Gardasil , also known as Gardisil or Silgard or recombinant human papillomavirus vaccine [type 6, 11, 16, 18] , is a vaccine for use in the prevention of certain types of human papillomavirus (HPV), especially HPV types 6, 11, 16 and 18. HPV types 16 and 18 cause about 70% of cervical cancers, and are responsible for most cases of anal, , vagina, and HPV-induced penis. HPV types 6 and 11 cause about 90% of cases of genital warts. Although not treating existing infections, vaccination is still recommended for HPV positive individuals, as it can protect against one or more different strains of the disease. The HPV strains that Gardasil protects against are sexually transmitted.
The vaccine was approved in the US in June 2006 by the US Food and Drug Administration (FDA). In 2011, Gardasil's vaccine has also been approved in 120 other countries. The FDA recommends vaccinations before adolescence and potential sexual activity.
In December 2014, the FDA approved a nine-nine Gardasil-based vaccine, Gardasil 9, to protect against infection with strains covered by Gardasil's first generation as well as five other HPV strains responsible for 20% of cervical cancers (HPV-31, HPV-33 , HPV-45, HPV-52, and HPV-58).
Video Gardasil
Medical use
Gardasil is a prophylactic HPV vaccine, which means that it is designed to prevent HPV infection. For maximum effect, it is recommended that girls receive the vaccine before it becomes sexually active. However, women already infected with one or more of the four HPV types targeted by the vaccine (6, 11, 16, or 18) are protected from clinical disease caused by the type of HPV remaining in the vaccine. Plantar warts commonly caused by HPV 1, 2 and 4, are not prevented by the administration of this vaccine.
Because Gardasil will not block infection with any type of HPV that can cause cervical cancer, the vaccine should not be considered a substitute for regular pap smears.
Fewer HPV infections mean fewer complications from viruses and less time and money spent on detecting, working, and treating cervical cancer and its precursors, cervical dysplasia. It prevents infertility caused by cervical biopsy and reduces severe respiratory problems in children infected with HPV from their mothers.
In addition, protection against HPV 6 and HPV 11 is expected to eliminate 90% of cases of genital warts. Gardasil also protects against vulvar and vaginal cancers caused by HPV types 16 and 18.
In December 2010, Gardasil was approved by the FDA for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people aged 9 to 26 years.
HPV infection, especially HPV 16, contributes to some head and neck cancers (HPV is found in about 26-35% of squamous cell carcinomas of the head and neck). In principle, HPV vaccine may help reduce the incidence of such cancers caused by HPV, but this has not been proven.
Merck has been denied FDA approval to market Gardasil for women aged 27 to 45. Although found to be safe and effective in the prevention of genital warts, it is not effective in the prevention of cervical cancer in that age group. This is because HPV levels rise rapidly during adolescence and early twenties, but the chances are declining as people reach the age of their early twenties.
Benefits
An alternative vaccine known as Cervarix is ​​produced by GlaxoSmithKline. It protects against two oncogenic strains of HPV, 16 and 18.
The National Cancer Institute says, "Gardasil and Cervarix have been shown to provide protection against severe cervical 16/18 HPV infection for up to 8 years, which is the maximum time of follow-up studies so far... HPV vaccination has also been found to prevent nearly 100 percent cell change cervical precanceres that may be caused by HPV 16/18 The data so far indicate a protection duration of up to 6.4 years with Cervarix and up to 5 years for Gardasil - in women uninfected with HPV at the time of vaccination. "
Gardasil has been shown to be partially effective (about 38%) in preventing cervical cancer caused by ten other high risk HPV types.
Levels of antibodies at 3 months (1 month postdosis 2) were substantially higher than at month 24 (18 months postdosis 3), indicating that protection was achieved at month 3 and possibly earlier. This does not mean that the third dose can be skipped. One study has shown that Cervarix may be effective with fewer than three doses. Following further studies, in April 2014, the World Health Organization recommended that countries offer vaccines in a two-dose schedule for girls under 15, with each dose of at least six months. The United Kingdom, Switzerland, Mexico and Quebec are some of the few countries or regions that have implemented this in June 2015. The CDC recommends vaccines be given in two shots for six months.
Men
Gardasil is also effective in men, providing protection against genital warts, anal warts, anal cancer, and some potential precancerous lesions caused by some types of HPV. Gardasil vaccine has been shown to significantly reduce the risk of young men contracting genital warts. In the United States, the US Food and Drug Administration (FDA) approved the administration of Gardasil vaccine to men between the ages of 9 and 26 in October 2009. The FDA approved the administration of Gardasil 9 vaccine to men between the ages of 9 and 15 in December 2014 and extended the age, by including men between the ages of 16 and 26, by December 2015. In the United Kingdom, HPV vaccines are licensed to men aged 9 to 15 and for women 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 a higher incidence among MSM including anal intraepithelial neoplasias, anal cancer, and genital warts. Type 16 is also associated with oropharyngeal squamous cell carcinoma, a form of throat cancer. A 2005 study in San Francisco found that 95% of HIV-infected gay men also had anal HPV infection, 50% of whom had HPV-induced lesions.
Administration
Gardasil was given in three injections for six months. The second injection is two months after the first, and the third injection is six months after the first injection is given. Or, in some countries are given as two injections with at least six months between them, for individuals aged 9 years up to and including 13 years.
Maps Gardasil
Adverse effects
Until April 2014, more than 170 million doses of Gardasil have been distributed worldwide. The vaccine was tested on thousands of women (ages 9 to 26). The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) consider the vaccine safe. It does not contain mercury, thiomersal, live virus or dead virus, but virus-like particles, which can not reproduce in the human body.
The FDA and CDC publications state that vaccines have minor side effects, such as pain around the injection area. Fainting is more common among teenagers who receive Gardasil vaccine than in other types of vaccinations. Patients should remain seated for 15 minutes after they receive HPV vaccine. There are reports that the shots are more painful than other general vaccines, and the Merck manufacturer partially connects these with virus-like particles in the vaccine. Common side effects from shooting may include joint and muscle pain, fatigue, physical weakness and general malaise.
Updates on adverse reactions were published by the American Medical Association Journal and looked at data from the Vaccine Adverse Event Reporting System (VAERS), which included 12,424 reported adverse reactions after about 23 million doses of vaccine between June 2006 and December 2008. Most side effects are mild and no greater than the background level compared to other vaccines, except for higher rates of syncope and thromboembolic events. Venous thromboembolism events were recorded in 56 reports at a rate of 0.2 cases per 100,000 doses distributed and included 19 cases of pulmonary embolism, four of which were fatal. Overall, 772 events (6.2% of total adverse events but only 0.003% of the total dose) were described as serious and included 32 reported deaths (1 per 1,000,000 doses).
Other side-effects include local site reactions (7.5 cases per 100,000 doses distributed), headache (4.1 cases per 100,000 distributed doses), hypersensitivity reactions (3.1 cases per 100,000 distributed doses), and urticaria (itching ) (2.6 cases per 100,000 doses distributed). A Kaiser Permanente study tracked the rate of autoimmune lupus, rheumatoid arthritis, juvenile rheumatoid arthritis, idiopathic thrombocytopenic purpura (ITP), hemolytic anemia, multiple sclerosis, thyroiditis and type 1 diabetes mellitus vaccinated populations are the same as unvaccinated populations.
The FDA and CDC say that with millions of vaccinations "by chance alone some serious side effects and death" will occur in the time period after vaccination, but they have nothing to do with the vaccine. More than twenty women who received the Gardasil vaccine have died, but this death is not causally related to the shot. When information is available, the cause of death is explained by other factors. Likewise, a small number of cases of Guillain-Barrà ©  © (GBS) syndrome have been reported after vaccination with Gardasil, although there is no evidence linking GBS with the vaccine. It is not known why a person develops GBS, or what initiates the disease.
The FDA and CDC monitor events to see if there is a pattern, or event that is more serious than expected from chance alone. The majority (68%) of the adverse effects data were reported by the manufacturer, but in about 90% of the manufacturers reporting the incident, no follow-up information was provided which would be useful for investigating further events. In February 2009, the Spanish health ministry suspended the use of a Gardasil batch after health authorities in the Valencia region reported that two girls became ill after receiving injections. Merck has stated that there is no evidence Gardasil is responsible for two diseases.
Materials
- L1 major capsid protein from HPV types 6, 11, 16, and 18
- aluminum amorphous hydroxyphosphate sulfate (adjuvant)
- yeast protein
- sodium chloride
- L-histidine
- polisorbat 80
- sodium borate
Biotechnology
The primary capsid proteins HPV, L1, can spontaneously self-assemble into viral-like particles (VLPs) that resemble authentic HPV virions. Gardasil contains recombinant VLPs that are assembled from L1 HPV proteins types 6, 11, 16 and 18. Because VLPs do not have viral DNA, they can not induce cancer. They, however, trigger an antibody response that protects the vaccine recipient from becoming infected with the HPV type represented in the vaccine. The L1 protein is produced by a separate fermentation in recombinant Saccharomyces cerevisiae and is self-assembled into VLPs.
Public health
The National Cancer Institute writes:
- Extensive 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. In addition, the vaccine may reduce the need for medical treatment, biopsy, and invasive procedures associated with the follow-up of abnormal Pap tests, thereby helping to reduce the costs of health care and anxiety associated with abnormal Pap tests and follow-up procedures./dd>
Long-term impact and cost effectiveness
Whether the effect is temporary or lifelong, extensive vaccination can have a major public health impact. 270,000 women died of cervical cancer worldwide in 2002. Acting FDA Administrator Andrew von Eschenbach said the vaccine would have a "dramatic effect" on women's health worldwide. Even in the United States, where screening programs are routine, the National Cancer Institute estimates that 9,700 women will have cervical cancer in 2006, and 3,700 will die.
Merck and CSL Limited are expected to market Gardasil as a cancer vaccine, rather than the STD vaccine. It remains unclear how broad the use of the three-shot series will be, in part because the list price is $ 525 ($ 175 apiece for three shots).
Studies using different pharmacoeconomic models predict that vaccinating young women with Gardasil in combination with screening programs may be more effective than screening alone. These results are important in decisions by many countries to initiate vaccination programs. For example, the Canadian government approved $ 300 million to buy the HPV vaccine in 2008 after deciding on research that the vaccine would be cost-effective especially with young women's immunization. Marc Steben, a vaccine investigator, wrote that the financial burden of HPV-related cancers in Canadians was $ 300 million annually in 2005, so the vaccine could reduce this burden and be cost-effective.
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.
The August 2009 issue of the Journal of the American Medical Association has articles that repeat Gardasil's security and others question his way of presenting it to doctors and parents.
The new vaccine against 4 types of human papillomavirus (HPV), Gardasil, like other immunizations appears to be a cost-effective intervention with the potential to improve teen health and adult life quality. However, the messages and methods used to market the vaccine present important challenges for medical practice and medical professionalism. By targeting cervical cancer vaccines, HPV sexual transmission is minimized, the threat of cervical cancer in teenagers is maximized, and the most at risk subpopulations are practically ignored. Vaccine manufacturers also provide educational assistance to professional medical associations (PMAs) concerned with the health and oncology of adolescents and women. Funding encourages many PMAs to create educational programs and a specialized loudspeaker product to promote the use of vaccines. However, most materials do not address the full complexity of the vaccine problem and do not provide balanced recommendations about risks and benefits. Just as important and appropriate as PMA to advocate for vaccination as a public good, their recommendations should be consistent with appropriate and cost-effective use.
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%).
History
The research findings that pioneered the development of vaccines began in 1991 by researchers Jian Zhou and Ian Frazer at The University of Queensland, Australia. Researchers at UQ found a way to form non-infectious virus-like particles (VLP), which can also greatly activate the immune system. Furthermore, the final form of the vaccine was developed in parallel, by researchers at Georgetown University Medical Center, the University of Rochester, the University of Queensland in Australia, and the US National Cancer Institute.
In December 2014, the FDA approved Gardasil-9, which protects against 9 HPV strains.
Society and culture
United States
The Texas governor, Rick Perry, issued an executive order adding Gardasil to the state's required vaccination list, which was later canceled by the Texas legislature. Perry also allows parents to quit the program more easily. Through lobbying efforts, Merck states that the government makes vaccinations with Gardasil mandatory for attendance at school, which has disappointed some conservative groups and libertarian groups. Some conservative groups, such as the Family Research Council (FRC), have expressed their fear that vaccination with Gardasil may give women a sense of false security about sex and cause promiscuity, but there is no evidence to suggest that vaccinated girls go to engage in activities more sexual than an unvaccinated girl. Perry's decision was later criticized on September 12, 2011 by fellow presidents, Rick Santorum and Michele Bachmann during Republican presidential debates, as outreach of state power in decisions submitted to parents.
Japanese
In June 2013, the Japanese government issued a notice that "cervical cancer vaccination should no longer be recommended for girls aged 12 to 16" while investigations were made on certain side effects including pain and numbness in 38 girls. The vaccine sold in Japan is Cervarix, made by GlaxoSmithKline from the United Kingdom, and Gardasil, manufactured by Merck Sharp & amp; Dohme. An estimated 3.28 million people have received vaccinations; 1,968 cases of adverse events that may have been reported. In January 2014, the Adverse Vaccine Reaction Reaction Committee concluded that there was no evidence to suggest a causal relationship between HPV vaccine and adverse events reported, but did not return a proactive recommendation for its use. A study of girls in Sapporo shows that since the Japanese government suspension recommends vaccines, the completion rate for the full vaccination program has dropped to 0.6%.
References
Further reading
External links
- Official website
Source of the article : Wikipedia
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