Gardasil, technically known as recombinant human papillomavirus vaccine [types 6, 11, 16, 18], is a vaccine for use in the prevention of certain strains of human papillomavirus (HPV), developed by Merck & Co. High-risk human papilloma virus (hr-HPV) genital infection is the most common sexually transmitted infection among women.
What are the medical uses of Gardasil?
Medical uses. 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 prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.
When should I not use Gardasil?
Do not use the product if particulates are present or if it appears discolored. Gardasil should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.
What is the dose of Gardasil?
All presentations for Gardasil contain a suspension of 120 mcg L1 protein from HPV types 6, 11, 16, and 18 in a 0.5-mL dose. Gardasil is supplied in vials and syringes. Carton of one 0.5-mL single-dose vial.
Is gardasil9 approved by the FDA?
^ "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 December 2014. Archived from the original on 27 October 2017.
Why do people get the Gardasil vaccine?
The HPV vaccine helps protect you against certain types of HPV that can lead to cancer or genital warts. Also known by the brand name Gardasil 9, the HPV vaccine protects against: HPV types 16 and 18 — the 2 types that cause 80% of cervical cancer cases. HPV types 6 and 11, which cause 90% of genital warts cases.
Is HPV a STI or STD?
HPV is a very common STI. Among 15- to 59-year-olds, 2 in 5 (40%) people will have HPV. There are many different types of HPV; most do not cause any health problems. HPV is a different virus than HIV or (HSV) herpes.
What does original Gardasil protect against?
Gardasil is a vaccine, licensed for use in June 2006, by the FDA. It targets four strains of human papillomavirus (HPV) -- HPV-6, 11, 16, and 18. HPV-16 and HPV-18 account for about 70% of all cervical cancers. HPV-6 and -11 cause about 90% of genital warts.
What are the signs of HPV in a woman?
HPV can infect cells in the vagina and around the vulva. If a female has low risk HPV, they may see warts on the vulva. These warts may present as: a cluster that looks like a cauliflower....Some symptoms of vaginal cancer include :bleeding after sex.unusual discharge.a lump in the vagina.pain while having sex.
Can a woman give a man HPV?
Can HPV be passed between a man and a woman? Yes, men can catch HPV from women. The virus can be passed on between sexual partners of any gender.
What cancers does HPV cause?
Almost all cervical cancer is caused by HPV. Some cancers of the vulva, vagina, penis, anus, and oropharynx (back of the throat, including the base of the tongue and tonsils) are also caused by HPV. Research is still being done to understand how and to what extent HPV causes these cancers.
How long does Gardasil vaccine last?
Studies have shown that the vaccine protects against HPV infection for at least 10 years, although experts expect protection to last for much longer.
Why do boys need HPV vaccine?
By offering boys the HPV vaccine before exposure to the virus, it will help to protect them against genital warts and some cancers, including anal and penile cancers. Some men, including men who have sex with men, may be able to have the HPV vaccine for free.
Before Receiving Gardasil
You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.To make sure Gardasil is safe fo...
How Is Human Papillomavirus Vaccine given?
Gardasil is given as an injection (shot) into a muscle in your upper arm or thigh. You will receive this injection in a doctor's office or other cl...
What Happens If I Miss A Dose?
Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no n...
Human Papillomavirus Vaccine Side Effects
Get emergency medical help if you have signs of an allergic reaction to Gardasil: hives; difficulty breathing; swelling of your face, lips, tongue,...
What Other Drugs Will Affect Human Papillomavirus Vaccine?
Other drugs may interact with HPV quadrivalent vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell...
What is the best age to get the Gardasil 9?
Gardasil 9 vaccine prevents diseases caused only by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. It will not prevent diseases caused by other types of HPV. The Centers for Disease Control and Prevention (CDC) recommends HPV vaccine for all boys and girls ages 11 or 12 years old. The vaccine is also recommended in teenage boys ...
Can you share Gardasil 9 with children?
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Gardasil 9 only for the indication prescribed. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Can you get Gardasil 9 if you have a wart?
You may receive Gardasil 9 even if you have already had genital warts , or had a positive HPV test or abnormal pap smear in the past. However, this vaccine will not treat active genital warts or HPV-related cancers, and it will not cure HPV infection. Gardasil 9 vaccine prevents diseases caused only by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
How does Gardasil work?
Gardasil works by stimulating the immune system to attack HPV types 6, 11, 16, and 18. Once Gardasil is administered, the body's immune system recognizes the viral proteins in Gardasil as foreign, and develops antibodies against them, thus providing immunity from future infections.
How to report a drug problem to the FDA?
Report Problems to the Food and Drug Administration. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Does Gardasil help with genital warts?
Gardasil protects against cervical cancer, abnormal or precancerous cervical, vaginal, or vulvar lesions, and genital warts. Side effects of Gardasil include fever, vomiting, nausea, fainting, dizziness, pain, swelling, itching, or redness at the site of injection.
What is the FDA's Gardasil 9?
In 2014, the U.S. Food and Drug Administration (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).
How old is the best age to get the Gardasil 9?
The FDA approved administration of the Gardasil 9 vaccine to males between ages 9 and 15 in 2014, and extended the age indication, by including males between ages 16 and 26, in 2015. In the UK, HPV vaccines are licensed for males aged 9 to 15 and for females aged 9 to 26.
What is HPV 16?
HPV type 16 is also responsible for almost 90% of HPV-positive oropharyngeal squamous-cell carcinoma (OPSCC), a form of cancer that affects the mouth, tonsils, and throat; the prevalence of HPV-positive oropharyngeal cancers is higher in males than females.
What is genital warts?
Genital warts (condyloma acuminata) caused by HPV types 6 and 11. 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: Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS).
Does Gardasil contain L1?
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.
How to treat HPV?
There is no treatment for the virus itself. However, there are treatments for the health problems that HPV can cause: 1 Genital warts can be treated by your healthcare provider or with prescription medication. If left untreated, genital warts may go away, stay the same, or grow in size or number. 2 Cervical precancer can be treated. Women who get routine Pap tests and follow up as needed can identify problems before cancer develops. Prevention is always better than treatment. For more information visit www.cancer.org#N#external icon#N#. 3 Other HPV-related cancers are also more treatable when diagnosed and treated early. For more information visit www.cancer.org#N#external icon
Can genital warts be treated?
Genital warts can be treated by your healthcare provider or with prescription medication. If left untreated, genital warts may go away, stay the same, or grow in size or number. Cervical precancer can be treated. Women who get routine Pap tests and follow up as needed can identify problems before cancer develops.
Prevention
Three HPV vaccines are licensed in the United States: Ceravrix, a 2-valent vaccine (2vHPV) that targets HPV types 16 and 18; Gardasil, a 4-valent vaccine (4vHPV) that targets HPV types 6, 11, 16, and 18; and Gardasil 9, a 9-valent vaccine (9vHPV) that targets HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Diagnostic Considerations
HPV tests are available for detecting oncogenic types of HPV infection and are used in the context of cervical cancer screening and management or follow-up of abnormal cervical cytology or histology (see Cervical Cancer).
Treatment
Treatment is directed to the macroscopic (e.g., genital warts) or pathologic precancerous lesions caused by HPV. Subclinical genital HPV infection typically clears spontaneously; therefore, specific antiviral therapy is not recommended to eradicate HPV infection.
Counseling
When counseling persons with anogenital HPV infection, the provider should discuss the following:
Concomitant Use
Concomitant administration of GARDASIL 9, at a separate injection site, did not interfere with the antibody responses to any of these vaccines when compared with nonconcomitant administration of GARDASIL 9:
Select Safety Information for GARDASIL 9
GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL ® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].
Overview
Gardasil, technically known as recombinant human papillomavirus vaccine [types 6, 11, 16, 18], is a vaccine for use in the prevention of certain strains of human papillomavirus (HPV), developed by Merck & Co. High-risk human papilloma virus (hr-HPV) genital infection is the most common sexually transmitted infection among women. The HPV strains that Gardasil protects a…
Types
Gardasil is available as Gardasil which protects against 4-types of HPV (6, 11, 16, 18) and Gardasil 9 which protects against an additional 5-types (31, 33, 45, 52, 58).
• Gardasil
• Gardasil 9
Medical uses
In the United States, Gardasil is indicated for:
• girls and women 9 through 45 years of age for the prevention of the following diseases:
• 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:
Adverse effects
As of April 2014 , more than 170 million doses of Gardasil had been distributed worldwide. The vaccine was tested in thousands of females (ages 9 to 26). 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.
Ingredients
The following are the ingredients found in the different formulations of HPV vaccines:
• Major capsid protein L1 epitope of HPV types 6, 11, 16, and 18 (Gardasil)
• Major capsid protein L1 epitope of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (Gardasil-9)
• Major capsid protein L1 epitope of HPV types 16 and 18 (Cervarix)
Public health
The National Cancer Institute writes:
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 fo…
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 i…
Society and culture
A few conservative groups, such as the Family Research Council (FRC), have expressed their fears that vaccination with Gardasil might give girls a false sense of security regarding sex and lead to promiscuity, but no evidence exists to suggest that girls who were vaccinated went on to engage in more sexual activity than unvaccinated girls. Merck, the manufacturer of the vaccine, has lobbied that state governments make vaccination with Gardasil mandatory for school attendanc…