Public Health Feature - April 2007
ByErin Prather Stafford
Gov. Rick Perry ignited a firestorm of criticism and set up a potential showdown with the Texas Legislature over the extent of his authority in February when he issued an executive order to mandate the human papillomavirus (HPV) vaccine for all girls entering sixth grade in 2008. He also sent health care officials scrambling to assess the mandate's impact.
Despite the criticism from lawmakers and others, the governor stood by his decision to require the vaccine to prevent cervical cancer.
"While I understand the concerns expressed by some," he said, "I stand firmly on the side of protecting life. The HPV vaccine does not promote sex, it protects women's health. In the past, young women who have abstained from sex until marriage have contracted HPV from their husbands and faced the difficult task of defeating cervical cancer. This vaccine prevents that from happening."
The governor is correct in his assessment that cervical cancer is a preventable killer. The Texas Cancer Registry report, Cervical Cancer in Texas, 2006 , says that while cervical cancer is one of the most preventable and detectable cancers through regular screenings, an estimated 1,168 Texas women would likely be diagnosed with the disease and 390 would die from it in 2006.
Moreover, being diagnosed or dying from cervical cancer varied among Texas women by race and ethnicity. From 1999 to 2003, both Hispanic and African-American women had higher cervical cancer incidence and mortality rates than those of white women. A study by the Centers for Disease Control and Prevention found that Hispanic women, particularly those who live in counties along the United States-Mexico border, are less likely than white women to receive routine screenings for cervical cancer.
These statistics are why the HPV vaccine is needed to save Texas women's lives, says Dallas pediatrician Molly Droge, MD, a member of the Texas Medical Association Council on Public Health.
She quickly dismisses critics' claims that the vaccine would encourage young girls to become sexually active. On the contrary, she says, physicians now have a way to broach the topic of sexual health with young patients and their parents.
"Giving young girls this vaccine does not encourage or give them permission to become sexually active. Rather, it gives physicians and parents the opportunity to talk to them about the risks of becoming sexually active early on," she said.
Dr. Droge acknowledges some drawbacks, the first being that the vaccine has only been on the market since June. Long-term effects are unknown, and it hasn't been determined if boosters will be needed to keep young girls and women immunized against the virus. Yet she quickly points out these are inherent risks with any new vaccine on the market.
The Mandate Difference
TMA has received calls from physicians concerned over the governor's order.
TMA President Ladon W. Homer, MD, explains that the association strongly supports physicians' ability to provide the HPV vaccine, but does not, at this point, support the mandate. TMA's position was developed by the Council on Public Health.
"Mandating a vaccine for a disease not spread by casual and/or occupational contact - and currently only available to one gender - represents a considerable departure from past practice concerning school immunization requirements. School immunization requirements came into existence to protect schoolchildren from outbreaks of contagious disease in the school setting, not to compel vaccination," he said.
And, he said, a provision allowing parents to opt out of the HPV vaccine requirement may have the unintended effect of reducing immunization rates for other vaccine-preventable diseases.
Dr. Homer went on to address physicians' concerns about the cost of the HPV vaccine. Much more expensive than any vaccine series now required, the $360 to $450 projected cost does not account for added expenses such as storage, insurance, occasional loss and expired doses, nonpayment, and labor. He also says the time until payment is received in the physician's office can be 30 to 45 days under the best of circumstances, which, along with the need to carry inventory, puts the office at significant financial risk.
Commented Dr. Droge, "To be able to provide this expensive vaccine in our offices, physicians and clinics must be reimbursed by payers for the total costs involved, including purchase costs, storage, handling, reminder/recall, and practice costs, as well as vaccine administration fees. Inadequate vaccine reimbursement is a serious issue. Even the initial investment required to purchase HPV vaccine is prohibitive for many practices. Payers may not adequately reimburse physicians for new vaccines sometimes up to a year or more, even though the vaccines are recommended by the Advisory Committee on Immunization Practices. The mandate has actually given physicians an opportunity to bring reimbursement concerns to the forefront and discuss how to correct the system."
In February, Teresa Devine, director of TMA's Payment Advocacy Department, began surveying insurance companies to determine their HPV reimbursement policy. At press time, Aetna, Unicare, and Blue Cross and Blue Shield of Texas said they are covering the cost of the vaccine, plus a fee for administering the vaccine.
The governor's mandate ordered the Department of State Health Services to make the HPV vaccine available through the Texas Vaccines for Children Program for eligible females up to age 18. Additionally, the Health and Human Services Commission will need to make the vaccine available to Medicaid-eligible females aged 19 to 21.
Dr. Homer concluded by saying TMA prefers that any vaccine mandate for school entry be vetted through the legislative and regulatory process to ensure stakeholder input from all interested parties.
HPV Vaccine and Cervical Cancer
On June 8, 2006, the U.S. Food and Drug Administration licensed the first vaccine developed to prevent cervical cancer and other diseases in women caused by certain types of genital human papillomavirus (HPV). The quadrivalent vaccine, Gardasil, protects against four HPV types (6, 11, 16, 18), which are responsible for 70 percent of cervical cancers and 90 percent of genital warts.
On June 29, 2006, the Advisory Committee on Immunization Practices (ACIP) voted to recommend use of this vaccine in females aged 9 to 26 years.
ACIP has assembled the following information on HPV and the vaccine for physicians.
Provisional HPV Vaccine Recommendations
The HPV vaccine is recommended for girls aged 11 to 12 years, but can be administered to girls as young as 9 years. It also is recommended for females aged 13 to 26 years who have not yet received or completed the vaccine series.
Ideally, the vaccine should be administered before the onset of sexual activity. However, females who are sexually active also may benefit from vaccination. Females who have not been infected with any HPV type in the vaccine would receive the full benefit of vaccination. Females already infected with one or more HPV type would still get protection from the HPV types they have not acquired. Few young women are infected with all four HPV types in the vaccine.
Currently, no test is available for clinical use to determine whether a female has had any or all of the four HPV types in the vaccine.
HPV Vaccine Safety
- The HPV vaccine has been tested in more than 11,000 females (aged 9-26 years) in many countries, including the United States.
- These studies found that the HPV vaccine is safe and causes no serious side effects. Adverse events were mainly injection site pain. This reaction was common but mild.
- A detailed and coordinated postlicensure safety monitoring plan is in place.
- There is no thimerosal or mercury in the vaccine.
HPV Vaccine Efficacy
- The efficacy of this vaccine has mainly been studied in young women (aged 16-26 years) previously not exposed to any of the four HPV types in the vaccine. These clinical trials have demonstrated 100 percent efficacy in preventing cervical pre-cancers caused by the targeted HPV types and nearly 100 percent efficacy in preventing vulvar and vaginal pre-cancers and genital warts caused by the targeted HPV types.
- The vaccine has no therapeutic effect on HPV-related disease. If a girl or woman is already infected with one of the HPV types in the vaccine, the vaccine will not prevent disease from that type.
- The ACIP recommendation for vaccine use in girls as young as 9 years is based on "bridging" immunogenicity and safety studies, which were conducted in about 1,100 females aged 9 to 15 years. These studies demonstrated that more than 99 percent of study participants developed antibodies after vaccination; titers were higher for young girls than for older females participating in the efficacy trials.
- While it is possible that vaccination of males with the quadrivalent vaccine may offer direct health benefits to males and indirect health benefits to females, there are currently no efficacy data available to support the use of HPV vaccine in males. Efficacy studies in males are ongoing.
Duration of Vaccine Protection
The duration of vaccine protection is unclear. Current studies (with five-year follow-up) indicate that the vaccine is effective for at least five years. There is no evidence of waning immunity during that time period. This information will be updated as additional data regarding duration of immunity become available.
HPV Vaccine Delivery (Provisional Recommendations)
- The vaccine should be delivered through a series of three intramuscular injections over six months. The second and third doses should be given two and six months after the first dose.
- The vaccine can be administered at the same visit as other age-appropriate vaccines, such as Tdap, Td, MCV4, and hepatitis B vaccines.
- The HPV vaccine can be given to females who have an equivocal or abnormal Pap test, a positive Hybrid Capture II high-risk test, or genital warts. However, women should be advised that data do not indicate the vaccine will have any therapeutic effect on existing Pap test abnormalities, HPV infection, or genital warts.
- Lactating women can receive the HPV vaccine.
- Immunocompromised females, either from disease or medication, can receive this vaccine; however, the immune response to vaccination and vaccine efficacy might be less than in immunocompetent females.
- The HPV vaccine is not recommended for use in pregnancy. The vaccine has not been causally associated with adverse outcomes of pregnancy or adverse events to the developing fetus. However, data on vaccination in pregnancy are limited. Any exposure to vaccine in pregnancy should be reported to the vaccine pregnancy registry at (800) 986-8999.
- The HPV vaccine is contraindicated for persons with a history of immediate hypersensitivity to yeast or to any vaccine component.
- The HPV vaccine can be administered to people with minor acute illnesses (e.g., diarrhea or mild upper respiratory tract infections, with or without fever). Vaccination of people with moderate or severe acute illnesses should be deferred until after the illness improves.
- Cervical cancer screening recommendations haven't changed for females who receive the vaccine.
- Vaccine providers should notify vaccinated women that they should continue to receive regular cervical cancer screening for three reasons. First, the vaccine will not provide protection against all types of HPV that cause cervical cancer. Second, women may not receive the full benefits of the vaccine if they do not complete the vaccine series. Third, women may not receive the full benefits of the vaccine if they receive the vaccine after they have already acquired a vaccine HPV type.
- Vaccine providers should notify vaccinated women that they should continue to practice protective sex behaviors (e.g., abstinence, monogamy, limiting the number of sex partners, and using condoms, which may have a protective effect on HPV acquisition, reduce the risk for HPV-associated diseases, and mitigate the adverse consequences of HPV infection) because the vaccine will not prevent all cases of genital warts, nor will it prevent other sexually transmitted infections.
Content provided by the Division of STD Prevention, part of Centers for Disease Control and Prevention. Information can be found online at www.cdc.gov/std/HPV/STDFact-HPV-vaccine-hcp.htm.
Survey Shows HPV Education Needed
In January, TMA's Physician Oncology Education Program surveyed Texas primary care physicians about human papillomavirus (HPV) vaccines. Approximately 484 responded to the Web-based survey (mean age 45 years, 56 percent male, 67 percent white, 12 percent Latino). The findings of this survey generally were consistent with other national physician surveys on this same subject.
The Texas study found that:
- Virtually all physicians (99%) were aware of HPV vaccines, but knowledge about HPV and HPV vaccines was not optimal; thus, educational initiatives for physicians are needed.
- Only 27 percent of respondents knew the lifetime risk of genital HPV infection among U.S. residents, and 45 percent knew what percentage of cervical cancer is caused by HPV.
- Almost 20 percent said they had not seen enough data to know whether the vaccine was safe, and 12 percent had not seen enough data to know if it was efficacious.
- Fifty-eight percent said more information about HPV vaccines would be helpful.
- Most physicians intended to recommend HPV vaccines within the next 12 months to girls in their practice. However, intention was lower for 11- to 12-year-olds compared with older girls; this is important in that national guidelines recommend targeting vaccination to the younger age group.
- Sixty-six percent intended to recommend HPV vaccines to 11- to 12-year-olds, 88 percent to 13- to 17-year-olds, and 85 percent to 18- to 26-year-olds.
Physicians believed that HPV vaccination would lead to important benefits, including patient awareness and education.
Ninety-eight percent believed vaccination would prevent most cases of cervical cancer, 98 percent that it would increase patient awareness of sexually transmitted infections, 90 percent that it would give them an opportunity to educate their patients about sexuality, 88 percent that it would prevent most cases of genital warts, and 85 percent that it would be cost effective.
Physicians reported a number of potential barriers to HPV vaccination, primarily related to insurance coverage, vaccine administration, and parental concerns.
The main barriers included an initial lack of insurance coverage (97 percent), lack of parental understanding of HPV (94 percent), difficulty getting children this age in the office for three immunizations (82 percent), and parental concern that vaccination could lead to riskier adolescent behaviors (70 percent).
Strategies physicians believed were important included insurance coverage (99 percent), affordability for those without insurance coverage (97 percent), coverage by the Vaccines for Children Program (93 percent), and mandates for school enrollment (62 percent).
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