Dr. Peter Marks, FDA’s Center for Biologics Evaluation and Research director, said the approval is an acknowledgment to help prevent cancers and other HPV-related diseases in older adults.
According to the CDC, HPV vaccination can help prevent over 90 percent of the cancers associated with the STD. This translates to 31,200 cases each year from being developed. The CDC estimates that 14 million Americans are infected with HPV annually. 12,000 women with HPV develop cervical cancer, with about 4,000 of those women dying from that disease.
Both men and women can develop various types of cancer because of HPV.
The FDA first approved Gardasil in 2009 to stop certain HPV-cancers and disease, but is no longer being used in the U.S. The agency approved the use of Gardasil 9 in 2014, covering nine kinds of HPV and was initially approved for person nine to 26-years-old.
After studying a group of 3,200 women between 27 and 45 years of age, the agency noted Gardasil 9 was 88 percent effective in stopping the development of genital warts, vaginal precancerous lesions, cervical cancer, etc. The FDA said its approval of the drug for this age group is based on the study conducted.
The most common side effect of the Gardasil 9 drug is swelling and redness at the shot site and headaches.
Written by Mark Riegel, MD
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