'Great Step Forward': Vaccine Against HPV-Related Cancers Approved for Those Up to Age 45

U.S. regulators have expanded the use of the HPV vaccine to include men and women between the ages of 27 and 45. This approval will help protect more people from several types of cancer caused by the human papillomavirus, known as HPV.

The U.S. Food and Drug Administration (FDA) on Friday broadened the approval of the vaccine, called Gardasil 9, which was previously approved for people ages 9 through 26. The vaccine, manufactured by Merck, is typically recommended to be given in two doses, several months apart, for those who are 9 through 14, and in three doses for those 15 through 26. For those older than 26, the recommended regimen will be three doses.

The HPV vaccine is important because it prevents infections that can cause cancer.

The U.S. Centers for Disease Control and Prevention (CDC) estimates about 14 million people become newly infected with HPV each year, mostly teens and young adults. About 12,000 women are diagnosed with — and about 4,000 women die from — cervical cancer caused by certain HPV viruses. Additionally, HPV viruses are associated with several other forms of cancer affecting men and women.

The broader age range of those who can receive the HPV vaccine is considered a major advancement in the fight against many types of cancers.

“This is a great step forward,” said Geoffrey Young, M.D., chief of head and neck surgery at Miami Cancer Institute. “Many adults have been exposed to some types of HPV. However, most have not been exposed to all nine types covered by the vaccine, some of which can cause cancer. I am 42 and I will be getting the vaccine now.”

Most sexually active individuals in the United States will become infected with HPV in their lifetimes, public health officials say. In most cases, the virus is cleared by the body’s immune system, but when that doesn’t occur, HPV infections can lead to cervical, anal, vaginal, penile and throat cancers.

About 70 percent of oropharyngeal cancers (cancers that form in the tissues of the throat) are caused by high-risk HPV infection, and the incidence of HPV-positive cancers has been increasing in the United States in recent decades. Each year, about 31,000 men and women in the U.S. are diagnosed with a cancer caused by an HPV infection.

Even though many adults have been exposed to some types of HPV, most have not been exposed to all nine strains covered by the vaccine.

“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,” says Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

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

The American Cancer Society (ACS) is bolstering a campaign to further educate primary care physicians and family doctors about the importance of informing parents that the HPV vaccine is about cancer prevention. There is much stigma attached to HPV, which is the most common sexually transmitted virus and infection in the U.S.

Dr. Young and Guilherme Rabinowits, M.D., a medical oncologist and hematologist at the Institute, attended an ACS conference in July. Physician attendants at the conference were informed that if the United States can reach an 80 percent vaccination rate by 2026, it’s very likely that the HPV virus could be eliminated by 2040 — much like vaccines against polio and smallpox virtually eliminated those two threats to the public health decades ago.