Merck’s 9-Valent HPV Vaccine, GARDASIL®9, Recommended by CDC’s Advisory Committee on Immunization Practices for Females Aged 9-26 and Males Aged 9-21
February 26, 2015 3:18 pm ET
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 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,
“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
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
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
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
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
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.
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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.,
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