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Gardasil is a vaccine intended for girls and young women between the ages 9 to 26 to protect against human papillomavirus (HPV), a virus which is currently linked to an estimated 70% of known cervical cancer cases. Because Gardasil prevents only the onset of HPV infections (rather than curing those who have already been infected by HPV), health officials have advocated that girls be vaccinated for HPV prior to adolescence (or as soon as possible thereafter) in order to head off the occurrence of cervical cancer later in life. The message quoted above warns that the Centers for Disease Control (CDC) has already received nearly 12,000 complaints about adverse medical issues related to Gardasil vaccinations, and that 32 young women died after receiving Gardasil vaccinations. Although this information is accurate in a strictly literal sense, it is a misleading presentation of raw data that does not in itself establish a causal connection between Gardasil and the posited medical dangers. The CDC, in conjunction with the Food and Drug Administration (FDA), operates a program known as the Vaccine Adverse Event Reporting System (VAERS). The VAERS program collects and analyzes reports on adverse events following immunizations in order to help track the safety and efficacy of various vaccines. It is important to note that reports collected by VAERS are raw data; they do not in themselves establish causal connections between vaccines and adverse medical issues — such determinations cannot be made until the reports have been investigated, evaluated, and analyzed. (To illustrate this concept, we offer the following [admittedly far-fetched] scenario: A man who received a flu vaccination and then accidentally hit his hand with a hammer a few hours later might legitimately report that soon after he received the flu vaccine, his hand began to throb painfully. Although such a report would be literally true, it would not establish any causal connection between the flu vaccine and the adverse medical symptom of a throbbing, painful hand.) As the CDC stated in its 2009 article on Reports of Health Concerns Following HPV Vaccination, before the Gardasil HPV vaccine was licensed it was studied in five clinical trials involving over 21,000 girls and women of ages 9 through 26. Since that licensing the CDC and FDA have been closely monitoring the safety of the HPV vaccine and found that: From June 2006 to March 2013, approximately 57 million doses of HPV vaccines were distributed and VAERS received approximately 22,000 adverse event reports occurring in girls and women who received them. As noted in a 2013 CDC follow-up announcement, 92% of those reports were classified as non-serious, the other 8% generally encompassed symptoms such as headache, nausea, vomiting, fatigue, dizziness, syncope, and generalized weakness, and adverse events reported to VAERS were consistent with those identified during the vaccine's pre-licensure clinical trials. The CDC also noted that: As Matthew Herper wrote for Forbes about the reported deaths caused by Gardasil phenomenon: A couple of other pieces of anti-Gardasil misinformation have been widely circulated, such as the video featuring Jenny Thompson of Health Sciences Institute which is linked at the end of the warning reproduced at the head of this page: Likewise, another much-reproduced article claims that in 2009, Dr. Diane Harper (who is consistently misidentified as the lead researcher in the development of Gardasil and Cervarix) gave a talk at which she came clean and admitted that Gardasil and Cervarix don't work, are dangerous, and weren't tested. That article grossly misrepresents what Dr. Harper actually said. Dr. Harper has expressed concerns such as how long protection from vaccines such as Gardasil will last (which is not a safety issue, but rather an issue of whether the expected results of an HPV immunization program will justify the financial costs), and whether the marketing of Gardasil might lead some women to avoid taking other STD-preventing precautions, but she has never said that Gardasil doesn't work, wasn't tested, or was dangerous, as explained in great detail at the Skeptical Raptor blog: A 2009 CBS News interview with Dr. Harper is often cited as contradicting this assessment, but it does not: Dr. Harper did not state during that interview that Gardasil doesn't work, is dangerous, or wasn't tested. Given questions about how long the vaccine is effective for, she questioned the efficacy of giving shots to girls as young as 11 years old in parts of the world (such as the U.S.) where women regularly undergo safety Pap screening repeatedly over their lifetimes, saying that the chances of their contracting cervical cancer may be less than the small risks associated with the vaccine. But Dr. Harper also noted that the risks of death surrounding the administration of Gardasil were very rare, and that she agrees with Merck and the CDC that Gardasil is safe for most girls and women. Additional information: Frequently Asked Questions About HPV Vaccine Safety (CDC)
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