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NEW THIS SUNDAY: HPV VACCINE IMPLEMENTATION BY COUNTRY, AND, FOR THE U.S., BY STATE

Friday, 19th of July 2013

• HPV VACCINE IMPLEMENTATION BY COUNTRY, AND, FOR THE U.S., BY STATE

From the Wikipedia article, “Human Papillomavirus Vaccination,” consulted online  21 July 2013

HPV Vaccine implementation

In developed countries, the widespread use of cervical "Pap smear" screening programs has reduced the incidence of invasive cervical cancer by 50% or more. Current preventive vaccines reduce, but do not eliminate the chance of getting cervical cancer. Therefore, experts recommend that women combine the benefits of both programs by seeking regular Pap smear screening, even after vaccination.^[79] The European Centre for Disease Prevention and Control (ECDC) has recommended all European teenage girls to be vaccinated however Bulgaria, Cyprus, Czech Republic, Estonia, Finland, Hungary, Lithuania, Malta, Poland, Slovakia and Turkey currently do not have a vaccination programme in place.

Australia

In April 2007, Australia became the first country to introduce a government funded National Human Papillomavirus (HPV) Vaccination Program to protect young women against HPV infections that can lead to cancers and disease.^[80] The National HPV Vaccination Program is listed on the National Immunisation Program (NIP) Schedule and funded under the Immunise Australia Program.^[81] The Immunise Australia Program is a joint Australian, State and Territory Government initiative to increase immunisation rates for vaccine preventable diseases.

The National HPV Vaccination Program for females was made up of two components: an ongoing school-based program for 12-13 year old girls; and a time-limited catch-up program (females aged 14 – 26 years) delivered through schools, general practices and community immunisation services, which ceased on 31 December 2009.

During 2007-2009, an estimated 83% of females aged 12-17 years received at least one dose of HPV vaccine and 70% completed the 3-dose HPV vaccination course.^[80] Latest HPV coverage data on the Immunise Australia website show that by 15 years of age, over 70% of Australian females have received all three doses. This has remained steady since 2009.^[82]

Since the National HPV Vaccination Program commenced in 2007, there has been a reduction in HPV-related infections in young women. A study published in The Journal of Infectious Disease in October 2012 found the prevalence of vaccine preventable HPV types (6, 11, 16 and 18) in Papanicolaou test results of women aged 18-24 years has significantly decreased from 28.7% to 6.7% four years after the introduction of the National HPV Vaccination Program.^[80] A separate report published in the Kirby Institutes Annual Surveillance Report 2011 (page 28) found the diagnosis of genital warts (caused by HPV types 6 and 11) had also decreased in young women and men.^[83]

In October 2010, the Australian regulatory agency, the Therapeutic Goods Administration, extended the registration of the quadrivalent vaccine (Gardasil) to include use in males aged 9 through 26 years of age, for the prevention of external genital lesions and infection with HPV types 6, 11, 16 and 18.

In November 2011, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the extension of the National HPV Vaccination Program to include males. The PBAC made its recommendation on the preventative health benefits that can be achieved, such as a reduction in the incidence of anal and penile cancers and other HPV-related disease. In addition to the direct benefit to males, it was estimated that routine HPV vaccination of adolescent males would contribute to the reduction of vaccine HPV-type infection and associated disease in women through herd immunity.^[84]

On 12 July 2012, the Australian Government announced funding to extend the National HPV Vaccination Program to include males, with implementation commencing in all states and territories in February 2013.^[85]

From February 2013, free HPV vaccine is being provided through school-based programs for:

• males and females aged 12-13 years (ongoing program); and
• males aged between 14-15 years – until the end of the school year in 2014 (catch up program).

Further information is available on the HPV Vaccination Program website at www.australia.gov.au/hpv

Austria

Introduced in 2006. Target age group 9-15 (male and female). Fully financed by patient.

Belgium

Introduced in 2007. Target age group 10-13. Finance is 75% supported by national health authorities.

Canada

Canada has approved use of Gardasil.^[86] Initiating and funding free vaccination programs has been left to individual Province/Territory Governments. In the provinces of Ontario, Prince Edward Island, Newfoundland and Nova Scotia,^[87] free vaccinations to protect women against HPV were slated to begin in September 2007 and will be offered to girls ages 11–14. Similar vaccination programs are being planned in British Columbia and Quebec.^[88][89][90] The cost for the 3 required shots is reported to be $510.00 .^{[citation needed]}

Denmark

Introduced in Denmark from 1 January 2009 as part of the Danish Childhood Vaccination program.^[91] Target age group 12. Fully financed by national health authorities.

France

On July 17, 2007, France issued a directive^[92] authorizing state-aided voluntary vaccination for girls aged 14–23 years who have not yet become sexually active, or have been sexually active for less than a year. The state refunds 65% of the cost, based on a program of 3 vaccinations at €135 (slightly less than $200) per shot, meaning that the patient covers €141.75 (slightly more than $200).

Germany and Italy

On March 26, 2007, early approval for Gardasil vaccinations was granted in both Germany and Italy.^[93]

Greece

On February 12, 2007, Greece made HPV vaccination mandatory for girls entering gymnasion (7th grade). All vaccines including hepatitis B are mandatory and are supplied free to everyone in Greece, with parents being allowed to opt out of vaccinating their child. Cervarix and Gardasil are supplied free to all girls and women between the ages of 12 and 26.^[94][95]

Iceland

Introduced in 2011. Target age group 12. Fully financed by national health authorities.

Israel

Introduced in 2012. Target age group 12. Fully financed by national health authorities.

Ireland

Introduced in 2008. Target age group 12-13. Fully financed by national health authorities.

Japan

Introduced in 2010, widely available only since April 2013. Fully financed by national health authorities. However in June 2013 Japan suspended recommendation of the vaccine.

Kenya

Both Cervarix and Gardasil are approved for use within Kenya by the Pharmacy and Poisons Board. However, at a cost of 20,000 Kenyan shillings, which is more than the average annual income for a family, the director of health promotion in the Ministry of Health, Nicholas Muraguri, states that many Kenyans are unable to afford the vaccine.^[65]

Latvia

Introduced in 2009. Target age group 12. Fully financed by national health authorities.

Luxembourg

Introduced in 2008. Target age group 12. Fully financed by national health authorities.

Macedonia

Introduced in 2009. Target age group 12 (female). Fully financed by national health authorities. Vaccination is mandatory, included in the national vaccination schedule.

Mexico

The vaccine was introduce in 2008 to 5% of the population. This percentage of the population had the lowest development index which leads to the highest incidence of cervical cancer.^[96] The HPV vaccine is deliver to girls 12 – 16 years old following the 0-2-6 dosing schedule. By 2009 Mexico had expanded the vaccine use to girls, 9 –12 years of aged, the dose schedule in this group was different, the time elapse between the first and second dose was six months and the third dose 60 months later.^[97] In 2011 Mexico approved a nationwide use of HPV vaccination program to include vaccination of all 9 year old girls.^[97]

Netherlands

Introduced in 2009. Target age group 12-13. Fully financed by national health authorities.

New Zealand

The publicly funded New Zealand HPV Immunisation Programme began on 1 September 2008. Gardasil is available free for New Zealand girls and young women born on or after 1 January 1990 through general practices, some family planning clinics and participating schools. HPV immunization is part of the regular immunization schedule for girls in year 8 at school (or age 12 if not delivered through a school-based programme). There is also a catch-up programme for older girls. Girls born in 1990 and 1991 have until 31 December 2011 to start the programme for free. Girls born from 1992 onwards have until their 20th birthday to start the programmme for free. Over 82,000 New Zealand girls and young women have chosen to get the HPV immunisation in the programmes first year.^[98]

Norway

In Norway, starting from the fall of 2009, HPV vaccination was introduced into the national immunisation programme, for girls aged 12–13. In March 2010, 57% of all girls born in 1997 had received the first dose of the vaccine.^[99]

Panama

The vaccine was added to the national immunization program in 2008, to target girls in the population aged 10.^[96] The vaccine is being administer by clinics and schools.^[97]

Portugal

Introduced in 2007. Target age group 13. Fully financed by national health authorities.

Romania

In November 2008, Romanian authorities launched a campaign to vaccinate 110,000 girls aged 10 and 11. The Ministry of Health acquired 330,000 vaccine doses for 23 million euros. By an order of the Ministry, the girls parents must approve or reject the vaccination in writing, and must "fully assume the consequences for their children" if they reject the vaccination.^[100]

Slovenia

Introduced in 2009. Target age group 11-12. Fully financed by national health authorities.

South Korea

On July 27, 2007, South Korean government approved Gardasil for use in girls and women aged 9 to 26 and boys aged 9 to 15.^[101] Approval for use in boys was based on safety and immunogenicity but not efficacy.

Spain

Introduced in 2007. Target age group 11-14. Fully financed by national health authorities.

Sweden

In Sweden, starting January 1, 2010, girls born in 1999 or later and in the ages 10 to 12 can receive a free HPV vaccine.^[102]

Switzerland

Introduced in 2008. Target age group 11-14. Fully financed by national health authorities.

Trinidad and Tobago

Introduced in 2013. Target Group 9-26. Fully financed by national health authorities. Administration in schools currently suspended owing to objections and concerns raised by the Catholic Board, but fully available in local health centers.

United Kingdom

In the UK the vaccine is licensed for girls aged 9 to 15, for women aged 16 to 26, and for boys aged 9–15.^[103]

HPV vaccination with Cervarix was introduced into the national immunisation programme in September 2008, for girls aged 12–13 across the UK. A two-year catch up campaign started in Autumn 2009 to vaccinate all girls up to 18 years of age. Catch up vaccination will be offered to:

• girls aged between 16 and 18 from autumn 2009, and
• girls aged between 15 and 17 from autumn 2010.

By the end of the catch up campaign, all girls under 18 will have been offered the HPV vaccine.

From September 2012, Gardasil will replace Cervarix as the HPV vaccination of choice due to its added protection against genital warts.

It will be many years before the vaccination programme has an effect upon cervical cancer incidence so women are advised to continue accepting their invitations for cervical screening.^[104]

United States

The cost of HPV vaccine for females under 18 who are uninsured is covered under the federal Vaccines for Children Program.

As of late 2007^[update], about one quarter of US females age 13–17 years had received at least one of the three HPV shots.^[105]

According to the US Centers for Disease Control and Prevention (CDC), getting as many girls vaccinated as early and as quickly as possible will reduce the cases of cervical cancer among middle-aged women in 30 to 40 years and reduce the transmission of this highly communicable infection. Barriers include the limited understanding by many people that HPV causes cervical cancer, the difficulty of getting pre-teens and teens into the doctors office to get a shot, and the high cost of the vaccine ($120/dose, $360 total for the three required doses, plus the cost of doctor visits).^[1][106]

A survey was conducted in 2009 to gather information about knowledge and adoption of the HPV vaccine. Thirty percent of 13- to 17-year-olds and 9% of 18- to 26-year-olds out of the total 1,011 young women surveyed reported receipt of at least one HPV injection. Knowledge about HPV varied; however, 5% or fewer subjects believed that the HPV vaccine precluded the need for regular cervical cancer screening or safe-sex practices. Few girls and young women overestimate the protection provided by the vaccine. Despite moderate uptake, many females at risk of acquiring HPV have not yet received the vaccine.^[107]

Since the approval of Gardasil in 2006 and despite low vaccine uptake, incidence of HPV among teenagers aged 14-19 has been cut in half. No decline in incidence was observed in other age groups, indicating the vaccine to have been responsible for the sharp decline in cases. The drop in number of infections is expected to in turn lead to a decline in cervical and other HPV-related cancers.^[108][109]

Legislation

Shortly after the first HPV vaccine was approved, bills to include the vaccine among those that are mandatory for school attendance were introduced in many states.^[110] Only two such bills passed (in Virginia and Washington DC) during the first four years after vaccine introduction.^[110] Mandates have been effective at increasing uptake of other vaccines, such as mumps, measles, rubella, and hepatitis B (which is also sexually transmitted).^[106] However most such efforts developed for five or more years after vaccine release, while financing and supply were arranged, further safety data was gathered, and education efforts increased understanding, before mandates were considered.^[110]

Other measures that have been considered include requiring insurers to cover HPV vaccination, and funding HPV vaccines for those without insurance.

Opt-out policies

Almost all pieces of legislation currently pending in the states that would make the vaccine mandatory for school entrance have an "opt-out" policy.^[111]

State-by-State

The National Conference of State Legislatures periodically issues summaries of HPV vaccine related legislation.^[111]

Other states are also preparing bills to handle issuing the HPV Vaccine.^[111]

State	Proposal	Status
Alabama	HB 42 would allow parents the option of immunizing female students entering the sixth grade, and requires the Department of Health and Senior Services to directly mail age appropriate information to parents or guardians to those students regarding the connection between HPV and cervical cancer and the availability of the immunization.	Passed
Alaska	Voluntary vaccination program	Passed
Florida	SB 1116 Would require the Department of Health to adopt a rule adding HPV/cervical cancer to the list of communicable diseases for which immunizations are recommended; requires that schools provide the parents or guardians of certain public school students information regarding the disease and the availability of a vaccine; requires the department to prescribe the required information.	Not passed
Georgia	HB 736 Would require public Schools to provide parents or guardians of sixth grade female students information concerning the infection and the immunization against the human papillomavirus.
Hawaii	HCR 71 Would request the Department of Health to make human papillomavirus immunization available to indigent patients and through the teen VAX program, and urging insurers to offer coverage for human papillomavirus immunization to female policyholders eleven to twenty-six years of age.	Not Passed
Iowa	SSB 3097 Would create a study bill for a HPV public awareness program and make appropriations for the public awareness program, provision of vaccinations, and cervical cancer screenings.	In committee
Kansas	HR 6019 Resolution would urge the U.S. Food and Drug Administration to use caution in approving new vaccines such as Gardasil which has had a number of health problems including some deaths associated with the use of this vaccine.	In committee
Kentucky	HR 80 Would urge females ages 9 to 26 and males ages 11 to 26 to obtain the Human papillomavirus (HPV) vaccination and all citizens to become more knowledgeable about the benefits of HPV vaccination.	Passed
Maryland	HB 411 Would require the Statewide Advisory Commission on Immunizations to study the safety of the human papillomavirus (HPV) vaccine; requires the Commission to include specified components in the study, make recommendations, and report the results of its study.	Passed
Minnesota	HF 1758 Would require the commissioner of health to prepare informational materials on vaccines including the HPV vaccines and encourages private and private schools with students in grades 6-12 to provide this information to parents in a cost-effective and programmatically effective manner. (Introduced 3/16/09)
Michigan	SB 1062 and SB 1063 Each would require health insurers to provide coverage for humpan papillomavirus screenings for cervical cancer.	In committee
Mississippi	HB 1512 Would require health benefit plans to cover HPV screenings.	Not Passed
Missouri	HB 1935 Would require health insurers to provide coverage for human papillomavirus screenings for cervical cancer.	In committee
New Jersey	S 1163 Would require health insurers and State Health Benefits Program and SEHBP to provide coverage for screening for cervical cancer, including testing for HPV. (Sent to Committee 1/23/12) A 2185 Would require insurers and State health care coverage programs to cover cost of HPV vaccine.	In committee
New York	SB 98 (same as AB 2360) Would encourage voluntary, informed vaccination against human papillomavirus (HPV). (Amended in Senate Committee on Health 1/5/12) AB 699 Would require immunization against HPV for children born after Jan. 1, 1996. (Sent to Assembly Committee on Health 1/5/11) AB 1946 Would require insurance companies to provide coverage for the vaccine against human papilloma virus. (Sent to committee 1/12/11) AB 2360 Would encourage voluntary, informed vaccination against human papillomavirus (HPV) for school-aged children and their parents or guardians. (Sent to committee 1/18/11) SB 4708 Would require insurance companies to cover HPV vaccine.	In committee
Oregon	HB 2794 Would require health benefit plans to provide coverage of human papillomavirus vaccine for female beneficiaries who are 11 years of age or older.	Passed
Pennsylvania	HB 524 Would require health insurance policies to provide coverage for vaccinations for human papilloma virus.	In committee
South Carolina	HB 4497 Would enact the Cervical Cancer Prevention Act and allow the Department of Health and Environmental Control to offer the option of an HPV vaccine series to female students entering the seventh grade at the request of their parent or guardian pending state and federal funding.	In committee
Texas	HB 2220 Would allow the Executive Commissioner of the Health and Human Services Commission to require immunization against human papillomavirus or other immunizations for a persons admission to elementary or secondary school.	In committee
Virginia	HB 1419 Would repeal the HPV vaccination requirement for female children. (Passed House 1/21/11, Indefinitely passed by the Senate Committee 2/17/11) HB 65 Would repeal the requirement for children to receive the HPV vaccination for school attendance. (Left in committee 2/14/12) HB 824 Would require that the Commonwealth shall assume liability for any injury resulting from administration of the human papillomavirus vaccine. HB 1112 Would eliminate the requirement for vaccination against human papillomavirus for female children.	Passed House and sent to Senate

Source: National Conference of State Legislatures

Immigrants

Between July 2008 and December 2009, proof of the first of three doses of HPV Gardasil vaccine was required for women ages 11–26 intending to legally enter the United States. This requirement stirred controversy because of the cost of the vaccine, and because all the other vaccines so required prevent diseases which are spread by respiratory route and considered highly contagious.^[112] The Centers for Disease Control and Prevention repealed all HPV vaccination directives for immigrants effective December 14, 2009.^[113]

Opposition in the United States[edit]

See also: Vaccine controversy

Health insurance companies[edit]

There has been significant opposition from health insurance companies to covering the cost of the vaccine ($360).^{[114][115][116]}

However, Medicaid covers HPV vaccination in accordance with the ACIP recommendations, and immunizations are a mandatory service under Medicaid for eligible individuals under age 21. [1]^{[citation needed]} In addition, Medicaid includes the Vaccines for Children Program. [1]^{[citation needed]} This program provides immunization services for children 18 and under who are Medicaid eligible, uninsured, underinsured, receiving immunizations through a Federally Qualified Health Center or Rural Health Clinic, or are Native American or Alaska Native.[1]^{[citation needed]}

The vaccine manufacturers also offer help for people who cannot afford HPV vaccination. GSK has the Vaccines Access Program, which provides Cervarix free of charge to women who do not have insurance and who have a low income, and who are ages 19 to 25 and therefore too old for the Medicaid Vaccines for Children Program. [1]^{[citation needed]} For example, Merck offers the Merck Vaccine Patient Assistance Program, which provides Gardasil for free to people over the age of 19 who do not have health insurance or cannot afford to pay for the vaccine. [1]^{[citation needed]}

Religious right and conservative groups

Several conservative^{[who?][quantify]} groups in the U.S. have publicly opposed the concept of making HPV vaccination mandatory for pre-adolescent girls, asserting that making the vaccine mandatory is a violation of parental rights. They also say that it will lead to early sexual activity, giving a false sense of immunity to sexually transmitted disease. (See Peltzman effect) Both the Family Research Council and the group Focus on the Family support widespread (universal) availability of HPV vaccines but oppose mandatory HPV vaccinations for entry to public school.^{[117][118][119][120]}

Many organizations^{[who?][quantify]} disagree with the argument that the vaccine increases sexual activity among teens. Dr. Christine Peterson, director of the University of Virginias Gynecology Clinic, said "The presence of seat belts in cars doesnt cause people to drive less safely. The presence of a vaccine in a persons body doesnt cause them to engage in risk-taking behavior they would not otherwise engage in."^[121][122]