Closer Look: Targeting a new population for HPV vaccine

Oct. 06--About one in four people are infected with the human papillomavirus in the United States. While not every HPV infection will result in cancer, the Centers for Disease Control and Prevention estimates that HPV results in 33,700 cases of cancer each year in the country.

Of those cancers, 31,200 can be prevented with an HPV vaccination.

Despite that and even after more than 10 years since the vaccine's inception, HPV vaccination rates among adolescents and teenagers are much lower compared to whooping cough and bacterial meningitis vaccinations. In many states, vaccination rates among youths for HPV is almost 30 or more percentage points lower than those for whooping cough and meningitis.

As this generation of children grow older and begin aging out of the recommended HPV vaccination age range of 21 for men and 26 for women and gay men, Merck & Co., the maker of HPV vaccine Gardasil, is looking at targeting a new population.

In June, the U.S. Food and Drug Administration granted a priority review of Merck's request to expand the use of Gardasil to women and men ages 27 to 45. The FDA will take action on that review Saturday.

Merck argues that while there is no proof Gardasil can protect against diseases from an HPV type that a person has already been exposed to, its 9-valent vaccine does protect against nine HPV types that most commonly result in cancers, and therefore could help a broader group of people.

"Women and men ages 27 to 45 continue to be at risk for acquiring HPV, which can lead to cervical cancer and certain other HPV-related cancers and diseases," Dr. Alain Luxembourg, director of clinical research at Merck Research Laboratories, said in June. "We look forward to working with the FDA on the review of this application for Gardasil 9, which, if approved, would enable more people to have access to the vaccine."

Rates

While Merck seeks to expand the age range of potential customers, health officials still encourage parents and guardians to get children vaccinated before they become sexually active.

In analyzing data from the 2017 National Immunization Survey-Teen for 20,949 adolescents aged 13 to 17 in 2017, the CDC estimates that about 65.5 percent of adolescents have had at least one dose of an HPV vaccine (the vaccine requires either two or three doses, depending on the product and the youth), while most youths have started a meningococcal conjugate vaccine for meningitis (85.1 percent) and had a Tdap vaccine for whopping cough/tetanus (88.7 percent).

In Pennsylvania, the disparity is a little larger than the national average. About 67.3 percent of teens in the state have started an HPV vaccine schedule, compared to 90.6 percent who have received a Tdap vaccine and 93.4 percent who received a meningococcal vaccine.

Pennsylvania's HPV vaccination rate is helped by Philadelphia, where 84.9 percent of teens have started an HPV vaccine schedule. The rest of the state has a vaccination rate of 65 percent.

Most other states are like Pennsylvania, though some have HPV vaccination rates of less than 60 percent: Utah (58.8 percent), Kansas (52.4 percent), Texas (57.8 percent), Oklahoma (58.5 percent), Indiana (59.3 percent), Tennessee (56.1 percent), Mississippi (49.6 percent), Kentucky (49.6 percent) and Wyoming (46.9 percent).

The highest rates of HPV vaccination are largely in the Northeast, save for New York and New Jersey: Virginia (75.6 percent), Delaware (75.3 percent), Rhode Island (88.6 percent), Vermont (78.7 percent), New Hampshire (74.2 percent), Massachusetts (81.9 percent), Maine (75.8 percent) and Connecticut (71.3 percent).

Washington, D.C., had the highest rate at 91.9 percent of vaccinated teens, which is higher than the vaccination rates for Tdap (86.1 percent) and meningococcal (91.3 percent).

Some of the states that had low HPV vaccination rates also had low vaccination rates in general, including Missouri for all three vaccines and Mississippi and Wyoming low on meningococcal vaccine.

Vaccination rates are also lower in rural areas than they are in urban areas, according to the CDC. The number of adolescents who started an HPV vaccine was about 11 percent lower in rural areas than then number of youths in urban areas.

Despite the lower numbers in much of the country, health officials are encouraged that the vaccination rate has been increasing about 5 percent each year over the last five years.

"While we understand it can be a challenge for some clinicians in rural areas to stock all recommended vaccines, these clinicians can still play a critical role in their patients' health and protect them from serious diseases by referring them to other vaccine providers," said Dr. Nancy Messonnier, director of CDC's National Center for Immunization and Respiratory Diseases.

Challenges

Getting more children vaccinated can be difficult given the sexual nature of the diseases that result from HPV infections -- and the ensuing discussion parents and doctors could have with the child, who could be as young as 9 when the vaccine schedule starts.

The HPV vaccine has also been attacked by those who oppose other vaccines, using the argument that the vaccine can cause infertility.

The CDC argues that isn't the case.

The CDC said on its website that "there is no evidence to suggest that HPV vaccine causes fertility problems." It added that not getting the vaccine could leave people, especially women, vulnerable to HPV-associated cancers that can cause infertility, or could result in infertility due to chemotherapy treatment or hysterectomy.

The side effects associated with HPV vaccines include dizziness, and Merck said a side effect can be syncope, or a brief loss of consciousness. The CDC said fainting is more common among adolescents, which is why they recommend those who get the vaccine sit or lie down for about 15 minutes after the shot to prevent fainting or fall injuries.

Other side effects can be pain, redness or swelling in the arm/injection site, as well as nausea or a headache.

"The benefits of HPV vaccination far outweigh any potential risk of side effects," the CDC said on its website.

"This vaccine is the best way to protect our youth from developing cancers caused by HPV infection," CDC Director Dr. Robert Redfield said. "Vaccination is the key to cervical cancer elimination. I'm pleased to see parents are taking advantage of this crucial public health tool and thank the clinicians who are working to ensure all children are protected from these cancers in the future."

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