)—results in higher, but expected, instances of fainting and blood clotting than similar vaccines. On August 20, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) released a statement, in conjunction with the results of the study, reiterating the government’s belief that the vaccine is “safe and effective and its benefits continue to outweigh its risks.” The study, published in the August 19th edition of the Journal of the American Medical Association, found adverse events including fainting, blood clotting, headache, nausea, and fever among vaccine recipients. However, the study also found that the rates for such events were not higher than expected once contributing “factors such as hormonal birth control, smoking, and obesity” are taken into account.

The FDA approved the Gardasil vaccine for females ages nine to 26 in June 2006. It protects against cervical, vulvar, and vaginal cancers and genital warts caused by four of the more than 100 different strains of the Human Papilloma Virus (HPV), which is the most common STD in the U.S. and is the leading cause of cervical cancer worldwide. HPV is transmitted almost exclusively through sexual activity, including skin-to-skin contact. The three-dose vaccination has been recommended for all girls ages 11 and 12, and for women through age 26 who did not receive any or all of the three doses. Nearly 4,000 of the 12,000 American women diagnosed with HPV every year will die of it. The FDA and CDC argue that the rate of adverse effects and the 32 deaths in the study did not reveal a pattern suggesting Gardasil was responsible for the complications or is dangerous in its currently approved use.

The statement concluded “Public health and safety are priorities for FDA and CDC. As with all licensed vaccines, we will continue to closely monitor the safety of Gardasil. FDA and CDC continue to find that Gardasil is a safe and effective vaccine that will potentially benefit the health of millions of women by providing protection against the types of HPV in the vaccine that cause cervical, vulvar and vaginal cancer, genital warts, and other HPV-related genital diseases in females.”

The North Carolina General Assembly recently amended the state’s sex education curriculum for 7-9th graders to “include information about the effects of contracting the Human Papilloma Virus, including sterility and cervical cancer.” Bill Brooks, president of the North Carolina Family Policy Council, applauded that requirement to provide accurate medical information to students about the consequences of sexual activity outside of marriage, but warned that “sex education that focuses on risk-reduction mechanisms like condoms and vaccines does not address the underlying cause of the spread of STDs, such as HPV. The best way to prevent HPV and other infectious diseases is to have honest conversations with our children encouraging them to reach the reasonable conclusion that it is wisest to delay sexual activity until marriage.”