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Update on Vaccines in Dermatology – Part 1 Human Papillomavirus Vaccine

by Neal D. Bhatia, MD

The more recent availability of multiple vaccines has raised questions regarding the role of the dermatologist in recognizing potential candidates for vaccines and in making specific recommendations. This article addresses some general questions regarding vaccines and specifically focuses on questions related to the currently available human papillomavirus vaccine.

Should dermatologists vaccinate patients before starting biologics such as anti-TNF agents?
A recent publication discussed the use of vaccines in patients receiving biologic therapy and no definitive conclusion was reached to either support or refute the need to vaccinate these patients.[1] The panel stated that although there is little evidence proving that vaccination reduces severity of infections, this lack of evidence does not mean that the vaccination would not be effective. However, patients receiving anti-TNF therapy did demonstrate “adequate but reduced immune responses” to vaccination.[1]

Who should receive the varicella (chickenpox) vaccine?
The varicella vaccine is indicated in a patient who does not have a reliable history of having had varicella (chickenpox) or herpes zoster (shingles), especially if the patient: 1) is a healthcare worker, a teacher of young children, a day-care worker, a resident or staff member in an institutional setting, a college student, an inmate or staff member of a correctional institution, in the military, or if the individual travels internationally, 2) is a woman of childbearing age who is not pregnant, and 3) has only received one dose of varicella vaccine.[2]

The varicella vaccine is not indicated if the patient: 1) has a reliable history of having had chickenpox, 2) has had serologic testing, which confirms immunity to varicella, 3) has received two doses of varicella vaccine, 4) was born in the US before 1980, or 5) has a reliable history of herpes zoster.[2]

Who should receive the human papilloma virus (HPV) vaccine?
The ideal candidate for the HPV vaccine is a female 9 to 26 years of age who has not completed the HPV vaccine series.[2] In fact, women who are sexually active are candidates for this vaccination. Ideally, the vaccine should be administered before onset of sexual activity. However, females who are sexually active also may benefit from this vaccination. Females who have not been infected with any HPV type incorporated in the vaccine would receive the full benefit of vaccination.

Who should receive varicella zoster vaccine?
The Advisory Committee on Immunization Practices (ACIP) recommends a single dose of the varicella zoster (herpes zoster) vaccine for adults 60 years of age or older.2 Recommendations made by the ACIP will be reviewed by the Director of the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS). Recommendations become official when published in Morbidity and Mortality Weekly Report (MMWR).

What is the level of responsibility of the dermatologist regarding vaccines?
Dermatologists may play an active role in screening potential high-risk candidates as well as considering which patients would benefit most from vaccinations.[3] Some adults may not have been vaccinated as children, others may not have completed the series, and as patients are living longer their susceptibility for serious diseases becomes higher as their immunity becomes less effective. In 1987, Wheeler[3] discussed issues pertaining to the future of treating and preventing important viral diseases. In his article, he stated, “Because of latency and infectious recurrences, eradication of herpes simplex and herpes zoster from the world by vaccines is likely to be much more difficult to accomplish than eradication of smallpox. For some time, we may have to settle for control of these diseases rather than their eradication. Maybe passive immunization will have a place in future therapies, especially for serious herpes simplex virus infections in immunocompromised hosts.”[3]

What is the currently available HPV vaccine?
On June 8, 2006, the Food and Drug Administration (FDA) approved the first vaccine developed to prevent cervical cancer and other diseases in females caused by certain types of genital HPV—Gardasil® (Merck & Co., Whitehouse Station, New Jersey).[4] On June 29, 2006, the ACIP voted to recommend use of this vaccine in females ages 9 to 26 years. This prophylactic vaccine, made from noninfectious HPV-like particles (VLP), offers a promising new approach to the prevention of HPV and associated conditions. However, this vaccine is not intended to replace other prevention strategies since it will not work for all genital HPV types and may not be effective in preventing 100 percent of cases.

How is the HPV vaccine administered?
It is recommended that the HPV vaccine (Gardasil®) be delivered through a series of three intramuscular injections over a six-month period. The second and third doses should be given two and six months after the first dose.[4]

How much does the HPV vaccine cost?
The private sector list price of the HPV vaccine (Gardasil®) at the time this article was submitted for publication (April 2008) was $119.75 per dose (about $360 for a full series). The federal Vaccines for Children (VFC) Program will provide free vaccines to children and adolescents under 19 years of age who are either uninsured, Medicaid-eligible, American Indian, or Alaska Native. While some insurance companies may cover the vaccine and cost of administration, others may not. Most large-group-insurance plans usually cover the cost of recommended vaccines. However, there is often a lag time after a vaccine is recommended before it is available and covered by health plans. Some states also provide free or low-cost vaccines at public-health-department clinics to those without health-insurance coverage for vaccines.

Are Pap smears still recommended in females who have received HPV vaccine?
Yes. No vaccine is 100-percent effective. Additionally, the currently available HPV vaccine does not provide protection against the HPV types not incorporated in the vaccine or against existing HPV infections. Routine gynecologic examinations and Pap screening remains critically important to detect precancerous changes in the cervix to allow treatment before cervical cancer develops, even in females who have received the HPV vaccine.[5]

If a female already has cervical disease related to HPV types 6, 11, 16, or 18 will the HPV vaccine help treat it?
No, the HPV vaccine is only helpful in preventing cervical cancer, precancerous genital lesions, and genital warts due to HPV.[5]

Will HPV vaccine provide preventative protection in a female who has already been infected by an HPV included in the vaccine?
Based on clinical trial results, females with current or past infection with one or more vaccine-related HPV types prior to vaccination were protected from the diseases caused by the other remaining HPV types contained in the vaccine.[5]

Is it possible to become infected with HPV after receiving the currently available HPV vaccine
No. The current HPV vaccine is not a live virus vaccine; it does not contain the HPV virus and, therefore, cannot cause the HPV infection.[5]

Does the current HPV vaccine contain thimerosal?
No, the current HPV vaccine does not contain thimerosal or any other preservative.[5]

Can women over the age of 26 who are sexually active receive the HPV vaccine?
There is no apparent reason why women older than age 26 cannot receive the HPV vaccine.[5] However, it is possible that most insurers probably will not cover the cost of the vaccine in those outside of the FDA-specified age group.

Why isn’t HPV vaccine being used to treat cervical cancer?
Data evaluating the efficacy of the currently available HPV vaccine to treat cervical cancer suggests unimpressive results.[5] The role of HPV vaccine at the present time remains preventative. The duration of protection was at least five years in trial participants.[5]

What would be the point of administering HPV vaccine to a female who already exhibits clinical HPV infection?
If a physician can confirm that a female patient has contracted only HPV types 6 and 11, she could still receive protection through the HPV vaccine against HPV types 16 and 18, which cause cervical cancer.[5] The American Cancer Society predicts more than 11,000 women will be diagnosed with cervical cancer in the US this year and nearly 3,700 will die of the disease.

Who should a dermatologist contact with questions about vaccines?
The following resources are available regarding vaccines:
•  Hotline: (800) CDC-INFO
•  Email: nipinfo@cdc.gov
•  Website: www.cdc.gov/vaccines/
•  Broadcast updates and resources web page: www.cdc.gov/vaccines/ed/
broadcasts.htm.

References
1.        Lebwohl M, Bagel J, Gelfand JM, et al. From the Medical Board of the National Psoriasis Foundation: monitoring and vaccinations in patients treated with biologics for psoriasis. J Am Acad Dermatol. 2008;58(1):94–105.
2.        Centers for Disease Control and Prevention. Vaccines and immunizations. http://www.cdc.gov/vaccines/.
3.        Wheeler CE. Comments on vaccines, August 1987. J Am Acad Dermatol. 1988;18(1 Pt 2):232–234.
4.        Gardasil. http://www.gardasil.com/. Accessed April 22, 2008.
5.        Bates B. How to field patient questions about Gardasil and Zostavax. Internal Medicine News. 15 Dec 2007;40(24):24.

Acknowledgments
Stephen K. Tyring, MD, PhD, MBA, Clinical Professor of Dermatology/ Microbiology/Molecular Genetics and Internal Medicine, University of Texas Health Science Center, Houston, Texas and Henry W. Buck, MD, Clinical Associate Professor of Obstetrics and Gynecology, University of Kansas School of Medicine, Kansas City, Kansas; Head of Gynecology Emeritus, Watkins Memorial Student Health Service, University of Kansas, Lawrence, Kansas.

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