FDA approves Gardasil 9

New vaccine protects against five more HPV types

Since 2006, when FDA approved the first vaccine for the prevention of certain strains of human papillomavirus (HPV), CDC’s Advisory Committee on Immunization Practices (ACIP) has recommended Gardasil (Merck) for routine vaccination of adolescent girls and boys aged 11–12 years in three doses. FDA-approved Cervarix (GlaxoSmithKline) is a similar vaccine recommended for girls this age as well.

Now a third vaccine has been approved by FDA. Gardasil 9 (Merck) protects against five more HPV types—31, 33, 45, 52, and 58—than Gardasil. According to FDA, it has the potential to prevent approximately 90% of cervical, vaginal, and anal cancers, and is approved for use in females aged 9–26 years and males aged 9–15 years.

“It really shores up our cancer protection side and bumps up cervical cancer coverage from 70[%] to 90%, which is good,” Jeff Goad, PharmD, MPH, FAPhA, FCPhA, FCSHP, Professor and Chair in the Department of Pharmacy Practice at Chapman University, told Pharmacy Today.

Gardasil 9 will be available in February, and ACIP is expected to release recommendations after its meeting at the end of February.

Increasing HPV vaccination rates

Besides a modest increase in 2013, HPV vaccination coverage rates in boys and girls—particularly completion rates—have remained low, according to results from CDC’s 2013 National Immunization Survey for teens (NIS-Teen).

“It will be interesting to see if there’s an increase in vaccination rates with the new Gardasil,” Dennis Stanley, BSPharm, Pharmacy Wellness Manager at Martin’s Food Market Pharmacy in Richmond, VA, told Pharmacy Today.

Virginia is 1 of 46 states that allow pharmacists to administer the HPV vaccine, although reimbursement challenges in all states prevent some pharmacies from stocking and offering the vaccine.

Stanley said he will typically administer the vaccine to young women aged 20–25 years who no longer see their pediatrician. In other cases, he occasionally administers follow-up of the second and third doses after the patient’s pediatrician administers the first dose.

“I think pediatricians have been good at recommending the vaccine. The issue is with the completion rates,” said Stanley.

He said having a working relationship with pediatricians is important. In Stanley’s case, local pediatricians oftentimes recommend that their patients go to their pharmacy if they can’t follow up on doses at the pediatrician’s office.

Strong recommendation for HPV vaccine needed

The NIS-Teen found that the percentage of parents who reported receiving a recommendation for HPV vaccine increased in 2013; but on the other hand, approximately one-third of parents of girls and more than one-half of parents of boys said that their child’s clinician did not recommend the HPV vaccination.

“Experts in HPV vaccination coverage believe that it is the lack of a strong recommendation from a health care provider that is a major contributor to the low HPV immunization rates among adolescents,” Mary Hayney, PharmD, MPH, BCPS, Professor in the School of Pharmacy at the University of Wisconsin–Madison, told Pharmacy Today.

The HPV vaccine has been notoriously hard for parents and teens to get on board with, in large part because HPV is transmitted sexually.

“When the public or legislatures hear ‘sexually transmitted,’ the walls go up and they are not hearing the protective side of the vaccine,” said Goad.

He said studies have shown that when a provider gives what is called a strong recommendation—“I recommend strongly that you get this vaccine”—it can carry a lot of weight.

“Even if they can’t give the vaccine in their state, pharmacists should give the strong recommendation,” said Goad.

He urges pharmacists to continue talking to patients and their parents about the vaccine.

“Pharmacists everywhere can participate in advocacy and identifying adolescents that are behind and haven’t been immunized,” said Goad.

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