A commentary from: Lani Wheeler, MD, FAAP, FASHA Partially reprinted with permission from School Health Professional May 25, 2007.

 In recent months there has been much debate over requiring the new HPV vaccine (GARDASIL ™) for public school attendance. In one state the Governor issued an executive order requiring all girls entering the 6th grade to receive the vaccination prior to attending school. Texas Governor Rick Perry’s order was issued in February 2007 and was intended to be enforced by 2009.  However, on May 9, Perry’s order was overturned after a State House Bill was passed into law overriding his executive order. In other states, including New Hampshire and New Mexico, state legislators are actively debating whether to impose legislation requiring girls to be vaccinated as part of the required vaccination schedule for schools. The debate over mandating the HPV vaccine is complex. However, most health professionals believe that vaccination is certainly the best prevention against HPV infections that could potentially lead to cervical cancer. In addition, it is important to note that the CDC recommends that the vaccine be given to girls 11-12 years of age before they become sexually active (thus making the vaccine more effective).  Why should HPV Vaccine be considered for a school mandate?School mandates improve immunization coverage rates.  They can help to ensure payment by private health insurers when mandated vaccines are added to the insurers’ list of covered vaccines.  Mandating the vaccine is likely to protect many high risk girls from HPV infections and cervical cancer.  What other issues should be considered before establishing school mandates?

• A vaccine should have a substantial safety and efficacy track record before it is mandated for school.  HPV vaccine was licensed in June 2006.
• It is important to ensure an adequate supply, reimbursement and insurance coverage, (Vaccines for Children — VFC and private insurance), before such a mandate is established.  Some private payers do not cover the cost of the vaccine ($360.00 per series) leaving some families responsible for the total cost.  Free vaccine must be available for these students to prevent exclusion from school.  Adequate reimbursement must be available so that pediatricians can recoup the cost and administrative fees of the vaccine.  Adequate VFC supply and public health infrastructure (ie school nurses, immunization clinics, etc) must be available to ensure that a safety net is available for students unable to access vaccine privately as well as to monitor compliance rates to avoid excluding thousands of girls from schools.  Recent experience in Maryland with Hep B and varicella mandates indicates that jurisdictions with lower income populations are disproportionately affected by exclusion. 
• Public and physician acceptance of a vaccine should be established prior to mandating a vaccine.  Adequate time for consumer education must be allowed to ensure such acceptance.   There is debate in the public and physician sectors regarding mandating a vaccine for a disease that is not typically transmitted among youth in the school setting.  The advantages and disadvantages of an opt-out provision for parents who “philosophically object” to the vaccine needs more discussion.
• Additional recommendations may be announced soon due to the development of another slightly different vaccine and the investigation of vaccines in males.

What are the Recommendations of the Advisory Committee on Immunization Practices (ACIP)? The vaccine is administered by intramuscular injection, and the recommended schedule is a 3-dose series with the second and third doses administered 2 and 6 months after the first dose. The recommended age for vaccination of females is 11–12 years.  The vaccine can be administered as young as age 9 years. Catch-up vaccination is recommended for females aged 13–26 years who have not been previously vaccinated. Vaccination is not a substitute for routine cervical cancer screening, and vaccinated females should have cervical cancer screening as recommended.

What do school health pediatricians recommend?The American Academy of Pediatrics supports the ACIP recommendations however, the AAP does not make national recommendations about any school vaccine mandates.  HPV should be included in routine adolescent health visits that are encouraged for all young adolescents.  School health pediatricians are not unanimous on the school mandate issue but most recommend addressing the above issues before issuing school mandates.   The Association of Immunization Managers developed a position statement that addresses many of these same concerns.

What is HPV?  Genital HPV is the most common sexually transmitted infection in the United States; an estimated 6.2 million persons are newly infected every year. Although the majority of infections cause no clinical symptoms and are self-limited, persistent infection with oncogenic types can cause cervical cancer in women. In most people, HPV goes away on its own without any treatment and does not cause health problems.  Experts do not know why HPV goes away in some cases, but not in others.  HPV infection also is the cause of genital warts and is associated with other anogenital cancers. Cervical cancer rates have decreased in the United States because of widespread use of Papanicolaou testing, which can detect precancerous lesions of the cervix before they develop into cancer; nevertheless, during 2007, an estimated 11,100 new cases will be diagnosed and approximately 3,700 women will die from cervical cancer. In certain countries where cervical cancer screening is not routine, cervical cancer is a common cancer in women.  What is the vaccine?  How well does it work?The licensed HPV vaccine (GARDASIL^TM) is composed of the HPV L1 protein, the major capsid protein of HPV. Expression of the L1 protein in yeast using recombinant DNA technology produces noninfectious virus-like particles (VLP) that resemble HPV virions. The quadrivalent HPV vaccine is a mixture of four HPV type-specific VLPs prepared from the L1 proteins of HPV 6, 11, 16, and 18 combined with an aluminum adjuvant. Clinical trials indicate that the vaccine has high efficacy in preventing persistent HPV infection, cervical cancer precursor lesions, vaginal and vulvar cancer precursor lesions, and genital warts caused by HPV types 6, 11, 16, or 18 among females who have not already been infected with the respective HPV type. No evidence exists of protection against disease caused by HPV types with which females are infected at the time of vaccination. However, females infected with one or more vaccine HPV types before vaccination would be protected against disease caused by the other vaccine HPV types.   For more information:HPV Vaccine Questions and Answers from the U.S. Centers for Disease Control and Prevention (CDC) .Human Papillomavirus (HPV) Infection from CDC .AAP HPV Policy Statement .

CDC’s National Center for Immunization and Respiratory Diseases Q & A.

 HPV and cervical cancer, the HPV vaccine, vaccine and implementation costs, and public acceptability – a background brief from the Kaiser Family Foundation.Q and A about the safety of Gardsil from CDC .

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This entry was posted on Tuesday, December 4th, 2007 at 12:46 pm and is filed under Health Conditions & Issues, Nursing & Medical Issues, Teaching About Health & Safety. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.