Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced the U.S. Centers for Disease Control and
Prevention’s (CDC’s) Advisory Committee on Immunization Practices
(ACIP) voted to recommend HPV vaccination with GARDASIL®9 (Human
Papillomavirus 9-valent Vaccine, Recombinant) based on shared
clinical decision making for individuals 27 through 45 years of age
who are not adequately vaccinated. The ACIP also voted to expand
routine and catch-up recommendations for males through 26 years of
age who are not adequately vaccinated. The CDC currently recommends
routine vaccination of females and males 11-12 years of age, and
vaccination can begin at age 9. If approved by the CDC, GARDASIL 9
recommendations would be expanded to include females and males
13-26 years of age who have not previously been vaccinated, and for
adults 27-45 years of age the decision to vaccinate would be made
between an individual and their healthcare provider.
Details of the ACIP recommendations for GARDASIL 9 will be
available from the CDC. The provisional recommendations are
reviewed by the director of the CDC and the Department of Health
and Human Services and final recommendations will become official
when published in the CDC's Morbidity and Mortality Weekly Report
(MMWR).
GARDASIL 9 is indicated for use in females aged 9-45 for the
prevention of cervical, vulvar, vaginal and anal cancers caused by
HPV types 16, 18, 31, 33, 45, 52 and 58, 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 also
indicated for use in males aged 9-45 for the prevention of anal
cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58,
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 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].
In the U.S., almost half of new HPV infections occur in adults
25 years of age or older. Approximately 23,000 Americans are
diagnosed with cervical, vaginal, vulvar, and anal cancers
associated with HPV every year, according to latest published
incidence from 2015. The nine types of HPV covered in GARDASIL 9
cause the majority of HPV-related cancers and other diseases in
women and men. Even though adults may have already been exposed to
some types of HPV covered by the vaccine, GARDASIL 9 may help
protect against certain cancers and diseases caused by any of the
nine HPV types to which someone has not yet been exposed.
“With more than a 100-year legacy in vaccines, Merck is deeply
passionate about impacting public health through providing our
broad portfolio of vaccines to people around the world,” said Dr.
Richard M. Haupt, vice president and head of vaccines and
infectious diseases, Global Medical Affairs at Merck. “We applaud
the ACIP and the CDC for their continued efforts to address the
significant burden of HPV-related cancers by continuously
evaluating vaccination recommendations utilizing a comprehensive
body of scientific evidence.”
About the ACIP and CDC recommendations
The ACIP develops written recommendations for the routine
administration of vaccines to children and adults. The ACIP, which
consists of 15 experts in immunization and related fields, provides
advice to assist the CDC and the nation in reducing the incidence
of diseases that may be prevented with vaccines and to increase the
safe usage of vaccines and related biological products. The CDC
reviews advice from the ACIP and publishes final recommendations in
the MMWR. The Affordable Care Act (ACA) generally requires coverage
for all vaccines administered in accordance with final CDC
recommendations. This requirement applies to all non-grandfathered
commercial plans and Medicaid expansion beneficiaries. Individuals,
or their healthcare providers, should contact their health
insurance plan to determine vaccine coverage and reimbursement
requirements as well as adoption timeframes.
Important information about GARDASIL 9
GARDASIL 9 does not eliminate the necessity for women to
continue to undergo recommended cervical cancer screening.
Recipients of GARDASIL 9 should not discontinue anal cancer
screening if it has been recommended by a health care
professional.
GARDASIL 9 has not been demonstrated to provide protection
against diseases from vaccine HPV types to which a person has
previously been exposed through sexual activity.
GARDASIL 9 is not a treatment for external genital lesions;
cervical, vulvar, vaginal, and anal cancers; or cervical
intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia
(VIN), vaginal intraepithelial neoplasia (VaIN) or anal
intraepithelial neoplasia (AIN).
Not all vulvar, vaginal, and anal cancers are caused by HPV, and
GARDASIL 9 protects only against those vulvar, vaginal, and anal
cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58.
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.
Because vaccines 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 GARDASIL 9 has not been
established.
Dosage and administration for GARDASIL 9
GARDASIL 9 should be administered intramuscularly in the deltoid
region of the upper arm or in the higher 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 HPV and HPV-related cancers and diseases
In the U.S., based upon modeled data, it is estimated that 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 U.S. each year, with roughly half
occurring in people 25 years of age and older. For most people, HPV
clears on its own, but for others who don't clear the virus it
could lead to cervical, vaginal, and vulvar cancers in women, and
anal cancer and genital warts in men and women. The majority of
these cancers and diseases are caused by the nine types of HPV
covered by GARDASIL 9. Studies suggest that sexually active adults
remain at risk for acquiring new HPV infections, and for men in
particular, the rate of new infection remains relatively constant,
irrespective of age. There is no way to know which people who have
HPV will develop cancer or other health problems.
According to the American Cancer Society, the number of new anal
cancer cases has been rising for many years. There is no routine
screening recommended for the general population to reduce the risk
of anal cancer. Approximately three out of four people get genital
warts after having genital contact with someone who has them.
Treatment of genital warts can be painful, and they can recur after
treatment, especially in the first three months. Persistent HPV
infection can also lead to abnormal Pap results that may require
additional follow-up procedures.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases.
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. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us on Twitter, Facebook,
Instagram, 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
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 2018
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®9 (Human
Papillomavirus 9-valent Vaccine, Recombinant) at
http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf
and Patient Information/Medication Guide for GARDASIL®9 (Human
Papillomavirus 9-valent Vaccine, Recombinant) at
http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf.
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Media: Pamela Eisele (267) 305-3558 Deb Wambold (267) 305-064
Investors: Teri Loxam (908) 740-1986 Michael DeCarbo (908)
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