Merck & Co., Inc. and QIAGEN N.V. today announced their
intent to collaborate on a new program to increase access to HPV
vaccination and HPV DNA testing in some of the most resource-poor
areas of the world. This initiative is the first time a vaccine
manufacturer and a molecular diagnostics company are collaborating
to address the burden of cervical cancer with a comprehensive
approach. Representing a combined value of approximately $600
million based on current U.S. prices, the commitments of Merck and
QIAGEN were highlighted today among a select group of corporate
initiatives announced at the annual meeting of the Clinton Global
Initiative.
"My dream of helping to reduce the burden of cervical cancer for
women is increasingly within reach. I commend Merck and QIAGEN for
their contribution to advancing women's health," said Graça Machel,
founder and president of the Foundation for Community Development
(FDC), Mozambique, and a passionate advocate for women's health.
"This program is a fine example of how vaccination and screening
can be used together in a comprehensive fashion. I hope that this
will pave the way for new partnerships, involving the public and
private sectors, donor organizations and global health leaders to
address cervical cancer in developing countries."
This collaboration will integrate two breakthrough and
complementary advances in healthcare, Merck's cervical cancer
vaccine, GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11,
16 and 18) Vaccine Recombinant], and QIAGEN's HPV tests, the digene
HC2 HPV DNA Test (called the digene HPV Test) and a new HPV DNA
test that is currently in development for use specifically in the
developing world.
Merck intends to provide, for free, up to five (5) million doses
of GARDASIL and QIAGEN intends to add to its existing one million
test donation program by providing HPV DNA tests to screen an
additional 500,000 women. Merck and QIAGEN plan to seek other
public and private partners to design and implement national public
sector cervical cancer programs, provide treatment as needed, and
support improvements in laboratory and vaccine delivery
infrastructure, training of healthcare workers, education and
advocacy. The two companies also plan to work with cervical cancer
experts to support the development and implementation of
sustainable best practice models for cervical cancer reduction in
low-income, high disease burden countries.
“Nearly every minute of every day a woman is diagnosed with
cervical cancer, and many of these women live in developing
countries where the burden of the disease is disproportionately
high and healthcare infrastructure is limited," said Margaret G.
McGlynn, president, Merck Vaccines and Infectious Diseases. "We see
this collaboration between the two companies as innovative and
fundamental to reaching our shared goal of reducing the global
burden of cervical cancer."
“With broadened access to both vaccines and testing through this
initiative, we hope to ensure that girls and women - regardless of
where they live – will benefit from these advances in healthcare,"
said Peer Schatz, CEO of QIAGEN. "Our complementary tools can
demonstrate the unique impact that collaborations between
pharmaceutical and diagnostic companies can have on global public
health.”
Merck and QIAGEN plan to reach out to select GAVI-eligible
countries to explore the feasibility of implementing cervical
cancer reduction programs. These programs are expected to be
national in scope - all girls within a defined age range in the
selected countries would be offered vaccination, and the program
would work towards implementation of screening - and treatment as
needed - for all women of a defined age group. The participating
countries will be announced once program details and implementation
strategies have been finalized. While both companies are willing to
work with countries on an individual basis, Merck and QIAGEN
strongly believe that working together to develop country-wide
programs that include cervical cancer vaccination and screening
would bring unique benefits to global public health.
GARDASIL has received WHO prequalification and is approved for
use in 112 countries, 23 of which are GAVI-eligible. In the U.S.,
the vaccine is indicated for use in girls and young women 9 through
26 years of age for the prevention of cervical, vulvar and vaginal
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. HPV types 16 and 18 cause approximately
70 percent of cervical cancer cases.
HPV testing identifies women with high-risk HPV infections that
can cause cervical cancer, enabling diagnosis and treatment to be
put in place before cervical cancer develops. The digene HPV Test
is approved in the U.S. and Europe where it is used as a screening
test. In the U.S., it is approved to be used together with a Pap
test in women 30 years and older. In Europe it is approved as an
initial general population screening test either alone or together
with a Pap test. It is also used as a follow-up to inconclusive Pap
test results and as a post-cervical cancer treatment follow-up. To
ensure that HPV testing can reach women in all regions of the
world, QIAGEN is developing a new HPV DNA test for public-health
programs in low-resource countries. The cervical cancer
collaboration with Merck will include the digene HPV Test as well
as the new HPV DNA test in development, when commercially
available.
Cervical cancer affects approximately 500,000 women worldwide
and about 85 percent of these women live in the developing world.
By affecting women in their most productive years, cervical cancer
strikes at the heart of families and deprives developing world
economies of the many important contributions women make.
Important information about GARDASIL
GARDASIL does not substitute for routine cervical cancer
screening, and women who receive GARDASIL should continue to
undergo screening.
GARDASIL has not been demonstrated to provide protection against
diseases from vaccine and non-vaccine HPV types to which a woman
has previously been exposed through sexual activity. GARDASIL is
not intended to be used for treatment of active genital warts;
cervical, vulvar, and vaginal cancers; cervical intraepithelial
neoplasia (CIN), vulvar intraepithelial neoplasia (VIN) or vaginal
intraepithelial neoplasia (VaIN).
GARDASIL has not been demonstrated to protect against diseases
due to HPV types not contained in the vaccine. Not all vulvar and
vaginal cancers are caused by HPV, and GARDASIL protects only
against those vulvar and vaginal cancers caused by HPV types 16 and
18.
Select safety information
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 is a ready-to-use, three-dose, intramuscular vaccine.
GARDASIL should be administered in three separate intramuscular
injections in the deltoid region of the upper arm or in the higher
anterolateral area of the thigh. The following dosage schedule is
recommended: first dose at elected date, second dose two months
after the first dose and the third dose six months after the first
dose.
Other Merck and QIAGEN access efforts for the developing
world
Merck is pursuing a systematic and thoughtful approach to
accelerate access to GARDASIL in the developing world through four
key pillars: innovation, partnerships, pricing and implementation.
In 2007 at the Clinton Global Initiative, Merck made a pledge to
donate at least three (3) million doses of GARDASIL through the
GARDASIL Access Program, which enables organizations and
institutions in eligible lowest income countries to gain
operational experience in the design and implementation of HPV
vaccination projects.
The collaboration between Merck and QIAGEN represents a new
commitment and approach that is in addition to the GARDASIL Access
Program.
QIAGEN is working to improve access to HPV testing through the
development of its new HPV test and the QIAGENcares corporate
social responsibility program. In April 2009, QIAGEN announced a
donation of one million HPV tests to low-income countries over five
years. This new collaboration with Merck increases QIAGEN’s HPV
test donation by 50 percent bringing a total commitment of 1.5
million HPV tests to be provided to developing regions. Both the
previous donation program and the Merck-QIAGEN collaboration are
part of the QIAGENcares effort.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical
company dedicated to putting patients first. Established in 1891,
Merck currently discovers, develops, manufactures and markets
vaccines and medicines to address unmet medical needs. The Company
devotes extensive efforts to increase access to medicines through
far-reaching programs that not only donate Merck medicines but help
deliver them to the people who need them. Merck also publishes
unbiased health information as a not-for-profit service. For more
information, visit www.merck.com.
About QIAGEN
QIAGEN N.V., (NASDAQ: QGEN; Frankfurt Prime Standard: QIA), a
Netherlands holding company, is the leading global provider of
sample and assay technologies. Sample technologies are used to
isolate and process DNA, RNA and proteins from biological samples
such as blood or tissue. Assay technologies are used to make such
isolated biomolecules visible. QIAGEN has developed and markets
more than 500 consumable products as well as automated solutions
for such consumables. The company provides its products to
molecular diagnostics laboratories, academic researchers,
pharmaceutical and biotechnology companies, and applied testing
customers for purposes such as forensics, animal or food testing
and pharmaceutical process control. QIAGEN’s assay technologies
include one of the broadest panels of molecular diagnostic tests
available worldwide. This panel includes the digene HPV Test, which
is regarded as the "gold standard" in testing for high-risk types
of human papillomavirus (HPV), the primary cause of cervical
cancer. QIAGEN employs more than 3,000 people in over 30 locations
worldwide. Further information about QIAGEN can be found at
http://www.qiagen.com/.
Forward-looking statements
Merck: This press release contains "forward-looking
statements" as that term is defined in the Private Securities
Litigation Reform Act of 1995. These statements are based on
management's current expectations and involve risks and
uncertainties, which may cause results to differ materially from
those set forth in the statements. The forward-looking statements
may include statements regarding product development, product
potential or financial performance. No forward-looking statement
can be guaranteed and actual results may differ materially from
those projected. Merck undertakes no obligation to publicly update
any forward-looking statement, whether as a result of new
information, future events, or otherwise.
Forward-looking statements in this press release should be
evaluated together with the many uncertainties that affect Merck's
business, particularly those mentioned in the risk factors and
cautionary statements in Item 1A of Merck's Form 10-K for the year
ended Dec. 31, 2008, and in any risk factors or cautionary
statements contained in the Company's periodic reports on Form 10-Q
or current reports on Form 8-K, which the Company incorporates by
reference.
QIAGEN: Statements contained in this release that are not
historical facts are forward-looking statements, including
statements about QIAGEN products, markets, strategy and operating
results. Such statements are based on QIAGEN’s current expectations
that involve risks and uncertainties including, but not limited to,
those associated with: management of growth and international
operations (including currency fluctuations and logistics),
variability of operating results, commercial development of markets
(including applied testing, clinical and academic research,
proteomics, women's health/HPV testing and molecular diagnostics),
relationships with customers, suppliers and strategic partners,
competition, changes in technology, fluctuations in demand,
regulatory requirements, identifying, developing and producing
integrated products differentiated from competitors' products,
market acceptance of products, and integration of acquired
technologies and businesses. For further information, refer to
QIAGEN’s reports filed with or furnished to the SEC, including its
latest Form 20-F. Information in this release is as of the date of
the release, and QIAGEN undertakes no duty to update this
information unless required by law.
Prescribing information and patient product information for
GARDASIL® are attached.
GARDASIL® is a registered trademark of Merck
& Co. Inc., Whitehouse Station, N.J., USA
Photos/Multimedia Gallery Available:
http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6056379&lang=en
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use GARDASIL safely and effectively. See full prescribing
information for GARDASIL.
GARDASIL
[Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18)
Vaccine, Recombinant]
Suspension for intramuscular injection
Initial U.S. Approval: 2006
RECENT MAJOR CHANGES
Indications and Usage (1) Indications (1.1) 09/2008
Limitations of GARDASIL Use and Effectiveness (1.2) 05/2009
Contraindications (4) 09/2008 Warnings and Precautions (5) Syncope
(5.1) 06/2009
INDICATIONS AND USAGE
GARDASIL is a vaccine indicated in girls and women 9 through 26
years of age for the prevention of the following diseases caused by
Human Papillomavirus (HPV) types included in the vaccine:
- Cervical, vulvar, and vaginal
cancer caused by HPV types 16 and 18
- Genital warts (condyloma
acuminata) caused by HPV types 6 and 11
And the following precancerous or dysplastic lesions caused by
HPV types 6, 11, 16, and 18:
- Cervical intraepithelial
neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ
(AIS)
- Cervical intraepithelial
neoplasia (CIN) grade 1
- Vulvar intraepithelial neoplasia
(VIN) grade 2 and grade 3
- Vaginal intraepithelial
neoplasia (VaIN) grade 2 and grade 3
Limitations of GARDASIL Use and Effectiveness
- Women who receive GARDASIL
should continue to undergo cervical cancer screening. (1.2)
(17.1)
- GARDASIL has not been
demonstrated to provide protection against disease from vaccine and
non-vaccine HPV types to which a woman has previously been exposed
through sexual activity. (1.2) (14.2)
- GARDASIL is not intended to be
used for treatment of active genital warts; cervical, vulvar, and
vaginal cancers; CIN; VIN; or VaIN. (1.2)
- GARDASIL has not been
demonstrated to protect against diseases due to HPV types not
contained in the vaccine. (1.2) (14.3)
- Not all vulvar and vaginal
cancers are caused by HPV, and GARDASIL protects only against those
vulvar and vaginal cancers caused by HPV 16 and 18. (1.2)
- GARDASIL does not protect
against genital diseases not caused by HPV. (1.2)
- Vaccination with GARDASIL may
not result in protection in all vaccine recipients. (1.2)
DOSAGE AND ADMINISTRATION
0.5-mL suspension for intramuscular injection at the following
schedule: 0, 2 months, 6 months. (2.1)
DOSAGE FORMS AND STRENGTHS
- 0.5-mL suspension for injection
as a single-dose vial and prefilled syringe (3) (11)
CONTRAINDICATIONS
- Hypersensitivity, including severe allergic reactions to yeast
(a vaccine component), or after a previous dose of GARDASIL.
(11)
WARNINGS AND PRECAUTIONS
- 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 by maintaining a supine or
Trendelenburg position.
ADVERSE REACTIONS
The most common adverse reaction was headache. Common adverse
reactions (frequency of at least 1.0% and greater than AAHS control
or saline placebo) are fever, nausea, dizziness; and injection-site
pain, swelling, erythema, pruritus, and bruising. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Merck &
Co., Inc. at 1-877-888-4231 or VAERS at 1-800-822-7967 or
www.vaers.hhs.gov.
DRUG INTERACTIONS
GARDASIL may be administered concomitantly with RECOMBIVAX HB.
(7.1)
USE IN SPECIFIC POPULATIONS
Safety and effectiveness of GARDASIL have not been established
in the following populations:
- Pregnant women. Physicians are
encouraged to register pregnant women exposed to GARDASIL by
calling 1-800-986-8999 so that Merck can monitor maternal and fetal
outcomes (8.1).
- Children below the age of 9
years and pediatric males of any age. (8.4)
- Immunocompromised individuals.
Response to GARDASIL may be diminished. (8.6)
- Women 27 years of age and older.
(14.4).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved
patient labeling.
Revised: 06/2009
FULL PRESCRIBING INFORMATION:
CONTENTS* 1 INDICATIONS AND USAGE
1.1 Indications
1.2 Limitations of GARDASIL Use and Effectiveness
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
2.2 Method of Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Syncope
5.2 Managing Allergic Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
7.1 Use with RECOMBIVAX HB
7.2 Use with Hormonal Contraceptives
7.3 Use with Systemic Immunosuppressive Medications
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Immunocompromised Individuals
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Prophylactic Efficacy – HPV Types 6, 11, 16, and 18 in
Women 16 Through 26 Years of Age
14.2 Effectiveness of GARDASIL in Prevention of HPV Types 6-,
11-, 16-, or 18-Related Disease in Women 16 Through 26 Years of
Age, Regardless of Current or Prior Exposure to Vaccine HPV
Types
14.3 Effectiveness of GARDASIL in Prevention of Any HPV Type
Related Genital Disease in Women 16 Through 26 Years of Age,
Regardless of Current or Prior Infection with Vaccine or
Non-Vaccine HPV Types
14.4 Other Studies
14.5 Immunogenicity
14.6 Studies with RECOMBIVAX HB
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Information for the Patient, Parent, or Guardian 17.2
FDA-Approved Patient Labeling
*Sections or subsections omitted from the full prescribing
information are not listed.
FULL PRESCRIBING INFORMATION1 INDICATIONS AND
USAGE
1.1 Indications
GARDASIL®1 is a vaccine indicated in girls and women 9 through
26 years of age for the prevention of the following diseases caused
by Human Papillomavirus (HPV) types included in the vaccine:
- Cervical, vulvar, and vaginal
cancer caused by HPV types 16 and 18
- Genital warts (condyloma
acuminata) caused by HPV types 6 and 11
And the following precancerous or dysplastic lesions caused by
HPV types 6, 11, 16, and 18:
- Cervical intraepithelial
neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ
(AIS)
- Cervical intraepithelial
neoplasia (CIN) grade 1
- Vulvar intraepithelial neoplasia
(VIN) grade 2 and grade 3
- Vaginal intraepithelial
neoplasia (VaIN) grade 2 and grade 3
1.2 Limitations of GARDASIL Use and
Effectiveness
The health care provider should inform the patient, parent, or
guardian that vaccination does not substitute for routine cervical
cancer screening. Women who receive GARDASIL should continue to
undergo cervical cancer screening per standard of care. [See
Patient Counseling Information (17.1).]
GARDASIL has not been demonstrated to provide protection against
disease from vaccine and non-vaccine HPV types to which a woman has
previously been exposed through sexual activity. [See Clinical
Studies (14.2).]
GARDASIL is not intended to be used for treatment of active
genital warts; cervical, vulvar, and vaginal cancers; CIN; VIN; or
VaIN.
GARDASIL has not been demonstrated to protect against diseases
due to HPV types not contained in the vaccine. [See Clinical
Studies (14.3).]
Not all vulvar and vaginal cancers are caused by HPV, and
GARDASIL protects only against those vulvar and vaginal cancers
caused by HPV 16 and 18.
GARDASIL does not protect against genital diseases not caused by
HPV.
Vaccination with GARDASIL may not result in protection in all
vaccine recipients.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
GARDASIL should be administered intramuscularly as a 0.5-mL dose
at the following schedule: 0, 2 months, 6 months. [See Clinical
Studies (14.5).]
2.2 Method of Administration
Shake well before use. Thorough agitation immediately before
administration is necessary to maintain suspension of the vaccine.
GARDASIL should not be diluted or mixed with other vaccines. After
thorough agitation, GARDASIL is a white, cloudy liquid. Parenteral
drug products should be inspected visually for particulate matter
and discoloration prior to administration. Do not use the product
if particulates are present or if it appears discolored.
GARDASIL should be administered intramuscularly in the deltoid
region of the upper arm or in the higher anterolateral area of the
thigh.
Do not administer GARDASIL intravenously, intradermally, or
subcutaneously.
Syncope has been reported following vaccination with GARDASIL
and may result in falling with injury; observation for 15 minutes
after administration is recommended. [See Warnings and Precautions
(5.1).]
Single-Dose Vial Use
Withdraw the 0.5-mL dose of vaccine from the single-dose vial
using a sterile needle and syringe and use promptly.Prefilled
Syringe Use With and Without Needle Guard (Safety) Device
Prefilled Syringe With Needle Guard (Safety) Device
Instructions for using the prefilled single-dose syringes
preassembled with needle guard (safety) device
(Graphic Omitted)
NOTE: Please use the enclosed needle for administration. If a
different needle is chosen, it should fit securely on the syringe
and be no longer than 1 inch to ensure proper functioning of the
needle guard device. Two detachable labels are provided which can
be removed after the needle is guarded.
At any of the following steps, avoid contact with the Trigger
Fingers to keep from activating the safety device
prematurely.
Remove Syringe Tip Cap and Needle Cap. Attach Luer Needle
by pressing both Anti-Rotation Tabs to secure syringe and by
twisting the Luer Needle in a clockwise direction until secured to
the syringe. Remove Needle Sheath. Administer injection per
standard protocol as stated above under DOSAGE AND ADMINISTRATION.
Depress the Plunger while grasping the Finger Flange until the
entire dose has been given. The Needle Guard Device will
NOT activate to cover and protect the needle unless the
ENTIRE dose has been given. While the Plunger is still
depressed, remove needle from the vaccine recipient. Slowly release
the Plunger and allow syringe to move up until the entire needle is
guarded. For documentation of vaccination, remove detachable labels
by pulling slowly on them. Dispose in approved sharps
container.
Prefilled Syringe Without Needle Guard (Safety) Device
This package does not contain a needle guard (safety device) or
a needle. Shake well before use. Attach the needle by twisting in a
clockwise direction until the needle fits securely on the syringe.
Administer the entire dose as per standard protocol.
3 DOSAGE FORMS AND STRENGTHS
GARDASIL is a suspension for intramuscular administration
available in 0.5-mL single dose vials and prefilled syringes. See
Description (11) for the complete listing of ingredients.
4 CONTRAINDICATIONS Hypersensitivity, including
severe allergic reactions to yeast (a vaccine component), or after
a previous dose of GARDASIL. [See Description (11).]
5 WARNINGS AND PRECAUTIONS
5.1 Syncope
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 by
maintaining a supine or Trendelenburg position.
5.2 Managing Allergic Reactions
Appropriate medical treatment and supervision must be readily
available in case of anaphylactic reactions following the
administration of GARDASIL.
6 ADVERSE REACTIONS
Overall Summary of Adverse Reactions
Headache, fever, nausea, and dizziness; and local injection site
reactions (pain, swelling, erythema, pruritus, and bruising)
occurred after administration with GARDASIL.
Syncope, sometimes associated with tonic-clonic movements and
other seizure-like activity, has been reported following
vaccination with GARDASIL and may result in falling with injury;
observation for 15 minutes after administration is recommended.
[See Warnings and Precautions (5.1).]
Anaphylaxis has been reported following vaccination with
GARDASIL.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials
of a vaccine cannot be directly compared to rates in the clinical
trials of another vaccine and may not reflect the rates observed in
practice.
Studies in Girls and Women 9 Through 26 Years of Age
In 5 clinical trials (3 Amorphous Aluminum Hydroxyphosphate
Sulfate [AAHS]-controlled, 1 saline placebo-controlled, and 1
uncontrolled), 8878 subjects were administered GARDASIL or AAHS
control or saline placebo on the day of enrollment, and
approximately 2 and 6 months thereafter, and safety was evaluated
using vaccination report cards (VRC)-aided surveillance for 14 days
after each injection of GARDASIL or AAHS control or saline placebo
in these subjects. The subjects who were monitored using VRC-aided
surveillance included 5088 girls and women 9 through 26 years of
age at enrollment who received GARDASIL and 3790 girls and women
who received AAHS control or saline placebo. Few subjects (0.1%)
discontinued due to adverse reactions. The race distribution of the
study subjects was as follows: 62.3% White; 17.6% Hispanic (Black
and White); 6.8% Asian; 6.7% Other; 6.4% Black; and 0.3% American
Indian.
Common Injection Site Adverse Reactions in Girls and Women 9
Through 26 Years of Age
The injection site adverse reactions that were observed among
recipients of GARDASIL at a frequency of at least 1.0% and also at
a greater frequency than that observed among AAHS control or saline
placebo recipients are shown in Table 1.
Table 1
Injection-Site Adverse
Reactions*
Adverse Reaction
(1 to 5 Days Postvaccination)
GARDASIL
(N = 5088)
%
AAHS Control**
(N = 3470)
%
Saline
Placebo
(N = 320)
%
Injection Site Pain 83.9 75.4 48.6 Swelling 25.4 15.8 7.3 Erythema
24.7 18.4 12.1 Pruritus 3.2 2.8 0.6 Bruising 2.8 3.2 1.6 *The
injection-site adverse reactions that were observed among
recipients of GARDASIL were at a frequency of at least 1.0% and
also at a greater frequency than that observed among AAHS control
or saline placebo recipients.
**AAHS Control = Amorphous
Aluminum Hydroxyphosphate Sulfate
Evaluation of Injection-Site Adverse Reactions by Dose in Girls
and Women 9 Through 26 Years of Age
An analysis of injection-site adverse reactions in girls and
women by dose is shown in Table 2. Overall, 94.3% of girls and
women who received GARDASIL judged their injection-site adverse
reaction to be mild or moderate in intensity.
Table 2
Postdose Evaluation of
Injection-Site Adverse Reactions
(1 to 5 Days
Postvaccination)
GARDASIL
(% occurrence)
AAHS Control*
(% occurrence)
Saline Placebo
(% occurrence)
Adverse
Reaction
Post-
dose
1
N** = 5011
Post-
dose
2
N = 4924
Post-
dose
3
N = 4818
Post-
dose
1
N = 3410
Post-
dose
2
N = 3351
Post-
dose
3
N = 3295
Post-
dose
1
N = 315
Post-
dose
2
N = 301
Post-
dose
3
N = 300
Pain 63.4 60.7 62.7 57.0 47.8 49.6 33.7 20.3 27.3
Mild/Moderate 62.5 59.7 61.2 56.6 47.3 48.9 33.3 20.3 27.0
Severe 0.9 1.0 1.5 0.4 0.5 0.6 0.3 0.0 0.3
Swelling*** 10.2 12.8 15.1 8.2 7.5 7.6 4.4 3.0 3.3
Mild/Moderate 9.6 11.9 14.2 8.1 7.2 7.3 4.4 3.0 3.3
Severe 0.6 0.8 0.9 0.2 0.2 0.2 0.0 0.0 0.0
Erythema*** 9.2 12.1 14.7 9.8 8.4 8.9 7.3 5.3 5.7
Mild/Moderate 9.0 11.7 14.3 9.5 8.4 8.8 7.3 5.3 5.7
Severe 0.2 0.3 0.4 0.3 0.1 0.1 0.0 0.0 0.0 *AAHS Control =
Amorphous Aluminum Hydroxyphosphate Sulfate
**N = Number of subjects with
follow up
***Intensity of swelling and
erythema was measured by size (inches): Mild = 0 to
≤1; Moderate = >1 to ≤2; Severe = >2.
Common Systemic Adverse Reactions in Girls and Women 9 Through
26 Years of Age
Headache was the most commonly reported systemic adverse
reaction in both treatment groups (GARDASIL = 28.2% and AAHS
control or saline placebo = 28.4%). Fever was the next most
commonly reported systemic adverse reaction in both treatment
groups (GARDASIL = 13.0% and AAHS control or saline placebo =
11.2%).
Adverse reactions that were observed among recipients of
GARDASIL, at a frequency of greater than or equal to 1.0% where the
incidence in the GARDASIL group was greater than or equal to the
incidence in the AAHS control or saline placebo group, are shown in
Table 3.
Table 3
Common Systemic Adverse
Reactions (GARDASIL ≥ Control)*
Adverse Reactions
(1 to 15 Days Postvaccination)
GARDASIL
(N = 5088)
%
AAHS control** or Saline Placebo
(N = 3790)
%
Pyrexia 13.0 11.2 Nausea 6.7 6.5 Dizziness 4.0 3.7 Diarrhea 3.6 3.5
Vomiting 2.4 1.9 Cough 2.0 1.5 Toothache 1.5 1.4 Upper respiratory
tract infection 1.5 1.5 Malaise 1.4 1.2 Arthralgia 1.2 0.9 Insomnia
1.2 0.9 Nasal congestion 1.1 0.9 *The adverse reactions in this
table are those that were observed among recipients of GARDASIL at
a frequency of at least 1.0% and greater than or equal to those
observed among AAHS control or saline placebo recipients.
**AAHS Control = Amorphous
Aluminum Hydroxyphosphate Sulfate
Evaluation of Fever by Dose in Girls and Women 9 Through 26
Years of Age
An analysis of fever in girls and women by dose is shown in
Table 4.
Table 4
Postdose Evaluation of
Fever
(1 to 5 Days
Postvaccination)
GARDASIL
(% occurrence)
AAHS Control* or Saline Placebo
(% occurrence)
Temperature
(°F)
Postdose 1
N** = 4945
Postdose 2
N = 4804
Postdose 3
N = 4671
Postdose 1
N = 3681
Postdose 2
N = 3564
Postdose 3
N = 3467
≥100 to
Qiagen NV (TG:QIA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Qiagen NV (TG:QIA)
Historical Stock Chart
From Jul 2023 to Jul 2024