The U.S. Food and Drug Administration announced today that it has approved Gardasil, a vaccine that prevents infection by some strains of the human papillomavirus, which can cause cervical cancer if left untreated.
"It marks a very important step forward in women's health," said Dr. John O. Agwunobi, the assistant secretary for health at the Department of Health and Human Services.
"It will be the first vaccine licensed by the FDA that can prevent a cancer that kills a large number of women each year," said Dr. Michael Keefer, an associate professor in the infectious disease division at the University of Rochester School of Medicine in New York. "If that's not a breakthrough, I don't know what is."
Gardasil is made by Merck & Co. Inc., a global pharmaceutical company. It's a series of 3 shots given over six months.
There are about 100 strains of human papillomaviruses, which can cause warts on different parts of the body. At least 30 strains are sexually transmitted, and about 10 of those can also cause cellular abnormalities that lead to cervical cancer, according to the Centers for Disease Control and Prevention.
Gardasil will protect against at least four of the 10 known cancer-causing strains, Merck said. About 270,000 women worldwide die from cervical cancer each year; about 4,000 die in the United States.
"The potential for vaccines, including Gardasil, to wipe out the major cause of death from cancer for women in the developing world ranks this as one of the most significant moments in the history of cancer treatment," said Dr. Joanna Cain, the director at the Center for Women's Health at the Oregon Health and Science University.
HPV is the most common sexually transmitted infection in the United States, with about 20 million people currently estimated to have it, according to the National Institute of Allergy and Infectious Diseases.
More than half of sexually active men will become infected with HPV at some point in their lives, and by age 50, as many as 80 percent of women will have had HPV, according to the CDC.
If left untreated, the virus can invade the cervical cells of the uterus and cause cancer. This is especially problematic in areas where women don't have access to the current treatments, such as cryotherapy, which removes abnormal cervical cells.
Now that the FDA has approved Gardasil, the next step "is the critical meeting of the CDC's Advisory Committee (ACIP), where they come out with recommendations about how the vaccine should be used," Dr. Tim Johnson, ABC News' medical editor, said today on "Good Morning America."
Which is more complex than it sounds: Even though many doctors support this new vaccine, it carries some controversy. For it to be effective, it needs to be given before a person becomes sexually active.
That means preteens would be the ideal candidates for the vaccine.
"There is a great debate because medically speaking, it is clear it would best be given to very young girls before they become sexually active, even if they intend to be abstinent," Johnson said.
The ACIP will make a recommendation for the age requirement of Gardasil after the FDA licenses the vaccine for certain age groups.
"The state decides whether it should be a school entry law, [so] these laws will vary state to state," said Curtis Allen, spokesperson for the CDC.
The recommendations of the ACIP are important since doctors practicing in the U.S. should follow them.