Merck (NYSE: MRK), known as MSD outside the United States and
Canada, announced today that the U.S. Centers for Disease Control
and Prevention’s (CDC’s) Advisory Committee on Immunization
Practices (ACIP) voted to include GARDASIL®9 (Human Papillomavirus
9-valent Vaccine, Recombinant) in the recommendations for use of
HPV vaccines. GARDASIL 9 has been added to the routine
recommendations for vaccination of 11- and 12- year-old females and
males. The vaccination series can be started at age nine.
Vaccination is also recommended for females aged 13 to 26 and for
males aged 13 to 21 who have not been vaccinated previously or have
not completed the 3-dose series. GARDASIL 9 is not approved by the
U.S. Food and Drug Administration (FDA) for use in males 16 years
of age and above.
GARDASIL 9 Package and Vial (Photo:
Business Wire)
GARDASIL 9 was approved by the FDA in December 2014 for use in
girls and young women 9 to 26 years of age for the prevention of
cervical, vulvar, vaginal, and anal cancers caused by HPV types 16,
18, 31, 33, 45, 52 and 58, pre-cancerous 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
approved for use in boys 9 to 15 years of age 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].
"The CDC has made increasing HPV vaccination rates a public
health priority,” said Jacques Cholat, M.D., president, Merck
Vaccines, “and today’s recommendation for GARDASIL 9 is an
important milestone in the shared effort to help further reduce the
burden of HPV-related cancers and diseases.”
The ACIP also recommends that if vaccination providers do not
know or do not have available the HPV vaccine previously
administered, or are in settings transitioning to GARDASIL 9, for
protection against HPV 16 and 18 any HPV vaccine may be used to
continue or complete the series for females; GARDASIL or GARDASIL 9
may be used to continue or complete the series for males. As stated
in the Prescribing Information for GARDASIL 9, studies using a
mixed regimen of HPV vaccines to assess interchangeability were not
performed for GARDASIL 9.
Due to the condensed meeting, the ACIP noted that vaccination
with GARDASIL 9 in prior HPV vaccine recipients will be considered
as a future policy discussion and vote at the June 2015 meeting.
Efficacy of GARDASIL 9 in preventing infection and disease related
to HPV types 31, 33, 45, 52, and 58, in individuals previously
vaccinated with GARDASIL [Human Papillomavirus Quadrivalent (Types
6, 11, 16, and 18) Vaccine, Recombinant] has not been assessed.
GARDASIL 9 (Human Papillomavirus 9-valent Vaccine,
Recombinant) added to CDC’s Vaccines for Children
program
During today’s meeting, the ACIP also voted to include GARDASIL
9 in the CDC’s Vaccines for Children (VFC) program for both boys
and girls.
Since 1994, the VFC program has provided vaccines to children
through the age of 18 who are Medicaid-eligible, uninsured,
underinsured1, American Indian or Alaska Native. After the ACIP has
made a recommendation for the use of a given vaccine, the Committee
votes on whether the vaccine should be included in the VFC program.
Eligible children may receive recommended vaccines through VFC once
the CDC contracts for the purchase of the vaccine have been
completed.
GARDASIL 9 is also available through Merck’s patient assistance
program for vaccines. Through this program, Merck will provide free
vaccines to adults who are uninsured and who are unable to afford
vaccines. More information can be found at www.MerckHelps.com.
About the ACIP
The ACIP develops written recommendations for the routine
administration of vaccines to children and adults, along with
schedules regarding the appropriate dosage and dosing frequency,
and contraindications applicable to the vaccines. The Committee,
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 ACIP recommendations do not result in requirements
for vaccine administration by individual states or coverage by
insurance companies. However, state health authorities and private
insurers typically follow the Committee’s guidance.
Details of the ACIP recommendations for GARDASIL 9 will be
available from the CDC. The recommendations are under review by the
director of the CDC and the Department of Health and Human Services
and will become official when published in the CDC's Morbidity and
Mortality Weekly Report.
Important Information about GARDASIL 9 (Human Papillomavirus
9-valent Vaccine, Recombinant)
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 provider.
GARDASIL 9 has not been demonstrated to provide protection
against disease from vaccine HPV types to which a person has
previously been exposed through sexual activity.
GARDASIL 9 has not been demonstrated to protect against diseases
due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and
58.
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 [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 by maintaining a
supine or Trendelenburg position.
Safety and effectiveness of GARDASIL 9 have not been established
in pregnant women.
The most common (≥10%) local and systemic adverse reactions in
females 16 through 26 years of age were injection-site pain,
swelling, erythema, and headache. The most common (≥10%) local and
systemic reactions in boys 9 through 15 years of age were
injection-site pain, swelling, and erythema.
Dosage and administration for GARDASIL 9 (Human
Papillomavirus 9-valent Vaccine, Recombinant)
GARDASIL 9 should be administered intramuscularly in the deltoid
region of the upper arm or in the higher anterolateral area of the
thigh at the following schedule: 0, 2 months, 6 months.
About Merck
Today's Merck is a global healthcare 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 healthcare through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
with us on Twitter, Facebook and YouTube.
Forward-Looking Statement
This news release includes “forward-looking statements” within
the meaning of the safe harbor provisions of the United States
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of Merck’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; Merck’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 Merck’s patents and other
protections for innovative products; the exposure to litigation,
including patent litigation, and/or regulatory actions.
Merck 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 Merck’s 2013 Annual
Report on Form 10-K and the company’s other filings with the 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.
The Patient Product Information for GARDASIL®9 is also available
at
http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf.
1 Underinsured children receive VFC vaccines at Federally
Qualified Health Centers.
GARDASIL®9 and GARDASIL® are
registered trademarks of Merck & Co., Inc., Whitehouse Station,
N.J., U.S.A.
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Media:Pamela Eisele, 267-305-3558Deb Wambold,
215-652-2913Investor:Justin Holko, 908-740-1879Amy Klug,
908-740-1898
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