المعرفة

گارداسيل

انظر أيضاً: HPV vaccines

Gardasil, technically known as recombinant human papillomavirus vaccine [types 6, 11, 16, 18],[3][4][5][6][7] is a vaccine for use in the prevention of certain strains of human papillomavirus (HPV).[8] High-risk human papilloma virus (hr-HPV) genital infection is the most common sexually transmitted infection among women.[9] The HPV strains that Gardasil protects against are sexually transmitted,[10] specifically HPV types 6, 11, 16 and 18.[11][12] HPV types 16 and 18 cause an estimated 70% of cervical cancers,[13][14] and are responsible for most HPV-induced anal,[15] vulvar, vaginal,[16] and penile cancer cases.[15] HPV types 6 and 11 cause an estimated 90% of genital warts cases.[17] 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.[18]

گارداسيل
Gardasil vaccine and box new.jpg
وصف اللقاح
TargetFor Gardasil 9: Human papillomavirus, Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
نوع اللقاحو.ف. پروتينية
البيانات السريرية
الأسماء التجاريةGardasil, Gardisil, Silgard, others
AHFS/Drugs.comMonograph
MedlinePlusa607016
فئة السلامة
أثناء الحمل
مسارات
الدواء		Intramuscular injection
رمز ATC
الحالة القانونية
الحالة القانونية
  • UK: POM (Prescription only) [2]
  • US: ℞-only
  • عموماً: ℞ (بوصفة فقط)
المعرفات
DrugBank
ChemSpider
  • none
UNII
KEGG
 ☒NYesY (what is this?)  (verify)
Gardasil

The vaccine was approved for medical use in the United States in 2006,[19][20] initially for use in females aged 9–26.[21] In 2007, the Advisory Committee on Immunization Practices (ACIP) recommended gardasil for routine vaccination of girls aged 11 and 12 years.[22] As of August 2009, vaccination was recommended before adolescence and the beginning of potential sexual activity.[11][23][24] By 2011, the vaccine had been approved in 120 other countries.[25]

In 2014, the FDA approved a nine-valent version, Gardasil 9, to protect against infection with 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).[3][26][27] In 2018, the FDA approved expanded use of Gardasil 9 for individuals 27 through 45 years old.[28]

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

الاستخدامات الطبية

انظر أيضاً: HPV vaccine § Prevalence of genital HPV

In the United States, Gardasil is indicated for:[29]

  • girls and women 9 through 45 years of age for the prevention of the following diseases:[29]
    • Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58.[29]
    • Genital warts (condyloma acuminata) caused by HPV types 6 and 11.[29]
  • girls and women 9 through 45 years of age for the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:[29]
    • Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS).[29]
    • Cervical intraepithelial neoplasia (CIN) grade 1.[29]
    • Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3.[29]
    • Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3.[29]
    • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.[29]
  • boys and men 9 through 45 years of age for the prevention of the following diseases:[29]
    • Anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.[29]
    • Genital warts (condyloma acuminata) caused by HPV types 6 and 11.[29]
  • boys and men 9 through 45 years of age for the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:[29]
    • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.[29]

In the European Union, Gardasil is indicated for active immunization of individuals from the age of nine years against the following HPV diseases:[6]

  • Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types[6]
  • Genital warts (Condyloma acuminata) caused by specific HPV types.[6]

Gardasil is a vaccine to prevent HPV, that, for maximum effect, is recommended for girls prior to their becoming sexually active.[بحاجة لمصدر] Moreover, evidence supports the conclusion that women who were already infected with one or more of 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.[18] HPV types 16 and 18 cause an estimated 70% of cervical cancers,[13][14] and are responsible for most HPV-induced anal cancers.[15] Gardasil also protects against vulvar and vaginal cancers caused by HPV types 16 and 18,[16] as well as most penile cancers caused by these two HPV types.[30] Since Gardasil will not prevent infection with all of the HPV types that can cause cervical cancer, the vaccine is not considered a substitute for routine pap smears.[بحاجة لمصدر]

In addition, protection against HPV types 6 and 11 may eliminate up to 90% of the cases of genital warts.[17] Common plantar warts—e.g., caused by HPV types 1, 2, and 4[31]—are not prevented by this vaccine.

Reports state the expectation that fewer HPV infections will necessarily lead to fewer complications from the virus, and less time and money spent on the detection, work-up, and treatment of cervical cancer (and its precursor, cervical dysplasia).[18] In addition, it is expected that vaccination will reduce the severe respiratory problems of laryngeal papillomatosis in children infected with HPV by their mothers,[بحاجة لمصدر] and that it will prevent infertility caused by cervical biopsies.[بحاجة لمصدر]

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 ages 9 through 26 years.[32]

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).[33][34] In principle, HPV vaccines may help reduce incidence of such cancers caused by HPV, but this has not been demonstrated.[35][needs update] In June 2020, the FDA approved the use of Gardasil for the treatment of head and neck cancers.[36][37]

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.[28]


الفعالية

An alternative vaccine known as Cervarix protects against two oncogenic strains of HPV, 16 and 18.[38]

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 (10), at least 9 years with Cervarix (11), and at least 6 years with Gardasil 9 (12). Long-term studies of vaccine efficacy that are still in progress will help scientists better understand the total duration of protection."[39]

Gardasil has been shown to be partially effective (approximately 38%) in preventing cervical cancer caused by ten other high-risk HPV types.[40]

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.[23] In 2014, the World Health Organization (WHO) recommended that countries offer the vaccine in a two dose schedule to girls aged under 15, with each dose at least six months apart.[41][17] The United Kingdom, Switzerland, Mexico, and Quebec province of Canada are among the countries or territories that have implemented this اعتبارا من June 2015. The CDC recommended the vaccines be delivered in two shots over six months.[42]

الذكور

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.[12][43] Gardasil vaccine has been shown to decrease the risk of young men contracting genital warts.[44] In the United States, the FDA approved administration of the Gardasil vaccine to males between ages 9 and 26 in 2009.[45][46] 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.[47][48][49] In the UK, HPV vaccines are licensed for males aged 9 to 15 and for females aged 9 to 26.[50]

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 include anal intraepithelial neoplasias, anal cancers, and genital warts. Type 16 is also associated with oropharyngeal squamous-cell carcinoma, a form of throat cancer.[51] A 2005 study found that 95% of HIV-infected gay men also had anal HPV infection, of whom 50% had precancerous HPV-caused lesions.[52]

إعطاء اللقاح

Gardasil 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.[11][23] 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.[2][53]

Adverse effects

اعتبارا من April 2014, more than 170 million doses of Gardasil had been distributed worldwide.[54] The vaccine was tested in thousands of females (ages 9 to 26).[55] The Food and Drug Administration (FDA) and the 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.[55]

The vaccine has mostly minor side effects, such as pain around the injection area.[55] Fainting 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.[23] 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.[56] General side effects of the shot may include joint and muscle pain, fatigue, physical weakness and general malaise.[23][57]

The FDA and 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.[58] 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.[58] Where information has been available, the cause of death was explained by other factors.[59][60] 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.[24][61][62] It is unknown why a person develops GBS, or what initiates the disease.[63]

The FDA and the CDC monitor events to see if there are patterns, or more serious events than would be expected from chance alone.[59] The majority (68%) of side effects data were reported by 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.[64] 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 was no evidence Gardasil was responsible for the two illnesses.[65]

Ingredients

The following are the ingredients found in the different formulations of HPV vaccines:[66]

Biotechnology

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 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.[67]

الصحة العامة

المقالة الرئيسية: لقاحات ڤيروس الورم الحليمي البشري

كتب معهد السرطان الوطني:

Widespread HPV vaccination has 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.[39]


History

Research findings that pioneered 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 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 U.S. National Cancer Institute.[68]

In December 2014, the FDA approved Gardasil-9, which protects against nine strains of HPV.[69]

المجتمع والثقافة

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

الولايات المتحدة

اليابان

References

  1. ^ أ ب "Human papillomavirus vaccine Use During Pregnancy". Drugs.com. 11 فبراير 2019. Retrieved 3 أبريل 2020.
  2. ^ أ ب "Gardasil 9 suspension for injection - Summary of Product Characteristics (SmPC)". (emc). 24 يناير 2020. Retrieved 3 أبريل 2020.
  3. ^ أ ب The nomenclature for virus types is also presented as HPV-6, HPV-11, HPV-16, HPV-18, and to HPV-31, HPV-33, HPV-45, HPV-52, and HPV-58, etc.[بحاجة لمصدر]
  4. ^ "Silgard European Public Assessment Report". European Medicines Agency. 25 سبتمبر 2009. Archived from the original on 25 ديسمبر 2008. Retrieved 5 ديسمبر 2009.
  5. ^ "Silgard EPAR". European Medicines Agency (EMA). Retrieved 3 أبريل 2020.
  6. ^ أ ب ت ث "Gardasil 9 EPAR". European Medicines Agency (EMA). Retrieved 3 أبريل 2020.   هذا المقال يضم نصاً من هذا المصدر، الذي هو مشاع.
  7. ^ Waknine, Yael (2 أكتوبر 2006). "International Approvals: Singulair and Gardasil/Silgard". Medscape Today. Archived from the original on 20 مايو 2013. Retrieved 18 ديسمبر 2008. {{cite web}}: Unknown parameter |name-list-format= ignored (|name-list-style= suggested) (help)
  8. ^ Richwine, Lisa (20 أغسطس 2009). "U.S. health officials back safety of Merck vaccine". Reuters. Archived from the original on 27 أغسطس 2009. Retrieved 12 نوفمبر 2009. {{cite news}}: Unknown parameter |name-list-format= ignored (|name-list-style= suggested) (help)
  9. ^ Gizzo S, Noventa M, Nardelli GB (سبتمبر 2013). "Gardasil administration to hr-HPV-positive women and their partners". Trends in Pharmacological Sciences. 34 (9): 479–80. doi:10.1016/j.tips.2013.07.001. PMID 23896431.
  10. ^ "Genital HPV Infection - Fact Sheet". www.cdc.gov. Centers for Disease Control and Prevention. Retrieved 18 أبريل 2020.
  11. ^ أ ب ت Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER (مارس 2007). "Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP)" (PDF). MMWR. Recommendations and Reports. 56 (RR-2): 1–24. PMID 17380109. Archived (PDF) from the original on 24 سبتمبر 2015.
  12. ^ أ ب "FDA licensure of quadrivalent human papillomavirus vaccine (HPV4, Gardasil) for use in males and guidance from the Advisory Committee on Immunization Practices (ACIP)" (PDF). MMWR. Morbidity and Mortality Weekly Report. 59 (20): 630–2. مايو 2010. PMID 20508594. Archived (PDF) from the original on 24 سبتمبر 2015.
  13. ^ أ ب Lowy DR, Schiller JT (مايو 2006). "Prophylactic human papillomavirus vaccines". The Journal of Clinical Investigation. 116 (5): 1167–73. doi:10.1172/JCI28607. PMC 1451224. PMID 16670757.
  14. ^ أ ب Muñoz N, Bosch FX, Castellsagué X, Díaz M, de Sanjose S, Hammouda D, et al. (أغسطس 2004). "Against which human papillomavirus types shall we vaccinate and screen? The international perspective". International Journal of Cancer. 111 (2): 278–85. doi:10.1002/ijc.20244. PMID 15197783.
  15. ^ أ ب ت Gao G, Smith DI (2016). "Human Papillomavirus and the Development of Different Cancers". Cytogenetic and Genome Research. 150 (3–4): 185–193. doi:10.1159/000458166. PMID 28245440.
  16. ^ أ ب "FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers" (Press release). U.S. Food and Drug Administration (FDA). 12 سبتمبر 2008. Archived from the original on 6 مارس 2010. Retrieved 11 نوفمبر 2009.
  17. ^ أ ب ت "Human papillomavirus vaccines: WHO position paper, May 2017". Releve Epidemiologique Hebdomadaire. 92 (19): 241–68. مايو 2017. hdl:10665/255353. PMID 28530369. {{cite journal}}: Unknown parameter |lay-url= ignored (help)
  18. ^ أ ب ت "Human Papillomavirus (HPV) Vaccines". www.cancer.gov. National Cancer Institute. Retrieved 18 أبريل 2020.
  19. ^ "Gardasil". U.S. Food and Drug Administration. 15 يونيو 2017. Archived from the original on 22 يوليو 2017. Retrieved 3 أبريل 2020.
  20. ^ "FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus" (Press release). U.S. Food and Drug Administration (FDA). 8 يونيو 2006. Archived from the original on 19 أكتوبر 2009. Retrieved 13 نوفمبر 2009.
  21. ^ "Gardasil". Britannica Academic. أبريل 2018.
  22. ^ Moro PL, Zheteyeva Y, Lewis P, Shi J, Yue X, Museru OI, Broder K (يناير 2015). "Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013". Vaccine. 33 (4): 519–22. doi:10.1016/j.vaccine.2014.11.047. PMC 6524774. PMID 25500173.
  23. ^ أ ب ت ث ج ح "Gardasil 9- human papillomavirus 9-valent vaccine, recombinant injection, suspension". DailyMed. Merck. 20 فبراير 2020. Retrieved 3 أبريل 2020.
  24. ^ أ ب "Gardasil Vaccine Safety". U.S. Food and Drug Administration (FDA). 20 أغسطس 2009. Archived from the original on 3 مايو 2019. Retrieved 21 أكتوبر 2019.
  25. ^ Haupt RM, Sings HL (نوفمبر 2011). "The efficacy and safety of the quadrivalent human papillomavirus 6/11/16/18 vaccine gardasil". The Journal of Adolescent Health. 49 (5): 467–75. doi:10.1016/j.jadohealth.2011.07.003. PMID 22018560.
  26. ^ "Gardasil 9". U.S. Food and Drug Administration (FDA). 10 أكتوبر 2018. Archived from the original on 23 أبريل 2019. Retrieved 3 أبريل 2020.
  27. ^ "FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV". U.S. Food and Drug Administration (FDA) (press release). 10 ديسمبر 2014. Archived from the original on 10 يناير 2015. Retrieved 28 فبراير 2015.
  28. ^ أ ب "FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old". U.S. Food and Drug Administration (FDA) (Press release). 5 أكتوبر 2018. Archived from the original on 14 أكتوبر 2019. Retrieved 14 أكتوبر 2018.
  29. ^ أ ب ت ث ج ح خ د ذ ر ز س ش ص ض "Gardasil 9". U.S. Food and Drug Administration (FDA). 12 يونيو 2020. Retrieved 15 يونيو 2020.   هذا المقال يضم نصاً من هذا المصدر، الذي هو مشاع.
  30. ^ Wang JW, Roden RB (فبراير 2013). "Virus-like particles for the prevention of human papillomavirus-associated malignancies". Expert Review of Vaccines. 12 (2): 129–41. doi:10.1586/erv.12.151. PMC 3835148. PMID 23414405.
  31. ^ "Humanitas Papiloma Virus". Archived from the original on 28 فبراير 2017. Retrieved 26 فبراير 2018.
  32. ^ "FDA: Gardasil approved to prevent anal cancer" (Press release). U.S. Food and Drug Administration (FDA). 22 ديسمبر 2010. Archived from the original on 18 ديسمبر 2014. Retrieved 4 يناير 2011.
  33. ^ Goon PK, Stanley MA, Ebmeyer J, Steinsträsser L, Upile T, Jerjes W, et al. (أكتوبر 2009). "HPV & head and neck cancer: a descriptive update". Head & Neck Oncology. 1 (1): 36. doi:10.1186/1758-3284-1-36. PMC 2770444. PMID 19828033.
  34. ^ Vousden KH (1994). Cell transformation by human papillomaviruses. New York: Press Syndicate of the University of Cambridge. pp. 27–46. ISBN 9780521454728. {{cite book}}: |work= ignored (help)
  35. ^ Masters, Coco (11 مايو 2007). "Oral Sex Can Add to HPV Cancer Risk". Time. Archived from the original on 4 أبريل 2020. {{cite journal}}: Unknown parameter |name-list-format= ignored (|name-list-style= suggested) (help)
  36. ^ "FDA Approves Merck's GARDASIL 9 for the Prevention of Certain HPV-Related Head and Neck Cancers". Merck (Press release). 12 يونيو 2020. Retrieved 15 يونيو 2020.
  37. ^ "Gardasil Supplement Accelerated Approval" (PDF). U.S. Food and Drug Administration (FDA). 12 يونيو 2020. Retrieved 15 يونيو 2020.
  38. ^ Centers for Disease Control Prevention (مايو 2010). "FDA licensure of bivalent human papillomavirus vaccine (HPV2, Cervarix) for use in females and updated HPV vaccination recommendations from the Advisory Committee on Immunization Practices (ACIP)" (PDF). MMWR. Morbidity and Mortality Weekly Report. 59 (20): 626–9. PMID 20508593.
  39. ^ أ ب "Human Papillomavirus (HPV) Vaccines". National Cancer Institute (NCI). 9 سبتمبر 2019. Archived from the original on 4 أبريل 2020. Retrieved 3 أبريل 2020.
  40. ^ Schieszer, John (نوفمبر 2007). "HPV Vaccine Protects Against 10 "Other" Strains". Internal Medicine World Report. Archived from the original on 4 ديسمبر 2008. {{cite journal}}: Unknown parameter |name-list-format= ignored (|name-list-style= suggested) (help)
  41. ^ World Health Organization (أبريل 2014). "Summary of the SAGE April 2014 meeting". Archived from the original on 31 يوليو 2015. Retrieved 2 يونيو 2015.
  42. ^ "CDC recommends only two HPV shots for younger adolescents" (Press release). Centers for Disease Control and Prevention (CDC). 19 أكتوبر 2016. Archived from the original on 23 مارس 2017. Retrieved 7 أكتوبر 2017.
  43. ^ Giuliano AR, Palefsky JM, Goldstone S, Moreira ED, Penny ME, Aranda C, et al. (فبراير 2011). "Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males". The New England Journal of Medicine. 364 (5): 401–11. doi:10.1056/NEJMoa0909537. PMC 3495065. PMID 21288094. {{cite journal}}: Unknown parameter |lay-url= ignored (help)
  44. ^ "Gay men seeking HPV vaccine". Cancer Research UK. 23 فبراير 2007. Archived from the original on 24 مارس 2010. Retrieved 12 نوفمبر 2009.
  45. ^ "FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys" (Press release). U.S. Food and Drug Administration (FDA). 16 أكتوبر 2009. Archived from the original on 24 أكتوبر 2009. Retrieved 12 نوفمبر 2009.
  46. ^ "October 16, 2009 Approval Letter – Gardasil". U.S. Food and Drug Administration (FDA). 16 أكتوبر 2009. Archived from the original on 24 أكتوبر 2009. Retrieved 12 نوفمبر 2009.
  47. ^ "FDA licensure of 9-valent human papillomavirus vaccine to include males aged 16–26 years" (PDF). U.S. Centers for Disease Control and Prevention (CDC). 14 ديسمبر 2015. Archived (PDF) from the original on 30 يناير 2017. Retrieved 10 أكتوبر 2016.
  48. ^ "Provider Information: Gardasil 9 VIS" (PDF). U.S. Centers for Disease Control and Prevention (CDC). ديسمبر 2015. Archived (PDF) from the original on 11 فبراير 2017. Retrieved 10 أكتوبر 2016.
  49. ^ "Highlights of Prescribing InformationI: Gardasil 9" (PDF). U.S. Food and Drug Administration (FDA). 14 ديسمبر 2015. Archived (PDF) from the original on 10 أكتوبر 2016. Retrieved 10 أكتوبر 2016.
  50. ^ Roberts, Michelle (23 فبراير 2007). "Gay men seek 'female cancer' jab". BBC News Online. Archived from the original on 30 يناير 2009. Retrieved 12 نوفمبر 2009. {{cite news}}: Unknown parameter |name-list-format= ignored (|name-list-style= suggested) (help)
  51. ^ D'Souza G, Kreimer AR, Viscidi R, Pawlita M, Fakhry C, Koch WM, et al. (مايو 2007). "Case-control study of human papillomavirus and oropharyngeal cancer". The New England Journal of Medicine. 356 (19): 1944–56. doi:10.1056/NEJMoa065497. PMID 17494927.
  52. ^ Bernard, Edwin J. (29 أغسطس 2005). "HAART is not reducing risk of anal cancer in gay men". AIDSmap. Archived from the original on 19 يونيو 2006. Retrieved 8 يونيو 2006. {{cite web}}: Unknown parameter |name-list-format= ignored (|name-list-style= suggested) (help)
  53. ^ "Gardasil suspension for injection - Summary of Product Characteristics (SmPC)". (emc). 7 مايو 2019. Retrieved 3 أبريل 2020.
  54. ^ McNeil Jr., Donald G. (31 مارس 2014). "Expansion in Use of Cancer Vaccine". The New York Times. Retrieved 20 ديسمبر 2019. {{cite news}}: Unknown parameter |name-list-format= ignored (|name-list-style= suggested) (help)
  55. ^ أ ب ت "HPV Vaccine Information For Young Women". Centers for Disease Control and Prevention (CDC). Archived from the original on 28 يونيو 2009. Retrieved 14 يونيو 2009.
  56. ^ Stobbe, Mike (9 فبراير 2009). "Cervical cancer shots are gaining reputation as painful". ABC News. Associated Press. {{cite news}}: Unknown parameter |name-list-format= ignored (|name-list-style= suggested) (help)
  57. ^ Fagan, Amy (10 يوليو 2008). "Merck, FDA expand Gardasil warnings". The Washington Times. Archived from the original on 17 يوليو 2008. {{cite news}}: Unknown parameter |name-list-format= ignored (|name-list-style= suggested) (help)
  58. ^ أ ب Rosenthal, Elisabeth (19 أغسطس 2008). "Drug Makers' Push Leads to Cancer Vaccines' Fast Rise". The New York Times. Archived from the original on 9 أبريل 2009. Retrieved 20 أغسطس 2008. {{cite news}}: Unknown parameter |name-list-format= ignored (|name-list-style= suggested) (help)
  59. ^ أ ب "Information from FDA and CDC on Gardasil and its Safety (Archived)". Centers for Disease Control and Prevention (CDC). 22 يوليو 2008. Archived from the original on 2 سبتمبر 2013. Retrieved 9 سبتمبر 2017.
  60. ^ "Reports of Health Concerns Following HPV Vaccination". Centers for Disease Control and Prevention (CDC). 26 أكتوبر 2010. Archived from the original on 17 سبتمبر 2013.
  61. ^ Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, et al. (أغسطس 2009). "Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine". JAMA. 302 (7): 750–7. doi:10.1001/jama.2009.1201. PMID 19690307.
  62. ^ "HPV Vaccine – Questions & Answers for the Public". 18 يوليو 2008. Archived from the original on 6 مارس 2008. Retrieved 22 أغسطس 2008.
  63. ^ "Guillain–Barré Syndrome Fact Sheet". National Institute of Neurological Disorders and Stroke (NINDS). 6 مايو 2010. Archived from the original on 5 أغسطس 2016.
  64. ^ Chustecka Z (18 أغسطس 2009). "HPV Vaccine: Debate Over Benefits, Marketing, and New Adverse Event Data". Medscape Today. Archived from the original on 14 نوفمبر 2010. Retrieved 27 أغسطس 2009.
  65. ^ "Spain halts batch of Merck's Gardasil". Reuters. 10 فبراير 2009. Archived from the original on 13 فبراير 2009. Retrieved 10 فبراير 2009.
  66. ^ Harper DM, DeMars LR (يوليو 2017). "HPV vaccines - A review of the first decade". Gynecologic Oncology. 146 (1): 196–204. doi:10.1016/j.ygyno.2017.04.004. PMID 28442134.
  67. ^ "Gardasil Product Monograph" (PDF). Merck Canada Inc. Archived (PDF) from the original on 4 أبريل 2020. Retrieved 3 أبريل 2020.
  68. ^ McNeil C (أبريل 2006). "Who invented the VLP cervical cancer vaccines?". Journal of the National Cancer Institute. 98 (7): 433. doi:10.1093/jnci/djj144. PMID 16595773.
  69. ^ "FDA Approves Merck's HPV Vaccine, GARDASIL9, to Prevent Cancers and Other Diseases Caused by Nine HPV types – Including Types that Cause About 90% of Cervical Cancer Cases". Merck (Press release). 11 ديسمبر 2014. Archived from the original on 27 أكتوبر 2017.

Further reading

External links

تمّ الاسترجاع من "https://www.marefa.org/w/index.php?title=گارداسيل&oldid=2236891"