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Bureau of Immunization: Immunizations Across the Lifespan
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Vaccine Topics

Human Papillomavirus (HPV) Vaccine

Vaccine Information Statement Updates

April 12, 2010 -- The Bureau of Immunization is pleased to highlight recent updates to several vaccine information statements: measles-mumps-rubela-varicella (MMRV), human papillomavirus (HPV), and pneumococcal conjugate vaccine-13 (PCV13). (VIS Updates)

ACIP Provisional Recommendations for Human Papillomavirus Vaccine

April 4, 2010 -- On October 21, 2009, the ACIP voted to approve updated recommendations for use of Human Papillomavirus (HPV) vaccine, including recommendations for the bivalent HPV vaccine (Cervarix®) for females and the quadrivalent HPV vaccine (Gardasil®) for females and males.

These recommendations are reflected in the ACIP Provisional Recommendations for HPV Vaccine and will replace recommendations published in Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2007; 56(No. RR-02).

Please Note: The bivalent HPV vaccine is currently not available, but VFC Program staff will inform you as soon as it becomes available for ordering.

Recommendations for Females

Two HPV vaccines are licensed for use to protect against common types of HPV that cause cervical cancers and precancers, and genital warts. The quadrivalent vaccine protects against HPV types 6, 11, 16, and 18, while the bivalent vaccine protects against HPV types 16 and 18. The ACIP recommends vaccination with either the bivalent or quadrivalent vaccine for prevention of cervical cancers and precancers. In addition, the quadrivalent HPV vaccine is recommended for prevention of genital warts and has been demonstrated to protect against vulvar and vaginal cancers and precancers.

Routine vaccination of females 11 and 12 years of age with 3 doses of HPV vaccine is recommended by the ACIP. The vaccination series can begin as early as 9 years of age. The VFC Program covers bivalent and quadrivalent HPV vaccine for eligible females age 9 through 18 years.

HPV 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 vaccination series, regardless of prior potential exposure to HPV through sexual contact, since sexually active individuals may still benefit from vaccination.

Recommendations for Males

HPV can cause genital warts and penile and anal cancer in men. Males can also carry HPV, which can be transmitted to their sexual partners.

The 3-dose series of quadrivalent HPV vaccine may be given to males 9 through 26 years of age to reduce the risk of acquiring genital warts. The VFC Program resolution allows permissive use of quadrivalent HPV vaccine for VFC-eligible males, 9 through 18 years of age.

Recommendations for Administration, Precautions and Contraindications

  • The quadrivalent and bivalent HPV vaccines are administered in a 3-dose schedule, with the second dose administered 1 to 2 months after the first dose, and the third dose 6 months after the first dose.
  • The minimum interval between the first and second doses of vaccine is 4 weeks. The minimum interval between the second and third dose of vaccine is 12 weeks. The minimum interval between the first and third dose is 24 weeks.
  • If the HPV vaccine schedule is interrupted, the vaccine series does not need to be restarted.
  • HPV vaccines are not live vaccines and can be administered either simultaneously or at any time before or after an inactivated or live vaccine.
  • Whenever possible, the same HPV vaccine product should be used for all doses in the series.
  • HPV vaccines are not recommended for use in pregnant women. However, pregnancy testing is not needed before vaccination. Any exposure to vaccine during pregnancy should be reported to the appropriate vaccine pregnancy registry:
    • (800) 986-8999 (Merck and Co., Inc. for quadrivalent HPV vaccine)
    • (888) 452-9622 (GlaxoSmithKline for bivalent HPV vaccine)

Vaccines for Children Resolution No. 010/09-1 - Human Papillomavirus Vaccine

December 11, 2009 -- The Bureau of Immunization is pleased to announce the release of Vaccines for Children (VFC) Program Resolution No. 010/09-1 for vaccines to prevent human papillomavirus (HPV). Resolution 6/08-2 is repealed and replaced. Resolution No. 010/09-1 was adopted and effective on October 21, 2009.

The purpose of Resolution 010/09-1 is to:

  • Add bivalent HPV vaccine to the previous HPV VFC Program Resolution.
  • Allow permissive use of the quadrivalent HPV vaccine for VFC-eligible males, 9 through 18 years of age.
  • Streamline the resolution through the use of links to published documents.

Recommended dosage for the bivalent HPV vaccine can be found in the package insert available at www.fda.gov/BiologicsBloodVaccines/Vaccines/
ApprovedProducts/UCM093833.

Recommended dosage for the quadrivalent HPV vaccine can be found in the package insert available at www.fda.gov/BiologicsBloodVaccines/Vaccines/
ApprovedProducts/UCM093833.

The resolution is available online at www.cdc.gov/vaccines/programs/vfc/downloads/
resolutions/1009hpv-508.pdf.

Please Note: The bivalent HPV vaccine is currently not available, but VFC Program staff will inform you as soon as it becomes available for ordering.

Key Points Concerning Journal of the American Medical Association Human Papillomavirus Article

August 19, 2009 -- The Bureau of Immunization is pleased to share the following information from the Centers for Disease Control and Prevention (CDC). In anticipation of inquiries about Journal of the American Medical Association's (JAMA) August 19, 2009 release of Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine, the CDC has prepared a set of key messages for your use that summarize the study, explain the main findings, and give information on FDA and CDC actions moving forward. The CDC's website has additional information relating to the safety of the HPV vaccine.

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:

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 9 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% 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/, www.cdc.gov/cancer/cervical/basic_info, and www.cdc.gov/hpv/.

HPV Vaccine in the U.S.

  • 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 HPV. The quadrivalent vaccine protects against four HPV types (6, 11, 16, and 18), which are responsible for 70% of cervical cancers and 90% of genital warts.
  • 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: VAERS

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 www.cdc.gov/vaccinesafety/Activities/vaers.html.

Update to Immunization Schedules for Human Papillomavirus

April 4, 2008 -- The Florida Department of Health, Bureau of Immunization directs your attention to the Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR) 2008; volume 57, number 12 on March 28, 2008. This MMWR contains an erratum on page 319 (Errata: Vol 57, No. 1) for the Recommended Immunization Schedules for Persons Aged 0--18 Years---United States, 2008.

Most important is the change/clarification to the intervals on the catch-up schedule for human papillomavirus (HPV) vaccine as follows:

On page Q-4, in the lower section of the Table titled, "Catch-up schedule for persons aged 7--18 years," in row "Human Papillomavirus", under column heading "Dose 2 to Dose 3", the text should read: "12 weeks (and 24 weeks after the first dose)." This change reflects addition of a 24-week minimum interval for the HPV series between dose 1 and dose 3. This means that the third dose needs to be administered no earlier than 6 months/24 weeks from the first dose. The minimum intervals between dose one and dose two, as well as between dose two and dose three, remain unchanged.

  • Dose 1 to 2: 4 weeks
  • Dose 2 to 3: 12 weeks (and 24 weeks after the first dose

The erratum may be viewed at www.cdc.gov/mmwr/preview/mmwrhtml/mm5712a6.htm.

The revised HPV interval was published on March 5, 2008 , and the correction to the human papillomavirus (HPV) vaccine regimen can be viewed on the CDC website at www.cdc.gov/vaccines/recs/schedules/child-schedule.htm.

The MMWR may be viewed at www.cdc.gov/mmwr/preview/mmwrhtml/mm5701a8.htm.

Quadrivalent Human Papillomavirus Vaccine Recommendations

-- SUPERSEDED INFORMATION -- HISTORICAL USE ONLY -- SEE UPDATED INFORMATION ABOVE --

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 ACIP on the use of a quadrivalent human papillomavirus (HPV) vaccine licensed by the Food and Drug Administration (FDA) 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 9 through 26 years of age in the U.S.

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 9 through 26 years of age 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 and 12 years of age. Vaccine can be administered as young as 9 years of age. Catch-up vaccination is recommended for females 13 through 26 years of age 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 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 females 11 and 12 years of age. HPV vaccine should also be made available to all other eligible females.

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

Update on Vaccines for Children Program Human Papillomavirus Vaccine Availability

-- SUPERSEDED INFORMATION -- HISTORICAL USE ONLY --

The Bureau of Immunization is providing this important update to the Advisory Committee On Immunization Practices (ACIP) recommendations regarding human papillomavirus (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 females 11 and 12 years of age. However, state-supplied HPV vaccine should also be made available to VFC-eligible females 9 through 18 years of age 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 Human Papillomavirus Vaccine Information Statement

-- SUPERSEDED INFORMATION -- HISTORICAL USE ONLY -- SEE UPDATED INFORMATION ABOVE --

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 (September 5, 2006) version may still be used. To access a ready-to-print (PDF) version of the updated (February 2, 2007) interim VIS, go to the CDC website at www.cdc.gov/vaccines/pubs/vis/default.htm#hpv or the IAC website at www.immunize.org/vis/hpv.pdf. 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 Vaccine

-- SUPERSEDED INFORMATION -- HISTORICAL USE ONLY -- SEE UPDATED INFORMATION ABOVE --

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 www.cdc.gov/.

The ACIP issued provisional recommendations that this vaccine be routinely administered to girls 11 and 12 years of age and used for catch-up immunization in females 13 through 26 years of age. Gardasi®, manufactured by Merck, is the first HPV vaccine approved by the Food and Drug Administration (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 September 5, 2006 is found at www.cdc.gov/vaccines/pubs/vis/default.htm.
VISs are information sheets produced by the 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 the 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 Vaccines for Children Program Information

-- SUPERSEDED INFORMATION -- HISTORICAL USE ONLY --

Florida's Vaccines for Children (VFC) Program will provide human papillomavirus (HPV) vaccine effective December 4, 2006. Due to limited vaccine supply, VFC Program HPV vaccine is presently available only to Florida VFC-eligible female clients who are 11 and 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 County Health Departments 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 Vaccine Information Statement

-- SUPERSEDED INFORMATION -- HISTORICAL USE ONLY -- SEE UPDATED INFORMATION ABOVE --

The Bureau of Immunization is pleased to announce the release of the Human Papillomavirus (HPV) Vaccine Information Statement (VIS) dated September 5, 2006. Once a VIS is available, it should be used, effective immediately. The VIS can be viewed online at www.cdc.gov/vaccines/pubs/vis/downloads/vis-hpv.pdf and www.cdc.gov/vaccines/pubs/vis/default.htm.

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

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.

Centers for Disease Control and Prevention Human Papillomavirus 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/hpv/
HPV Vaccine Information For Young Women: http://www.cdc.gov/std/hpv/STDFact-HPV-vaccine-young-women.htm

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

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