US FDA approves HPV vaccine for men and women aged 27-45
pharmafile | October 8, 2018 | News story | Sales and Marketing | CDC, Cancer, FDA, HPV, approval, infectious diseases, vaccines
The US Food and Drug Administration have approved the use of HPV vaccine Gardasil 9 for both men and woman between the ages of 27 and 45. Previously the vaccine had only been approved for those between the ages of 9 and 26.
“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing.”
An estimated 14 million Americans become infected with HPV each year, according to statistics released by the Center of Disease Control (CDC). Meanwhile 12,000 women are diagnosed with and 4,000 women die from cervical cancer connected to HPV.
The safety of Gardasil 9 was determined through clinical trials involving 13,000 men and women. The most common adverse reactions were site pain, swelling, redness and headaches.
Furthermore the vaccine was shown to be 88% effective in preventing persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine, in a study of 3,200 women aged between 27 and 45 years of age.
While previously patients may have had to pay for the vaccine upfront, the FDA approval should clear the way for insurance companies to cover the cost of the vaccine for men and woman between the ages of 27 and 45.
Dr. Charles Leath, a gynecologic oncology specialist at the University of Alabama at Birmingham. Commented: “We do have a group of individuals over the age of 26 who can certainly benefit from the protection this vaccine provides and have had to pay out of pocket for that protection”
Louis Goss
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