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The FDA approved Gardasil 9 as a preventive measure against cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58, and to prevent genital warts caused by HPV types 6 or 11.
In December 2014, the Food and Drug Administration approved Merck’s Gardasil 9, a vaccine for the prevention of diseases caused by nine types of human papillomavirus (HPV).
During a presentation on new drugs and concepts at the MauiDerm 2015 conference in Hawaii, Ted Rosen, M.D., professor of dermatology at the Baylor College of Medicine and chief of dermatology at the Houston VA Medical Center, discussed Gardasil 9, which is approved for use in females ages 9 through 26 and males 9 through 15. The FDA approved the vaccine as a preventive measure against cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58, and to prevent genital warts caused by HPV types 6 or 11. It is recommended that Gardasil 9 be administered as three separate shots, with the initial injection being followed by shots two and six months later. According to the FDA, Gardasil 9 has the potential to prevent approximately 90% of cervical, vulvar, vaginal, and anal cancers.
Inevitably, the controversy that has surrounded its predecessor, Gardasil, spread to the new vaccine. “It’s a brand new vaccine which has brought out the ‘best’ in people,” Dr. Rosen told his audience with a touch of irony. “Now there’s a whole new set on the Internet of anti-HPV vaccine propaganda.” The negative focus of some websites has been on deaths that are anecdotally associated with the vaccine.
In e-mailed comments for this story, citing statistics from the CDC web site (cdc.gov), Dr. Rosen set the record straight about the Gardasil recipients who died. In the clinical studies overall, 10 deaths occurred, five each among recipients of Gardasil 9 and Gardasil. None were found to be vaccine-related. In the Gardasil 9 group, one person died in a car crash, one was a suicide, one succumbed to acute lymphocytic leukemia, and one to hypovolemic septic shock. The fifth death was sudden and unexplained death, but occurred nearly two years after the recipient had received Gardasil 9. In the Gardasil control group, one recipient died in a car crash, one in a plane crash, one from cerebral hemorrhage, one from a gunshot wound, and one from stomach adenocarcinoma.
“But even if all the deaths were related to the vaccine, the death rate would be 0.13 percent,” he says. “The general death rate in the U.S. population is 0.8 percent.”
Some opponents of the vaccine complain that the FDA approved Gardasil 9 without having it assessed by the Vaccines and Related Biological Products Advisory Committee.
“If this is true, then it would have been approved based on the fact that it used the precise same technology in an already rigorously tested and studied vaccine, but just added some extra antigens,” Dr. Rosen tells Dermatology Times. “This is not uncommon. I don’t find it a justifiable gripe.”
Indeed, Dr. Rosen says he knows of no legitimate studies that have found Gardasil to be unsafe or even ineffective.
“The only well-documented problem is syncope,” he says. “For that reason, vaccine recipients are asked to remain in the office for half an hour to an hour after administration. To the best of my knowledge, there is no meaningful data to suggest any long-term ill effects.”
Dr. Rosen is a strong advocate of both Gardasil versions-“All three of my daughters have received the Gardasil vaccine, I recommend it to all patients who have not been vaccinated who fall in the appropriate age range, and I will now recommend Gardasil 9, since the spectrum of coverage is even better.”
For the foreseeable future, and in the face of the anti-vaccine contingent, it appears that Gardasil and Gardasil 9 will be the gold standard for combating HPV-related diseases. Dr. Rosen says he knows of nothing in the development pipeline.
Given the availability of information available to anyone online, it’s likely physicians will face questions from patients who want protection against HPV-related diseases but are concerned about what they might have found when they Googled Gardasil. Dr. Rosen suggests the following strategy to physicians seeking to allay concerns: Direct people to the CDC website, where they can review for themselves the safety data on this vaccine.
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Reference for background on the approval of Gardasil 9: