The FDA has agreed to put Merck’s application for expanded approval of Gardasil, a cervical cancer vaccine, on the fast track. It is already approved for women and girls ages 9 through 26, and the expansion would allow it for use in women ages 27 through 45.
The FDA’s decision has disturbed many people who are concerned over the high number of side effects reported in relationship to Gardasil. A 2007 analysis revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil.
Gardasil side effect reports include blood clots, miscarriages, paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures. Despite this, Merck continues to market Gardasil as virtually side-effect free, and the FDA has thus far refused to conduct a formal safety review of Gardasil.