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See Latest ArticlesCDC, FDA Study Reinforces Safety, Efficacy of Gardasil. Agencies Found Vast Majority of Adverse Events Not Serious
American Family Physician, 09/04/09
Mitchell D – After a joint review of more than 12,000 adverse events reported after administration of quadrivalent human papillomavirus, or HPV, vaccine, FDA and CDC researchers concluded the vaccine "continues to be safe and effective, and its benefits continue to outweigh the risks." The vaccine, which is manufactured by Merck & Co. Inc. and sold as Gardasil, is recommended for teens ages 11–18 and young women ages 19–26. Since its licensure in 2006, more than 23 million doses of Gardasil had been administered as of Dec. 31, 2008. After reviewing all 12,424 reports of adverse events after HPV immunization made to the joint CDC–FDA Vaccine Adverse Events Reporting system from June 2006 through December 2008, researchers from the two agencies reported that, generally, adverse event rates were similar to what is seen in safety reviews of other vaccines. However, they did acknowledge the presence of "disproportional reporting" of syncope (8.2 per 100,000 doses) and blood clots (0.2 per 100,000), compared with that seen with administration of other vaccines. The vast majority of adverse events reported after vaccine administration (94 percent) were not classified as serious. The most common events reported were syncope, pain and redness at the injection site, dizziness, nausea, and headache. The researchers reiterated the need for physicians to observe the recommended 15–minute postvaccination waiting period. Of the more than 1,800 reports of fainting immediately following vaccination, 293 instances resulted in falls, of which 200 resulted in head injuries.
Today in Preventive Medicine...keeping you current
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