HPV vaccine

Human papillomavirus (HPV) vaccine is a vaccine that prevents infection with certain species of human papillomavirus associated with the development of cervical cancer, genital warts¹, and some less common cancers (e.g., anal², vulvar³, vaginal³, penile²). Two HPV vaccines are currently on the market: Gardasil and Cervarix.⁴ Both vaccines protect against two of the HPV types that cause cervical cancer, and some other genital cancers; Gardasil also protects against two of the HPV types that cause genital warts.¹

Public health officials in the Australia, Canada, Europe and United States recommend vaccination of young women against HPV because of high infection rates worldwide, a desire to reduce the number of painful and costly treatments for cervical dysplasia, which is caused by HPV, and the desire to prevent genital warts and cervical cancer.⁵ Worldwide, HPV is the most common sexually transmitted infection in adults.⁶ For example, more than 80% of American women will have contracted at least one strain of HPV by age fifty.⁷⁸⁹¹⁰¹¹

Although most women infected with genital HPV will not have complications from the virus,¹² worldwide there are an estimated 470,000 new cases of cervical cancer that result in 233,000 deaths per year.¹³ About eighty percent of deaths from cervical cancer occur in poor countries.¹⁴ In the United States, most of the approximately 11,000 cervical cancers found annually¹⁵ occur in women who have never had a Pap smear, or not had one in the previous five years.

Since the vaccine only covers some high-risk types of HPV, experts still recommend regular Pap smear screening even after vaccination.¹⁶

History

In work that was initiated in the mid 1980s, the vaccine was developed, in parallel, by researchers at Georgetown University Medical Center, the University of Rochester, the University of Queensland in Australia, and the U.S. National Cancer Institute ¹⁷. In 2006, the U.S. Food and Drug Administration approved the first preventive HPV vaccine, marketed by Merck & Co. under the trade name Gardasil. According to Merck press release ¹⁸, in the second quarter 2007, it had been approved in 80 countries, many under fast-track or expedited review. Early in 2007, GlaxoSmithKline filed for approval in the United States for a similar preventive HPV vaccine, known as Cervarix. In June 2007 this vaccine was licenced in Australia, and it was approved in the European Union in September 2007.¹⁹

Therapeutic HPV vaccines

In addition to preventive vaccines, such as Gardasil and Cervarix, laboratory research and several human clinical trials are focused on the development of therapeutic HPV vaccines. In general these vaccines focus on the main HPV oncogenes, E6 and E7. Since expression of E6 and E7 is required for promoting the growth of cervical cancer cells (and cells within warts), it is hoped that immune responses against the two oncogenes might eradicate established tumors.²⁰

Prevalence of genital HPV

United States

According to the Centers for Disease Control, by the age of 50 more than 80% of American women will have contracted at least one strain of genital HPV.²¹ Both men and women can be carriers of HPV.²² HPV is the most common sexually transmitted infection in the US.²¹ A large percentage of the American population is infected with genital HPV²³ because HPV is highly communicable. As a result, American public health experts recommend wide-spread HPV vaccination.²⁴

Only a small percentage of women with HPV develop cervical cancer.²⁵ Each year, between 250,000 and 1 million American women are diagnosed with cervical dysplasia, which is caused by HPV and is a potential precursor to cervical cancer.²⁶ About 11,000 American women are diagnosed with cervical cancer every year, and about 3,700 die per year of the disease.¹⁵ Most cancers occur in those who have not had Pap smears within the previous five years.

There are 19 "high-risk" HPV types that can lead to the development of cervical cancer or other genital/anal cancers; some forms of HPV, particularly type 16, have been found to be associated with a form of throat cancer.²⁷ Studies have found that human papillomavirus (HPV) infection is responsible for virtually all cases of cervical cancer.²⁸²⁵

Condoms protect against HPV, but do not completely prevent transmission.²⁹³⁰³¹ College freshmen women who used condoms consistently had a 37.8% per patient-year incidence of genital HPV, compared to an incidence of 89.3% among those who did not.²⁹³⁰³¹

No data is kept by the U.S. government on genital wart infection rates³², however it is estimated that 20 million people are presently infected with genital warts, and there are six million new cases of genital warts every year in the United States.³³

Worldwide

Worldwide, cervical cancer is the fifth most deadly cancer in women.³⁴ There are an estimated 470,000 new cases of cervical cancer, and 233,000 deaths per year.¹³

Vaccination and public health

According to the American National Cancer Institute, "Widespread vaccination has the potential to reduce cervical cancer deaths around the world by as much as two-thirds, if all women were to take the vaccine and if protection turns out to be long-term. In addition, the vaccines can reduce the need for medical care, biopsies, and invasive procedures associated with the follow-up from abnormal Pap tests, thus helping to reduce health care costs and anxieties related to abnormal Pap tests and follow-up procedures (2)."¹⁶

Current preventive vaccines protect against the two HPV types (16 & 18) that cause about 70% of cervical cancers worldwide.³⁵ Because of the distribution of HPV types associated with cervical cancer, the vaccines are likely to be most effective in Asia and Europe/North America.³⁵ Vaccines covering more of the types common in cancers would prevent more cancers, and be less subject to regional variation.³⁵

Only 41% of women with cervical cancer in the developing world are able to access medical treatment for their illness.³⁶ Therefore, prevention of HPV by vaccination may be a more effective way of lowering the disease burden in developing countries than cervical screening.^{citation needed}

Vaccine target populations

Gardasil and Cervarix are preventative (rather than therapeutic) vaccines, recommended for women who are 9 to 25 years old and have not contracted HPV. However, since it is unlikely that a woman will have already contracted all four viruses, and because HPV is primarily sexually transmitted, the U.S. Centers for Disease Control and Prevention has recommended vaccination for women up to 26 years of age.

When Gardasil was first introduced, it was recommended as a prevention for cervical cancer for women that were 25 years old or younger. New evidence suggests that all Human Papillomavirus (HPV) vaccines are effective in preventing cervical cancer for women up to 45 years of age.³⁷

In November 2007, Merck presented new data on Gardasil. This data indicated that in an investigational study, their HPV vaccine reduced incidence of HPV 6, 11, 16 and 18-related persistent infection and disease in women through age 45. The study evaluated women who were free of infection from at least one vaccine HPV type at the beginning of the study, and who remained free of infection with the relevant HPV type(s) until they completed the three-dose vaccination series. Merck planned to submit this data before the end of 2007 to the U.S. Food and Drug Administration (FDA), and to seek an indication for Gardasil for women through age 45.³⁸

Vaccination during pregnancy

In the Gardasil clinical trials, 1,115 pregnant women received the HPV vaccine. Overall, the proportions of pregnancies with an adverse outcome were comparable in subjects who received Gardasil and subjects who received placebo ³⁹. However, the clinical trials had a relatively small sample size. Currently the vaccine is not recommended for pregnant women.¹ The long term effects of this vaccine on fertility are not known, but no effects are anticipated.

Vaccination of males

Gardasil can also be used in males to reduce their risk of genital warts and precancerous lesions caused by HPV.² The reduction in precancerous lesions is expected to reduce the rates of penile and anal cancers in men.² Since penile and anal cancers are much less common than cervical cancer, HPV vaccination of young men is likely to be much less cost-effective than for young women.⁴⁰ From a public health point of view, vaccinating men as well as women might be useful if it decreased the virus pool within the population. Gardasil is in particular demand among gay men, who are at significantly increased risk for genital warts, penile cancer, and anal cancer.⁴¹

Just as with females, the vaccine must be administered before infection with the HPV types covered by the vaccine occurs. Vaccination before adolescence makes it more likely that the recipient has not been exposed to HPV.

In the UK, HPV vaccines are licensed for boys aged 9 to 15.⁴² Merck, the maker of Gardasil, is expected to ask the FDA for permission to market the vaccine in the United States for boys and men between ages 9 to 26.² The vaccine is already available in the United States and can be used off label for the vaccination of males.²

Safety

According to the FDA and CDC, the vaccine has only minor side effects, such as soreness around the injection area. The FDA and CDC consider the vaccine to be safe. It does not contain mercury, thimerosal or live or dead virus, only virus-like particles, which cannot reproduce in the human body.¹ Merck, the manufacturer of Gardasil, will continue to test women who have received the vaccine to determine the vaccine's efficacy over the period of a lifetime.

Mechanism of action

The latest generation of preventive HPV vaccines are based on hollow virus-like particles (VLPs) assembled from recombinant HPV coat proteins. The vaccines target the two most common high-risk HPVs, types 16 and 18. Together, these two HPV types currently cause about 70 percent of all cervical cancer.³⁵ Gardasil also targets HPV types 6 and 11, which together currently cause about 90 percent of all cases of genital warts.²⁵

Gardasil and Cervarix are designed to elicit virus-neutralizing antibody responses that prevent initial infection with the HPV types represented in the vaccine. The vaccines have been shown to offer 100 percent protection against the development of cervical pre-cancers and genital warts caused by the HPV types in the vaccine, with few or no side effects. The protective effects of the vaccine are expected to last a minimum of 4.5 years after the initial vaccination.⁴³

While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions (or dysplasias) is believed highly likely to result in the prevention of those cancers.⁴⁴

Although a 2006 study suggests that the vaccines may offer limited protection against a few HPV types that are closely related to HPVs 16 and 18, there are other high-risk HPV types are not affected by the vaccines.⁴³ Ongoing research is focused on the development of HPV vaccines that will offer protection against a broader range of HPV types.⁴⁵ There is also substantial research interest in the development of therapeutic vaccines, which seek to elicit immune responses against established HPV infections and HPV-induced cancers.

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.⁴⁶

Australia

Commencing in 2007 The Australian federal government began funding a voluntary program to make the Gardasil vaccine available free of charge to women aged between 12 and 26 for a period of two years, with an ongoing vaccination program for 12-13 year olds as part of the pre-existing high school vaccination program.⁴⁷⁴⁸

In Australia, the Australian government and the PBS (Pharmaceutical Benefits Scheme) have approved the vaccine for use and in 2007 began a nationwide vaccination program free of charge to schoolgirls in years 7 to 12. These programs are run by local councils with funding and vaccine supplies coming from the government. The subsidization approval process, however, appears to have been heavily influenced by political interference from politicians of all political parties, and by the Prime Minister who publicly advised that it would be approved (before approval). In addition, women between 18 and 26 years of age at the time of the first dose may receive the vaccine for free upon request from their general practitioner. After June 2009, the program will be scaled down to 12–13 year old girls only. Australia also approved Gardasil for boys 9–15 years old, but Australia is not providing government funding for vaccinating boys.⁴⁹⁵⁰

Canada

Canada has approved use of Gardasil⁵¹. 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 Scotia⁵², free vaccinations to protect women against HPV are slated to begin in September 2007 and will be offered to girls 11-14 in age. Similar vaccination programs are also being planned in British Columbia and Quebec.⁵³⁵⁴⁵⁵

France

On July 17, 2007, France issued a directive⁵⁶ 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.⁵⁷

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 kids. Cervarix and Gardasil are supplied free to all girls and women between the ages of 12 and 26.⁵⁸⁵⁹.

New Zealand

From September 2008, Gardasil will be available for New Zealand girls and young women born in 1990 and 1991 through primary care and from 2009, the HPV immunization program will be part of the regular immunization schedule for 12 year old girls.

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 15.⁶⁰ Approval for use in boys was based on safety and immunogenicity but not efficacy.

United Kingdom

In the UK the vaccine is licensed for girls and boys aged 9 to 15 and for women aged 16 to 26.⁴²

HPV vaccination will be introduced into the national immunisation programme in September 2008, for girls aged 12-13 across the UK. Then, starting in autumn 2009, a two year catch up campaign will vaccinate all girls up to 18 years of age. This catch up campaign will offer to vaccinate:

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

When the HPV vaccination programme begins in 2008, women over the age of 18 will not be vaccinated as it would not be cost effective in preventing cervical cancer. This is because as soon as a woman becomes sexually active, she is at risk of infection with the virus.

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.⁶¹

United States

As of late 2007, about one quarter of US females age 13-17 years had received at least one of the three HPV shots.⁶²

Legislation

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.⁶³

State-by-State

Opposition in the United States

Health insurance companies

There has been significant opposition from health insurance companies to covering the cost of the vaccine ($360).⁶⁴⁶⁵⁶⁶

Religious right and conservative groups

Several conservative 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. 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.⁶⁷⁶⁸⁶⁹⁷⁰

Response

Many organizations disagree with the assessment that the vaccine would increase sexual activity among teens. Dr. Christine Peterson, director of the University of Virginia's Gynecology Clinic, said "The presence of seat belts in cars doesn't cause people to drive less safely. The presence of a vaccine in a person's body doesn't cause them to engage in risk-taking behavior they would not otherwise engage in." ⁷¹ All states offer an "opt-out" policy which allows parents not to vaccinate their girls for religious reasons.

References

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Contents

History

Therapeutic HPV vaccines

Prevalence of genital HPV

United States

Worldwide

Vaccination and public health

Vaccine target populations

Vaccination during pregnancy

Vaccination of males

Safety

Mechanism of action

Vaccine implementation

Australia

Canada

France

Germany and Italy

Greece

New Zealand

South Korea

United Kingdom

United States

Legislation

Opt-out policies

State-by-State

Opposition in the United States

Health insurance companies

Religious right and conservative groups

Response

References

External links

Information about the HPV and vaccination

Major media coverage

Organizations in favor of vaccination

Organizations opposed to vaccination