In June 2006, FDA approved Gardasil, the first vaccine for the prevention of Human papillomavirus (HPV) types 6, 11, 16 and 18-related cervical cancers, genital lesions, and warts.
The HPV 16 and 18 strains are responsible for 70 percent of cervical cancer cases.1 According CDC, the prevalence of HPV is approximately 20 million people in the U.S. with an incidence of 6.2 million Americans every year.
An estimated 80 percent of sexually active women will become infected with HPV during their lifetime.2
Pap smear testing for cervical cancer has significantly reduced mortality rates in the U.S. However, the evaluation of abnormal Pap tests, and the treatment of precancerous cervical intraepithelial neoplasia (CIN) lesions, cost an estimated $3.6 billion annually.3
While the vaccine does not eradicate the need for Pap smear screening, it does put into question how frequently and aggressively screenings must be done.
The introduction of the Gardasil vaccine has the potential to decrease mortality and morbidity rates globally and drastically reduce health expenditures related to HPV 6, 11, 16 and 18. The vaccine is manufactured by Merck Pharmaceuticals.
HPV's sensitive nature as a sexually transmitted infection creates barriers in the access and delivery of the vaccine. There is rising controversy as to whether implementing it would encourage sexual behavior. Other debates include recommended age for the vaccine, cost, and whether it should be required as a mandatory vaccine for school entrance. Understanding public attitudes towards HPV vaccine will prove helpful in enabling HPV vaccine introduction and acceptance.
Nurses as agents for change
Nurses have a powerful position from which to facilitate the use of and provide access to the HPV vaccine. The nursing role embodies a variety of functions including prevention, education, advocacy and collaboration.
Nurses are often the mediators between patients and the healthcare system. They can reinforce current scientific information about vaccines and clarify misunderstanding to the patient and/or family.
Nurses are tremendously resourceful because of their connections with allied healthcare teams. They can assess patient's needs and connect them to services and programs meeting those needs.
Lastly, by improving the acquisition and delivery of the HPV vaccine, nurses can decrease the global burden of cervical cancer and facilitate an improved healthcare system.
Evidence and Efficacy
Two Phase II and Two Phase III4 clinical trials confirmed the success of the HPV vaccine in concert with three other double blinded studies from Harper5 Koutsky6 and Mao7.
The clinical trials followed 20,541 women age 16-25 for 5 years. In all 4 trials no new HPV 16 or 18 related cervical precancerous lesions were found as compared to 53 in the placebo group. Only 1 new case of genital warts was found in the vaccine group compared with 91 in the placebo group yielding 99 percent efficacy.
Understanding this evidence, nurses can educate their patients and families on the safety and effectiveness of this vaccine.
Before vaccines can be disseminated in the United States, pharmaceutical companies such as Merck must file with the FDA for approval.
Once the FDA has approved the immunization Advisory Committee on Immunizations Practice (ACIP) determines guidelines for the routine administration of vaccines for pediatric and adult populations.
Professional organizations such as American College of Obstetricians and Gynecologists (ACOG) or American Cancer Society can choose to adopt ACIP's guidelines.
In addition, money or direct assistance from Vaccines for Children (VFC) and 317 programs are solicited. A successful immunization introduction requires all of these components.
ACIP currently recommends girls be vaccinated for HPV between 11-12 years (ACIP, 2006). The recommendation allows girls to be immunized starting at 9 years of age and as late as 26 years.8
In August 2006, ACOG released recommendations regarding the HPV vaccine adopting ACIP's counsel.9 More recently, VFC added HPV vaccine as one of the drugs provided to children who are enrolled in Medicaid or are uninsured.10