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94-626: Gardasil is an HPV vaccine for use in the prevention of certain strains of human papillomavirus (HPV). It was developed by Merck & Co. High-risk human papilloma virus (hr-HPV) genital infection is the most common sexually transmitted infection among women. The HPV strains that Gardasil protects against are sexually transmitted, specifically HPV types 6, 11, 16 and 18. HPV types 16 and 18 cause an estimated 70% of cervical cancers , and are responsible for most HPV-induced anal , vulvar , vaginal , and penile cancer cases. HPV types 6 and 11 cause an estimated 90% of genital warts cases. HPV type 16
188-450: A 9-valent HPV vaccine that protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, came to the result that the rate of high-grade cervical, vulvar, or vaginal disease was the same as when using a quadrivalent HPV vaccine. A lack of a difference may have been caused by the study design of including women 16 to 26 years of age, who may largely already have been infected with the five additional HPV types that are additionally covered by
282-419: A cost-effective intervention with the potential to enhance both adolescent health and the quality of their adult lives. However, the messages and the methods by which the vaccine was marketed present important challenges to physician practice and medical professionalism. By making the vaccine's target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents
376-481: A false sense of security regarding sex and lead to promiscuity, but no evidence exists to suggest that girls who were vaccinated went on to engage in more sexual activity than unvaccinated girls. Merck, the manufacturer of the vaccine, has lobbied that state governments make vaccination with Gardasil mandatory for school attendance, which has upset some conservative and libertarian groups. The governor of Texas, Rick Perry , issued an executive order adding Gardasil to
470-509: A higher incidence among MSM include anal intraepithelial neoplasias, anal cancers, and genital warts. HPV type 16 is also responsible for almost 90% of HPV-positive oropharyngeal squamous-cell carcinoma (OPSCC), a form of cancer that affects the mouth, tonsils, and throat ; the prevalence of HPV-positive oropharyngeal cancers is higher in males than females. A 2005 study found that 95% of HIV -infected gay men also had anal HPV infection, of whom 50% had precancerous HPV-caused lesions. Gardasil
564-813: A large portion of the population may also benefit the unvaccinated by way of herd immunity . The HPV vaccine is on the World Health Organization's List of Essential Medicines . The World Health Organization (WHO) recommends HPV vaccines as part of routine vaccinations in all countries, along with other prevention measures. The WHO's priority purpose of HPV immunization is the prevention of cervical cancer , which accounts for 82% of all HPV-related cancers and more than 95% of which are caused by HPV. 88% (2020 figure) of cervical cancers and 90% of deaths occur in low- and middle-income countries and 2% (2020 figure) in high-income countries. The WHO-recommended primary target population for HPV vaccination
658-548: A larger proportion of the remaining cancers are adenocarcinomas. Trials suggest that HPV vaccines may also reduce the incidence of adenocarcinoma. As of 2022, 47 countries (24% of WHO member states) have introduced HPV vaccine in their national immunization programme for boys. For instance, it is the case in Switzerland, Portugal, Canada, Australia, Ireland, South Korea, Hong Kong, the United Kingdom, New Zealand,
752-407: A one or two-dose schedule for girls aged 9–14 years, the same for girls and women aged 15–20 years, and two doses with a 6-month interval for women older than 21 years. The vaccines provide protection for at least five to ten years. The primary target group in most of the countries recommending HPV vaccination is young adolescent girls, aged 9–14. The vaccination schedule depends on the age of
846-549: A placebo (control) vaccine taken by women, there is no difference in the risk of severe adverse events. As of 8 September 2013 , there were more than 57 million doses of Gardasil vaccine distributed in the United States, though it is unknown how many were administered. There have been 22,000 Vaccine Adverse Event Reporting System (VAERS) reports following the vaccination. 92% were reports of events considered to be non-serious (e.g., fainting, pain and swelling at
940-452: A proprietary adjuvant that has been found to boost the immune system response for a longer period of time. Cervarix is manufactured by GlaxoSmithKline . An alternative product, from Merck & Co. , is known as Gardasil . Cervarix was voluntarily taken off of the market in the US in 2016 due to low demand. HPV is a virus, usually transmitted sexually, which can cause cervical cancer in
1034-802: A researcher for the HPV vaccines, questioned whether the benefits of the vaccine outweigh its risks in countries where Pap smear screening is common. She has also encouraged women to continue pap screening after they are vaccinated and to be aware of potential adverse effects. In 2012, according to the CDC, use of the HPV vaccine had cut rates of infection with HPV-6, -11, -16 and -18 in half in American teenagers (from 11.5% to 4.3%) and by one third in American women in their early twenties (from 18.5% to 12.1%). HPV vaccines are safe and well tolerated and can be used in persons who are immunocompromised or HIV-infected. Pain at
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#17327768470961128-531: A small percentage of those women genital infected. Cervarix is a preventative HPV vaccine, not therapeutic. HPV immunity is type-specific, so a successful series of Cervarix shots will not block infection from cervical cancer-causing HPV types other than HPV types 16 and 18 and some related types, so experts continue to recommend routine cervical Pap smears even for women who have been vaccinated. Vaccination alone, without continued screening, would prevent fewer cervical cancers than regular screening alone. Cervarix
1222-533: A substantial public health impact. As of 2018, studies have proven that cervical cancer rates have dropped significantly since the introduction of Gardasil. Before Gardasil was introduced in 2006, 270,000 women died of cervical cancer worldwide in 2002. As of 2014, the mortality rate from cervical cancer has dropped 50% from 1975 which is due to the Gardasil vaccination along with increased focus on cervical screening. Acting FDA administrator Andrew von Eschenbach said
1316-596: A two-dose schedule on 2 August 2024) HPV vaccines are used to prevent HPV infection and therefore in particular cervical cancer . Vaccinating females between the ages of nine to thirteen is typically recommended, with many countries also vaccinating males in that age range. In the United States, the Centers for Disease Control and Prevention (CDC) recommends that all 11- to 12-year-olds receive two doses of HPV vaccine, administered 6 to 12 months apart. The vaccines require three doses for those ages 15 and above. Gardasil
1410-461: A vaccine against the seven types most common in cervical cancers (16, 18, 45, 31, 33, 52, 58) would prevent an estimated 87% of cervical cancers worldwide. In 2008, only 41% of women with cervical cancer in the developing world got medical treatment. Therefore, prevention of HPV by vaccination may be a more effective way of lowering the disease burden in developing countries than cervical screening. The European Society of Gynecological Oncology sees
1504-524: A woman has previously been exposed through sexual activity and protection may not be obtained by all recipients. It is therefore recommended that women continue to adhere to cervical cancer screening procedures. In common with some other prefilled syringe vaccination products, the tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals . The vial stopper does not contain latex. The active components of
1598-448: Is a three-dose (injection) vaccine. HPV vaccines are recommended in the United States for women and men who are 9–26 years of age, and are also approved for those who are 27–45 years of age. HPV vaccination of large percentage of people within a population has been shown to decrease rates of HPV infections, with part of the benefit from herd immunity . Since the vaccines only cover some high-risk types of HPV, cervical cancer screening
1692-464: Is estimated that HPV vaccines may prevent 70% of cervical cancer, 80% of anal cancer , 60% of vaginal cancer , 40% of vulvar cancer , and show more than 90% effectiveness in preventing HPV-positive oropharyngeal cancers . They also protect against penile cancer . They additionally prevent genital warts (also known as anogenital warts), with the quadrivalent and nonavalent vaccines providing virtually complete protection. The WHO recommends
1786-517: Is girls aged 9–14 years before they become sexually active. It aims the introduction of the HPV vaccine in all countries and has set a target of reaching a coverage of 90% of girls fully vaccinated with HPV vaccine by age 15 years. Females aged ≥15 years, boys, older males or men who have sex with men (MSM) are secondary target populations. HPV vaccination is the most cost-effective public health measure against cervical cancer, particularly in resource-constrained settings. Cervical cancer screening
1880-444: Is given in three injections over six months. The second injection is two months after the first, and the third injection is six months after the first shot was administered. Alternatively, in some countries it is given as two injections with at least six months between them, for individuals aged 9 years up to and including 13 years. As of April 2014, more than 170 million doses of Gardasil had been distributed worldwide. The vaccine
1974-625: Is having 90% of girls fully vaccinated with the HPV vaccine by 15 years of age. The WHO-recommended primary target population for HPV vaccination is girls aged 9–14 years before they become sexually active. Females aged ≥15 years, boys, older males or MSM are secondary target populations. Cervical cancer screening is still required following vaccination. The large majority of cervical cancer cases in 2020 (88%) occurred in LMICs, where they account for 17% of all cancers in women, compared with only 2% in high-income countries (HICs). In sub-Saharan Africa,
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#17327768470962068-407: Is important to note that for any reported event, no cause-and-effect relationship has been established. VAERS receives reports on all potential associations between vaccines and adverse events." As of 1 September 2009 , in the US there were 44 reports of death in females after receiving the vaccine. None of the 27 confirmed deaths of women and girls who had taken the vaccine were linked to
2162-410: Is indicated for the prevention of the following diseases caused by oncogenic HPV types 16 and 18: cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and CIN grade 1. In the United States, Cervarix is approved for use in females 10 through 25 years of age while in some other countries the age limit is at least 45. As of September 2009 , Cervarix
2256-588: Is likely to be much less cost-effective than for young women yet is still recommended due to the existent risk (including oral cancer). The August 2009 issue of the Journal of the American Medical Association had an article reiterating the safety of Gardasil and another questioning the way it was presented to doctors and parents. The new vaccine against 4 types of human papillomavirus (HPV), Gardasil, like other immunizations appears to be
2350-493: Is more common among adolescents receiving the Gardasil vaccine than in other kinds of vaccinations. Patients should remain seated for 15 minutes after they receive the HPV vaccine. There have been reports that the shot is more painful than other common vaccines, and the manufacturer Merck partly attributes this to the virus-like particles within the vaccine. General side effects of the shot may include joint and muscle pain, fatigue, physical weakness and general malaise. The FDA and
2444-499: Is on the WHO Model List of Essential Medicines . The WHO recommends HPV vaccines as part of routine vaccinations in all countries, along with other prevention measures. The WHO's priority purpose of HPV immunization is the prevention of cervical cancer, which accounts for 82% of all HPV-related cancers and more than 95% of which are caused by HPV. The WHO has a global strategy for cervical cancer elimination. Its first pillar
2538-573: Is recommended even after vaccination. In the US, the recommendation is for women to receive routine Pap smears beginning at age 21. In Australia, the national screening program has changed from the two yearly cytology (pap smears) to being based on tests for HPV DNA, based on work by Karen Canfell and others. As of 2021, the World Health Organization recommends HPV DNA testing as the preferred screening method. The HPV vaccine has been shown to prevent cervical dysplasia from
2632-434: Is responsible for almost 90% of HPV-positive oropharyngeal cancers , and the prevalence is higher in males than females. Though Gardasil does not treat existing infection, vaccination is still recommended for HPV-positive individuals, as it may protect against one or more different strains of the disease. The vaccine was approved for medical use in the United States in 2006, initially for use in females aged 9–26. In 2007,
2726-487: Is still required following vaccination. A growing number of vaccine products initially prequalified for use in a 2-dose schedule can now be used in a single-dose schedule. Cecolin (WHO prequalified HPV vaccine product, confirmed for use in a single-dose schedule), in the second edition of WHO's technical document on considerations for HPV vaccine product choice Cervarix (bivalent) Gardasil (quadrivalent) and Gardasil 9 nonavalent vaccine) Walrinvax (WHO prequalified with
2820-439: Is very limited and vaccination during the pregnancy term should be delayed until more information is available. If a woman is found to be pregnant during the three-dose series of vaccination, the series should be postponed until pregnancy has been completed. While there is no indication for intervention for vaccine dosages administered during pregnancy, patients and healthcare providers are encouraged to report exposure to vaccines to
2914-586: The Advisory Committee on Immunization Practices recommended Gardasil for routine vaccination of girls aged 11 and 12 years. As of August 2009, vaccination was recommended for both males and females before adolescence and the beginning of potential sexual activity. By 2011, the vaccine had been approved in 120 other countries. In 2014, the US Food and Drug Administration (FDA) approved a nine-valent version, Gardasil 9, to protect against infection with
Gardasil - Misplaced Pages Continue
3008-642: The Food and Drug Administration (FDA) of the USA license Gardasil in the United States for boys and men ages 9–26 for the prevention of genital warts. Soon after that, the vaccine was approved by the FDA for use in males aged 9 to 26 for prevention of genital warts and anal cancer . In 2011, an advisory panel for the US Centers for Disease Control and Prevention (CDC) recommended the vaccine for boys ages 11–12. This
3102-700: The University of Queensland in Australia, and the US National Cancer Institute . MedImmune , GSK , and Merck & Co. advanced these technologies and conducted clinical trials. In December 2014, the FDA approved Gardasil 9, which protects against nine strains of HPV. A few conservative groups, such as the Family Research Council (FRC), have expressed their fears that vaccination with Gardasil might give girls
3196-596: The University of Rochester , the University of Queensland in Australia, and the U.S. National Cancer Institute . Phase III trials have been conducted, including over 18,000 women from 14 countries in Asia-Pacific , Europe , Latin America and North America . As of 2009, the manufacturer was conducting a trial to compare the immunogenicity and safety of Cervarix with Gardasil . Subsequent studies showed Cervarix generated higher antibody levels than Gardasil,
3290-471: The $ 1.4 million Nobel Prize in Medicine in 2008 for his work. Verification that cervical cancer is caused by an infectious agent led several other groups to develop vaccines against HPV strains that cause most cases of cervical cancer. The other half of the award went to Françoise Barré-Sinoussi and Luc Montagnier , two French virologists, for their part in the discovery of HIV . Harald zur Hausen
3384-510: The 9-valent vaccine. Neither Cervarix nor Gardasil prevent other sexually transmitted infections, and they do not treat existing HPV infection or cervical cancer. When Gardasil was first introduced, it was recommended as a prevention for cervical cancer for women 25 years old or younger. Evidence suggests that HPV vaccines are effective in preventing cervical cancer for women up to 45 years of age. Gardasil and Gardasil 9 protect against HPV types 6 and 11 which can cause genital warts , with
3478-454: The CDC continued to recommend Gardasil vaccination for the prevention of four types of HPV. The manufacturer of Gardasil has committed to ongoing research assessing the vaccine's safety. According to the Centers for Disease Control and Prevention (CDC) and the FDA, the rate of adverse side effects related to Gardasil immunization in the safety review was consistent with what has been seen in
3572-480: The CDC recommends vaccination. Also in 2011, Harald zur Hausen 's support for vaccinating boys (so that they will be protected, and thereby so will women) was joined by professors Harald Moi and Ole-Erik Iversen. In 2018, the US Food and Drug Administration (FDA) released a summary basis for regulatory action and approval for expansion of usage and indication for Gardasil 9, the 9-valent HPV vaccine, to include men and women 27 to 45 years of age. The HPV vaccine
3666-416: The CDC said that with millions of vaccinations "by chance alone some serious adverse effects and deaths" will occur in the time period following vaccination, but they have nothing to do with the vaccine. More than twenty women who received the Gardasil vaccine have died, but these deaths have not been causally connected to the shot, as correlation does not imply causation . Where information has been available,
3760-583: The Canadian government approved $ 300 million to buy the HPV vaccine in 2008 after deciding from studies that the vaccine would be cost-effective especially by immunizing young women. Marc Steben, an investigator for the vaccine, wrote that the financial burden of HPV related cancers on the Canadian people was already $ 300 million per year in 2005, so the vaccine could reduce this burden and be cost-effective. Since penile and anal cancers are much less common than cervical cancer, HPV vaccination of young men
3854-572: The FDA approved the use of Gardasil for the prevention of head and neck cancers. The FDA approved Gardasil 9 for women and men aged 27 to 45 based on the vaccine being 88% effective against persistent HPV infections that cause certain types genital warts and cancers in females. Vaccine efficacy in males in this age group was inferred. A 2020 longitudinal study tracking over 1.6 million Swedish girls and women over an eleven-year period found half as many cervical cancer cases in all women who had been vaccinated, and amongst women who had been vaccinated before
Gardasil - Misplaced Pages Continue
3948-928: The Gardasil 9 vaccines have been approved for males, a third HPV vaccine, Cervarix , has not. Unlike the Gardasil-based vaccines, Cervarix does not protect against genital warts. 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. Gardasil is also used among men who have sex with men (MSM), who are at higher risk for genital warts, penile cancer, and anal cancer. In 2013, Australia introduced HPV vaccination for boys. while UK and Ireland introduced HPV vaccination for boys aged 12 and 13 as part of their National Immunization Plan in 2019. Portugal introduced universal HPV vaccination for boys aged 10 years and above as part of its National Immunization Plan in 2020. On 9 September 2009, an advisory panel recommended that
4042-430: 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. While the study period was not long enough for cervical cancer to develop,
4136-552: The Japanese government issued a notice that "cervical cancer vaccinations should no longer be recommended for girls aged 12 to 16" while an investigation is conducted into certain adverse events including pain and numbness in 38 girls. The vaccines sold in Japan are Cervarix, made by GSK plc (formerly GlaxoSmithKline) of the United Kingdom, and Gardasil, made by Merck Sharp & Dohme. An estimated 3.28 million people have received
4230-597: The Netherlands, and the United States. In males also, Gardasil and Gardasil 9 protect against HPV types 6 and 11 which can cause genital warts , with the quadrivalent and nonavalent vaccines providing virtually complete protection. They reduce their risk of precancerous lesions caused by HPV. This reduction in precancerous lesions is predicted to reduce the rates of penile and anal cancer in men. Gardasil has been shown to also be effective in preventing high-risk HPV types 16 and 18 in males. While Gardasil and
4324-587: The United States for a similar preventive HPV vaccine, known as Cervarix . In June 2007, this vaccine was licensed in Australia, and it was approved in the European Union in September 2007. Cervarix was approved for use in the US in October 2009. Harald zur Hausen , a German researcher who suspected, and later helped to prove that genital HPV infection can lead to cervical cancer, was awarded half of
4418-495: The United States, Gardasil is indicated for: In the European Union, Gardasil is indicated for active immunization of individuals from the age of nine years against the following HPV diseases: Gardasil is a vaccine to prevent HPV, that, for maximum effect, is recommended for individuals prior to them becoming sexually active. Moreover, evidence supports the conclusion that women who were already infected with one or more of
4512-620: The University of Queensland have been accorded priority under the US patent law for the invention of the HPV vaccine's basis, the VLPs. In 2006, the FDA approved the first preventive HPV vaccine, marketed by Merck & Co. under the trade name Gardasil. According to a Merck press release, by the second quarter of 2007 it had been approved in 80 countries, many under fast-track or expedited review. Early in 2007, GlaxoSmithKline filed for approval in
4606-562: The age of 17 a 78% reduction in cervical cancer, "a substantially reduced risk of invasive cervical cancer at the population level." An alternative vaccine known as Cervarix protects against two oncogenic strains of HPV, 16 and 18. The National Cancer Institute says, "To date, protection against the targeted HPV types has been found to last for at least 10 years with Gardasil, at least 9 years with Cervarix, and at least 6 years with Gardasil 9. Long-term studies of vaccine efficacy that are still in progress will help scientists better understand
4700-1000: The appropriate HPV vaccine pregnancy registry. The HPV vaccines are based on hollow virus-like particles (VLPs) assembled from recombinant HPV coat proteins . The natural virus capsid is composed of two proteins, L1 and L2, but vaccines only contain L1. Gardasil contains inactive L1 proteins from four different HPV strains: 6, 11, 16, and 18, synthesized in the yeast Saccharomyces cerevisiae . Each vaccine dose contains 225 μg of aluminum, 9.56 mg of sodium chloride, 0.78 mg of L-histidine , 50 μg of polysorbate 80 , 35 μg of sodium borate, and water. The combination of ingredients totals 0.5 mL. HPV types 16 and 18 cause about 70% of all cervical cancer . Gardasil also targets HPV types 6 and 11, which together cause about 90 percent of all cases of genital warts . Gardasil and Cervarix are designed to elicit virus-neutralizing antibody responses that prevent initial infection with
4794-598: The cases of genital warts . Common plantar warts —e.g., caused by HPV types 1, 2, and 4—are not prevented by this vaccine. In 2010, Gardasil was approved by the FDA for prevention of anal cancer and associated precancerous lesions due to HPV types 6, 11, 16, and 18 in people aged 9 through 26 years. HPV infections, especially HPV 16, contribute to some head and neck cancer (HPV is found in an estimated 26–35% of head and neck squamous cell carcinoma). In principle, HPV vaccines may help reduce incidence of such cancers caused by HPV, but this has not been demonstrated. In June 2020,
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#17327768470964888-492: The cause of death was explained by other factors. Likewise, a small number of cases of Guillain–Barré syndrome (GBS) have been reported following vaccination with Gardasil, though there is no evidence linking GBS to the vaccine. It is unknown why a person develops GBS, or what initiates the disease. The FDA and the CDC monitor events to see if there are patterns, or more serious events than would be expected from chance alone. The majority (68%) of side effects data were reported by
4982-412: The clinical trials had a relatively small sample size. As of 2018 , the vaccine is not recommended for pregnant women. The FDA has classified the HPV vaccine as a pregnancy Category B, meaning there is no apparent harm to the fetus in animal studies. HPV vaccines have not been causally related with adverse pregnancy outcomes or adverse effects on the fetus. However, data on vaccination during pregnancy
5076-474: The developing world as most likely to benefit from HPV vaccination. However, individuals in many resource-limited nations, Kenya for example, are unable to afford the vaccine. In more developed countries, populations that do not receive adequate medical care, such as poor or minorities in the United States or parts of Europe also have less access to cervical screening and appropriate treatment, and are similarly more likely to benefit. In 2009, Dr. Diane Harper ,
5170-400: The development of the vaccine began in 1991 by The University of Queensland investigators Jian Zhou and Ian Frazer in Australia . Researchers at UQ found a way to form non-infectious virus-like particles (VLP), which could also strongly activate the immune system. Subsequently, the final form of the vaccine was developed in parallel, by researchers at Georgetown University Medical Center,
5264-478: The development of the vaccine began in 1991 by investigators Jian Zhou and Ian Frazer in The University of Queensland , Australia. Researchers at UQ found a way to form non-infectious virus-like particles (VLP), which could also strongly activate the immune system. Subsequently, the vaccine was developed in parallel by researchers at Georgetown University Medical Center, the University of Rochester ,
5358-722: The early years of Gardasil's introduction it was unclear how widespread the use of the three-shot series would be, in part because of its $ 525 list price ($ 175 each for three shots). But as of 2013, vaccine coverage has been rising. In 2013, about 55% of girls ages 13–17 years had at least one dose of the vaccination covered, up from 29% in 2007. Coverage for women ages 18–34 also has increased significantly since 2007. Studies using different pharmacoeconomic models predict that vaccinating young women with Gardasil in combination with screening programs may be more cost effective than screening alone. These results have been important in decisions by many countries to start vaccination programs. For example,
5452-518: The four HPV types targeted by the vaccine (HPV types 6, 11, 16, or 18) were protected from clinical disease caused by the remaining HPV types in the vaccine. HPV types 16 and 18 cause an estimated 70% of cervical cancers , and are responsible for most HPV-induced anal cancers. Gardasil also protects against vulvar and vaginal cancers caused by HPV types 16 and 18, as well as most penile cancers caused by these two HPV types. In addition, protection against HPV types 6 and 11 may eliminate up to 90% of
5546-582: The full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on risks and benefits. As important and appropriate as it is for PMAs to advocate for vaccination as a public good, their recommendations must be consistent with appropriate and cost-effective use. According to the CDC, as of 2012, use of the HPV vaccine had cut rates of infection with HPV-6, -11, -16 and -18 in half in American teenagers (from 11.5% to 4.3%) and by one third in American women in their early twenties (from 18.5% to 12.1%). Research findings that pioneered
5640-453: The high-risk HPV types 16 and 18 and provide some protection against a few closely related high-risk HPV types. However, there are other high-risk HPV types that are not affected by the vaccine. The protection against HPV 16 and 18 has lasted at least eight years after vaccination for Gardasil and more than nine years for Cervarix. It is thought that booster vaccines will not be necessary. As of September 2024, 57 countries are implementing
5734-402: The injection site (arm), headache, nausea and fever), and the rest were considered to be serious (death, permanent disability, life-threatening illness and hospitalization). However, VAERS reports include any reported effects whether coincidental or causal. In response to concerns regarding the rates of adverse events associated with the vaccine, the CDC stated: "When evaluating data from VAERS, it
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#17327768470965828-520: The manufacturer, but in about 90% of the manufacturer reported events, no follow-up information was given that would be useful to investigate the event further. In February 2009, the Spanish Ministry of Health suspended use of one batch of Gardasil after health authorities in the Valencia region reported that two girls had become ill after receiving the injection. Merck has stated that there
5922-496: The other commercially available HPV vaccine, upon testing seven months later, with twice the level for HPV type 16 and six times for HPV type 18. In the United Kingdom it was included in the national vaccination programme for teenage and pre-teenage girls aged 12–13 and 17–18 from September 2008 to August 2012. This caused some controversy since Cervarix was chosen over Gardasil , even though Gardasil protects against additional HPV types 6 and 11 (which cause genital warts ). However,
6016-494: 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." In 2004, preventive vaccines already protected against
6110-438: The potential to reduce cervical cancer incidence around the world by as much as 90%. In addition, the vaccines may reduce the need for screening and subsequent medical care, biopsies, and invasive procedures associated with follow-up from abnormal cervical screening, thus helping to reduce health care costs and anxieties related to follow-up procedures. Whether the effects are temporary or lifelong, widespread vaccination could have
6204-450: The prevention of these cervical precancerous lesions (or dysplasias ) is believed highly likely to result in the prevention of those cancers. The vaccine was first developed by the University of Queensland in Australia. The final form was made by researchers at the University of Queensland, Georgetown University Medical Center , University of Rochester , and the US National Cancer Institute . Researchers Ian Frazer and Jian Zhou at
6298-453: The quadrivalent and nonavalent vaccines providing virtually complete protection. HPV types 16, 18 and 45 contribute to 94% of cervical adenocarcinoma (cancers originating in the glandular cells of the cervix). While most cervical cancer arises in the squamous cells, adenocarcinomas make up a sizable minority of cancers. Further, Pap smears are not as effective at detecting adenocarcinomas , so where Pap screening programs are in place,
6392-621: The region with the highest rates of young WLWH, approximately 20% of cervical cancer cases occur in WLWH [women living with HIV]. HPV infection is more likely to persist and to progress to cancer in WLWH.33 Mortality rates vary 50-fold between countries, ranging from <2 per 100 000 women in some HICs to >40 per 100 000 in some countries of sub-Saharan Africa. Of the 20 hardest hit countries by cervical cancer, 19 are in Africa. The US National Cancer Institute states "Widespread vaccination has
6486-421: The research community to characterize the natural history of HPV infection, and to develop a better understanding of mechanisms of HPV-induced carcinogenesis. In December 2014, the US Food and Drug Administration (FDA) approved a vaccine called Gardasil 9 to protect females between the ages of 9 and 26 and males between the ages of 9 and 15 against nine strains of HPV. Gardasil 9 protects against infection from
6580-639: The risk of young men contracting genital warts. In the United States, the FDA approved administration of the Gardasil vaccine to males between ages 9 and 26 in 2009. The FDA approved administration of the Gardasil 9 vaccine to males between ages 9 and 15 in 2014, and extended the age indication, by including males between ages 16 and 26, in 2015. In the UK, HPV vaccines are licensed for males aged 9 to 15 and for females aged 9 to 26. Men who have sex with men (MSM) are particularly at risk for conditions associated with HPV types 6, 11, 16, and 18; diseases and cancers that have
6674-484: The safety studies carried out before the vaccine was approved and were similar to those seen with other vaccines. However, a higher proportion of syncope (fainting) was seen with Gardasil than is usually seen with other vaccines. The FDA and CDC have reminded health care providers that, to prevent falls and injuries, all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes after vaccination. The HPV vaccination does not appear to reduce
6768-456: The single-dose schedule. A growing number of vaccine products initially prequalified for use in a 2-dose schedule can now be used in a single-dose schedule. Before, it was unsure whether two doses of the vaccine may work as well as three doses. The US Centers for Disease Control and Prevention (CDC) recommends two doses in those less than 15 years and three doses in those over 15 years. A single dose might be effective. A study with 9vHPV,
6862-410: The site of injection occurs in between 35% to 88% of people Redness and swelling at the site and fever may also occur. No link to Guillain–Barré syndrome has been found. There are no increased risk of serious adverse effects. Extensive clinical trial and post-marketing safety surveillance data indicate that both Gardasil and Cervarix are well tolerated and safe. When comparing the HPV vaccine to
6956-472: The state's required vaccination list, which was later overturned by the Texas legislature. Even though Perry also allowed parents to opt out of the program more easily, Perry's order was criticized, by fellow presidential candidates Rick Santorum and Michele Bachmann during the 2012 Republican Party presidential debate as being an overreach of state power in a decision properly left to parents. In June 2013,
7050-680: The strains covered by the first generation of Gardasil (HPV-6, HPV-11, HPV-16, and HPV-18) and protects against five other HPV strains responsible for 20% of cervical cancers (HPV-31, HPV-33, HPV-45, HPV-52, and HPV-58). Cervarix Cervarix is a vaccine against certain types of cancer-causing human papillomavirus (HPV). Cervarix is designed to prevent infection from HPV types 16 and 18, that cause about 70% of cervical cancer cases. These types also cause most HPV-induced genital and head and neck cancers. Additionally, some cross-reactive protection against virus strains 45 and 31 were shown in clinical trials. Cervarix also contains AS04 ,
7144-427: The strains covered by the first generation of Gardasil as well as five other HPV strains responsible for 20% of cervical cancers (types 31, 33, 45, 52, and 58). In 2018, the FDA approved expanded use of Gardasil 9 for individuals 27 to 45 years old. Gardasil is available as Gardasil which protects against 4 types of HPV (6, 11, 16, 18) and Gardasil 9 which protects against an additional 5 types (31, 33, 45, 52, 58). In
7238-468: The total duration of protection." Gardasil has been shown to be partially effective (approximately 38%) in preventing cervical cancer caused by ten other high-risk HPV types. Antibody levels at month 3 (one month post-dose number two) are substantially higher than at month 24 (18 months post-dose number three), suggesting that protection is achieved by month 3 and perhaps earlier. In 2014, the World Health Organization (WHO) recommended that countries offer
7332-536: The two HPV types (16 and 18) that cause about 70% of cervical cancers worldwide. Because of the distribution of HPV types associated with cervical cancer, the vaccines were likely to be most effective in Asia, Europe, and North America. Some other high-risk types cause a larger percentage of cancers in other parts of the world. Vaccines that protect against more of the types common in cancers would prevent more cancers, and be less subject to regional variation. For instance,
7426-580: The vaccination; 1,968 cases of possible side effects have been reported. In January 2014, the Vaccine Adverse Reactions Review Committee concluded that there was no evidence to suggest a causal association between the HPV vaccine and the reported adverse events, but did not reinstate proactive recommendations for its use. A study on girls in Sapporo showed that since the Japanese government's suspension of recommending
7520-439: The vaccine are: Cervarix is created using the L1 protein of the viral capsid . L1 protein is in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses High Five Rix4446 cells derived from the insect Trichoplusia ni . The vaccine contains no live virus and no DNA, so it cannot infect the patient. The research findings that pioneered
7614-558: The vaccine in a two dose schedule to girls aged under 15, with each dose at least six months apart. The United Kingdom, Switzerland , Mexico, and Quebec province of Canada are among the countries or territories that have implemented this as of June 2015. The CDC recommended the vaccines be delivered in two shots over six months. Gardasil is also effective in males, providing protection against genital warts, anal warts, anal cancer , and some potentially precancerous lesions caused by some HPV types. Gardasil vaccine has been shown to decrease
7708-545: The vaccine recipient. As of 2023, 27% of girls aged 9–14 years worldwide received at least one dose (37 countries were implementing the single-dose schedule, 45% of girls aged 9–14 years old vaccinated in that year). As of September 2024, 57 countries are implementing the single-dose schedule. At least 144 countries (at least 74% of WHO member states) provided the HPV vaccine in their national immunization schedule for girls, as of November 2024. As of 2022, 47 countries (24% of WHO member states) also did it for boys. Vaccinating
7802-433: The vaccine will have "a dramatic effect" on the health of women around the world. Gardasil is an important tool in reducing cervical cancer rates even in countries where screening programs are routine. The National Cancer Institute estimated that 9,700 women would develop cervical cancer in 2006, and 3,700 would die. Merck and CSL Limited are expected to market Gardasil as a cancer vaccine, rather than an STD vaccine. In
7896-1259: The vaccine, completion rates for the full course of vaccination have dropped to 0.6%. On 26 November 2021, the Ministry of Health, Labour, and Welfare of Japan officially issued an announcement to resume active recommendations of the HPV vaccine after 8.5 years of suspension and municipalities are expected to restart such active recommendations from April 2022. HPV vaccine Human papillomavirus ( HPV ) vaccines are vaccines intended to provide acquired immunity against infection by certain types of human papillomavirus (HPV). The first HPV vaccine became available in 2006. Currently there are six licensed HPV vaccines: three bivalent (protect against two types of HPV), two quadrivalent (against four), and one nonavalent vaccine (against nine) All have excellent safety profiles and are highly efficacious, or have met immunobridging standards. All of them protect against HPV types 16 and 18, which are together responsible for approximately 70% of cervical cancer cases globally. The quadrivalent vaccines provide additional protection against HPV types 6 and 11. The nonavalent provides additional protection against HPV types 31, 33, 45, 52 and 58. It
7990-593: The vaccine. There is no evidence suggesting that Gardasil causes or raises the risk of Guillain–Barré syndrome . Additionally, there have been rare reports of blood clots forming in the heart, lungs, and legs. A 2015 review conducted by the European Medicines Agency 's Pharmacovigilance Risk Assessment Committee concluded that evidence does not support the idea that HPV vaccination causes complex regional pain syndrome or postural orthostatic tachycardia syndrome . As of 8 September 2013 ,
8084-401: The viral DNA , they cannot induce cancer. They do, however, trigger an antibody response that protects vaccine recipients from becoming infected with the HPV types represented in the vaccine. The L1 proteins are produced by separate fermentations in recombinant Saccharomyces cerevisiae and self-assembled into VLPs. The National Cancer Institute writes: Widespread HPV vaccination has
8178-533: The willingness of women to undergo pap tests . While the use of HPV vaccines can help reduce cervical cancer deaths by two-thirds around the world, not everyone is eligible for vaccination. There are some factors that exclude people from receiving HPV vaccines. These factors include: 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. However,
8272-469: Was difficult because only parts of the viral DNA were integrated into the host genome. He found novel HPV-DNA in cervix cancer biopsies, and thus discovered the new, tumourigenic HPV16 type in 1983. In 1984, he cloned HPV16 and 18 from patients with cervical cancer. The HPV types 16 and 18 were consistently found in about 70% of cervical cancer biopsies throughout the world. His observation of HPV oncogenic potential in human malignancy provided impetus within
8366-435: Was intended to prevent genital warts and anal cancers in males, and possibly prevent head and neck cancer (though the vaccine's effectiveness against head and neck cancers has not yet been proven). The committee also made the vaccination recommendation for males 13 to 21 years who have not been vaccinated previously or who have not completed the three-dose series. For those under the age of 27 who have not been fully vaccinated
8460-405: Was maximized, and the subpopulations most at risk practically ignored. The vaccine manufacturer also provided educational grants to professional medical associations (PMAs) concerned with adolescent and women's health and oncology. The funding encouraged many PMAs to create educational programs and product-specific speakers' bureaus to promote vaccine use. However, much of the material did not address
8554-411: Was no evidence Gardasil was responsible for the two illnesses. The following are the ingredients found in the different formulations of HPV vaccines: The HPV major capsid protein, L1, can spontaneously self-assemble into virus-like particles (VLPs) that resemble authentic HPV virions . Gardasil contains recombinant VLPs assembled from the L1 proteins of HPV types 6, 11, 16 and 18. Since VLPs lack
8648-466: Was shown to be effective 7.3 years after vaccination. Immunization with Cervarix consists of 3 doses of 0.5-mL each, by intramuscular injection according to the following schedule: 0, 1, and 6 months. The preferred site of administration is the deltoid region of the upper arm. Cervarix is available in 0.5-mL single-dose vials and prefilled TIP-LOK syringes. Cervarix does not provide protection against disease due to all HPV types, nor against disease if
8742-537: Was skeptical of the prevailing dogma and postulated that oncogenic HPV caused cervical cancer. He realized that HPV-DNA could exist in an inactive state in the tumours, and should be detectable by specific searches for viral DNA. He and workers at the Pasteur Institute found HPV to be a heterogeneous family of viruses. Only some HPV types cause cancer. Harald zur Hausen pursued his research for over ten years searching for different HPV types. This research
8836-426: Was tested in thousands of females (ages 9 to 26). The US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC) consider the vaccine to be safe. It does not contain mercury , thiomersal , live viruses or dead viruses, but virus-like particles, which cannot reproduce in the human body. The vaccine has mostly minor side effects, such as pain around the injection area. Fainting
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