Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, today announced that new clinical and real-world data for
the company’s 9-valent Human Papillomavirus (HPV) vaccine,
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant),
evaluating the burden and incidence of certain HPV-related cancers
and diseases, will be presented at the International Papillomavirus
Conference (IPVC) 2024 in Edinburgh, UK, from November 12-15.
Data to be presented include results from the BROADEN and
PROGRESS studies evaluating the prevalence of oral HPV infection
and burden of HPV-related oropharyngeal and other head and neck
cancers, as well as studies evaluating the age of disease-causal
HPV infection among females and highlighting the importance of
protecting both females and males from HPV-related cancers and
diseases through vaccination.
“These data support the value of adult vaccination and
strengthen our understanding that disease-causal HPV infection can
happen later in life, reinforcing the importance of HPV vaccination
for both females and males beginning at age 9,” said Dr. Eliav
Barr, senior vice president, head of global clinical development
and chief medical officer, Merck Research Laboratories. “While
historically the HPV vaccination conversation has focused on
preventing certain HPV-related cervical cancers in women, we also
continue to see the growing incidence of HPV-related oropharyngeal
and other head and neck cancers, particularly in men. In both men
and women globally, there are approximately 666,000 new diagnoses
of certain HPV-related cancers annually. The breadth of data we are
presenting at the conference continues to demonstrate the link
between HPV and certain HPV-related cancers in males and females
and the role HPV vaccination can play in prevention.”
Details on key abstracts for Merck:
New Data Analyses of HPV-Related
Cancers and Diseases in Women and Men
Abstract Title
Details
Immunogenicity Of 9-Valent HPV (9VHPV)
Vaccine In Male Clinical Trial Participants: A Post-Hoc Analysis By
Baseline Demographic Characteristics. A. Luxembourg.
ID #2172. TOPIC AS02: CLINICAL RESEARCH.
CLINICAL SCIENCE ORAL ABSTRACT SESSION 05: HPV VACCINES
Sequential Human Papillomavirus Infection
Between Anogenital Anatomical Sites In Men. G. Nahhas.
Poster #230. Session: 1
Estimating The Age of Acquisition of
Disease-Causal HPV Infection Onset In Women Who Develop CIN2+ In
England. K. Engelbrecht.
Poster #209. Session: 1
Estimating The Age Of Disease-Causal HPV
Infection Based On The Natural History Of CIN2+ Among Females In
Canada. A. Cherif.
Poster #219. Session: 2
Data Assessing Burden of Oral HPV
Infection and HPV-Related Head and Neck Cancers in Men and
Women
Abstract Title
Details
Oral Human Papillomavirus Prevalence And
Genotyping Among Adults In The United Kingdom – PROGRESS Study. O.
Ovcinnikova.
Poster #229. Session: 1
Oral Human Papillomavirus Incidence Among
A General Adult Population In The US: Results From The PROGRESS
(Prevalence Of Oral HPV Infection, A Global Assessment) Study. M.
Felsher.
Poster #228. Session: 1
Preliminary Results Of The BROADEN Study:
Burden Of Human Papillomavirus-Related Head And Neck Cancers. T.
Waterboer.
ID#1292. TOPIC AS03: PUBLIC HEALTH,
EPIDEMIOLOGY AND IMPLEMENTATION SCIENCE. ORAL ABSTRACTS SESSION 01:
HPV AND HPV-DRIVEN CANCER IN THE HEAD AND NECK
The BROADEN-China Study: Increasing Burden
of Human Papillomavirus-Related Head and Neck Cancers in China. S.
Zhang.
ID#2397. TOPIC AS03: PUBLIC HEALTH,
EPIDEMIOLOGY AND IMPLEMENTATION SCIENCE. ORAL ABSTRACTS SESSION:
PUBLIC HEALTH LATE BREAKING ORAL ABSTRACTS
Indication for GARDASIL 9
GARDASIL 9 is a vaccine indicated in females 9 through 45 years
of age for the prevention of 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;
cervical, vulvar, vaginal, and anal precancerous or dysplastic
lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58;
and genital warts caused by HPV Types 6 and 11.
GARDASIL 9 is indicated in males 9 through 45 years of age for
the prevention of anal, oropharyngeal and other head and neck
cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal
precancerous or dysplastic lesions caused by HPV Types 6, 11, 16,
18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6
and 11.
The oropharyngeal and head and neck cancer indication is
approved under accelerated approval based on effectiveness in
preventing HPV-related anogenital disease. Continued approval for
this indication may be contingent upon verification and description
of clinical benefit in a confirmatory trial.
GARDASIL 9 does not eliminate the necessity for vaccine
recipients to undergo screening for cervical, vulvar, vaginal,
anal, oropharyngeal and other head and neck cancers as recommended
by a health care provider.
GARDASIL 9 has not been demonstrated to provide protection
against diseases caused by:
- HPV types not covered by the vaccine - HPV
types to which a person has previously been exposed through sexual
activity
Not all vulvar, vaginal, anal, oropharyngeal and other head and
neck cancers are caused by HPV, and GARDASIL 9 protects only
against those vulvar, vaginal, anal, oropharyngeal and other head
and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and
58.
GARDASIL 9 is not a treatment for external genital lesions;
cervical, vulvar, vaginal, anal, oropharyngeal and other head and
neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar
intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia
(VaIN), or anal intraepithelial neoplasia (AIN).
Vaccination with GARDASIL 9 may not result in protection in all
vaccine recipients
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].
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 HPV vaccination. When syncope is associated with
tonic-clonic movements, the activity is usually transient and
typically responds to restoring cerebral perfusion. Safety and
effectiveness of GARDASIL 9 have not been established in pregnant
women. The most common (≥10%) local and systemic adverse reactions
in females were injection-site pain, swelling, erythema, and
headache. The most common (≥10%) local and systemic reactions in
males were injection-site pain, swelling, and erythema. The
duration of immunity of a 2-dose schedule of GARDASIL 9 has not
been established.
Dosage and Administration
GARDASIL 9 should be administered intramuscularly in the deltoid
or anterolateral area of the thigh.
For individuals 9 through 14 years of age, GARDASIL 9 can be
administered using a 2-dose or 3-dose schedule. For the 2-dose
schedule, the second dose should be administered 6–12 months after
the first dose. If the second dose is administered less than 5
months after the first dose, a third dose should be given at least
4 months after the second dose. For the 3-dose schedule, GARDASIL 9
should be administered at 0, 2 months, and 6 months.
For individuals 15 through 45 years of age, GARDASIL 9 is
administered using a 3-dose schedule at 0, 2 months, and 6
months.
About Merck
At Merck, known as MSD outside of the United States and Canada,
we are unified around our purpose: We use the power of leading-edge
science to save and improve lives around the world. For more than
130 years, we have brought hope to humanity through the development
of important medicines and vaccines. We aspire to be the premier
research-intensive biopharmaceutical company in the world – and
today, we are at the forefront of research to deliver innovative
health solutions that advance the prevention and treatment of
diseases in people and animals. We foster a diverse and inclusive
global workforce and operate responsibly every day to enable a
safe, sustainable and healthy future for all people and
communities. For more information, visit www.merck.com and connect
with us on X (formerly Twitter), Facebook, Instagram, YouTube and
LinkedIn.
About Merck’s global commitment to supply and access to HPV
vaccines
Merck is committed to ensuring adequate global supply and
supporting broader, equitable access to our HPV vaccines to help
protect against certain HPV-related cancers and diseases.
This commitment is enabled through significant capital
investments, including more than $2 billion to help increase
capacity through additional manufacturing facilities that allowed
for a nearly doubling of supply of our HPV vaccines from 2017-2020
and then, supply was doubled again between 2020-2024 to address
increasing global demand. As a result, we expect to supply
sufficient quantities of our HPV vaccines to meet anticipated
demand and will continue to expand supply capacity in the
future.
Global equitable access to our HPV vaccines is a key part of our
efforts and key partnerships help us achieve these goals. In 2024,
Merck reaffirmed its commitment to Gavi, the Vaccine Alliance,
through an agreement with UNICEF, to supply low- and middle-income
countries with over 115 million doses of HPV vaccine by 2025, to
appropriately support local immunization programs. Merck has
consistently increased our supply commitment to Gavi from 1.7
million doses in 2017 to more than 30 million doses in 2024.
Additionally, we are working to ensure continued supply in
countries with existing HPV vaccination programs and currently
supply approximately 150 National Immunization Programs
globally.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA
This news release of Merck & Co., Inc., Rahway, 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
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
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 Annual
Report on Form 10-K for the year ended December 31, 2023 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 9 (Human
Papillomavirus 9-valent Vaccine, Recombinant) at
https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf
and Patient Information/Medication Guide for GARDASIL 9
at
https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf
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