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Human Papillomavirus (HPV) Vaccine

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Vaccine Safety Monitoring and Human Papillomavirus Vaccination

July 28, 2008 -- Human Papillomavirus (HPV) vaccine safety has recently been mentioned in both the national and state news. Please refer to the Centers for Disease Control and Prevention (CDC) website at: www.cdc.gov/vaccines/vpd-vac/hpv/default.htm for additional information about the vaccine and the disease. The Department of Health, Bureau of Immunization provides the following summary points:

Human Papillomavirus (HPV) Vaccination

  • The CDC continues to recommend HPV vaccination because of its importance for the health of women. The CDC maintains this is a safe and effective vaccine. However, as with all vaccines, we will continue to review the safety of this vaccine and take appropriate action if there are issues with the vaccine. The risk of any vaccine causing serious harm, or death, is extremely small.
  • Parents and providers are encouraged to report any adverse events to the Vaccine Adverse Event Reporting System (VAERS) vaers.hhs.gov (phone 1-800-822-7967).
  • Parents are encouraged to discuss HPV vaccination with their pre-teen’s doctor. The routine recommendation is to administer HPV vaccine at 11 and 12 years of age.
  • The recommendation allows for vaccination to begin at nine years of age.
  • Vaccination also is recommended for females 13 through 26 years of age who have not been previously vaccinated or who have not completed the full series of shots.
  • Syncope, or fainting, is a common event occurring with needle injections and vaccinations, especially in adolescents. CDC recommends that patients who receive HPV vaccine remain in the clinic for 15 minutes after vaccination to avoid potential injury from a fall.

HPV Disease

  • HPV is a common virus. It is the major cause of cervical cancer in women.
  • HPV infection usually occurs in people in their teens and early 20s.
  • There are about 20 million people currently infected with HPV.
  • Each year in the U.S., about 11,000 women will be diagnosed with cervical cancer, and 3,600 will die.
  • Women have an 80 percent chance of developing HPV by the time they are 50.
  • Because the vaccine is a preventative and not a cure, it is important that the vaccine be given prior to beginning sexual activity.

HPV disease and vaccine information is available at: www.cdc.gov/vaccines/vpd-vac/hpv/#disease, www.cdc.gov/cancer/cervical/basic_info, and www.cdc.gov/std/hpv/default.htm.

HPV Vaccine in the United States

  • On June 8, 2006, the Food and Drug Administration (FDA) licensed the first vaccine (Gardasil®), developed to prevent cervical cancer and other diseases in females caused by certain types of genital human papillomavirus (HPV). The quadrivalent vaccine, Gardasil®, protects against four HPV types (6, 11, 16, and 18), which are responsible for 70 percent of cervical cancers and 90 percent of genital warts. See the FDA HPV fact sheet at: http://www.fda.gov/womens/getthefacts/pdfs/hpv.pdf.
  • On June 29, 2006, the Advisory Committee on Immunization Practices (ACIP) voted to recommend routine vaccination of females 11 and 12 years of age. Gardasil was tested in over 11,000 females (9 through 26 years of age) in many countries around the world, including the U.S. These studies found that the HPV vaccine was safe and caused no serious side effects. Adverse events were mainly injection site pain. This reaction was common but mild.
  • Since licensure, more than 12 million doses of Gardasil® vaccine have been distributed in the U.S. In 2006, a total of 2,151,000 doses were distributed, and in 2007, another 11,317,902. At this time, the U.S. does not have a national registry for immunization and vaccination, and therefore cannot report the total number of people who have received Gardasil.
  • The number of serious adverse events reported to VAERS following HPV vaccine is less than seven percent of the total number of reports received. In comparison, the overall average in VAERS for any serious adverse event ranges from 10 to 15 percent; thus, the percentage of serious reports for Gardasil® is less than the overall average.

Vaccine Safety Monitoring: Vaccine Adverse Event Reporting System

VAERS is part of a larger system that helps to ensure vaccines are safe and work as intended. VAERS is managed by the CDC and the FDA. To ensure vaccines are safe, vaccines are developed in accordance with the highest standards of safety. The FDA requires extensive safety testing before a vaccine is licensed and distributed to the public. After licensing, VAERS is used to continually monitor vaccines for safety and efficacy.

VAERS receives reports of many events that occur after immunization. Some of these events may occur coincidentally following vaccination, while others may truly be caused by vaccination. It is important to remember that many adverse events reported to VAERS may not be caused by vaccines. More indepth studies are usually required to investigate the association between a vaccine and an adverse event. Since 1990, most of the reported adverse events describe mild side effects, such as fever and rash. Through continued monitoring, VAERS helps to ensure that the benefits of vaccines are far greater than the risks. More information about VAERS can be found at http://www.cdc.gov/vaccinesafety/vaers.

Centers for Disease Control and Prevention (CDC) Human Papillomavirus (HPV) Publications

Information for the Public:

Information for Clinicians:

HPV Links

Centers for Disease Control and Prevention (CDC)
HPV Vaccine - Questions & Answers:
http://www.cdc.gov/vaccines/vpd-vac/hpv/vac-faqs.htm
Human Papillomavirus (HPV) Infection: http://www.cdc.gov/std/hpv/default.htm
HPV Vaccine Questions and Answers: http://www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm
Fast facts that address statements made in a press release by the National Vaccine Information Center on 08/15/07 regarding Gardasil and Guillain-Barre Syndrome (GBS): http://www.cdc.gov/vaccines/vpd-vac/hpv/downloads/hpv-gardasil-gbs.pdf [PDF 47 KB]

U.S. Food and Drug Administration
Product Approval Information - Licensing Action: GARDASIL® Questions and Answers: http://www.fda.gov/cber/products/hpvmer060806qa.htm

American Cancer Society
Frequently Asked Questions About Human Papilloma Virus (HPV) Vaccines: http://www.cancer.org/docroot/CRI/content/CRI_2_6x_FAQ_HPV_Vaccines.asp

National Cancer Institute
HPV (Human Papillomavirus) Vaccines for Cervical Cancer: http://www.cancer.gov/cancertopics/hpv-vaccines
Human Papillomaviruses and Cancer: Questions and Answers: http://www.cancer.gov/cancertopics/factsheet/Risk/HPV

National Cervical Cancer Coalition
NCCC Section on the HPV Vaccine: http://www.nccc-online.org/hpv-vaccine.php

Cancer Research and Prevention Foundation
Make the Commitment: http://www.makethecommitment.org/default.asp

American Social Health Association
National HPV & Cervical Cancer Prevention Resource Center: http://www.ashastd.org/hpv/hpv_overview.cfm?gclid=CKDqvbzZsIoCFQo3gQodHFo_qw

The Henry J. Kaiser Family Foundations
Daily Women's Health Policy - National Politics & Policy | CDC Panel Recommends HPV Vaccine Gardasil for All Girls Ages 11, 12, Recommends Coverage by Federal Program: http://www.kaisernetwork.org/Daily_reports/rep_index.cfm?DR_ID=38231

Merck: Gardasil.com

HPV News Archive

Quadrivalent Human Papillomavirus Vaccine Recommendations

The Bureau of Immunization is pleased to announce the release of the Morbidity and Mortality Weekly Report (MMWR) March 12, 2007, Volume 56, Early Release titled- Quadrivalent Human Papillomavirus Vaccine, Recommendations of the Advisory Committee on Immunization Practices (ACIP).

These recommendations represent the first statement by the Advisory Committee on Immunization Practices (ACIP) on the use of a quadrivalent human papillomavirus (HPV) vaccine licensed by the U.S. Food and Drug Administration on June 8, 2006. This report summarizes the epidemiology of HPV and associated diseases, describes the licensed HPV vaccine, and provides recommendations for its use for vaccination among females aged 9-26 years in the United States.

In June 2006, the quadrivalent HPV vaccine types 6, 11, 16, 18, under the trade name GARDASIL® (manufactured by Merck and Co.), was licensed for use among females aged 9-26 years for prevention of HPV-type-related cervical cancer, cervical cancer precursors, vaginal and vulvar cancer precursors, and anogenital warts. 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. 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.

Please note: The information detailed in the HPV Vaccine Update correspondence dated February 16, 2007, regarding provision of HPV vaccine to VFC-eligible females by County Health Departments, is still effective.

Update to the Advisory Committee On Immunization Practices (ACIP) recommendations regarding HPV vaccine that were distributed on December 1, 2006: As recommended by the ACIP, the bureau encourages all providers to routinely target HPV vaccine to all 11- and 12-year old females. HPV vaccine should also be made available to all other eligible females.

The MMWR can be viewed online at:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr56e312a1.htm

Update on Vaccines for Children (VFC) Human Papillomavirus (HPV) Vaccine Availability

The Bureau of Immunization is providing this important update to the Advisory Committee On Immunization Practices (ACIP) recommendations regarding HPV vaccine that were distributed on December 1, 2006.

As recommended by the ACIP, the bureau encourages county health departments to target HPV vaccine to all 11- and 12-year old females. However, state-supplied HPV vaccine should also be made available to VFC-eligible females age 9-18 who request the vaccine. Note: in those instances where insurance does not cover the HPV vaccine, children can obtain VFC vaccine free of charge at Federally Qualified Health Centers (FQHCs). As we monitor early vaccine uptake and inventory, providers may receive fewer doses than ordered.

Call the VFC Manager if you have questions regarding the VFC vaccine supply, and the Executive Community Health Nursing Director for questions regarding the vaccine recommendations at 850-245-4342.

Revised HPV Vaccine Information Statement (VIS)

The revised human papillomavirus (HPV) Vaccine Information Statement (VIS) dated 2/2/07 has been released. On February 2, the Centers for Disease Control and Prevention (CDC) made a minor change to the interim VIS for HPV vaccine. Section 3 of the HPV VIS has been revised. Specifically, the VIS clarifies that the routine 3-dose schedule also applies to catch-up immunizations. The updated VIS is now available. Existing stocks of the previous (9/5/06) version may still be used. To access a ready-to-print (PDF) version of the updated (2/2/07) interim VIS, go to the CDC website at: http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-hpv.pdf [PDF 46 KB] or the IAC website at: http://www.immunize.org/vis/hpv.pdf [PDF 48 KB]. Please widely distribute this VIS and vaccine information to colleagues, members, coalitions, and partners with an interest in the supply, distribution, management, and administration of human papillomavirus vaccine, and place this information on your website.

Please call the Bureau of Immunization if you have questions regarding the HPV VIS statement at 850-245-4342.

Provisional Recommendations for use of quadrivalent human papillomavirus (HPV) vaccine

The Bureau of Immunization is pleased to announce the release of the Provisional Recommendations for use of quadrivalent human papillomavirus (HPV) vaccine by the Centers for Disease Control and Prevention (CDC) and the National Immunization Program (NIP). Please ensure that the Advisory Committee on Immunization Practices (ACIP) provisional recommendations are shared with colleagues, members, coalitions, and partners with an interest in the prevention of HPV infection and administration of HPV vaccine. The recommendations may be viewed at: http://www.cdc.gov/.

The Advisory Committee on Immunization Practices issued provisional recommendations that this vaccine be routinely administered to girls aged 11-12 years and used for catch-up immunization in females aged 13-26 years. Gardasil™, manufactured by Merck, is the first HPV vaccine approved by FDA to prevent cervical cancer. Gardasil is licensed as a 3-dose series, with dose number two given two months after dose number one, and dose number three given four months after dose number two. The minimum interval between doses number one and two is four weeks, and between doses number two and three is 12 weeks. The vaccine should be administered intramuscular (IM) in the deltoid. For more information on the use of HPV vaccine, see the recommendations.

Clinicians should be prepared to discuss prevention of HPV infection with their adolescent patients. The interim HPV Vaccine Information Statement (VIS) dated 9/5/06 is attached and is found at: http://www.cdc.gov/vaccines/pubs/vis/default.htm.
VISs are information sheets produced by the Centers for Disease Control and Prevention (CDC) that explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Federal law requires that VISs be handed out (before each dose) whenever certain vaccinations are given.

ACIP recommendations do not become official until they are published in CDC's Morbidity and Mortality Weekly Report (MMWR), which is expected to occur later this year. While no MMWR has been issued as yet, providers can begin using HPV vaccine with the provisional ACIP recommendation. Providers should also observe indications and contraindications, as listed in the manufacturer's package insert.

Important VFC Information

Florida's Vaccines for Children (VFC) Program will provide HPV vaccine effective December 4, 2006. Due to limited vaccine supply, VFC HPV vaccine is presently available only to Florida VFC-eligible female clients who are 11-12 years of age. At this time, there are no federal or state funds available to provide HPV vaccine to non-VFC-eligible clients who do not meet these criteria. Please note: Vaccine supply is based on product availability. This may result in CHDs receiving fewer doses of HPV vaccine than originally requested. The updated order form will be posted on the internet in time for December 4, 2006 orders.

Human Papillomavirus (HPV) Vaccine Information Statement (VIS)

The Bureau of Immunization is pleased to announce the release of the Human Papillomavirus (HPV) Vaccine Information Statement (VIS) dated 9/5/06. Once a VIS is available, it should be used, effective immediately. The VIS can be viewed online at: http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-hpv.pdf [52K PDF] and http://www.cdc.gov/vaccines/pubs/vis/default.htm.

While 3 doses of HPV vaccine are routinely recommended for girls 11 through 12 years of age, the vaccine is licensed for vaccination of girls and women age 9 through 26.

Please note: The vaccine is not presently available through the Florida Vaccines for Children (VFC) program. The VFC program will notify providers when the vaccine is available for order. There are no plans at this time to add HPV to the Florida school entry requirement.

You may contact the VFC Coordinator if you have questions regarding the Human Papillomavirus VFC vaccine supply, and the Executive Community Health Nursing Director for questions regarding the vaccine recommendations at 850-245-4342.