Studies Published over the Last 10 Years
Report Reductions in Cervical Pre-cancers and Other HPV-related
Diseases
Merck (NYSE:MRK), known as MSD outside of the United States and
Canada, announced today that in a systematic review conducted of
the global impact and effectiveness of GARDASIL® [Human
Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine,
Recombinant], substantial reductions were observed in HPV
6/11/16/18-related infection, genital warts, Pap abnormalities and
cervical pre-cancers. This evaluation of 58 effectiveness and
impact studies published during the past 10 years examined the use
of GARDASIL in routine vaccination programs in Australia, Europe,
North America and New Zealand, and will be presented for the first
time during an oral session at the European Research Organization
on Genital Infection and Neoplasia (EUROGIN) congress in Austria. A
paper detailing this review was also published online on June 14 in
the journal Clinical Infectious Diseases (CID).
Following introduction of vaccination programs with GARDASIL,
the earliest impact of the vaccine was seen in the reduction of
genital warts. Reductions in genital warts were observed in all
nine countries included in this review (based on 28 publications),
with declines occurring as early as one year after vaccine
introduction in Australia and Germany. Reductions in HPV 6/11/16/18
infection, assessed in 14 publications from five countries
(Australia, Belgium, Germany, Sweden and the United States), were
also observed shortly after vaccination; for example, reductions in
HPV 6/11/16/18 infection were seen within four years in several
studies from Australia and the United States. Subsequently, as
successive birth cohorts began cervical screening, reductions in
cervical pre-cancers were observed within 3-5 years of vaccine
program implementation in Australia, Canada, Denmark, Sweden and
the United States.
GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16
and 18) Vaccine, Recombinant] is indicated for use in females 9
through 26 years of age for the prevention of cervical, vulvar,
vaginal and anal cancers caused by HPV types 16 and 18; genital
warts caused by HPV types 6 and 11; and precancerous or dysplastic
lesions caused by HPV types 6, 11, 16 and 18. GARDASIL is also
approved for use in males 9 through 26 years of age for the
prevention of anal cancer caused by HPV types 16 and 18, for the
prevention of anal dysplasias and precancerous lesions caused by
HPV types 6, 11, 16 and 18, and for the prevention of genital warts
caused by HPV types 6 and 11. GARDASIL is contraindicated in
individuals with hypersensitivity, including severe allergic
reactions to yeast, or after a previous dose of GARDASIL.
The review identified 58 studies published from January 2007
through February 2016 that met the pre-specified criteria for
assessment of the real-world impact of vaccination with GARDASIL on
HPV-related disease. These studies were conducted in nine different
countries (Australia, Denmark, Sweden, Belgium, Germany, France,
United States, Canada and New Zealand) with varying degrees of HPV
vaccination coverage, among populations of different ages, and used
different study methods and disease endpoints. Studies reporting
only on the bivalent HPV vaccine were excluded. GARDASIL was
predominantly, but not exclusively, used in all publications
reviewed. Short-term endpoints (reduction in HPV infection and
genital warts) and medium-term endpoints (reduction in Pap
abnormalities and cervical pre-cancers) were assessed. Cervical
cancer, however, was not identified because most vaccinated cohorts
have not yet reached ages when cervical cancer is typically
diagnosed. Thus the anticipated benefit of vaccination on certain
HPV-related cancer rates cannot be fully determined yet, because of
the long latency periods following exposure to HPV.
In this review of the studies, decreases in the prevalence of
HPV 6/11/16/18 infections, genital warts, Pap abnormalities and
cervical pre-cancers were observed among females in their teens and
20s subsequent to the introduction of GARDASIL. Decreases were
generally highest in younger populations, reflecting a lower
likelihood of pre-existing HPV infection at time of vaccination,
supporting global recommendations for routine use of HPV vaccine in
adolescents.
“Based on this comprehensive review of studies published during
the past 10 years since the licensure of GARDASIL, reductions in
HPV infections as well as reductions in the prevalence of HPV
6/11/16/18-related diseases, as noted by decreases in Pap
abnormalities, cervical pre-cancers, and genital warts, were
detected within four years after vaccine introduction,” said
Professor Suzanne Garland, M.D., director of microbiological
research and head of clinical microbiology and infectious diseases,
The Royal Women's Hospital, Victoria, Australia, who will present
these data at EUROGIN and is lead author on the CID publication.
“Despite the progress we have made with Pap screening and
vaccination, cervical cancer and other HPV-related diseases are
still a public health issue in both developed and developing
nations, which underscores the need for comprehensive HPV
vaccination programs in adolescents before they’re at risk of
contracting the virus,” added Garland.
Results varied depending on the vaccine coverage (percent of the
population who had been vaccinated), breadth of the immunization
program (the age range of those vaccinated and whether catch-up
vaccination was included), the number of doses received, the study
design, and the disease outcome assessed. The overall impact on the
population was greatest in countries that achieved high vaccination
rates soon after the introduction of GARDASIL [Human Papillomavirus
Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] and in
the youngest cohorts. For example, in Australia, a country with
3-dose vaccination coverage of 73 percent among adolescent females,
prevalent HPV 6/11/16/18-related infection decreased by 86 percent
in females 18-24 years of age after three doses within six years of
vaccine introduction, compared to unvaccinated women during the
same timeframe. Furthermore, a 92.6 percent reduction in genital
warts diagnosed among females <21 years of age was observed four
years after the vaccine program was initiated. Within four years of
vaccine introduction in Australia, reductions in cervical
pre-cancers were seen in females 11-27 years old at the start of
the vaccination program in 2007 and who received all three vaccine
doses, with declines ranging from 57 percent in females 15-18 years
old to 5 percent in females 23-27 years old. Reductions in disease
endpoints were generally lower in older individuals and in
countries with lower vaccine coverage. For example, in the same
Australian study where a 92.6 percent reduction in genital warts
was observed in females <21 years of age, the reduction in
genital warts in females 21-30 years of age was 72.6 percent.
Reductions in genital warts were <50 percent in teens 15-19
years old in France and Germany where vaccine coverage was much
lower than Australia.
"These data reinforce that GARDASIL is important in the fight
against cervical cancer and certain other HPV-related cancers and
diseases, however the full public health potential of HPV
vaccination of males and females is not yet realized even after a
decade of use,” said Jacques Cholat, M.D., president of Merck
Vaccines. “Increasing HPV vaccination rates and access to the
vaccine has the potential to make an even greater impact
globally."
Systematic review of 58 peer-reviewed publications
This review synthesized available data assessed through a
systematic search of PubMed and Embase for peer-reviewed
manuscripts from January 2007 through February 2016. The search
identified observational studies that reported on the impact or
effectiveness of GARDASIL on HPV infection, genital warts, cervical
abnormalities and pre-cancers. Both vaccine effectiveness and
impact aim at evaluating ‘real-life benefit’ and are typically
measured through observational studies. Vaccine impact denotes the
population-prevented fraction of infection or disease and is
assessed by comparing prevalence or incidence in the vaccine era to
a comparable population from the prevaccine era or by measuring
population-level trends over time. Vaccine effectiveness
corresponds to the proportion of infection or disease prevented
among vaccinated individuals, and is estimated by comparing the
incidence in vaccinated versus unvaccinated individuals within
similar populations. After screening 903 papers, 58 publications
from nine countries met the pre-specified inclusion criteria.
Important information about GARDASIL® [Human
Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine,
Recombinant]
GARDASIL does not eliminate the necessity for women to continue
to undergo recommended cervical cancer screening. Recipients of
GARDASIL should not discontinue anal cancer screening if it has
been recommended by a health care provider.
GARDASIL has not been demonstrated to provide protection against
diseases from vaccine and non-vaccine HPV types to which a person
has previously been exposed through sexual activity.
GARDASIL is not intended to be used for treatment of active
external genital lesions; cervical, vulvar, vaginal and anal
cancers; cervical intraepithelial neoplasia (CIN), vulvar
intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia
(VaIN), or anal intraepithelial neoplasia (AIN).
GARDASIL has not been demonstrated to protect against diseases
due to HPV types not contained in the vaccine.
Not all vulvar, vaginal and anal cancers are caused by HPV, and
GARDASIL protects only against those vulvar, vaginal and anal
cancers caused by HPV Types 16 and 18.
GARDASIL does not protect against diseases not caused by HPV.
Vaccination with GARDASIL may not result in protection in all
vaccine recipients.
Select safety information for GARDASIL® [Human
Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine,
Recombinant]
GARDASIL is contraindicated in individuals with
hypersensitivity, including severe allergic reactions to yeast, or
after a previous dose of GARDASIL.
Because vaccinees may develop syncope, sometimes resulting in
falling with injury, observation for 15 minutes after
administration is recommended. Syncope, sometimes associated with
tonic-clonic movements and other seizure-like activity, has been
reported following vaccination with GARDASIL. When syncope is
associated with tonic-clonic movements, the activity is usually
transient and typically responds to restoring cerebral
perfusion.
GARDASIL is not recommended for use in pregnant women.
The most common adverse reaction was headache. Common adverse
reactions that were observed among recipients of GARDASIL at a
frequency of at least 1.0 percent and greater than placebo were
fever, nausea, dizziness; and injection-site pain, swelling,
erythema, pruritus and bruising.
Dosage and administration for GARDASIL
GARDASIL should be administered in 3 separate intramuscular
injections in the deltoid region of the upper arm or in the higher
anterolateral area of the thigh over a 6-month period with the
first dose at an elected date, the second dose 2 months after the
first dose, and the third dose 6 months after the first dose.
About GARDASIL
GARDASIL is approved for use in 132 countries. To date, more
than 208 million doses have been distributed worldwide.
About HPV and related cancers and diseases
In the United States, human papillomavirus (HPV) will infect
most sexually active males and females in their lifetime. According
to the CDC, there are approximately 14 million new genital HPV
infections in the United States each year, half of which occur in
people 15 through 24 years of age. For most people, HPV clears on
its own, but for others who don't clear the virus, it could lead to
cancers and other diseases in males as well as females, and there
is no way to predict who will clear the virus.
In women, HPV causes virtually all cervical cancer cases of
which an estimated 70 percent are caused by HPV types 16 and 18.
Each day another 35 women are diagnosed with cervical cancer in the
United States — about 12,900 women per year. HPV also causes
approximately 70-75 percent of vaginal cancer cases and
approximately 30 percent of vulvar cancer cases. HPV types 16 and
18 cause an estimated 65% of hpv-related vaginal cancer cases and
75% of hpv-related vulvar cancer cases. Additionally, there are an
estimated 3 million abnormal Pap results, many of which are caused
by HPV, that require follow-up each year in the United States.
HPV causes approximately 85-90 percent of anal cancers in both
males and females, and HPV types 16 and 18 cause an estimated 85%
of those cases. According to the American Cancer Society, an
estimated 2,600 men and 4,600 women in the United States will be
diagnosed with anal cancer in 2015, and overall rates have been
increasing. There is no routine screening recommended for the
general population to screen for anal cancer.
HPV causes approximately 90 percent of genital warts in both
males and females. There are approximately 360,000 cases of genital
warts each year in the United States. Treatment of genital warts
can be painful, and they may recur after treatment, especially in
the first three months. Approximately 3 out of 4 people get them
after having genital contact with someone who has genital
warts.
About Merck
For 125 years, Merck has been a global health care leader
working to help the world be well. Merck is known as MSD outside
the United States and Canada. Through our prescription medicines,
vaccines, biologic therapies, and animal health products, we work
with customers and operate in more than 140 countries to deliver
innovative health solutions. We also demonstrate our commitment to
increasing access to health care through far-reaching policies,
programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, YouTube and
LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
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actions.
The company undertakes no obligation to publicly update any
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future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2015
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Please see Prescribing Information for GARDASIL®
[Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18)
Vaccine, Recombinant] at
https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf
and Patient Information for GARDASIL at
https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf.
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MerckMedia:Pamela Eisele, 267-305-3558Deb Wambold,
215-652-2913orInvestors:Teri Loxam, 908-740-1986Justin Holko,
908-740-1879
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