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FDA Approves Expanded Use of HPV Vaccine for People Up to Age 45

Penelitian - The U.S. Food and Drug Administration (FDA) approved on Friday an expanded use of the Human Papillomavirus (HPV) vaccine to include women and men aged 27 through 45 years.

The vaccine, called Gardasil 9, was previously approved for use for people aged nine through 26 years. It prevents certain cancers and diseases caused by nine HPV types that may lead to cervical, anal, vaginal, penile and throat cancers.

Penelitian FDA Approves Expanded Use of HPV Vaccine for People Up to Age 45

The expanded approval "represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a press release.

According to the U.S. Centers for Disease Control and Prevention (CDC), every year about 14 million Americans become infected with HPV; about 12,000 women are diagnosed with and about 4,000 women die from cervical cancer caused by certain HPV viruses.

"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," Marks said.

Gardasil 9 is most effective when administered before the initiation of sexual activity, but experts believe that it can also benefit the older group.

"Most individuals have been sexually active and exposed to HPV by their mid-20s," said Dr. Trey Leath, a gynecologic oncologist at the University of Alabama at Birmingham's Comprehensive Cancer Center.

"An individual may be exposed to one or two or three types of high-risk HPV, but not all the types," said Leath.

The safety of Gardasil 9 was evaluated in about a total of 13,000 males and females, the FDA said. The most commonly reported adverse reactions were injection site pain, swelling, redness and headaches.



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