Human papillomavirus (HPV) vaccine is a vaccine that targets certain sexually transmitted strains of human papillomavirus associated with the development of cervical cancer and genital warts. A vaccine is a biological preparation which is used to establish or improve immunity to a particular disease A sexually transmitted disease ( STD) or venereal disease ( VD) is an illness that has a significant probability of transmission between Humans In biology strain is a low-level Taxonomic rank used in three related ways A human papillomavirus ( HPV) is a Papillomavirus that infects the skin and Mucous membranes of Humans Approximately 130 HPV types have been Cervical cancer is Malignant Cancer of the Cervix uteri or cervical area Genital warts (or Condyloma, Condylomata acuminata, or venereal warts) is a highly contagious Sexually transmitted [1] Two HPV vaccines are currently on the market: Gardasil and Cervarix. Gardasil ( Merck & Co) is a Vaccine against certain types of Human papillomavirus (HPV Cervarix is a Vaccine against certain types of the Human papillomavirus (HPV [2]
Of the more than 100 known HPV types, 37 are known to be transmitted through sexual contact. Infection with sexually transmitted HPVs is very common in adult populations worldwide. According to the American Centers for Disease Control, by the age of 50 more than 80% of American women will have contracted at least one strain of HPV. The Centers for Disease Control and Prevention (or CDC) is an agency of the United States Department of Health and Human Services based in unincorporated [3]
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HPV is highly communicable. A human papillomavirus ( HPV) is a Papillomavirus that infects the skin and Mucous membranes of Humans Approximately 130 HPV types have been A large percentage of the American population is infected with genital HPV. [3] Because of the infection rate, some American public health experts recommend mandatory HPV vaccination. [4] 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. [5] About 11,000 American women are diagnosed with cervical cancer every year, and about 3,700 die per year of the disease. [6] Condoms protect against HPV, but do not completely prevent transmission. [7][8][9] Both men and women can be carriers of HPV.
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. Cervical cancer is Malignant Cancer of the Cervix uteri or cervical area [10] Most scientific studies have found that human papillomavirus (HPV) infection is responsible for virtually all cases of cervical cancer. A human papillomavirus ( HPV) is a Papillomavirus that infects the skin and Mucous membranes of Humans Approximately 130 HPV types have been [11][12] Only a small percentage of women with HPV develop cervical cancer. [12]
The latest generation of preventive HPV vaccines are based on hollow virus-like particles (VLPs) assembled from recombinant HPV coat proteins. Virus like particles (VLPs consist of viral Protein (s derived from the structural proteins of a Virus. Recombinant DNA is a form of synthetic DNA that is engineered through the combination or insertion of one or more DNA strands thereby combining DNA sequences Proteins are large Organic compounds made of Amino acids arranged in a linear chain and joined together by Peptide bonds between the Carboxyl 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. Cervical cancer is Malignant Cancer of the Cervix uteri or cervical area Gardasil also targets HPV types 6 and 11, which together currently cause about 90 percent of all cases of genital warts. Genital warts (or Condyloma, Condylomata acuminata, or venereal warts) is a highly contagious Sexually transmitted [12]
Gardasil and Cervarix are designed to elicit virus-neutralizing antibody responses that prevent initial infection with the HPV types represented in the vaccine. Antibodies (also known as immunoglobulins, abbreviated Ig) are Gamma globulin Proteins that are found in Blood or other Bodily 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. Carcinoma in situ (CIS is an early form of Carcinoma defined by the absence of invasion of surrounding tissues The protective effects of the vaccine are expected to last a minimum of 4. 5 years after the initial vaccination. [13]
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. Dysplasia (from Greek roughly "bad formation" is a term used in Pathology to refer to an abnormality in maturation of cells within a tissue [14]
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, it is clear that other high-risk HPV types can circumvent the vaccines,[13] and a 2006 study of HPV infection in female university students found that only 14 of 78 infections with high-risk types of HPV were by types 16 and 18, the remaining 64 infections being with 16 other high-risk types of HPV. Ongoing research is focused on the development of HPV vaccines that will offer protection against a broader range of HPV types. [15] 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.
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 as old as 26. The Centers for Disease Control and Prevention (or CDC) is an agency of the United States Department of Health and Human Services based in unincorporated
Although HPV types 6 and 11 do not cause cervical cancer, they can cause genital warts. Genital warts (or Condyloma, Condylomata acuminata, or venereal warts) is a highly contagious Sexually transmitted "Warts cause considerable discomfort and psycho-social trauma, so this makes the vaccine more attractive and also provides a reason other than altruism for men to be immunized," explains John Schiller of the National Cancer Institute. The National Cancer Institute (NCI is part of the United States Federal government's National Institutes of Health. [16] From a public health point of view, vaccinating men as well as women might be important if it decreased the virus pool within the population. HPV also causes anal and penile cancer. Anal cancer is a type of Cancer which arises from the Anus, the distal orifice of the Gastrointestinal tract. Penile cancer is a malignant growth found on the skin or in the tissues of the Penis. In the UK the vaccine is licensed for girls and boys aged 9 to 15 and for women aged 16 to 26. Thus, the vaccine has to be administered to adult men "off license". [17]
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 Papilloma Virus (HPV) vaccines are effective in preventing cervical cancer for women up 45 years of age. [18]
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. [19]
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 [20]. 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.
In developed countries, the widespread use of good-quality cervical "Pap smear" screening programs has reduced the incidence of invasive cervical cancer by 50% or more. Vaccination policy refers to the policy a government adopts in relation to Vaccination. The Papanicolaou test (also called Pap smear, Pap test, cervical smear, or smear test) is a screening test used in Gynecology Current preventive vaccines offer protection against the two HPV types (16 & 18) that currently cause about 70% of cervical cancer cases. Therefore, experts recommend that women combine the benefits of both programs by seeking regular Pap smear screening, even after vaccination. [21]
HPV-induced cervical cancer remains the fifth most common cancer in women worldwide. [22]
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. This article describes the federal government of Australia See Australian governments for other jurisdictions [23][24]
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. A general practitioner, or GP is a medical practitioner who provides Primary care and specializes in Family medicine. 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. [25][26]
Canada has approved use of Gardasil[27], however initiating and funding free vaccination programs has been left to individual Province/Territory Governments. Country to "Dominion of Canada" or "Canadian Federation" or anything else please read the Talk Page In the provinces of Ontario, Prince Edward Island, Newfoundland and Nova Scotia[28], free vaccinations to protect women against HPV are slated to begin in September 2007 and will be offered to girls 11-14 in age. Ontario (ɒnˈtɛrioʊ is a province located in the central part of Canada, the largest by population and second largest after Quebec Prince Edward Island (ˌprɪns ˌɛdwɚd ˈaɪlɨnd ( PEI or P Newfoundland and Labrador (ˈnuːfɨn(dlənd ən(d ˈlæbrəˌdɔr (Terre-Neuve-et-Labrador is a province of Canada, the tenth and latest to join the Confederation Nova Scotia (ˌnəʊvəˈskəʊʃə ( Latin for New Scotland; Alba Nuadh Nouvelle-Écosse is a Canadian province located on Canada 's Similar vaccination programs are also being planned in British Columbia and Quebec. British Columbia (ˌbrɪtɨʃ kəˈlʌmbiə ( BC) ( (la Colombie-Britannique C Quebec (kwɨˈbɛk [29][30][31]
On July 17, 2007, France issued a directive[32] 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. Events 180 - Twelve inhabitants of Scillium in North Africa are executed for being Christians Year 2007 ( MMVII) was a Common year starting on Monday of the Gregorian calendar in the 21st century. This article is about the country For a topic outline on this subject see List of basic France topics. 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).
On March 26, 2007, early approval was granted in both Germany and Italy. Events 1026 - Pope John XIX crowns Conrad II as Holy Roman Emperor. Year 2007 ( MMVII) was a Common year starting on Monday of the Gregorian calendar in the 21st century. Germany, officially the Federal Republic of Germany ( ˈbʊndəsʁepuˌbliːk ˈdɔʏtʃlant is a Country in Central Europe. Italy (Italia officially the Italian Republic, (Repubblica Italiana is located on the Italian Peninsula in Southern Europe, and on the two largest [33]
From September 2008, Gardasil will be available for New Zealand girls and young women up to the age of 18. From 2009, the HPV immunization program will be part of the regular immunization schedule for 12 year old girls.
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. Events 1214 - Battle of Bouvines: In France, Philip II of France defeats John of England. Year 2007 ( MMVII) was a Common year starting on Monday of the Gregorian calendar in the 21st century. South Korea, officially the Republic of Korea and often referred to as Korea ( Korean: 대한민국 tɛː [34] Approval for use in boys was based on safety and immunogenicity but not efficacy. Immunogenicity is the ability of a particular substance which is called the Antigen, to provoke an Immune response.
In the U. K. a free vaccination program is being considered. [35]
On October 26, 2007, the UK government announced that all girls aged 12 and over in the UK will be vaccinated against HPV for free, in a programme costing £100m. By 2009, this vaccination will become standard NHS practice in the UK.
The vaccination will reduce the cervical screening programme from 3-yearly attendance (from age 25 to 50), to a single check at age 35. Currently attendance of cervical screening is 80%.
Almost all pieces of legislation currently pending in the states that would make the vaccine mandatory for school entrance have an "opt-out" policy. The term opt-out refers to several methods by which individuals can avoid receiving unsolicited product or service information [36]
There has been significant opposition from health insurance companies to covering the cost of the vaccine ($360). [37][38][39]
Other states are also preparing bills to handle issuing the HPV Vaccine. [40]
| State | Proposal | Status | Opt Out Policy |
|---|---|---|---|
| Alaska | Voluntary vaccination program | Passed | N/A |
| California | Bill would have required girls entering the sixth grade to be vaccinated. | Withdrawn for further consideration. | Yes |
| Colorado | Bill would require 12-year-old girls to be vaccinated to attend school. Allows parents to opt their daughters out. | Pending | Yes |
| Connecticut | Bill would require girls receive a first dose of the vaccine before entering the sixth grade. Allows parents to opt their daughters out on medical or religious grounds. | Pending | Yes |
| District of Columbia | Bill would require girls to be vaccinated before they turn 13 to attend school. Allows parents to opt their daughters out. | Pending | Yes |
| Florida | Bill would have required 11- and 12-year-old girls to be vaccinated to attend school. Allows parents to opt their daughters out. | Died in committee | Yes |
| Georgia | Bill would require girls entering the sixth grade to be vaccinated unless parents can't afford the vaccine or object to it on medical or religious grounds. | Died in Committee | Yes |
| Illinois | Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out. | Pending | Yes |
| Kansas | Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on medical or religious grounds. | Pending | Yes |
| Kentucky | Bill would require girls entering middle school to be vaccinated. Allows parents to opt their daughters out. | Passed House, to Senate | Yes |
| Maryland | Bill would have required girls entering the sixth grade to be vaccinated. | Withdrawn | Yes |
| Massachusetts | Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on religious grounds. | Pending | Yes |
| Michigan | Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out. | Pending. | Yes |
| Missouri | Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on medical or religious grounds. | Pending | Yes |
| Minnesota | Bill would require 12-year-old girls to be vaccinated to attend school. Allows parents to opt their daughters out. | Pending | Yes |
| Mississippi | Bill would have required girls entering the sixth grade to be vaccinated. | Died. Sponsor planning to re-introduce it with an opt-out clause. | No |
| Nevada | Bill would require health insurance companies to cover the cost of the vaccine | Passed into law | N/A |
| New Hampshire | Voluntary program provides vaccine free of charge to girls between the ages of eleven and eighteen. | Passed and presently in effect. | Yes |
| New Jersey | Bill would require girls in grades seven through 12 to be vaccinated. Allows parents to opt their daughters out on medical or religious grounds. | Pending | Yes |
| New Mexico | Bill would require nine- to 14-year-old girls to be vaccinated to attend school. Allows parents to opt their daughters out. | Passed legislature. Vetoed by governor. | Yes |
| Ohio | Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out. | Pending | Yes |
| Oklahoma | Bill would require girls entering the sixth grade to be vaccinated. | Pending | Yes |
| South Carolina | Bill would require girls entering the seventh grade or 11 years of age to be vaccinated. Allows parents to opt their daughters out on medical or religious grounds. | Pending | Yes |
| Texas | Governor issued executive order requiring that girls entering the sixth grade be vaccinated. Allows parents to opt their daughters out. | Texas legislature overrode executive order and barred mandatory vaccination until at least 2011. | Yes |
| Vermont | Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on medical, moral or religious grounds. | Pending | Yes |
| Virginia | Bill requires girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out. | Passed the legislature. Goes into effect Oct. 1, 2008; to be implemented in fall of 2009. | Yes |
| West Virginia | Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on medical grounds. | Died | n/a |
Source: National Conference of State Legislatures, state legislatures
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. Georgetown University is a Jesuit Private university located in Georgetown Washington D The University of Rochester ( U of R UR) is a private, nonsectarian Coeducational Research University located in Rochester The University of Queensland (UQ is one of Australia's premier learning and research institutions S. National Cancer Institute [41]. The National Cancer Institute (NCI is part of the United States Federal government's National Institutes of Health. In 2006, the U.S. Food and Drug Administration approved the first preventive HPV vaccine, marketed by Merck & Co. under the tradename Gardasil. Year 2006 ( MMVI) was a Common year starting on Sunday of the Gregorian calendar. The United States of America —commonly referred to as the Merck & Co Inc ( also known as Merck Sharp & Dohme or MSD outside the USA and Canada, is one of the largest Pharmaceutical companies According to Merck press release [42], 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. Year 2007 ( MMVII) was a Common year starting on Monday of the Gregorian calendar in the 21st century. GlaxoSmithKline plc () is a United Kingdom -based pharmaceutical, biological and Healthcare Company. Cervarix is a Vaccine against certain types of the Human papillomavirus (HPV In the European Union, GlaxoSmithKline filed the application for approval in March 2006. The European Union ( EU) is a political and economic union of twenty-seven member states, located primarily in In June 2007 this vaccine was licenced in Australia.
According to the FDA and CDC, the vaccine has only minor side effects, such as soreness around the injection area. A vaccine controversy is a dispute over the morality ethics effectiveness or safety of Vaccination. The FDA and CDC consider the vaccine to be completely safe. It does not contain mercury, thimerosal or live or dead virus, only virus-like particles, which cannot reproduce in the human body. [43] 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. Merck & Co Inc ( also known as Merck Sharp & Dohme or MSD outside the USA and Canada, is one of the largest Pharmaceutical companies
A group called the National Vaccine Information Center released an article on Feb 22, 2007, about Gardasil. The National Vaccine Information Center (NVIC headquartered in Vienna Virginia, was founded in 1982 by parents of vaccine injured children NVIC is a non-governmental, non-profit organization "dedicated to preventing vaccine injuries and deaths through public education. " The NVIC does not conduct scientific research, but is highly critical of most vaccinations including the influenza, chickenpox, tetanus, and the Measles, Mumps and Rubella (MMR) vaccines. [44] The NVIC claims "new analysis of the federal Vaccine Adverse Event Reporting System reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006. The Vaccine Adverse Event Reporting System is a United States program for vaccine safety co-sponsored by the Centers for Disease Control and Prevention (CDC and " However, reports from the Vaccine Adverse Event Reporting System database are subject to interpretation as explained at the official website: "When evaluating data from VAERS, it is important to note that for any reported event, no cause and effect relationship has been established. . . VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. " The NVIC interprets the information in VAERS to mean that "two thirds of the 385 adverse incidents are related to Gardasil injections required secondary medical treatment. " The FDA does not believe the vaccine causes serious health problems. The NVIC article goes on to say, "event reports to VAERS do[es] not prove causation. " At this time, however, the NVIC chooses to draw a causal relationship between Gardasil and what the FDA believes are unrelated illnesses. However, anti-vaccine groups note that the FDA is not an infallible body. For example, the FDA estimates that Vioxx (another Merck product) may have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003 during the time the FDA believed the drug to be safe. Rofecoxib (Rofecoxib is a nonsteroidal anti-inflammatory drug ( NSAID) marketed by Merck & Co [2]
In October 2007, the conservative group Judicial Watch reported they had obtained Vaccine Adverse Event Reporting System (VAERS) reports relating to Gardasil, “bringing the known total to 3,461 adverse reactions including eleven deaths since FDA approval. Conservatism is a term used to describe political philosophies that favour Tradition, where tradition refers to various religious cultural or nationally defined Judicial Watch is an organization which describes itself as "a conservative non-partisan American educational foundation that promotes transparency accountability and integrity in The Vaccine Adverse Event Reporting System is a United States program for vaccine safety co-sponsored by the Centers for Disease Control and Prevention (CDC and "[45] Similar to other anti-vaccination groups, Judicial Watch chooses to interpret VAERS reports as proof of vaccination injuries. The FDA and CDC considers the HPV vaccine to be safe and effective.
Several other 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. The Family Research Council (FRC is a Christian right Non-profit Think tank and Lobbying organization. [46][47][48][49]
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. " [50] All states offer an "opt-out" policy which allows parents not to vaccinate their girls for religious reasons.
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. An oncogene is a protein encoding Gene, which — when deregulated — participates in the onset and development of Cancer. 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. See also Cancer A tumor or tumour is the name for a swelling or lesion formed by an abnormal growth of cells (termed neoplastic [51]
A Mexican pharmaceuticals company, ORBI (Organizacion de Reactivos, Biologicos e Inmunologia) in Mexico City, is about to launch a therapeutical vaccination in 2008 called ONCOVACC™. [3]