Gardasil is an
HPV vaccine
Human papillomavirus (HPV) vaccines are vaccines that prevent infection by certain types of human papillomavirus (HPV). Available HPV vaccines protect against either two, four, or nine types of HPV. All HPV vaccines protect against at least HP ...
for use in the prevention of certain
strains of
human papillomavirus
Human papillomavirus infection (HPV infection) is caused by a DNA virus from the ''Papillomaviridae'' family. Many HPV infections cause no symptoms and 90% resolve spontaneously within two years. In some cases, an HPV infection persists and res ...
(HPV).
[ Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.] It was developed by
Merck & Co
Merck & Co., Inc. is an American multinational pharmaceutical company headquartered in Rahway, New Jersey, and is named for Merck Group, founded in Germany in 1668, of whom it was once the American arm. The company does business as Merck Sharp ...
. High-risk human papilloma virus (hr-HPV) genital infection is the most common sexually transmitted infection among women. The HPV strains that Gardasil protects against are sexually transmitted,
specifically HPV types 6, 11, 16 and 18.
HPV types 16 and 18 cause an estimated 70% of
cervical cancer
Cervical cancer is a cancer arising from the cervix. It is due to the abnormal growth of cells that have the ability to invade or spread to other parts of the body. Early on, typically no symptoms are seen. Later symptoms may include abnormal ...
s,
and are responsible for most HPV-induced
anal
Anal may refer to:
Related to the anus
*Related to the anus of animals:
** Anal fin, in fish anatomy
** Anal vein, in insect anatomy
** Anal scale, in reptile anatomy
*Related to the human anus:
** Anal sex, a type of sexual activity involvin ...
,
vulvar,
vaginal
In mammals, the vagina is the elastic, muscular part of the female genital tract. In humans, it extends from the vestibule to the cervix. The outer vaginal opening is normally partly covered by a thin layer of mucosal tissue called the hyme ...
,
and
penile cancer cases.
HPV types 6 and 11 cause an estimated 90% of
genital warts
Genital warts are a sexually transmitted infection caused by certain types of human papillomavirus (HPV). They are generally pink in color and project out from the surface of the skin. Usually they cause few symptoms, but can occasionally be pai ...
cases.
HPV type 16 is responsible for almost 90% of
HPV-positive oropharyngeal cancer
Oropharyngeal cancer (OPC), also known as oropharyngeal squamous cell carcinoma (OPSCC) and tonsil cancer, is a disease in which abnormal cells with the potential to both grow locally and spread to other parts of the body are found in the oral ca ...
s,
and the
prevalence is higher in males than females.
Though Gardasil does not treat existing infection, vaccination is still recommended for HPV-positive individuals, as it may protect against one or more different strains of the disease.
The vaccine was approved for medical use in the United States in 2006, initially for use in females aged 9–26. In 2007, the
Advisory Committee on Immunization Practices
The Advisory Committee on Immunization Practices (ACIP) is a committee within the United States Centers for Disease Control and Prevention (CDC) that provides advice and guidance on effective control of vaccine-preventable diseases in the U.S. civ ...
(ACIP) recommended Gardasil for routine vaccination of girls aged 11 and 12 years. As of August 2009, vaccination was recommended for both males and females before adolescence and the beginning of potential sexual activity.
By 2011, the vaccine had been approved in 120 other countries.
In 2014, the US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(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).
[ ] In 2018, the FDA approved expanded use of Gardasil 9 for individuals aged 27 through 45 years old.
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).
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:
** 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.
** 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).
** Cervical intraepithelial neoplasia (CIN) grade 1.
** Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3.
** Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3.
** Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
* boys and men 9 through 45 years of age for the prevention of the following diseases:
** Anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
** Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
* 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:
** Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.
In the European Union, Gardasil is indicated for active immunization of individuals from the age of nine years against the following HPV diseases:
* Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types
* Genital warts (Condyloma acuminata) caused by specific HPV types.
Gardasil is a vaccine to prevent HPV, that, for maximum effect, is recommended for individuals prior to their becoming sexually active.
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.
HPV types 16 and 18 cause an estimated 70% of
cervical cancer
Cervical cancer is a cancer arising from the cervix. It is due to the abnormal growth of cells that have the ability to invade or spread to other parts of the body. Early on, typically no symptoms are seen. Later symptoms may include abnormal ...
s,
and are responsible for most HPV-induced
anal
Anal may refer to:
Related to the anus
*Related to the anus of animals:
** Anal fin, in fish anatomy
** Anal vein, in insect anatomy
** Anal scale, in reptile anatomy
*Related to the human anus:
** Anal sex, a type of sexual activity involvin ...
cancers.
Gardasil also protects against
vulvar and
vaginal cancer
Vaginal cancer is an extraordinarily rare form of cancer that develops in the tissue of the vagina. Primary vaginal cancer originates from the vaginal tissue – most frequently squamous cell carcinoma, but primary vaginal adenocarcinoma, sarcoma ...
s caused by HPV types 16 and 18,
[ ] as well as most
penile cancer
Penile cancer is cancer that develops in the skin or tissues of the penis. Symptoms may include abnormal growth, an ulcer or sore on the skin of the penis, and bleeding or foul smelling discharge.
Risk factors include phimosis (inability to retrac ...
s caused by these two HPV types.
In addition, protection against HPV types 6 and 11 may eliminate up to 90% of the cases of
genital wart
Genital warts are a sexually transmitted infection caused by certain types of human papillomavirus (HPV). They are generally pink in color and project out from the surface of the skin. Usually they cause few symptoms, but can occasionally be pai ...
s.
Common
plantar wart
A plantar wart, or verruca vulgaris, is a wart occurring on the sole (foot), bottom of the foot or toes. Its color is typically similar to that of the skin. Small black dots often occur on the surface. One or more may occur in an area. They may r ...
s—e.g., caused by HPV types 1, 2, and 4—are not prevented by this vaccine.
In 2010, Gardasil was approved by the FDA for prevention of anal cancer and associated precancerous lesions due to HPV types 6, 11, 16, and 18 in people aged 9 through 26 years.
HPV infections, especially HPV 16, contribute to some
head and neck cancer
Head and neck cancer develops from tissues in the lip and oral cavity (mouth), larynx (throat), salivary glands, nose, sinuses or the skin of the face. The most common types of head and neck cancers occur in the lip, mouth, and larynx. Symptoms ...
(HPV is found in an estimated 26–35% of head and neck squamous cell carcinoma).
In principle, HPV vaccines may help reduce incidence of such cancers caused by HPV, but this has not been demonstrated.
In June 2020, the FDA approved the use of Gardasil for the prevention of head and neck cancers.
The FDA approved Gardasil 9 for women and men aged 27 to 45 based on the vaccine being 88% effective against persistent HPV infections that cause certain types genital warts and cancers in females. Vaccine efficacy in males in this age group was inferred.
Efficacy
A 2020 longitudinal study tracking over 1.6 million Swedish girls and women over an eleven-year period found half as many cervical cancer cases in all women who had been vaccinated, and amongst women who had been vaccinated before the age of 17 a 78% reduction in cervical cancer, "a substantially reduced risk of invasive cervical cancer at the population level."
An alternative vaccine known as
Cervarix
Cervarix is a vaccine against certain types of cancer-causing human papillomavirus (HPV).
Cervarix is designed to prevent infection from HPV types 16 and 18, that cause about 70% of cervical cancer cases. These types also cause most HPV-induced ...
protects against two oncogenic strains of HPV, 16 and 18.
The
National Cancer Institute
The National Cancer Institute (NCI) coordinates the United States National Cancer Program and is part of the National Institutes of Health (NIH), which is one of eleven agencies that are part of the U.S. Department of Health and Human Services. ...
says, "To date, protection against the targeted HPV types has been found to last for at least 10 years with Gardasil, at least 9 years with Cervarix, and at least 6 years with Gardasil 9. Long-term studies of vaccine efficacy that are still in progress will help scientists better understand the total duration of protection."
Gardasil has been shown to be partially effective (approximately 38%) in preventing cervical cancer caused by ten other high-risk HPV types.
Antibody levels at month 3 (one month post-dose number two) are substantially higher than at month 24 (18 months post-dose number three), suggesting that protection is achieved by month 3 and perhaps earlier.
In 2014, the
World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
(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.
The United Kingdom,
Switzerland
). Swiss law does not designate a ''capital'' as such, but the federal parliament and government are installed in Bern, while other federal institutions, such as the federal courts, are in other cities (Bellinzona, Lausanne, Luzern, Neuchâtel ...
, Mexico, and
Quebec
Quebec ( ; )According to the Canadian government, ''Québec'' (with the acute accent) is the official name in Canadian French and ''Quebec'' (without the accent) is the province's official name in Canadian English is one of the thirtee ...
province of Canada are among the countries or territories that have implemented this . The CDC recommended the vaccines be delivered in two shots over six months.
Males
Gardasil is also effective in males, providing protection against
genital warts
Genital warts are a sexually transmitted infection caused by certain types of human papillomavirus (HPV). They are generally pink in color and project out from the surface of the skin. Usually they cause few symptoms, but can occasionally be pai ...
, anal warts,
anal cancer
Anal cancer is a cancer which arises from the anus, the distal opening of the gastrointestinal tract. Symptoms may include bleeding from the anus or a lump near the anus. Other symptoms may include pain, itchiness, or discharge from the anus. ...
, and some potentially
precancerous lesions
A precancerous condition is a condition, tumor or lesion involving abnormal cells which are associated with an increased risk of developing into cancer. Clinically, precancerous conditions encompass a variety of abnormal tissues with an increased ...
caused by some HPV types.
Gardasil vaccine has been shown to decrease the risk of young men contracting genital warts. In the United States, the FDA approved administration of the Gardasil vaccine to males between ages 9 and 26 in 2009. The FDA approved administration of the Gardasil 9 vaccine to males between ages 9 and 15 in 2014, and extended the age indication, by including males between ages 16 and 26, in 2015. In the UK, HPV vaccines are licensed for males aged 9 to 15 and for females aged 9 to 26.
Men who have sex with men
Men who have sex with men (MSM) are male persons who engage in sexual activity with members of the same sex. The term was created in the 1990s by epidemiology, epidemiologists to study the spread of disease among all men who have sex with men, r ...
(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. HPV type 16 is also responsible for almost 90% of HPV-positive oropharyngeal squamous-cell carcinoma (OPSCC), a form of cancer that affects the mouth, tonsils, and throat; the prevalence of HPV-positive oropharyngeal cancers is higher in males than females. A 2005 study found that 95% of HIV
The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...
-infected gay men also had anal HPV infection, of whom 50% had precancerous HPV-caused lesions.
Administration
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. 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.
Adverse effects
, more than 170 million doses of Gardasil had been distributed worldwide. The vaccine was tested in thousands of females (ages 9 to 26). The US Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) and the US Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgi ...
(CDC) consider the vaccine to be safe. It does not contain mercury
Mercury commonly refers to:
* Mercury (planet), the nearest planet to the Sun
* Mercury (element), a metallic chemical element with the symbol Hg
* Mercury (mythology), a Roman god
Mercury or The Mercury may also refer to:
Companies
* Merc ...
, thiomersal
Thiomersal (INN), or thimerosal (USAN, JAN), is an organomercury compound. It is a well-established antiseptic and antifungal agent.
The pharmaceutical corporation Eli Lilly and Company gave thiomersal the trade name Merthiolate. It has been u ...
, live viruses or dead viruses, but virus-like particles, which cannot reproduce in the human body.
The vaccine has mostly minor side effects, such as pain around the injection area. Fainting is more common among adolescents receiving the Gardasil vaccine than in other kinds of vaccinations. Patients should remain seated for 15 minutes after they receive the HPV vaccine. There have been reports that the shot is more painful than other common vaccines, and the manufacturer Merck
Merck refers primarily to the German Merck family and three companies founded by the family, including:
* the Merck Group, a German chemical, pharmaceutical and life sciences company founded in 1668
** Merck Serono (known as EMD Serono in the Unite ...
partly attributes this to the virus-like particles within the vaccine. General side effects of the shot may include joint and muscle pain, fatigue, physical weakness and general malaise.
The FDA and the CDC said that with millions of vaccinations "by chance alone some serious adverse effects and deaths" will occur in the time period following vaccination, but they have nothing to do with the vaccine. More than twenty women who received the Gardasil vaccine have died, but these deaths have not been causally connected to the shot, as correlation does not imply causation
The phrase "correlation does not imply causation" refers to the inability to legitimately deduce a cause-and-effect relationship between two events or variables solely on the basis of an observed association or correlation between them. The id ...
. Where information has been available, the cause of death was explained by other factors. Likewise, a small number of cases of Guillain–Barré syndrome
Guillain–Barré syndrome (GBS) is a rapid-onset muscle weakness caused by the immune system damaging the peripheral nervous system. Typically, both sides of the body are involved, and the initial symptoms are changes in sensation or pain often ...
(GBS) have been reported following vaccination with Gardasil, though there is no evidence linking GBS to the vaccine. It is unknown why a person develops GBS, or what initiates the disease.
The FDA and the CDC monitor events to see if there are patterns, or more serious events than would be expected from chance alone. The majority (68%) of side effects data were reported by the manufacturer, but in about 90% of the manufacturer reported events, no follow-up information was given that would be useful to investigate the event further. In February 2009, the Spanish Ministry of Health suspended use of one batch of Gardasil after health authorities in the Valencia
Valencia ( va, València) is the capital of the Autonomous communities of Spain, autonomous community of Valencian Community, Valencia and the Municipalities of Spain, third-most populated municipality in Spain, with 791,413 inhabitants. It is ...
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.
Ingredients
The following are the ingredients found in the different formulations of HPV vaccines:
* Major capsid protein L1 epitope
An epitope, also known as antigenic determinant, is the part of an antigen that is recognized by the immune system, specifically by antibodies, B cells, or T cells. The epitope is the specific piece of the antigen to which an antibody binds. The p ...
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)
* amorphous aluminum hydroxyphosphate sulfate (adjuvant In pharmacology, an adjuvant is a drug or other substance, or a combination of substances, that is used to increase the efficacy or potency of certain drugs. Specifically, the term can refer to:
* Adjuvant therapy in cancer management
* Analgesic ...
)
* sodium chloride
Sodium chloride , commonly known as salt (although sea salt also contains other chemical salts), is an ionic compound with the chemical formula NaCl, representing a 1:1 ratio of sodium and chloride ions. With molar masses of 22.99 and 35.45 g ...
* yeast
Yeasts are eukaryotic, single-celled microorganisms classified as members of the fungus kingdom. The first yeast originated hundreds of millions of years ago, and at least 1,500 species are currently recognized. They are estimated to constitut ...
protein
* L-histidine
Histidine (symbol His or H) is an essential amino acid that is used in the biosynthesis of proteins. It contains an α-amino group (which is in the protonated –NH3+ form under biological conditions), a carboxylic acid group (which is in the d ...
* polysorbate 80
Polysorbate 80 is a nonionic surfactant and emulsifier often used in pharmaceuticals, foods, and cosmetics. This synthetic compound is a viscous, water-soluble yellow liquid.
Chemistry
Polysorbate 80 is derived from polyethoxylated sorbitan and ...
* sodium borate Sodium borate is a generic name for any salt of sodium with an anion consisting of boron and oxygen, and possibly hydrogen, or any hydrate thereof. It can be seen as a hydrated sodium salt of the appropriate boroxy acid, although the latter may n ...
* sodium dihydrogen phosphate
Monosodium phosphate (MSP), also known as monobasic sodium phosphate and sodium dihydrogen phosphate, is an inorganic compound of sodium with a dihydrogen phosphate (H2PO4−) anion. One of many sodium phosphates, it is a common industrial chemical ...
dihydrate (Cervarix only)
* 3-O-Desacyl-4′-monophosphoryl lipid (MPL) A (Cervarix only)
* Aluminum hydroxide
Aluminium hydroxide, Al(OH)3, is found in nature as the mineral gibbsite (also known as hydrargillite) and its three much rarer polymorphs: bayerite, doyleite, and nordstrandite. Aluminium hydroxide is amphoteric, i.e., it has both basic and ...
(Cervarix only)
* ''Trichoplusia ni'' insect cells (Cervarix only)
Biotechnology
The HPV major capsid
A capsid is the protein shell of a virus, enclosing its genetic material. It consists of several oligomeric (repeating) structural subunits made of protein called protomers. The observable 3-dimensional morphological subunits, which may or may ...
protein, L1, can spontaneously self-assemble into virus-like particle
Virus-like particles (VLPs) are molecules that closely resemble viruses, but are non-infectious because they contain no viral genetic material. They can be naturally occurring or synthesized through the individual expression of viral structural pro ...
s (VLPs) that resemble authentic HPV virion
A virus is a submicroscopic infectious agent that replicates only inside the living cells of an organism. Viruses infect all life forms, from animals and plants to microorganisms, including bacteria and archaea.
Since Dmitri Ivanovsky's 1 ...
s. 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
An antibody (Ab), also known as an immunoglobulin (Ig), is a large, Y-shaped protein used by the immune system to identify and neutralize foreign objects such as pathogenic bacteria and viruses. The antibody recognizes a unique molecule of the ...
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
''Saccharomyces cerevisiae'' () (brewer's yeast or baker's yeast) is a species of yeast (single-celled fungus microorganisms). The species has been instrumental in winemaking, baking, and brewing since ancient times. It is believed to have been o ...
'' and self-assembled into VLPs.
Public health
The National Cancer Institute
The National Cancer Institute (NCI) coordinates the United States National Cancer Program and is part of the National Institutes of Health (NIH), which is one of eleven agencies that are part of the U.S. Department of Health and Human Services. ...
writes:
Long-term impact and cost-effectiveness
Whether the effects are temporary or lifelong, widespread vaccination could have a substantial public health impact. As of 2018, studies have proven that cervical cancer rates have dropped significantly since the introduction of Gardasil. Before Gardasil was introduced in 2006, 270,000 women died of cervical cancer worldwide in 2002. As of 2014, the mortality rate from cervical cancer has dropped 50% from 1975 which is due to the Gardasil vaccination along with increased focus on cervical screening. Acting FDA administrator Andrew von Eschenbach
Andrew C. von Eschenbach (born October 30, 1941) was the Commissioner of the United States Food and Drug Administration from 2006 to 2009. He became acting Commissioner on September 26, 2005, after the resignation of his predecessor Lester Crawfo ...
said the
vaccine will have "a dramatic effect" on the health of women around the world. Gardasil is an important tool in reducing cervical cancer rates even in countries where screening programs are routine. The National Cancer Institute
The National Cancer Institute (NCI) coordinates the United States National Cancer Program and is part of the National Institutes of Health (NIH), which is one of eleven agencies that are part of the U.S. Department of Health and Human Services. ...
estimated that 9,700 women would develop cervical cancer in 2006, and 3,700 would die.[SEER Stat Fact Sheets: Cervix Uteri](_blank)
. National Cancer Institute
The National Cancer Institute (NCI) coordinates the United States National Cancer Program and is part of the National Institutes of Health (NIH), which is one of eleven agencies that are part of the U.S. Department of Health and Human Services. ...
. Retrieved 30 March 2007.
Merck and CSL Limited
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. CSL's product areas include blood plasma derivative ...
are expected to market Gardasil as a cancer vaccine, rather than an STD vaccine. In the early years of Gardasil's introduction it was unclear how widespread the use of the three-shot series would be, in part because of its $525 list price ($175 each for three shots). But as of 2013, vaccine coverage has been rising. In 2013, about 55% of girls ages 13–17 years had at least one dose of the vaccination covered, up from 29% in 2007. Coverage for women ages 18–34 also has increased significantly since 2007.
Studies using different pharmacoeconomic models predict that vaccinating young women with Gardasil in combination with screening programs may be more cost effective than screening alone. These results have been important in decisions by many countries to start vaccination programs. For example, the Canadian government approved $300 million to buy the HPV vaccine in 2008 after deciding from studies that the vaccine would be cost-effective especially by immunizing young women. Marc Steben, an investigator for the vaccine, wrote that the financial burden of HPV related cancers on the Canadian people was already $300 million per year in 2005, so the vaccine could reduce this burden and be cost-effective.
Since penile and anal cancers are much less common than cervical cancer, HPV vaccination of young men is likely to be much less cost-effective than for young women yet is still recommended due to the existent risk (including oral cancer).
The August 2009 issue of the ''Journal of the American Medical Association
''The Journal of the American Medical Association'' (''JAMA'') is a peer-reviewed medical journal published 48 times a year by the American Medical Association. It publishes original research, reviews, and editorials covering all aspects of bio ...
'' had an article reiterating the safety of Gardasil and another questioning the way it was presented to doctors and parents.
According to the CDC, as of 2012, use of the HPV vaccine had cut rates of infection with HPV-6, -11, -16 and -18 in half in American teenagers (from 11.5% to 4.3%) and by one third in American women in their early twenties (from 18.5% to 12.1%).
History
Research findings that pioneered the development of the vaccine began in 1991 by investigators Jian Zhou
Jian Zhou (; 1957 – March 1999) was a Chinese virologist and cancer researcher, who with fellow researcher Ian Frazer, invented Gardasil and Cervarix, the vaccines for stimulating human immunological resistance to the cervical cancer-inducin ...
and Ian Frazer
Ian Hector Frazer (born 6 January 1953) is a Scottish-born Australian immunologist, the founding CEO and Director of Research of the Translational Research Institute (Australia). Frazer and Jian Zhou developed and patented the basic technolog ...
in The University of Queensland
, mottoeng = By means of knowledge and hard work
, established =
, endowment = A$224.3 million
, budget = A$2.1 billion
, type = Public research university
, chancellor = Peter Varghese
, vice_chancellor = Deborah Terry
, city = B ...
, 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
Georgetown University is a private university, private research university in the Georgetown (Washington, D.C.), Georgetown neighborhood of Washington, D.C. Founded by Bishop John Carroll (archbishop of Baltimore), John Carroll in 1789 as Georg ...
Medical Center, the University of Rochester
The University of Rochester (U of R, UR, or U of Rochester) is a private research university in Rochester, New York. The university grants undergraduate and graduate degrees, including doctoral and professional degrees.
The University of Roc ...
, the University of Queensland
, mottoeng = By means of knowledge and hard work
, established =
, endowment = A$224.3 million
, budget = A$2.1 billion
, type = Public research university
, chancellor = Peter Varghese
, vice_chancellor = Deborah Terry
, city = B ...
in Australia, and the US National Cancer Institute
The National Cancer Institute (NCI) coordinates the United States National Cancer Program and is part of the National Institutes of Health (NIH), which is one of eleven agencies that are part of the U.S. Department of Health and Human Services. ...
.
In December 2014, the FDA approved Gardasil 9, which protects against nine strains of HPV.
Society and culture
United States
A few conservative groups, such as the Family Research Council
The Family Research Council (FRC) is an American evangelical activist group and think-tank with an affiliated lobbying organization. FRC promotes what it considers to be family values. It opposes and lobbies against: access to pornography, emb ...
(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 attendance, which has upset some conservative and libertarian
Libertarianism (from french: libertaire, "libertarian"; from la, libertas, "freedom") is a political philosophy that upholds liberty as a core value. Libertarians seek to maximize autonomy and political freedom, and minimize the state's e ...
groups.
The governor of Texas, Rick Perry
James Richard Perry (born March 4, 1950) is an American politician who served as the 14th United States secretary of energy from 2017 to 2019 and as the 47th governor of Texas from 2000 to 2015. Perry also ran unsuccessfully for the Republica ...
, issued an executive order adding Gardasil to the state's required vaccination list, which was later overturned by the Texas legislature. Even though Perry also allowed parents to opt out of the program more easily, Perry's order was criticized, by fellow presidential candidates Rick Santorum
Richard John Santorum ( ; born May 10, 1958) is an American politician, attorney, and political commentator. A member of the Republican Party, he served as a United States Senator from Pennsylvania from 1995 to 2007 and was the Senate's thir ...
and Michele Bachmann
Michele Marie Bachmann (; née Amble; born April 6, 1956) is an American politician who was the U.S. representative for from 2007 until 2015. A member of the Republican Party, she was a candidate for President of the United States in the 20 ...
during the 2012 Republican Party presidential debate as being an overreach of state power in a decision properly left to parents.
Japan
In June 2013, the Japanese government issued a notice that "cervical cancer vaccinations should no longer be recommended for girls aged 12 to 16" while an investigation is conducted into certain adverse events including pain and numbness in 38 girls.[Japan Times. (16 June 2013).]
Cervix vaccine issues trigger health notice
." Accessed 9 July 2013. The vaccines sold in Japan are Cervarix, made by GlaxoSmithKline
GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the ten ...
of the United Kingdom, and Gardasil, made by Merck Sharp & Dohme. An estimated 3.28 million people have received the vaccination; 1,968 cases of possible side effects have been reported.[The Asahi Shimbun. (15 June 2013).]
Health ministry withdraws recommendation for cervical cancer vaccine
." Accessed 9 July 2013. In January 2014, the Vaccine Adverse Reactions Review Committee concluded that there was no evidence to suggest a causal association between the HPV vaccine and the reported adverse events, but did not reinstate proactive recommendations for its use. A study on girls in Sapporo
( ain, サッ・ポロ・ペッ, Satporopet, lit=Dry, Great River) is a city in Japan. It is the largest city north of Tokyo and the largest city on Hokkaido, the northernmost main island of the country. It ranks as the fifth most populous city ...
showed that since the Japanese government's suspension of recommending the vaccine, completion rates for the full course of vaccination have dropped to 0.6%. On 26 November 2021, the Ministry of Health, Labour, and Welfare of Japan officially issued an announcement to resume active recommendations of the HPV vaccine after 8.5 years of suspension and municipalities are expected to restart such active recommendations from April 2022.
References
Further reading
Silgard EPAR summary for the public
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