Experts: Promotion of HPV vaccination must focus on cancer prevention

Issue: July 25, 2016

In December 2014, the FDA approved a next-generation HPV vaccine that protects against nine HPV types among females aged 9 through 26 years and males aged 9 through 15 years.

Earlier this year, the CDC’s Advisory Committee on Immunization Practices recommended a 9-valent HPV vaccine (Gardasil 9, Merck) as one of the three HPV vaccines that may be used for routine vaccination.

William Schaffner

This next-generation vaccine has been shown to protect against four HPV types the quadrivalent vaccine is designed to prevent — HPV 6, 11, 16 and 18 — plus five other types not targeted by the quadrivalent vaccine: HPV 31, 33, 45, 52 and 58.

“New data have emerged suggesting that the next generation of the vaccine protects against nine different kinds of HPV and, therefore, prevents even more of the cancers that we are concerned about. If this vaccine could be better, it has now been made better,” William Schaffner, MD, infectious disease specialist and professor of preventive medicine at Vanderbilt University, told HemOnc Today.

Data from clinical trials have demonstrated the safety and efficacy of all three HPV vaccines, according to Schaffner, yet HPV vaccination rates remain lower in the United States compared with other areas of the world.

“There are other countries — such as Australia, for example — where they have achieved vaccination rates of over 90%,” Schaffner said. “We need to do better here in the United States. We should be promoting this vaccine for cancer prevention. It is safe and effective.”

The basics

HPV infection is known to cause genital warts, as well as cervical, vaginal, vulvar, penile, anal and oropharyngeal cancers. Nearly 80 million people are infected with HPV in the United States, and approximately 14 million people — including adolescents — become newly infected with the virus annually, according to CDC statistics.

The CDC recommends that all children receive the three-dose HPV vaccine starting at age 11. The American Academy of Pediatrics, American Academy of Family Physicians and American College of Obstetricians and Gynecologists, along with many other professional organizations, support the CDC’s recommendation.

All three doses of the vaccine are important as the trials that led to its approval used three doses. However, a two-dose series is currently being investigated, and it is possible that two doses may be enough.

“The HPV vaccine is a splendidly effective and safe anticancer vaccine. People have been discussing the HPV vaccine for years and have wanted an anticancer vaccine,” Schaffner said. “We now have an anticancer vaccine that appears to be wonderfully effective and extraordinarily safe. I am more than enthusiastic about this vaccine because it can prevent so much devastating illness down the road. The HPV vaccine is a 21st century vaccine that we should all be excited about and support universal use.”

Uptake low among males

Despite data that supports the safety and efficacy of the three currently approved HPV vaccines, vaccine uptake remains low, particularly among males.

One reason for low uptake among boys is because the vaccine was first only licensed and recommended for use in girls. The vaccine became known as the cervical cancer vaccine, which is limited in scope.

HPV vaccination among boys is really just getting going because the vaccine is relatively newer for boys, according to Mark H. Einstein, MD, MS, professor in the department of obstetrics and gynecology and women’s health and the department of epidemiology and population health at Albert Einstein College of Medicine.

“Quite frankly, most of the disease still rests in women, particularly the cervical part of the disease,” Einstein told HemOnc Today. “The trend in the delayed approval in boys was because the FDA wanted to see a trial showing that the vaccine works well in boys, which has been provided and the data suggest the vaccine works extremely well in boys, in fact, similarly as well as it works in girls. I think this delay has now started to sift down to the education of pediatricians and adolescent gynecologists who are now doing more vaccinations for boys.”

Vaccine stigma

The HPV vaccine has been stigmatized, as the focus appears to remain on the fact HPV is transmitted sexually rather than the cancers the vaccine prevents.

“HPV vaccine uptake is very much lower than we would like, and this is frankly in agony,” Schaffner said. “Parents have thought about this vaccine in terms of sexual transmission, which bothers parents because they see very young children being vaccinated. But it is important to remember that the reasons for initiating the vaccine series at such a young age is to do so before the adolescent becomes exposed to the virus, which is the way we do it with every vaccine.”

Moreover, research indicates that the immune response to the HPV vaccine has been well demonstrated to be the most robust when administered at a young age and the longest duration of protection is anticipated.

“Those who say [the HPV vaccine] may be good for some children but not their child because they are not sexually active have lost the point,” Schaffner said. “This vaccine is cancer protection. Immunologically it is the best time to provide it at a young age and it is safe.”

Einstein agreed that vaccination prior to exposure to HPV is the purpose of vaccination ̶ to prevent.

“The idea is to vaccinate both boys and girls before the onset of sexual activity as the HPV virus is most commonly transmitted via skin to skin contact — usually by sexual contact,” Einstein said. “When patients are vaccinated prior to exposure to HPV, [the vaccine] works incredibly well. We have not seen breakthrough lesions, which is why we continue to not have to recommend a booster dose even 10 years after the earliest cohorts have been tracked.”

Provider hesitancy and school mandates

Another reason why HPV vaccine uptake is so low has to do with the fact that some pediatricians and family doctors are “gun shy” when it comes to discussing HPV vaccination during routine office visits, Schaffner said.

“Physicians discuss other vaccines when children come in for an office visit, but only mention considering the HPV vaccine to parents. Physicians are not including the HPV vaccine in the discussion because they are weary about what they may get in terms of a response from parents,” Schaffner said. “Now, I will say that that there has been a great deal of education of parents and there is less intense concern from parents about this vaccine. So it really defines the current issue of low vaccine uptake as provider hesitancy. If physicians were forthright about the vaccine and included it in the middle of the list of other vaccines that are to be given, things move along the way they are supposed to. The focus should be on the disease that is being prevented, not how it is acquired. If we can get over provider hesitancy, then we can get the vaccine to everyone who needs it, because who would not want to prevent cancer?”

Although HPV vaccination is routinely recommended, it is not currently mandated for school vaccinations across the majority of U.S. states, except for Virginia and Washington D.C.

“However, these mandates include an ‘opt-out’ clause,” Einstein said. “So, this is a complicated issue, but with more education, it will be overcome.”

The American Cancer Society recently organized the National HPV Vaccination Roundtable — comprised of various scientific organizations as well as patient advocacy groups and health care insurers — with the purpose of increasing HPV vaccination rates in the United States through strategic planning and advocacy efforts.

“All of these organizations are coming together to figure out a way to overcome some of the very low HPV vaccine uptake that we see in this country as compared with other high income areas of the world,” Einstein said. “Many of us in the field have recognized that these vaccines work and they work much better than what people have anticipated that they were going to work. HPV vaccines are highly effective in neutralizing antibody responses across men, women and all walks of life and medical comorbidities. As a physician who takes care of a lot of women who suffer from cervical cancer, I look forward to the day that I am not seeing another human being suffer from this disease that is largely preventable. HPV is a virus that we can live without.” – by Jennifer Southall

For more information:

Mark H. Einstein, MD, MS, can be reached at Albert Einstein College of Medicine, 1695 Eastchester Road, Suite 601, Bronx, NY 10461; email: mark.einstein@einstein.yu.edu.

William Schaffner, MD, can be reached at Vanderbilt University, 2201 West End Ave., Nashville, TN 37235; email: william.schaffner@vanderbilt.edu.

Disclosure: Einstein and Schaffner report no relevant financial disclosures.