Human papilloma virus ( HPV ) vaccine is a vaccine that prevents infection by certain types of human papillomavirus. The available vaccines protect against two, four, or nine HPV types. All vaccines protect against at least HPV types 16 and 18 that cause the greatest risk of cervical cancer. It is estimated that they can prevent 70% of cervical cancers, 80% of anal cancer, 60% of vaginal cancers, 40% of vulvar cancers, and possibly some cancers. They also prevent some genital warts with vaccines against 4 and 9 HPV types that provide greater protection.
The World Health Organization (WHO) recommends HPV vaccine as part of routine vaccination in all countries, along with other preventive measures. Vaccines require two or three doses depending on the person's age and immune status. Girls' vaccination around the age of nine to thirteen is usually recommended. Vaccines provide protection for at least 5 to 10 years. Cervical cancer examination is still needed after vaccination. Vaccination of most populations can also be beneficial to unvaccinated ones. In those already infected with the vaccine is not effective.
HPV vaccine is very safe. Pain at the injection site occurs in about 80% of people. Redness and swelling on the site and fever may also occur. No link to Guillain-BarrÃÆ' à © à © syndrome has been found.
The first HPV vaccine was available in 2006. By 2017, 71 countries have included the vaccine in their routine vaccination, at least for girls. They are on the World Health Organization's Essential Drug List, the most effective and safe medicines needed in the health system. Wholesale costs in developing countries are around US $ 47 per dose in 2014. In the United States it costs more than US $ 200. Vaccinations may be cost-effective in developing countries.
Video HPV vaccines
Medical use
The HPV vaccine is used to prevent HPV infection and therefore cervical cancer. They are recommended for women aged 9 to 25 who have not been exposed to HPV. However, as it is unlikely that a woman has contracted nine viruses, and since HPV is primarily sexually transmitted, the US Centers for Disease Control and Prevention has recommended vaccinations for women up to age 26.
Since the vaccine includes only some high-risk HPV types, cervical cancer screening is recommended even after vaccination. In the US, the recommendation for women is to receive routine Pap smears starting at age 21. Additional candidate vaccine studies occur for next-generation products to extend protection against additional HPV types.
Men
HPV vaccine is approved for men in several countries, including Canada, Australia, South Korea, Hong Kong (China SAR), United Kingdom, New Zealand and the United States.
In males, Gardasil may reduce the risk of genital warts and precancerous lesions caused by HPV. Reduction of precancerous lesions is expected to reduce the rate of penile and anal cancer in men. Gardasil has been shown to be also effective in preventing genital warts in men. While the Gardasil and Gardasil-9 vaccine has been approved for men, the third HPV vaccine, Cervarix, is not given to men. Unlike Gardasil-based vaccines, Cervarix does not protect against genital warts. As in women, vaccines should be given before infection with the type of HPV covered by the vaccine occurs. Vaccinations before adolescence, therefore, make it more likely that recipients have not been exposed to HPV.
Because penile and rectal cancer is much more common than cervical cancer, HPV vaccination in young men is probably much cheaper than for young women. From a public health standpoint, male and female vaccinations reduce virus collection in the population, but are only cost-effective if the absorption of the female population is very low. In the United States, the cost-per-life-adjusted annual cost is greater than US $ 100,000 to vaccinate the male population, compared with less than US $ 50,000 to vaccinate the female population. This assumes a 75% vaccination rate.
In early 2013 the two companies that sold the most common vaccines announced price cuts of less than US $ 5 per dose to poor countries, compared to US $ 130 per dose in the US.
Gardasil is a special request among men who have sex with men, who are at higher risk for genital warts, penile cancer, and anal cancer.
Recommendations by national agencies
On September 9, 2009, the advisory panel recommended that the FDA Gardasil licenses in the United States for boys and boys ages 9-26 for the prevention of genital warts. Shortly thereafter, the vaccine is approved by the FDA for use in men aged 9 to 26 for the prevention of genital warts and anal cancer.
On October 25, 2011, advisory panel for the Centers for Disease Control and Prevention (CDC) voted to recommend that vaccines should be given to boys ages 11-12. The panel recommendations are intended to prevent genital warts and anal cancer in men, and may prevent head and neck cancer (although vaccine effectiveness against head and neck cancer has not been proven). The committee also makes vaccination recommendations for men 13 to 21 years who have not been vaccinated before or who have not completed the three-dose series.
Harald zur Hausen's support for vaccinating boys (so they will be protected, and thus so do women) joins professors Harald Moi and Ole-Erik Iversen in 2011.
Older woman
When Gardasil was first introduced, it was recommended as a precaution for cervical cancer for women aged 25 years or younger. New evidence suggests that all HPV vaccines are effective in preventing cervical cancer for women up to 45 years.
In November 2007, Merck presented new data in Gardasil. In one study, Gardasil reduced the incidence of HPV types 6, 11, 16 and 18 associated with persistent and persistent infections in women up to the age of 45 years. This study evaluated women who did not contract at least one of the HPV types targeted by the vaccine. at the end of the three-dose vaccination series. Merck plans to submit this data before the end of 2007 to the FDA, and to look for indications for Gardasil for women through the age of 45.
Benefits
The HPV vaccine has been shown to prevent the cervical dysplasia of high-risk type 16 and 18 HPV and provides protection against certain high-risk strain-associated HPV types. However, there are other high-risk types of HPV that are not affected by the vaccine. Protection against HPV 16 and 18 has lasted at least 8 years after vaccination for Gardasil and more than 9 years for Cervarix. It is estimated that booster vaccine is not necessary.
Gardasil also protects against low risk HPV types 6 and 11, which are much less likely to cause cancer, but cause genital warts.
Recent data analysis from Cervarix clinical trials found that the vaccine is just as effective in protecting women from persistent HPV infection 16 and 18 in the anus as it protects them from this infection in the cervix. Overall, about 30 percent of cervical cancers will not be prevented by this vaccine. Also, in the case of Gardasil, 10 percent of genital warts will not be prevented by the vaccine. Both vaccines prevent other sexually transmitted diseases, nor do they treat existing HPV infections or cervical cancer.
HPV types 16, 18 and 45 contribute to 94% cervical adenocarcinoma (cancer derived from cervical gland cells). While most cervical cancers appear in squamous cells, adenocarcinoma forms a fairly large minority of cancers. Furthermore, Pap smears are not effective in detecting adenocarcinoma, so that where the Pap smear program is in place, a larger proportion of the remaining cancers is adenocarcinoma. Experiments show that HPV vaccine may also reduce the incidence of adenocarcinoma.
Two doses of vaccine can work as well as three doses. The CDC recommends two doses in those with fewer than 15 and three doses in those over 15 years of age.
A study with 9vHPV, a 9-valent HPV vaccine that protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, to the result that high-grade cervical, vulvar, or vaginal diseases are the same as when using quadrivalent HPV vaccine. The lack of discrepancies may be due to research design including women aged 16 to 26, who may be most infected with five additional HPV types that are also covered by the 9-valent vaccine.
Public health
The National Cancer Institute states, "Broad vaccination has the potential to reduce deaths from cervical cancer worldwide by two-thirds if all women take the vaccine and if protection is long term, and vaccines may reduce the need for medical care, biopsy and procedures invasive associated with follow-up of an abnormal Pap test, thereby helping to reduce the cost of health care and anxiety associated with abnormal Pap tests and follow-up procedures. "
The current preventive vaccine protects against two types of HPV (16 and 18) that cause about 70% of cervical cancers worldwide. Because of the distribution of HPV types associated with cervical cancer, vaccines tend to be most effective in Asia, Europe, and North America. Several other high-risk types cause a greater percentage of cancers in other parts of the world. Protecting vaccines more than the common type of cancer will prevent more cancers, and less subject to regional variations. For example, the vaccine against the seven most common types of cervical cancers (16, 18, 45, 31, 33, 52, 58) will prevent about 87% of cervical cancers worldwide.
Only 41% of women with cervical cancer in developing countries are receiving medical care. Therefore, prevention of HPV with vaccination may be a more effective way to reduce the burden of disease in developing countries than cervical screening. The European Society of Gynecology Oncology sees the developing world as being most likely to benefit from HPV vaccination. However, individuals in many resource-limited countries, eg Kenya, can not afford the vaccine.
In more advanced countries, populations that do not receive adequate medical care, such as the poor or minority in the United States or parts of Europe also have less access to appropriate cervical screening and treatment, and are also more likely to benefit. Comments made by Dr. Diane Harper, a researcher for HPV vaccine, are interpreted as demonstrating that in countries where Pap smear screening is common, it would take the vaccination of most women to further reduce the rate of cervical cancer. She also encourages women to continue the pap examination after they are vaccinated and to be aware of potential side effects.
According to the CDC, in 2012, the use of HPV vaccine has reduced rates of infection with HPV-6, -11, -16 and -18 half in American adolescents (from 11.5% to 4.3%) and one third in American women in early two tens (from 18.5% to 12.1%).
Maps HPV vaccines
Side effects
While the use of HPV vaccine may help reduce deaths from cervical cancer by two-thirds worldwide, not everyone is eligible for vaccination. There are several factors that exclude people from receiving HPV vaccines. These factors include:
- People with a history of direct hypersensitivity to the vaccine component. Patients with hypersensitivity to yeast should not receive Gardasil because yeast is used in its production.
- People with moderate or severe acute illness. It does not completely exclude patients from vaccinations, but delays the vaccination time until the disease improves.
Pregnancy
In the Gardasil clinical trial, 1,115 pregnant women received HPV vaccine. Overall, the proportion of pregnancies with poor outcomes was comparable in the subjects receiving Gardasil and the subjects receiving placebo. However, clinical trials have relatively small sample sizes. Currently, vaccines are not recommended for pregnant women. Long-term effects of vaccines on fertility are unknown, but no anticipated effects.
The FDA has classified HPV vaccine as a Category B pregnancy, which means there is no obvious danger to the fetus in animal studies. The HPV vaccine has not been causally associated with adverse pregnancy outcomes or adverse effects on the fetus. However, data on vaccination during pregnancy is very limited and vaccinations during pregnancy should be postponed until further information becomes available. If a woman is found pregnant for three series of doses of vaccination, the series will be postponed until the pregnancy has been completed. Although there is no indication for interventions for vaccine doses administered during pregnancy, patients and health care providers are encouraged to report vaccine exposure to appropriate HPV vaccine registration registrations.
Security
The preventive HPV vaccine is generally safe without an increased risk of serious adverse events. The HPV vaccine is approved for use in more than 100 countries, with over 100 million doses distributed worldwide. Extensive clinical trials and post-marketing safety surveillance data show that Gardasil and Cervarix are well tolerated and safe. When comparing the HPV vaccine with the placebo (control) vaccine taken by women, there was no difference in the risk of severe side-effects.
Gardasil is a 3-dose (injectable) vaccine. As of September 8, 2013 there are over 57 million doses distributed in the United States, though it is unknown how much has been given. There are 22,000 Vaccine Adverse Event Reporting System (VAERS) reports after vaccination. Ninety-two percent are reports of incidents that are considered non-serious (eg, fainting, pain and swelling at the injection site (sleeve), headache, nausea and fever), and 9 percent are considered serious (death, permanent disability, life-threatening illness and inap). There is no proven causal link between the vaccine and the serious side effects; The VAERS report includes either coincidental or causal effects. The CDC states: "When evaluating data from the VAERS, it is important to note that for each reported event, no cause-and-effect relationship has been established.VAERS receives reports of all potential relationships between vaccines and adverse events."
As of September 1, 2009, there have been 44 reports of US deaths on women after receiving the vaccine. None of the 27 confirmed confirmed deaths of women and girls who have used the vaccine were associated with the vaccine. There is no evidence to suggest that Gardasil causes or increases the risk of Guillain-Barrà © à © syndrome. In addition, there are reports of rare blood clots that form in the heart, lungs, and legs. The 2015 review conducted by the Pharmacovigilance Risk Assessment Committee of the European Drug Agency concluded that the evidence does not support the idea that HPV vaccination causes complex regional pain syndromes or postural orthostatic tachycardia syndrome.
On September 8, 2013, the CDC continues to recommend Gardasil vaccination for the prevention of four types of HPV. Merck, the manufacturer of Gardasil, has committed to ongoing research to assess vaccine safety.
According to the Centers for Disease Control and Prevention (CDC) and the FDA, the extent of adverse events associated with Gardasil immunization in a safety review is consistent with what has been seen in safety studies conducted before the vaccine is approved and similar to those seen with other vaccines. However, a higher proportion of syncope (fainting) is seen with Gardasil than is usually seen with other vaccines. The FDA and CDC have warned healthcare providers that, to prevent falls and injuries, all vaccine recipients should remain seated or lying down and observed closely for 15 minutes after vaccination. HPV vaccination does not seem to reduce the willingness of women to undergo pap tests.
Action mechanism
The HPV vaccine is based on hollow virus-like particles (VLPs) that are assembled from recombinant HPV coat proteins. The virus has double circular stranded DNA and a viral shell of 72 capsomeres. Each viral subunit consists of two protein molecules, L1 and L2. The reason why this virus has the ability to affect the skin and mucosal lining is due to its structure. The main structures expressed in this area are E1 and E2, these proteins are responsible for viral replication. E1 is a highly sustainable protein in the virus, E1 is responsible for the production of virus copies are also involved in every step of the replication process. The second component of this process is that E2 ensures that non-specific interactions occur when interacting with E1. As a result of these proteins working together ensure that many copies are made in the host cell. Virus structure is very important because it affects the affinity of viral infections. Knowing the structure of the virus allows for the development of efficient vaccines, such as Gardasil and Cervarix. The vaccine targets two high risk HPVs, types 16 and 18 that cause the most cervical cancer. Gardasil protein is synthesized by Saccharomyces cerevisiae yeast. Its protein makeup allows to target four types of HPV. Gardasil contains inactivated L1 proteins from four different HPV strains: 6, 11, 16, and 18. Each dose of vaccine contains 225 Ã, μg aluminum, 9.56 mg sodium chloride, 0.78 mg L-histidine, 50 à , Ãμg polysorbate 80, 35Ã,Ãμg sodium borate, and water. Combination of total ingredients 0.5 mL. Together, both types of HPV currently cause about 70 percent of all cervical cancers. Gardasil also targets HPV types 6 and 11, which together currently account for about 90 percent of all cases of genital warts.
Gardasil and Cervarix are designed to induce a virus-binding antibody response that prevents early infection with the type of HPV that is represented in the vaccine. The vaccine has been shown to offer 100 percent protection against the development of pre-cancerous cervix and genital warts caused by HPV types in the vaccine, with little or no side effects. The effects of vaccine protection are expected to last at least 4.5 years after the initial vaccination.
While the study period is not long enough to develop cervical cancer, prevention of cervical precancerous lesions (or dysplasia) is believed to be most likely to result in the prevention of these cancers.
History
The vaccine was first developed by the University of Queensland in Australia and the final form was made by researchers at the University of Queensland, the Georgetown University Medical Center, the University of Rochester, and the National Cancer Institute. Researchers Ian Frazer and Jian Zhou at Queensland University have been given priority under US patent law for the foundation of HPV vaccine, VLPs. In 2006, the FDA approved the first HPV prevention vaccine, marketed by Merck & amp; Co under the trade name Gardasil. According to Merck's press release, in the second quarter of 2007, it has been approved in 80 countries, many under a quick review or quick review. Early 2007, GlaxoSmithKline filed for approval in the United States for a similar HPV-prevention vaccine, known as Cervarix. In June 2007, the vaccine was licensed in Australia, and approved in the European Union in September 2007. Cervarix is ââapproved for use in the US in October 2009.
Harald zur Hausen, a German researcher who initially suspected and later helped prove that genital HPV infection can cause cervical cancer, was awarded half of the $ 1.4 million Nobel Prize in Medicine for his work. Verifying that cervical cancer is caused by an infectious agent causes some other groups (see above) to develop a vaccine against HPV strains that cause most cases of cervical cancer. The other half of the award was given to FranÃÆ'çoise BarrÃÆ'à © -Sinoussi and Luc Montagnier, two virologists of France, for their part in the discovery of HIV.
zur Hausen opposes the current dogma and postulates that the oncogenic human papilloma virus (HPV) causes cervical cancer. He realizes that HPV-DNA can exist in an unproductive state in tumors, and must be detected by specific searches for viral DNA. He and others, especially workers at the Pasteur Institute, found HPV as a heterogeneous family of viruses. Only a few types of HPV cause cancer.
Harald zur Hausen pursued his idea of ââHPV for more than 10 years by looking for a different type of HPV. [3] This study is difficult due to the fact that only part of the viral DNA is integrated into the host genome. He found a novel HPV-DNA in a biopsy of cervical cancer, and then found a new HPV16 type, tumorourigenic in 1983. In 1984, he cloned HPV16 and 18 of patients with cervical cancer. HPV types 16 and 18 are consistently found in about 70% of cervical cancer biopsies worldwide.
Observing the oncogenic potential of HPV in human malignancies provides a boost within the research community to characterize the natural history of HPV infection, and to develop a better understanding of the mechanisms of carcinogenesis induced by HPV.
In December 2014, the United States Food and Drug Administration (FDA) approved a vaccine called Gardasil 9 to protect women between the ages of 9 and 26 and men between the ages of 9 and 15 against nine strains of HPV. Gardasil 9 protects against infection with strains covered by first generation 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).
Vaccine implementation
In developed countries, the widespread use of the cervical "Pap smear" screening program has reduced the incidence of invasive cervical cancer by 50% or more. The current preventive vaccine reduces but does not eliminate the possibility of cervical cancer. Therefore, experts recommend that women combine the benefits of both programs by looking for regular Pap smear screening, even after vaccination. The European Center for Disease Prevention and Control (ECDC) has recommended all European teenage girls to be vaccinated; but Bulgaria, Cyprus, Czech Republic, Estonia, Lithuania, Poland, Slovakia and Turkey do not currently have a vaccination program.
Africa
With support from the GAVI Alliance, a number of low-income African countries have begun rolling HPV vaccines, with others to follow. In 2013 Ghana, Kenya, Madagascar, Malawi, Niger, Sierra Leone, and the United Republic of Tanzania initiated the implementation of the vaccine. In 2014, Rwanda will begin a national launch, and a demonstration program will take place in Mozambique and Zimbabwe.
Australia
In April 2007, Australia became the first country to introduce the Government-funded National Humane Papillomavirus (HPV) Vaccination Program to protect young women against HPV infections that can cause cancer and disease. The National HPV Vaccination Program is registered on the National Immunization Program Schedule (NIP) and is funded under the Australian Immunization Program. The Australian immunization program is a joint initiative of the Australian, State and Territory Governments to improve immunization rates for vaccine-preventable diseases.
The National HPV Vaccination Program for women consists of two components: an ongoing school-based program for girls aged 12 and 13; and limited time-chasing program (women aged 14-26) delivered through schools, public practice and community immunization services, which ended on 31 December 2009.
During 2007-2009, an estimated 83% of women aged 12-17 years received at least one dose of HPV vaccine and 70% completed a 3-dose HPV vaccination course. The latest HPV coverage data on the Immunize Australia website shows that at age 15, more than 70% of Australian women have received all three doses. It has remained stable since 2009.
Since the National HPV Vaccination Program started in 2007, there has been a reduction of HPV-related infections in young women. A study published in The Journal of Infectious Disease in October 2012 found the prevalence of preventable vaccine-preventable HPV types (6, 11, 16 and 18) in Papanicolaou test results of women 18-24 years old significantly decreased from 28.7% to 6.7% four years after the introduction of the National HPV Vaccination Program. A published 2011 report found the diagnosis of genital warts (caused by HPV types 6 and 11) also decreased in women and young men.
In October 2010, the Australian regulatory agency, Therapeutic Goods Administration, extended the registration of the quadrivalent vaccine (Gardasil) to include use in men aged 9 to 26, for the prevention of external genital lesions and HPV infections of types 6, 11, 16 and 18.
In November 2011, the Pharmaceutical Benefit Advisory Committee (PBAC) recommended an extension of the National HPV Vaccination Program to include men. PBAC makes recommendations on the attainable preventive health benefits, such as reducing the incidence of anal and penile cancers and other HPV-related diseases. In addition to direct benefits to men, it is estimated that routine adult HPV vaccinations will contribute to the reduction of HPV infection-the type of vaccine and related diseases in women through herd immunity.
On July 12, 2012, the Australian Government announced funding to extend the National HPV Vaccination Program to involve men, with execution beginning in all states and territories in February 2013.
Updated results reported in 2014.
Starting February 2013, free HPV vaccines are provided through a school-based program to:
- men and women aged 12-13 years (ongoing program); and
- males between 14-15 years old - until the end of the school year in 2014 (pursuit program).
More information is available on the HPV Vaccination Program website at www.australia.gov.au/hpv
Canada
In July 2006, human papillomavirus vaccine against 4 HPV types was validated in Canada for women aged 9 to 26 years. In February 2010, use in men aged 9 to 26 years for the prevention of genital warts is legitimate.
Currently, all Canadian provinces and territories fund HPV-based immunization programs for women. Three provinces have implemented HPV immunization programs for men: Prince Edward Island, Alberta, and Saskatchewan.
Canada has approved the use of Gardasil. Initiating and funding free vaccination programs has been submitted to each Provincial/District Government. In the provinces of Ontario, Prince Edward Island, Newfoundland and Labrador, and Nova Scotia, free vaccinations to protect women against HPV are scheduled to begin in September 2007 and will be offered to women ages 11-14. A similar vaccination program is being planned in British Columbia and Quebec.
China
GSK China announced on July 18, 2016, that Cervarix (HPV 16 and 18 vaccines) has been approved by the China Food and Drug Administration (CFDA), therefore being the first approved HPV vaccine in China. Cervarix is ââregistered in China for girls aged 9 to 25, adopting a 3-dose program within 6 months. Cervarix is ââexpected to be marketed in China in early 2017.
On the same day, the China Food and Drug Administration (CFDA) also announced that the application for the import of Human Papillomavirus Absorbed Vaccine (Cervarix), a biological preventive product manufactured by GlaxoSmithKline, was approved on July 12, 2016. This vaccine approval will provide a new method effective to prevent cervical cancer.
Colombia
The vaccine was introduced in 2012, approved for 9 older girls. The HPV vaccine is being sent to girls aged nine and over and attending the four-grade school. Since 2013 the age of coverage is extended for girls in schools of the fourth grade who have reached the age of 9 to grade 11 independent of age; and not attending school from 9-17 years 11 months and 29 days.
Europe
Israel
Introduced in 2012. Target age group 13-14. Fully funded by national health authorities only for this age group. For 2013-2014, girls in eighth grade can get free vaccines only in schools, and not in the offices or clinics of the Department of Health. Girls in ninth grade can receive free vaccines only at the Ministry of Health offices, and not in schools or clinics. Religious and conservative groups are expected to reject vaccinations.
Japanese
Introduced in 2010, widely available only since April 2013. Fully funded by national health authorities. However, in June 2013, the Japan Vaccine Reaction Reaction Committee (VARRC) suspended the vaccine recommendation due to worries of adverse events. This directive has been criticized by researchers at the University of Tokyo as a government failure because the decision was taken without showing sufficient scientific evidence.
Kenya
Both Cervarix and Gardasil are approved for use in Kenya by the Pharmaceutical and Poison Bodies. However, at the cost of Kenya's 20,000 shillings, which is more than the average annual income for the family, health promotion director at the Health Ministry, Nicholas Muraguri, stated that many Kenyans are unable to pay for the vaccine.
Laos
In 2013 Laos started to implement the HPV vaccine, with the help of the Gavi Alliance.
Mexico
Vaccines were introduced in 2008 to 5% of the population. The percentage of this population has the lowest developmental index that correlates with the highest incidence of cervical cancer. HPV vaccine is sent to girls aged 12-16 years after a dosing schedule of 0-2-6. In 2009 Mexico has expanded the use of vaccines for girls, ages 9-12 years, the dosing schedule in this group is different, the time elapsed between the first and second doses is six months and the third dose is 60 months later. In 2011 Mexico approved the use of a nationwide HPV vaccination program to include vaccinations of all 9-year-old girls.
New Zealand
Immunization in 2017 is free for men and women ages 9 to 26 years.
Public funding began on September 1, 2008. It was initially only for girls, usually through a school-based program in Class 8 (around age 12), but also through common practice and some family planning clinics. More than 200,000 young New Zealand girls and women have received HPV immunization in November 2015, about 60% of eligible girls.
Panama
The vaccine was added to the national immunization program in 2008, to target girls in a 10-year-old population. The vaccine is managed by clinics and schools.
South Africa
Cervical cancer is the most common cause of cancer-related deaths - more than 3,000 deaths per year - among women in South Africa due to high HIV prevalence, making vaccine introduction highly desirable. The Papanicolaou test program was established in 2000 to help screen for cervical cancer, but since the program has not been widely applied, vaccination will offer a more efficient form of prevention. In May 2013 South African Health Minister Aaron Motsoaledi announced the government will provide free HPV vaccines for girls aged 9 and 10 in 80% of the poorest schools that began in February 2014 and the fifth quintile in the future. South Africa will be the first African nation with an immunization schedule that includes a vaccine to protect people from HPV infection, but because the effectiveness of vaccines in women who later became infected with HIV has not been fully understood, it is difficult to assess how cost-effective the vaccine is. Negotiations are currently underway for more affordable HPV vaccines because they are 10 times more expensive than those already included in the immunization schedule.
South Korea
On July 27, 2007, the South Korean government approved Gardasil for use in girls and women aged 9 to 26 and boys aged 9 to 15. Approval for use in boys is based on safety and immunogenicity but not effective.
Since 2016, HPV vaccination has become part of the National Immunization Program, offered free of charge to all children under 12 years of age in South Korea, at full cost to the Korean government.
For the year 2016 alone, Korean girls born between January 1, 2003 and December 31, 2004 are also eligible to receive free shots as a limited time offer. Starting in 2017, free shots will be available for those under 12 years old.
Trinidad and Tobago
Introduced in 2013. Group Goals 9-26. Fully funded by national health authorities. Administration in schools is currently suspended due to objections and concerns filed by the Catholic Council, but is fully available at local health centers.
United Kingdom
In the UK, the vaccine is licensed to girls aged 9 to 15, for women aged 16 to 26, and for boys aged 9-15 years.
HPV vaccination with Cervarix was introduced into the national immunization program in September 2008, for girls aged 12-13 in the UK. The two-year campaign began in Fall 2009 to vaccinate all girls until the age of 18. The vaccination will be offered to:
- girls between the ages of 16 and 18 from fall 2009, and
- girls between the ages of 15 and 17 from the fall of 2010.
At the end of a chase campaign, all girls under the age of 18 will be offered the HPV vaccine.
In September 2012, Gardasil replaced Cervarix as the preferred HPV vaccination due to its additional protection against genital warts.
It will be years before vaccination programs have an effect on the incidence of cervical cancer so women are advised to continue accepting their invitations for cervical screening.
Boots UK created its own HPV vaccination service for boys and boys aged 12-44 years in April 2017 at a cost of Ã, à £ 150 per vaccination. Children aged 12-14 years need two vaccinations, while those aged 15-44 require three courses.
United States
Adoption
By the end of 2007, about a quarter of US women aged 13-17 years had received at least one in three HPV shots. By 2014, the proportion of women receiving vaccination has increased to 38%. The government began recommending vaccinations for boys in 2011; by 2014, the rate of vaccination among boys (at least one dose) has reached 35%.
According to the US Centers for Disease Control and Prevention (CDC), getting as many women as possible is vaccinated as early as possible and as soon as possible will reduce cases of cervical cancer among middle-aged women within 30 to 40 years and reduce this transmission to highly contagious infections. Barriers include a limited understanding by many that HPV causes cervical cancer, difficulty getting pre-teens and teenagers to the doctor's office for injections, and high vaccine costs ($ 120/dose, total $ 360 for the three required). dose, plus the cost of doctor visits). Community-based interventions can increase HPV vaccination acceptance among adolescents.
The survey was conducted in 2009 to collect information on the knowledge and adoption of HPV vaccine. Thirty percent of children aged 13 to 17 years and 9% of 18 to 26 years out of a total of 1,011 young women surveyed reported receiving at least one HPV injection. Knowledge of HPV varies; However, 5% or fewer subjects believe that HPV vaccine precludes the need for regular cervical cancer screening or safe sex practices. Some young girls and women exaggerate the protection provided by the vaccine. Despite moderate uptake, many women at risk of acquiring HPV have not received the vaccine. For example, young black women are less likely to receive HPV vaccine than young white women. In addition, young women of all races and ethnicity without health insurance are less likely to start vaccine-taking.
Since Gardasil's approval in 2006 and despite the low vaccine uptake, the prevalence of HPV among adolescents aged 14-19 has been cut in half by a decrease of 88% among women vaccinated. No decrease in prevalence was observed in other age groups, suggesting that the vaccine is responsible for the sharp decline in cases. A decrease in the number of infections is expected to lead to a decline in cervical cancer and other HPV-related cancers in the future.
Legislation
Shortly after the first HPV vaccine was approved, a bill to make a mandatory vaccine for school attendance was introduced in many states. Only two bills were passed (in Virginia and Washington DC) for the first four years after the introduction of the vaccine. Mandates have been effective in increasing the absorption of other vaccines, such as mumps, measles, rubella, and hepatitis B (which are also sexually transmitted). But most of these efforts are developed over five years or more after the vaccine release, while financing and supply are regulated, further security data is gathered, and educational efforts improve understanding, before mandates are considered. Most public policies including school mandates have not been effective in promoting HPV vaccination when receiving recommendations from doctors raising the possibility of vaccination.
Country-by-Countries
The State Legislative National Conference periodically publishes a summary of legislation related to HPV-related vaccines.
Almost all of the currently pending pieces of law in the state that will make the mandatory school entrance vaccine have a "opt out" policy.
In July, 2015, Rhode Island added the HPV vaccine requirement for admission to public schools. This mandate requires that all students enter the 7th grade to receive a dose of HPV vaccine starting September 2015. No legislative action is required for the Rhode Island Health Department to add a new vaccine mandate. Rhode Island is the only country in need of a vaccine for boys and girls 7th grade boys.
Other countries also set up bills related to HPV vaccine.
Source: National Legislative Country Conference
Immigrant
Between July 2008 and December 2009, the first evidence of three doses of the Gardasil HPV vaccine was needed for women ages 11 to 26 who intend to enter the United States legally. This need creates controversy because of the cost of the vaccine, and because all other vaccines are needed to prevent the disease spread by the respiratory route and is considered highly contagious. The Centers for Disease Control and Prevention revoked all HPV vaccination vaccinations for effective immigrants December 14, 2009.
Coverage
Measures have been considered including requiring insurance companies to protect HPV vaccinations, and funding HPV vaccines for those who do not have insurance. The cost of HPV vaccine for women under 18 years of uninsured is covered by the federal Children's Vaccine Program. On September 23, 2010, the vaccine must be covered by the insurance company under Patient Protection and Affordable Care Act. The HPV vaccine in particular should be closed at no cost to women, including those who are pregnant or breastfeeding.
Medicaid covers HPV vaccination in accordance with ACIP recommendations, and immunization is mandatory under Medicaid services for eligible individuals under 21. [1] In addition, Medicaid includes the Vaccine for Children Program. [1] This program provides immunization services for children aged 18 and under who are eligible for Medicaid, are not insured, underinsured, receive immunizations through the Federal Qualified Healthcare Center or Rural Health Clinic, or Native American or Alaskan Native. [1]
Vaccine manufacturers also offer help to people who can not afford HPV vaccination. The GlaxoSmithKline Vaccine Access Program provides free Cervarix 1-877-VACC-911 for low-income women, aged 19 to 25, who have no insurance. The Ventric Vaccine Patient Assistance Program, 1-800-293-3881 provides free Gardasil for low-income women and men, aged 19 to 26, who have no insurance, including immigrants who are official residents.
Opposition in the United States
Insurance Company
There is a significant controversy from health insurance companies to cover the cost of the vaccine ($ 360).
Religious and conservative groups
The opposition due to vaccine safety has been tackled through the study, leaving the opposition focusing on the sexual implications of the vaccine to remain. Conservative groups in the US have opposed the concept of making mandatory HPV vaccinations for teenage girls, insisting that making mandatory vaccines is a violation of parental rights. They also said that it would lead to early sexual activity, giving a false sense of immunity to sexually transmitted diseases. (See Peltzman effect) Both the Family Research Council and the Family Focus group support the availability of extensive (universal) HPV vaccines but against mandatory HPV vaccination for admission to public schools. Parents also expressed confusion over the recent mandate to enter public schools by showing that HPV is transmitted through sexual contact, not through schooling with other children.
Conservative groups worry that children will see the vaccine as a protection against STD and will have sex sooner than those without vaccines while failing to use contraception. However; Many organizations such as the American Academy of Pediatrics disagree with the argument that vaccines increase sexual activity among adolescents. Dr Christine Peterson, director of the University of Virginia Gynecology Clinic, said: "The presence of seat belts does not cause people to drive less safely.The presence of a vaccine in a person's body does not cause them to engage in risk-taking behavior they will not use."
Parent opposition
Many parents who oppose giving HPV vaccine to their pre-teens agree that the vaccine is safe and effective, but finds talking to their children about uncomfortable sex. Elizabeth Lange, of Waterman Pediatrics in Providence, RI, overcomes this concern by emphasizing what the vaccine does for the child. Dr. Lange suggests parents should focus on aspects of cancer prevention without being distracted by words such as 'sexually transmitted'. Everyone wants cancer prevention, but here parents refuse their children a form of protection because of the nature of cancer - Lagne points out that much of this controversy will not surround breast cancer or colon cancer vaccines. HPV vaccine is recommended for children aged 11 years should be given before the possibility of HPV exposure, yes, but also because the immune system has the highest response to create antibodies around this age. Dr. Lange also emphasized studies showing that HPV vaccine does not cause children to be more choosy than without vaccines.
Controversy over HPV vaccine remains in the media. Parents in Rhode Island have created a Facebook group called "Rhode Islanders Against Mandated HPV Vaccinations" in response to the Rhode Island mandate that men and women enter the 7th grade, as of September 2015, vaccinated for HPV before attending public schools.
Impact of physician
The effectiveness of doctors' recommendations for HPV vaccine also contributes to low vaccination rates and controversy surrounding vaccines. A 2015 study of national physician communication and support for the HPV vaccine found doctors routinely recommend the HPV vaccine less strongly than those recommending Tdap or meningitis vaccine, finding discussions about HPV to be lengthy and burdensome, and discussing the last HPV vaccine, after all the other vaccines. The researchers suggest these factors prevent patients and parents from preparing HPV vaccines on time. To increase the rate of vaccination, this issue should be addressed and clinicians should be better trained to handle discussing the importance of HPV vaccine with patients and their families.
Research
There is a high risk type of HPV, which is not affected by the available vaccines. Ongoing research is focused on developing an HPV vaccine that will offer protection against a wider variety of HPV. One such method is a vaccine based on a minor capsid L2 protein, which is highly sustainable throughout the HPV genotype. Efforts for this have included increasing the immunogenicity of L2 by linking together short L 2 amino acid sequences of various oncogenic HPV types or by displaying L2 peptides in more immunogenic carriers. There is also a great research interest in the development of therapeutic vaccines, which seek to get immune responses to existing HPV infections and HPV-induced cancers.
Therapeutic 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, this vaccine focuses on the main HPV oncogene, E6 and E7. Because E6 and E7 expressions are necessary to promote the growth of cervical cancer cells (and cells in the warts), it is expected that an immune response to two oncogenes can eradicate an existing tumor.
There is a working therapeutic HPV vaccine. It has passed 3 clinical trials. The vaccine is officially called the MEL-1 vaccine but is also known as the MVA-E2 vaccine. In a study it has been suggested that immunogenic peptide pools contain epitopes that can be effective against all of the globally circulated high-risk strains of HPV and 14 preserved immunogenic peptide fragments of the 4 initial proteins (E1, E2, E6 and E7) of 16 high- HPV that provides CD8 responses.
The VGX-3100 therapeutic DNA vaccine, consisting of plasmids pGX3001 and pGX3002, has been given a waiver by the European Drug Agency for the treatment of pediatric cervical squamous intraepithelial lesions caused by HPV types 16 and 18. According to an article published Sep 16, 2015 at The Lancet, which reviews the safety, efficacy, and immunogenicity of VGX-3100 in a double-blind randomized controlled trial (phase 2b) targeting HPV-16 and HPV-18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3 , this is the first therapeutic vaccine to demonstrate efficacy against CIN 2/3 associated with HPV-16 and HPV-18. In June 2017, VGX-3100 entered a phase 3 clinical trial called REVEAL-1 for the treatment of high-grade squamous intraepithelial lesions induced by HPV. Estimated turnaround time to collect primary clinical endpoint data is August 2019.
Awards
In 2009 as part of the Q150 celebration, the cervical cancer vaccine was announced as one of the Queensland Q150 icons for its role in "innovation and invention".
In 2017, National Cancer Institute scientists, Douglas R. Lowy and John T. Schiller received the Lasker-DeBakey Clinical Medical Research Award for their contributions that led to the development of HPV vaccine.
References
External links
- Information about cervical cancer vaccine or HPV vaccine , Cancer Council Australia .
- "HPV", MedlinePlus , NIH .
- Human Papillomavirus (HPV) , Centers for Disease Control and Prevention (CDC) .
- Human Papillomavirus (HPV) vaccine (National Cancer Institute Fact Sheet), USA: National Institutes of Health, October 22, 2009 .
Source of the article : Wikipedia