CDC Says Gardasil's Side Effects Minor, Additional Warning Labels Unnecessary

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Women's Health / Gynecology
Article Date: 26 Feb 2007 - 3:00 PST

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CDC officials on Thursday plan to present data at a meeting in Atlanta showing that 542 adverse health complaints have been reported about Merck's human papillomavirus vaccine Gardasil, but agency officials said the side effects of the vaccine are minor and that the vaccine does not require additional warning labels, the AP/Long Island Newsday reports (Stobbe, AP/Long Island Newsday, 2/21). Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. According to Merck, Gardasil is about 99% effective in preventing HPV strains 6 and 11, which together with strains 16 and 18 cause about 90% of genital wart cases. Gardasil also protects against vaginal and vulvar cancers, two other gynecological cancers that are linked to HPV, according to a study presented in June 2006 at a meeting of the American Society of Clinical Oncology in Atlanta. FDA in July 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine (Kaiser Daily Women's Health Policy Report, 1/19). According to the AP/Newsday, health officials estimate hundreds of thousands of women and girls have received at least one dose of the vaccine, but they do not have an exact count. According to CDC data, nearly 20% of the complaints about Gardasil involved soreness at the injection site and 9% involved fever or nausea. There were three cases of Guillain-Barre syndrome, which is a paralyzing side effect that has occurred with other vaccines. About 11% of the complaints involved fainting or dizziness. There have been no deaths or serious injuries resulting from fainting reported.

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Health experts said it is common for teenagers to faint from other vaccinations, and the number of fainting cases related to Gardasil is not higher than expected. "There is absolutely no reason to think that there is anything in this vaccine, as opposed to another vaccine, that's going to make people more likely to faint," John Iskander of CDC's immunization safety office said, adding that it is not "worrisome" to the agency that there is "any sort of association" between Gardasil and Guillain-Barre. Health officials have recommended that patients wait 15 minutes before leaving a physicians office after receiving Gardasil in case of fainting or other side effects. The National Vaccine Information Center on Wednesday issued a release about Gardasil's side effects that said there was not enough research on whether Gardasil could lead to problems when given with other vaccinations (AP/Long Island Newsday, 2/21).

Chicago Tribune Examines Whether Boys Should Receive HPV Vaccine
The Chicago Tribune on Tuesday examined whether boys also should receive a vaccine against HPV. Rick Haupt, executive director of medical affairs for Merck, said the company by 2008 hopes to have data on how the vaccine prevents HPV in men (Peres, Chicago Tribune, 2/20).


NBC's "Nightly News" on Wednesday reported on Merck's decision to suspend its campaign to lobby for state proposals that would mandate girls receive an HPV vaccine. The segment includes comments from Texas Rep. Jessica Farrar (D); Haupt; a man whose wife survived cervical cancer; and a parent who opposes the Texas executive order (Teague, "Nightly News," NBC, 2/21). In addition, "Nightly News" included a discussion with Nancy Snyderman, chief medical editor for NBC News, about the vaccine (Williams, "Nightly News," NBC, 2/21). Video of the segments is available online.

NPR's "Morning Edition" also reported on Merck's decision to suspend its lobbying campaign. The segment includes comments from Larry Gostin, an expert in public health law at Georgetown University, and Neal Halsey, a pediatrician and vaccine expert in the Department of International Health at the Bloomberg School of Public Health at Johns Hopkins University (Wilson, "Morning Edition," NPR, 2/22). Audio of the segment is available online.

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.