Current News |
NVIC
Vaccine
E-Newsletter
-
May
08,
2008
Examining
the
Science
&
Politics
of
HPV
Vaccine
by
Barbara
Loe
Fisher
It
has
been
nearly
two
years
since
the
FDA
fast
tracked
the
licensure
of
Merck's
GARDASIL
vaccine
and
the
CDC's
Advisory
Committee
on
Immunization
Practices
(ACIP)
recommended
it
for
universal
use
by
all
11
year
old
girls.
Calls
for
state
mandates
for
sixth
grade
entry
soon
followed
with
Merck
leading
an
aggressive
lobbying
campaign
with
pro-forced
vaccination
proponents
talking
about
12
year
old
girls
having
sex.
The
National
Vaccine
Information
Center
countered
by
publicly
framing
the
debate
about
GARDASIL
mandates
as a
product
safety
and
informed
consent
issue:
the
vaccine
had
only
been
tested
in
fewer
than
1200
girls
under
age
16
followed
up
for
less
than
two
years.
Now,
a
leading
HPV
vaccine
researcher
has
spoken
out
opposing
mandates
in a
three-part
series
produced
by
CBS4-TV
in
Miami.
Speaking
to
investigative
journalist
Michele
Gillen
Harper
said
"We
don't
know
yet
what's
going
to
happen
when
millions
of
doses
of
the
vaccine
have
been
given
and
to
put
in
process
a
place
that
says
you
must
have
this
vaccine,
it
means
you
must
be
part
of a
big
public
experiment.
So
we
can't
do
that
until
we
have
more
data."
It
takes
a
lot
of
courage
for
any
scientist
or
physician
to
stand
up
and
speak
out
about
the
need
for
government,
industry
and
physicians
to
embrace
the
precautionary
principle:
First,
do
no
harm.
Dr.
Harper
has
upheld
high
standards
for
scientific
and
ethical
integrity
by
responsibly
calling
for
rigorous
post-
marketing
surveillance
of
licensed
HPV
vaccines
and
adherence
to
the
informed
consent
ethic.
The
National
Vaccine
Information
Center
has
received
nearly
100
reports
of
serious
health
problems
following
vaccination.
NVIC
issued
three
reports
on
GARDASIL
adverse
events
reported
to
the
federal
Vaccine
Adverse
Events
Reporting
System
(VAERS).
In
August
2007,
NVIC
called
on
the
CDC
to
warn
doctors
that
the
safety
of
giving
GARDASIL
simultaneously
in
combination
with
other
vaccines
had
not
been
proven
safe.
A
family
support
group
for
those
who
have
reported
HPV
vaccine
reactions
to
NVIC
is
being
created.
If
you
or a
loved
one
has
suffered
an
HPV
vaccine
reaction,
you
can
make
a
report
to
NVIC's
26-
year
old
Vaccine
Reaction
Registry
by
going
to
https://www.nvic.org/report/reaction.htm.
Please
indicate
if
you
would
like
to
participate
in
the
HPV
Vaccine
Reaction
Family
Support
Group.
***********************************************************
"According
to
Dr.
Diane
Harper,
"the
vaccine
has
not
been
out
long
enough
for
us
to
have
post
marketing
surveillance
to
really
understand
what
all
the
potential
side
effects
are
going
to
be.
We
feel
it
is
very
safe."
However,
she
adds,
"We
don't
know
yet
what's
going
to
happen
when
millions
of
doses
of
the
vaccine
have
been
given
and
to
put
in
process
a
place
that
says
you
must
have
this
vaccine,
it
means
you
must
be
part
of a
big
public
experiment.
So
we
can't
do
that
until
we
have
more
data."
Barbara
Loe
Fisher
agrees.
She
took
to
the
streets
a
grass
roots
fight
credited
with
derailing
many
efforts
around
the
country
to
mandate
the
vaccine.
"It
was
the
quickest
effort
I
have
ever
seen
in
25
years
for
a
vaccine
to
be
mandated,"
says
Fisher.
A
mother
of a
son
who
she
say
was
left
with
learning
disabilities
following
a
routine
vaccination
in
the
1980's,
Fisher
is
President
and
Co
Founder
of
the
National
Vaccine
Information
Center.
It
is a
non-profit
independent
clearinghouse
for
information
on
vaccines
and
disease.
Fisher
says
her
organization
has
been
contacted
by
nearly
100
parents
claiming
their
daughters
have
suffered
some
type
of
adverse
reaction
following
a
Gardasil
shot
- at
times
given
in
combination
with
other
vaccines.
She
says
many
parents
are
frustrated
in
their
search
for
answers
and
that
they
don't
know
where
to
turn.
She
tells
Gillen
"the
National
Vaccine
Information
Center
is
getting
reports
every
week,
mostly
mothers,
of
what
is
happening
to
their
11-year
old
girls
after
receiving
Gardasil."
-
CBS4-TV
(Miami),
Michele
Gillen
reporting
(May
7,
2008)
http://cbs4.com/video/?
id=54565@wfor.dayport.com
"Bell
says
she
now
finds
herself
on a
search
for
answers
as
to
what
happened
to
her
daughter,
Brittney,
just
weeks
following
an
injection
of
Gardasil
and
a
tetanus
shot.
The
former
cheerleader
and
runner's
left
leg
was
mysteriously
affected
by
paralysis.
The
family
wants
to
know
if
the
condition
could
have
been
triggered
by
the
vaccines
she
received
that
day.
Reported
adverse
events
following
vaccine
injections,
including
Gardasil,
have
come
under
increasing
scrutiny
by
parents
reviewing
them
on
the
U.S.
Vaccine
Adverse
Event
Reporting
System
(VAERS)....."Brittany's
case
is
at a
quandary,"
said
Sean
Cronin,
attorney
for
the
Bell
family.
Cronin
says
it
is
an
uphill
battle
trying
to
investigate
whether
the
Gardasil
shot
played
any
role
in
what
has
happened
to
Brittney.
Christina
Bell
says
Brittney's
pediatrician
does
not
believe
there
is a
link.
Now
the
Bell
family
has
learned
that
Merck
can't
be
sued
over
its
Gardasil
vaccine
because
it
has
been
added
to a
federal
list
of
vaccines
recommended
by
the
government.
The
vaccine
manufacturers
are
insulated
from
liability."
-
CBS4-TV
(Miami),
Michele
Gillen
reporting
(May
25,
2008)
http://cbs4.com/video/id
=53934@wfor.dayport.com
"Christina
Bell's
daughter,
Brittney,
was
one
of
the
young
girls
who
recieved
the
vaccine.
Just
weeks
later,
her
life
took
a
radical
turn
for
the
worse.
Seemingly,
in a
moment's
time,
Brittney's
left
leg
became
paralyzed,
her
ankle
swinging
like
a
rag
doll's.
Even
with
a
shoe
brace,
she
walks
with
a
limp.
"It's
hard
for
me
to
lift
it
up,"
Brittney
told
Gillen.
Brittney's
limb
paralysis
occurred
shortly
after
the
12
year
old
went
to
the
doctor
for
a
routine
tetanus
shot
for
school.....Last
February,
the
FDA
told
CBS4
that
it
was
investigating
reports
of
13
deaths
following
an
HPV
vaccination.
At
the
time,
the
agency
said
it
was
confident
that
none
were
tied
to
the
vaccine
and
that
reports
of
adverse
events
were
under
review
but
not
considered
anything
out
of
the
ordinary.
An
FDA
spokeswoman
told
CBS4
this
week
that
she
could
not
provide
an
update
on
the
number
of
reported
events,
including
deaths.
"I
haven't
seen
updated
numbers
for
several
months.
We
monitor
on a
daily
basis
but
we
don't
total
it
up.
We
are
not
seeing
a
problem,"
said
Susan
Cruzan,
spokesperson
for
the
FDA.....Brittney's
mom
said
she
can't
find
a
doctor
willing
to
report
an
adverse
reaction
following
the
administration
of
her
daughter's
vaccines.
CBS4
informed
her
that
parents,
just
like
doctors,
can
report
an
adverse
event
and
the
Bell
family
has
done
just
that."
-
CBS4-TV
(Miami),
April
24,
2007
http://cbs4.com/video/?
id=53899@wfor.dayport.com
==========================================
HPV Scientist Speaks Out
CBS4 - Miami
May 7, 2008
Michele Gillen reporting
http://cbs4.com/video/? id=54565@wfor.dayport.com
http://cbs4.com/iteam/Gardisil.Girls.Vaccin e.2.71859html
(CBS4 - Miami) Gardasil. It is a first of its kind vaccine designed to prevent cervical cancer and approved by the Food and Drug Administration on June 8, 2006 for use in females aged 9 to 26. Within weeks the vaccine was unanimously approved by the CDC's Advisory Committee on Immunization Practices for 11 and 12- year old girls. What followed was a cascade of calls by legislators around the country, including in Florida, pushing for this new to the market vaccine to be mandated for scores of young girls.
"This is a real danger zone, " says Dr. Diane Harper.
Why might you care about what she says? Dr. Harper is one of the world's top experts on the Human Papilloma virus, HPV, which can lead to cervical cancer. In fact, she's one of the leading scientists the pharmaceutical industries turned to for help to conduct clinical trials - including those that led to approval by the US Food and Drug Administration of Gardasil - and the recommendations that followed.
Speaking out in her first such television interview with WFOR-TV Chief Investigative Reporter Michele Gillen, Dr. Harper expresses concerns over what she considers a rush to recommend and mandate the vaccination of very young girls with the vaccine. "It went too fast, it went too fast without any breaks," says Harper, who devoted nearly two decades of her career to research on HPV.
Dr. Harper says she believes the vaccine is safe but cautions that time is needed to study potential side effects in larger numbers of young girls before any consideration should be given to mandating such a vaccine.
According to Dr. Harper, "the vaccine has not been out long enough for us to have post marketing surveillance to really understand what all the potential side effects are going to be. We feel it is very safe." However, she adds, "We don't know yet what's going to happen when millions of doses of the vaccine have been given and to put in process a place that says you must have this vaccine, it means you must be part of a big public experiment. So we can't do that until we have more data."
Barbara Loe Fisher agrees. She took to the streets a grass roots fight credited with derailing many efforts around the country to mandate the vaccine. "It was the quickest effort I have ever seen in 25 years for a vaccine to be mandated," says Fisher. A mother of a son who she say was left with learning disabilities following a routine vaccination in the 1980's, Fisher is President and Co Founder of the National Vaccine Information Center. It is a non-profit independent clearinghouse for information on vaccines and disease.
Fisher says her organization has been contacted by nearly 100 parents claiming their daughters have suffered some type of adverse reaction following a Gardasil shot - at times given in combination with other vaccines. She says many parents are frustrated in their search for answers and that they don't know where to turn. She tells Gillen "the National Vaccine Information Center is getting reports every week, mostly mothers, of what is happening to their 11-year old girls after receiving Gardasil."
Fisher says she has heard from parents upset that their doctors are refusing to report reactions potentially tied to this vaccine they recommended, if not aggressively pushed.
"I think that this has caused a real crisis of trust in the hearts and minds of parents who are being more educated about vaccines and all types of products they give their children," says Fisher.
Harper says parents need to be armed with as much information as possible. She believes the vaccine should be an educated choice. She explained that many parents do not realize or are not being told by physicians, that their daughters might end up needing a booster shot. She says what can be considered key study trials lasted at most 5 years and that there is no way to know exactly how long the vaccine will be effective.
"I think the thought is that there probably will be efficacy for longer than 5 years but its probably not going to be lifetime efficacy. There probably will be some need for a booster. There will be some need for understanding when we going to need to be able to revaccinate those women. Those are all open questions," says Dr.Harper.
Given that it is unknown for how long the vaccine will be effective, Dr. Harper says she can't stress enough the need for pap tests throughout a woman's lifetime, even if she has received an HPV vaccine.
Dr. Harper understands why some parents are left wondering how young might be too young?
Gillen asked Dr. Harper what she thought the optimum age of a girl should be to receive the shot.
"I would have started at 15, and not at 12," explained they physican.
Fisher says she applauds Dr. Harper for being willing to address controversial questions regarding HPV vaccines and concerns by parents who say they want more information before deciding if the shot is right for their daughters.
"I think that Dr. Harper has done a tremendous public service to stand up," says Fisher.
Dr. Harper says she is convinced HPV vaccines can help prevent cancers in the long run. But that parents and women should have a choice. Dr. Harper has also served as a consulting researcher for study trials for another HPV vaccine named Cervarix, being developed by GlacoSmith Kline, GSK. "I am the first author on two of the GSK papers," she noted.
But again she expressed her disapproval for any potential effort to mandate a Cervex vaccine for young girls. As Dr. Harper explains " It's still like-wise with Gardasil. They haven't been out long enough , there isn't enough information to have a mandate that you can't go to school until you have this vaccine. It does not make any sense."
Dr. Harper served as a researcher on study trials for Gardasil and Cervarix while employed as a professor at Dartmouth College. The University was contracted by both Merck and Co.. and Glaxo Smith Kline for the HPV studies who paid for the studies. Dr. Harper has disclosed receiving speaking fees from both Merck and from GSK for speaking about the HPV vaccines, and has received consultation fees from both Merck and GSK for consulting about trial development and data interpretation, in addition to the monies paid to Dartmouth to conduct the trials.
In asking a representative from Merck. for a response to the WFOR-TV interview with Dr. Harper and the types of concerns she raised a Merck representative provided WFOR-TV with the following statement:
Merck's research program for GARDASIL® [Human Papillomavirus Quadrivalent] (Types 6, 11, 16, 18) Vaccine, Recombinant] spans more than 10 years of rigorous study of more than 25,000 individuals around the world and the labeling for GARDASIL reflects the extensive data available from our clinical trials.
In addition, the data from our clinical trials have been discussed in public settings by leading medical and policy experts, including an FDA Advisory Committee meeting in May 2006, publications in The New England Journal of Medicine and The Lancet and meetings of the CDC's Advisory Committee on Immunization Practices (ACIP).
In February of 2006 the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for GARDASIL and designated the file for priority review. A priority designation is intended for products that address unmet medical needs and under the prescription Drug User Fee Act (PDUFA), the FDA's goal is to review and act on BLAs designated as priority review within six months of receipt.
GARDASIL received its U.S. FDA approval on June 8, 2006 and on June 29, 2006 received a universal ACIP recommendation for use in 9-26 year old girls and young women.
We began discussions of data from the clinical trials with the ACIP's HPV Working Group as early as 2004. It is important to note that the three week time period between FDA licensure and the ACIP recommendation in June of 2006 does not represent the total amount of time the ACIP Working Group and full ACIP membership actually discussed the data and potential recommendation for GARDASIL - this time period was more than two years.
Since FDA licensure in June 2006 GARDASIL has been approved in 101 countries around the world and through March 31, 2008 more than 26 million doses have been distributed globally.
We are very confident in GARDASIL, and look forward to continuing to lead in the fight against cervical cancer. Here are some additional milestones you may be interested in as you complete your story.
· By 1996, Merck started production of the HPV-16 targeted prototype of GARDASIL.
· Merck filed an Investigational New Drug Application and started Phase I clinical trials of the HPV-16 prototype in 1997.
· Phase II trials of the prototype began in 1998.
· In 2000, Merck conducted the first dose-ranging trial of a vaccine to protect against HPV types 6, 11, 16 and 18.
· The first pivotal Phase III trial of GARDASIL, FUTURE 1, started in 2001.
· November 2001: An FDA Advisory Committee agreed on clinical trial design.
· The results from the first phase II trials of the HPV-16 prototype were published in NEJM in 2002.
· Merck presented results from the pivotal Phase III trials of GARDASIL at the Infectious Diseases Society of America (IDSA) meeting in October 2005.
· In December, 2005, Merck submitted its first license application for GARDASIL to the FDA. FDA later grants priority review. Merck also begins to file regulatory applications worldwide.
· May 2006: An U.S. FDA Advisory Committee unanimously agrees that the clinical data support the efficacy and safety of GARDASIL.
· June 8: U.S. FDA approves GARDASIL.
· June 29, 2006: In the U.S., the Center's for Disease Control (CDC's) Advisory Committee on Immunization Practices (ACIP) unanimously recommended broad vaccination with GARDASIL - routine for girls and women ages 11-26, with 9- and 10-year-old girls vaccinated at their physicians' discretion.
· Since July 2006: GARDASIL receives approval in more than 70 countries worldwide, including Canada, those in the European Union, Australia, New Zealand, Brazil, Peru, Taiwan and two countries in Africa.
· Nov. 1, 2006 - GARDASIL is added to the CDC's Vaccines for Children (VFC) Program
· In January 2007, GARDASIL was added to 2007 U.S. Childhood and Adolescent Immunization Schedules released jointly by the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP).
· Recommendations have since been made by health agencies in other countries (i.e. Canada's National Advisory Committee on Immunization (NACI) on Jan. 30, 2007 and by the Australian Government in November 2006) and funding and reimbursement for GARDASIL is also becoming available in additional countries as well (i.e. Austria, Germany).
· In March 2007 the CDC finalized the provisional recommendation of its Advisory Committee on Immunization Practices (ACIP) for the use of GARDASIL. These vaccination guidelines were published in the March 23, 2007, issue of the CDC's Morbidity and Mortality Weekly Report (MMWR).
|
CBS4 I-Team: Vaccine Concern Part 2
MIAMI (CBS4)
April 25, 2008
Michele Gillen Reporting
http://cbs4.com/video/? id=53934@wfor.dayport.com
http://cbs4.com/health/vaccine.gardasil.i.2.708478.html
MIAMI (CBS4) ¯ The Gardasil television commercial is a popular one which markets a vaccine that is considered a major breakthrough in a fight the U.S. federal government is convinced can prevent cervical cancer. Within weeks of approval by the FDA, the Centers for Disease Control immediately recommended it for every 11 and 12-year-old girl.
Christina Bell, like many mothers, found her pediatrician recommending it for her daughter.
CBS4 Chief Investigative Reporter Michele Gillen asked Bell if it seemed like a no-brainer.
"I thought so," Bell told Gillen.
However, Bell says she now finds herself on a search for answers as to what happened to her daughter, Brittney, just weeks following an injection of Gardasil and a tetanus shot. The former cheerleader and runner's left leg was mysteriously affected by paralysis. The family wants to know if the condition could have been triggered by the vaccines she received that day.
Reported adverse events following vaccine injections, including Gardasil, have come under increasing scrutiny by parents reviewing them on the U.S. Vaccine Adverse Event Reporting System (VAERS).
"I think it's a marvelous addition to the scope of therapy I can offer kids," said Dr. Lorena Siqueira, Director of Adolescent Medicine at Miami Children's Hospital.
She says she believes the vaccine is safe and well worth prescribing for adolescents.
"Fortunately, I have no reports of serious reactions. I have seen occasional fainting episodes," Dr. Siqueira told Gillen.
Dr. Siqueira says she believes the fainting episodes are not tied to just the Gardasil vaccine but is the reaction of certain adolescents to an injection. Because of concerns over some girls who have reportedly fainted and injured themselves falling, the National Vaccine Information Center recommends that girls receive the shot lying down and that they be observed for 15 minutes after the injection.
"Brittany's case is at a quandary," said Sean Cronin, attorney for the Bell family.
Cronin says it is an uphill battle trying to investigate whether the Gardasil shot played any role in what has happened to Brittney. Christina Bell says Brittney's pediatrician does not believe there is a link.
Now the Bell family has learned that Merck can't be sued over its Gardasil vaccine because it has been added to a federal list of vaccines recommended by the government. The vaccine manufacturers are insulated from liability.
It's a fact many parents, and even some doctors, may not be aware of.
"You can't sue Merck over Gardasil," Gillen told Dr. Siqueira. She replied, "It's because vaccines are protected."
------------------
Statement from Merck regarding the GARDASIL vaccine:
Merck actively monitors adverse event databases throughout the world, including the U.S. Vaccine Adverse Event Reporting System (VAERS). An event report does not mean that a causal relationship between an event and vaccination has been established - just that the event occurred after vaccination.
The labeling for GARDASIL reflects the extensive data available from our clinical trials. The data, including safety information, have been thoroughly reviewed and discussed by medical experts.
Since its FDA approval in June 2006 through March 31, 2008, Merck has distributed more than 26 million doses of GARDASIL worldwide.
Merck will continue to evaluate all reports in the context of our own post-marketing adverse experience database and our clinical trial database. Post- marketing adverse event reports received by the Company are sent to regulatory authorities worldwide in accordance with regulatory requirements, and Merck updates its product labels with new safety information as appropriate.
Merck encourages healthcare providers and consumers to report any potential adverse experiences following vaccination with GARDASIL to the Company and to adverse event reporting systems.
|
CBS4 I-Team: Vaccine Concern Part 1
MIAMI (CBS4)
April 24, 2008
Michelle Gillen Reporting
http://cbs4.com/video/? id=53899@wfor.dayport.com
http://cbs4.com/iteam/vaccine.gardasil.i.2.708 105.html
MIAMI (CBS4) ¯ If you are the parent of a young girl you most likely have heard of a first of its kind vaccine named GARDASIL, developed to protect against the viruses which can cause cervical cancer.
The FDA's approval of the vaccine triggered efforts in Florida and across the nation to mandate its use for 11 and 12 year old girls. CBS4 Chief Investigative Reporter Michele Gillen has learned there is an increasing concern over the use of the vaccine.
Christina Bell's daughter, Brittney, was one of the young girls who recieved the vaccine. Just weeks later, her life took a radical turn for the worse.
Seemingly, in a moment's time, Brittney's left leg became paralyzed, her ankle swinging like a rag doll's. Even with a shoe brace, she walks with a limp.
"It's hard for me to lift it up," Brittney told Gillen.
Brittney's limb paralysis occurred shortly after the 12 year old went to the doctor for a routine tetanus shot for school. That is when Bell says the doctor suggested Brittney also have the GARDASIL vaccine on the same day. And she did.
GARDASIL is a first-of-its-kind vaccine approved by the U.S. Food and Drug Administration (FDA) for girls as young as nine. The vaccine is profiled on the FDA website with the headline, "New vaccine prevents cervical cancer."
In trials, the vaccine was shown to prevent pre- cancerous lesions due to certain types of Human Papillomavirus (HPV).
In searching for answers as to why her daughter now suffers from a limb paralysis, Christina Bell says she couldn't shake the idea that it might somehow be tied to the HPV vaccine. She hasn't found a doctor to agree with her, including the pediatrician who recommended the shot.
"He doesn't believe it has anything to do with the shot at all," said Bell.
She says he stopped returning her calls. When the CBS4 I-Team tried calling him, he didn't return the calls.
Bell began to research the vaccine herself and what she found startled her - government-compiled reports, filed from around the country, of adverse events that occurred sometimes within hours, other times within weeks, of a GARDASIL vaccination.
While they don't prove a link, they do document that in some cases an adverse event occurred following an injection. These types of events have been reported to VAERS, a federal vaccine reporting system.
"We've seen reports of] paralysis, convulsions, seizures in young girls. It's very, very, scary and very unfortunate," said Irene Garcia, spokesperson for Judicial Watch, a government watchdog group that obtained the VAERS records from the FDA through the Freedom of Information Act and posted them on the Internet.
When the data was finally released, Garcia said she felt outraged.
"It was outrage because all that I had seen publicly in the media and on television and from pediatricians was positive," said Garcia.
Last February, the FDA told CBS4 that it was investigating reports of 13 deaths following an HPV vaccination. At the time, the agency said it was confident that none were tied to the vaccine and that reports of adverse events were under review but not considered anything out of the ordinary.
An FDA spokeswoman told CBS4 this week that she could not provide an update on the number of reported events, including deaths.
"I haven't seen updated numbers for several months. We monitor on a daily basis but we don't total it up. We are not seeing a problem," said Susan Cruzan, spokesperson for the FDA.
In some states across the U.S., it is mandatory to report a suspected reaction to VAERS. But in others, it isn't.
"It varies by state and there is no blanket federal law, unfortunately," said Garcia.
Brittney's mom said she can't find a doctor willing to report an adverse reaction following the administration of her daughter's vaccines. CBS4 informed her that parents, just like doctors, can report an adverse event and the Bell family has done just that.
"It might always be that people will say you can't prove that this is linked," Gillen told Bell.
"I am still going to speak and tell everybody what I think. I tell everybody," replied Bell.
"What do I want today? I want my daughter back to normal," said Bell.
In a response to this report Merck, which makes the GARDASIL vaccine, issued the following statement:
Merck actively monitors adverse event databases throughout the world, including the U.S. Vaccine Adverse Event Reporting System (VAERS). An event report does not mean that a causal relationship between an event and vaccination has been established - just that the event occurred after vaccination.
The labeling for GARDASIL reflects the extensive data available from our clinical trials. The data, including safety information, have been thoroughly reviewed and discussed by medical experts.
Since its FDA approval in June 2006 through March 31, 2008, Merck has distributed more than 26 million doses of GARDASIL worldwide.
Merck will continue to evaluate all reports in the context of our own post-marketing adverse experience database and our clinical trial database. Post-marketing adverse event reports received by the Company are sent to regulatory authorities worldwide in accordance with regulatory requirements, and Merck updates its product labels with new safety information as appropriate.
Merck encourages healthcare providers and consumers to report any potential adverse experiences following vaccination with GARDASIL to the Company and to adverse event reporting systems.
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National Vaccine Information Center |
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NVIC is funded through the financial support of its members and does not receive any government subsidies. Barbara Loe Fisher, President and Co- founder.
Learn more about vaccines, diseases and how to protect your informed consent rights www.nvic.org
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