PROGRESS TOWARD IMPLEMENTATION OF HUMAN PAPILLOMAVIRUS VACCINATION -- THE AMERICAS, 2006-2010/ EDITORIAL ON HPV

Saturday, 19th of November 2011

1) PROGRESS TOWARD IMPLEMENTATION OF HUMAN PAPILLOMAVIRUS VACCINATION – THE AMERICAS, 2006-2010

Morbidity and Mortality Weekly Report

October 14, 2011 / 60(40);1382-1384

Cervical cancer is a major cause of morbidity and mortality in the Americas, where an estimated 80,574 new cases and 36,058 deaths were reported in 2008, with 85% of this burden occurring in Latin America and the Caribbean (1). Two oncogenic human papillomavirus (HPV) types (16 and 18) cause approximately 70% of cervical cancers and a substantial proportion of other HPV-related cancers (2). HPV vaccination provides an opportunity to greatly reduce cervical cancer burden through primary prevention of HPV infection. This report summarizes the progress toward HPV vaccine introduction in the Americas, focusing on countries that have introduced the vaccine in national or regional immunization programs. As of January 2011, four countries in the Americas had introduced HPV vaccine. Overcoming issues related to financing and delivery of HPV vaccine remains a key public health challenge to more widespread implementation of HPV vaccination in the Americas.

Two brands of HPV vaccine are available. Both are effective against oncogenic types HPV 16 and 18: a quadrivalent vaccine (Gardasil, Merck & Co., Inc.) and a bivalent vaccine (Cervarix, GlaxoSmithKline). Quadrivalent HPV vaccine is also effective against nononcogenic types HPV 6 and 11, which cause most genital warts. Pre- and post-licensure studies have shown that both vaccines are safe and well tolerated (3,4). Because HPV infections are acquired soon after initiation of sexual activity, HPV vaccine is most effective if administered before onset of sexual activity. The World Health Organization (WHO) recommends a 3-dose vaccine schedule, completed over the course of 6 months, for a likely primary target population of girls within the age range of 9 or 10 years through 13 years (3).

In April 2009, WHO issued a position statement recommending that routine HPV vaccination of females be included in national immunization programs, provided that 1) cervical cancer and/or HPV-related diseases constitute a public health priority; 2) vaccine introduction is programmatically feasible; 3) sustainable financing can be secured; and 4) cost-effectiveness of vaccination strategies in the country or region is considered. Preferably, HPV vaccines should be introduced as part of a coordinated strategy to prevent cervical cancer and should not undermine or divert funding from effective cervical cancer screening programs (3).

Information on HPV vaccine introduction in the United States and Canada was reviewed. Information about Latin America and the Caribbean was obtained through the Pan American Health Organization (PAHO), which, as part of ongoing cooperation with its member states, monitors HPV vaccine introduction in the region.* Country-specific information was verified by representatives of PAHO member states. As of January 2011, four countries in the Americas had included HPV vaccine in their immunization programs: the United States, Canada, Panama, and Mexico (Table). HPV vaccination coverage varied widely. For the 3-dose vaccination series, coverage among girls aged 13--17 years in the United States was 32% in 2010; in parts of Canada, ≥80% coverage has been reported among girls in the target age ranges.

In the United States, HPV vaccine has been available since 2006. HPV vaccine administration occurs mainly through pediatric and family medicine primary-care providers; a publicly funded program, Vaccines for Children, provides vaccine at no charge to children aged ≤18 years who are uninsured or meet eligibility criteria. Coverage rates have increased each year since introduction in 2006. In 2010, overall coverage among girls aged 13--17 years was 48.7% for ≥1 dose of HPV vaccine and 32.0% for 3 doses (5).

In Canada, HPV vaccine has been available since 2006. School-based HPV vaccination programs delivered by public health agencies began in 2007, and all provinces and territories had publicly funded programs in place by 2009 (6). Year of introduction, target age groups, and dosing schedules varied across provinces and territories; however, all offered HPV vaccine, free of charge, to girls in at least one of grades 4 to 9 (ages 9--15 years) (6). Ten of the 13 jurisdictions offered the vaccine to more than one grade as part of a time-limited catch-up program (7). Although most provinces and territories followed a 0-, 2-, 6-month dosing schedule, Quebec implemented a different approach; the first 2 vaccine doses were administered in grade 4 (ages 9--10 years), and the third dose in grade 9 (ages 14--15 years) (7). In September 2010, British Columbia also began using an extended dosing schedule. Series coverage varied nationally among jurisdictions that reported, with a range of 80% to 85% in the Atlantic (eastern) provinces to 51% in Ontario, after the first year of the program.

In Panama, the Ministry of Health added bivalent HPV vaccine to the national immunization program in 2008 for a target population of girls aged 10 years (8). Vaccine has been delivered through adolescent health services in both clinics and schools. Coverage rates have improved since vaccine introduction in 2008. In 2009, 1-dose coverage among girls aged 10 years was 89%, and 3-dose coverage was 46% (8). In 2010, 3-dose coverage was 67%.

In Mexico, HPV vaccine was introduced in 2008 to 125 targeted municipalities (comprising approximately 5% of Mexico's population) with the lowest human development index, which were estimated to have the highest incidence of cervical cancer (8). Quadrivalent HPV vaccine was delivered via mobile health clinics to girls aged 12--16 years in these municipalities using a 0-, 2-, 6-month dosing schedule (8). In 2008, 1-dose coverage among girls in the target age range within these municipalities was 98%, and 3-dose coverage was 81%. In 2009, Mexico expanded its HPV vaccination program to include 182 municipalities with the lowest human development index and changed to an extended dosing schedule that targets girls aged 9--12 years for the first 2 doses, delivered 6 months apart, followed by the third dose 60 months later. Using the extended dosing schedule, 1-dose coverage was 85%, and 2-dose coverage was 67%; 3-dose coverage at 60 months is yet to be measured. In 2011, Mexico's National Immunization Council approved a nationwide expansion of its HPV vaccination program to include school-based vaccination of all girls aged 9 years.

Reported by

Andrea S. Vicari, DVM, PhD, Lara G. Dilsa, Pan American Health Organization. Shelley Deeks, MD, Surveillance and Epidemiology, Ontario Agency for Health Protection and Promotion, Ontario, Canada. Susana P. Cerón Mireles, MD, Mirella Loustalot Laclette San Román, MD, Raquel Espinosa Romero, MD, National Center for Gender Equity and Reproductive Health; Maria del Carmen Domínguez Mulato, MD, Vesta Richardson López-Collada, MD, National Center for Child and Adolescent Health, Ministry of Health, Mexico. Yadira de Moltó, MD, Itzel S. de Hewitt, Ministry of Health, Panama. Mona Saraiya, MD, Div of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion; Terri Hyde, MD, Global Immunization Div, National Center for Immunization and Respiratory Diseases; Lauri E. Markowitz, MD, Eileen F. Dunne, MD, Elissa Meites, MD, Diya Surie, Div of Sexually Transmitted Diseases, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC. Corresponding contributor: Elissa Meites, emeites@cdc.gov, 404-639-8368.

Editorial Note

HPV vaccines are safe and effective, and HPV vaccination offers an opportunity to reduce the substantial burden of cervical cancer for women in the Americas. Although progress has been made in HPV vaccine introduction in the Americas, only four of 35 (11%) PAHO countries included the vaccine in their immunization programs as of January 2011. Several important challenges to implementation of HPV vaccination in the Americas exist, including cost, competing demands for the introduction of other new vaccines, and limited health-care delivery systems that reach adolescents.

HPV vaccines are among the most expensive vaccines available, and current prices in high-income countries† are not affordable for low- and middle-income countries. As with other new vaccines, international cooperation aims to increase HPV vaccine affordability by reducing the cost per dose. For instance, PAHO's Revolving Fund for vaccine procurement is a mechanism that aggregates vaccine purchases by countries in Latin America and the Caribbean and thus achieves economies of scale. Under this fund, HPV vaccine was first offered in 2010; the price per dose for participating countries in mid-2011 was $14 (U.S. dollars). The GAVI Alliance (formerly the Global Alliance for Vaccines and Immunization) is a public-private partnership that provides financing and programmatic support for vaccine introduction in low-income countries. As of October 2011, GAVI had not committed funds for HPV vaccination, and only three Latin American and Caribbean countries (Guyana, Haiti, and Nicaragua) were GAVI-eligible, limiting the potential impact of this program in the Americas. Access to HPV vaccine at more affordable prices is critical for widespread introduction and long-term sustainability of this vaccine in Latin America and the Caribbean, where most countries are considered middle-income.

Another important challenge for implementation of HPV vaccination is limited experience in health-care delivery to adolescents. Historically, most immunization programs have focused on infant vaccination and therefore are less experienced with accessing and vaccinating adolescents. Some countries in the region have participated in demonstration projects to explore options for vaccine delivery. HPV vaccination projects, including school-based implementation projects, have been piloted in Bermuda, Bolivia, Cayman Islands, Haiti, and Peru. In addition to Mexico, the governments of Argentina, Guyana, Peru, and Suriname have been planning to implement national HPV vaccination programs in 2011. Efforts to identify the most effective and affordable strategies for vaccine delivery continue to be investigated (9). Although some countries are using an extended 3-dose schedule, PAHO/WHO and CDC recommend a 3-dose schedule administered over 6 months.

The pace of global introduction of vaccines can be slow. For example, worldwide introduction of hepatitis B vaccine took approximately 20 years. During the past 4 years, several countries in Latin America have introduced rotavirus and/or pneumococcal conjugate vaccines, marking the first time that new vaccines were introduced in middle- and low-income countries at the same time as in high-income countries (10). Additional strategies are needed to overcome challenges to increasing HPV vaccine introduction, especially in regions with a disproportionate burden of cervical cancers. New opportunities to focus on health issues for women could support prioritization of this vaccine for Latin America and the Caribbean.

References

Arbyn M, Castellsagué X, de Sanjosé S, et al. Worldwide burden of cervical cancer in 2008. Ann Oncol 2011; April 6. [Epub ahead of print].
de Sanjose S, Quint WG, Alemany L, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol 2010;11:1048--56.
World Health Organization. Human papillomavirus vaccines. WHO position paper. Wkly Epidemiol Rec 2009;84:118--31.
Gee J, Naleway A, Shui I, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine 2011 (in press).
CDC. National and state vaccination coverage among adolescents aged 13 through 17 years---United States, 2010. MMWR 2011;60:1117--23.
Colucci R, Hryniuk W, Savage C. HPV vaccination programs in Canada: are we hitting the mark? Report card on cancer in Canada, 2008. Toronto, Canada: Cancer Advocacy Coalition of Canada; 2008. Available at http://www.canceradvocacy.ca/reportcard/2008/HPV%20Vaccination%20Programs%20in%20Canada.pdf . Accessed October 12, 2011.
Public Health Agency of Canada. Publicly funded immunization programs in Canada: routine schedule for infants and children including special programs and catch-up programs (as of September 2011). Ottawa, Canada: Public Health Agency of Canada; 2011. Available at http://www.phac-aspc.gc.ca/im/ptimprog-progimpt/table-1-eng.php . Accessed October 12, 2011.
Pan American Health Organization. New technologies for cervical cancer prevention: from scientific evidence to program planning. Report of the Latin American Subregional Meeting on Cervical Cancer Prevention, Panama City, Panama, June 2--3, 2010.
LaMontagne DS, Barge S, Le NT, et al. Human papillomavirus vaccine delivery strategies that achieved high coverage in low- and middle-income countries. Bull World Health Organ 2011; September 1. [Epub ahead of print].
de Oliveira LH, Danovaro-Holliday MC, Sanwogou NJ, Ruiz-Matus C, Tambini G, Andrus JK. Progress in the introduction of the rotavirus vaccine in Latin America and the Caribbean: four years of accumulated experience. Pediatr Infect Dis J 2011;30(1 Suppl):S61--6.

* PAHO countries include Antigua and Barbuda, Argentina, Bahamas, Barbados, Belize, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, Dominica, Dominican Republic, Ecuador, El Salvador, Grenada, Guatemala, Guyana, Haiti, Honduras, Jamaica, Mexico, Nicaragua, Panama, Paraguay, Peru, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname, Trinidad and Tobago, the United States, Uruguay, and Venezuela.

† Additional information available at http://www.cdc.gov/vaccines/programs/vfc/cdc-vac-price-list.htm.

What is already known on this topic?

Cervical cancer is a major cause of morbidity and mortality in the Americas, where an estimated 80,574 new cases and 36,058 deaths were reported in 2008. Human papillomavirus (HPV) vaccines are safe and effective, and HPV vaccination offers an opportunity to reduce the substantial burden of cervical cancer.

What is added by this report?

This report summarizes the progress toward HPV vaccine introduction in the Americas. As of January 2011, four (11%) of the 35 countries in the Americas had included HPV vaccine in national or regional immunization programs: the United States, Canada, Panama, and Mexico. HPV vaccination coverage varied widely. For the 3-dose vaccination series, coverage among girls aged 13--17 years in the United States was 32% in 2010; in parts of Canada, ≥80% coverage has been reported among girls in the target age ranges.

What are the implications for public health practice?

Overcoming issues related to financing and delivery of HPV vaccine remain key public health challenges to more widespread implementation of HPV vaccination, especially in regions with a disproportionate burden of cervical cancers.

TABLE. Implementation of human papillomavirus (HPV) vaccination in national immunization programs, by country and selected characteristics --- the Americas, 2006--2010
Country	Year of implementation	Target population and age group	Catch-up age group	Geographic scope
United States*	2006	Females, 11--12 yrs	13--26 yrs	National
Canada†	2007	Females, 9--15 yrs	Varies	National
Panama	2008	Females, 10 yrs	None	National
Mexico§	2008	Females, 9--12 yrs	Varies	Partial (5%)
* In the United States, quadrivalent HPV vaccine is approved by the Food and Drug Administration for use in females and males; the Advisory Committee on Immunization Practices (ACIP) states that quadrivalent HPV vaccine may be given to males aged 9--26 years, but currently it is not part of the routine immunization schedule for males. † In Canada, quadrivalent HPV vaccine is approved for use in both females and males aged 9--26 years and females up to age 45 years by Health Canada; no recommendations from the National Advisory Committee on Immunization currently exist for women aged >26 years or for males of any age. Target ages vary across provinces and territories; the upper catch-up age in some jurisdictions ranges from 15 to 26 years. § In Mexico, target age and catch-up age ranges varied by year, with an upper catch-up age as high as 16 years.

2) Editorial, The New York Times

‘vaccinating the nation’s 11- and 12-year-old boys could cost almost $140 million a year and a one-time catch-up to vaccinate boys 13 to 21 would cost hundreds of millions more, with the government paying half the bill.’

FOR THEIR OWN GOOD

Published: October 28, 2011

The case for vaccinating all preteens against a sexually transmitted virus that causes cancer keeps getting stronger. After a thorough review of the evidence, an influential federal advisory committee recommended that boys ages 11 and 12 should routinely be vaccinated against the human papillomavirus, or HPV, echoing a 2006 recommendation for vaccinating girls of that age.

The main concern about the virus remains what it always was — it can cause cervical cancer in women. But now we know that it is also associated with cancers of the vulva and vagina in women, the penis in men, and anal and throat cancers in both men and women. All told, the virus is linked to 18,000 cancers each year among women in the United States and 7,000 among men. It is also associated with most cases of genital warts.

Conservative politicians have railed against the vaccine and the efforts by some states to require it. Many parents are appalled at the notion of vaccinating youngsters against a sexually transmitted virus before most have even begun to think about sex. The reason for starting early is clear: the immune response is strong then and the vaccine is most effective before exposure to the virus.

If that window is missed, the Advisory Committee on Immunization Practices said the vaccine should still be given routinely to women up to age 26 and men up to age 21. The federal Centers for Disease Control and Prevention is expected to adopt the recommendations soon.

Vaccination rates among teenage girls have been disappointing; only a third have received all three recommended doses. Federal officials expect the rate among young boys will be even lower.

The only vaccine approved for boys — Merck’s Gardasil — is expensive. It typically costs $390 for all three doses. A public insurance program pays for poor and uninsured children, and Merck has assistance programs. But, as Gardiner Harris reported in The Times, vaccinating the nation’s 11- and 12-year-old boys could cost almost $140 million a year and a one-time catch-up to vaccinate boys 13 to 21 would cost hundreds of millions more, with the government paying half the bill.

The advisory panel concluded that the vaccinations would be cost effective because they would reduce the burden of illness in the future. Public health officials should focus on increasing vaccination rates.