NVIC Vaccine E-NewsletterOctober 24, 2008



CDC Gardasil Risk Report Is A Cover-up

by Barbara Loe Fisher


www.vaccineawakening.blogspot.com
(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjwmhHqA4rtKTZJYFEHO4jPd69TTHj7WHfofJRu1BXdS\
TQQhbSHcnfqhpU_b0AoaJVfwjoMCLu8JoBi8Mr7_3mzNkJWu5PWN-hiEzuwA7xdKjyMW9DOze3xLYy0J\
JjlOXCU=)

www.NVIC.org
(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjzm5tBaScKkH6hu9sUOvAp5IbwxYaQ3dEy8jYTSBdF0\
AUT_vVCWaWoFxt_DmejmtiXcgtUuC_iQWhbqe19UEjGOssXPeKEMheM=)


www.StandUpBeCounted.org
(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjyhocBsiXiySsHTzi3lFinZgMduam3QotkgQlhUjCgf\
hTdZo2ZyXn-2_WlNsN6cqQHPvPYMxp23RqKz38joNA01m5AcNnSV8OoZ9Pec0YkXqw==)

This week the Centers for Disease Control (CDC) in
association with the Food and Drug Administration
(FDA) in the U.S. Department of Health and Human
Services (DHHS) issued a report on Gardasil vaccine safety
(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjys8otT5rv00cWZpW69WVE105d3knTphuBgq6XE5MHG\
nNm1N-Qv4lFMqsGoEKfEp_bBB0aQH_dWwgwYT9stzkKVL9Qz-r_Bpt8rPDUTD8fpxyEwgsyxjuxHzXBp\
bcAu1-T1mhQWXPvKQ2iwKEjW2iPC)
that amounts to a cover-up of serious reactions
(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjyoTrb80eFRe3Xd-d78Q-rh8kp3DrnQXejyAkFjov9s\
PrBAzPkJlFwCZGKFhx1Gdh9xmsCkGWsfuNr0q5XZUUWWliE0EcEIBuzEYJbONg5aQ3RimxrWSTAn2Uy-\
ugmUf9ejm3nEv_e6pkCPFms6H9A1GwGgofxOAuo_I-YSAbUbdrxVQfc8rRqSxYTgVXnXTdVRUW3QpNyj\
BA==),

including paralysis and deaths
(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjx5ZtGa0pcZgnjFgzJcbe8MsQZUaU1hoUlaL1Aw2mWR\
dEDVEwDylTpSIKWGisbSOjnSy5yCPJ4h__V5cznPcFLUAThSzDyGD1h7lvtoqCRhoaUMuIs-Sbd4ykGt\
cSkOdHw=),
that
have been reported to the government's Vaccine
Adverse Events Reporting System (VAERS).



Today (October 24, 2008), the National Vaccine
Information Center issued a press release
(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjyBDE_SugYWF_LwrbBc3oGF2mr5HPSxBOFlMoO3YS_7\
1SqVCiwisBS31_hTfiHCQgpfvj57Cg31TcIlq4Qjlo_bIeAOB1hj-GZE-NU94izBP5yYHHnVRRll-JZZ\
cH8GSc9XgWqtIn_yLux1Y197HuGc)
that calls on the
CDC and FDA to
release to the public the study design, data and
names of principal investigators involved in the report
maintaining that Gardasil vaccine is safe
(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjyPxIDiH8_ztOIPcYDDt1HHJi-ua6yEztnTZstrIVsC\
Xx54oLMaYzMKy6wUDNDUfE1k8Izojpw2OTzOxfQyw1L68NrrDRekhSULtZEu41CISxeNoQzy17iwGdlg\
p-DsS6igOHZ1a6Gnpykx_ehQ9Zmu)
with no serious side effects. NVIC will also be
calling on the newly elected President and members
of Congress to remove the nation's vaccine safety
monitoring system from DHHS and place it in a
separate entity reporting directly to Congress.





Sadly, U.S. government officials have learned
nothing in the past 26 years from parents asking for
investigation of vaccination side effects and
identification of individuals at higher risk for having
vaccine reactions so their lives can be spared. Now, a
callous disregard for human life, which has been
tragically demonstrated for decades, is once again
illustrated in this latest refusal to properly evaluate the
risks of the newly licensed Gardasil vaccine. Why
should anyone have confidence in government and
drug company officials who do not bother to
scientifically investigate the biological mechanisms
contributing to serious reactions, injuries and deaths
and why some individuals may be more vulnerable
than others for suffering Gardasil reactions?



Conflicts of interest are rampant in a mass
vaccination infrastructure that has the same people,
who are regulating and promoting vaccines, also
evaluating vaccine safety. This kind of conflict of
interest cannot be tolerated. The people - and only the
people being told and often forced to buy and use
vaccines - can reform the system by getting involved

(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjzQBn_QjMNGe1_8Ocgx_SI8STOjPBIRItIZBF1m5N9H\
knWabrmnLm5xOSxKCPHxR0hHBApOVF4AHJOKb_cQ5LUPoG82vqiHhDLsLPKvcdyO-mxbbFZ4ROS3aWTW\
xtcOu59urQFnitCl-4ppqj3cSPg9h9d9TGdR1sFfaau-UmWdesOC3wNu02ux)inthe democratic
process and appealing to their elected
officials(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjxuCbN8v66Bke6_FDb6hjMKTCX5x5wtU-r\
Gc7XX3__ll3XI-8GC1QEc-97kAaA7io-zSfMoz-vJeFqi2JubYTjbCM3lBtnGJs7V1U1m7_U7D3cgik4\
UDDILrxthOJZEnvE8YroZkeme9hej--mMQvUIHqSv9Ya2e6o=) anddemanding change. Because
26 years islong enough to wait for those in governmentresponsible for ensuring
vaccine safety to do the rightthing.At the end of the day, the only way we can
havethe ability to place economic and political pressure onthe public health
system to change is to have the rightto make informed, voluntary
decisions(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjxKBR53rzJR0p-XSL3jLBRQfgyxlCHCkJu\
1zKzQu0GQhHwsaKaTc-clSN4ZNOlNt9ut77JRt6CxD8jcNdsTx9ft4aRVihf249-YO-vuMXcO9ub1mGz\
LEv8D83Yb4CbFE0TdbvCmWZubJg==)about which vaccines we and our children use.
Theright to informed consent to vaccination or any medicalintervention which
carries a risk of injury or death is ahuman right. Anything less, as we can see
from thelatest whitewash of Gardasil vaccine risks bygovernment health officials
we are supposed to trust,is a threat to both individual and public
health.</a>__________________________________________* Make a difference SUPPORT
NVIC~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~...~~~~~~~~~~~~~~~~~~~~~~~~~~~~\
~~~~~~~~~~~~~~~~~...Video(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjyuFbV6cxTt5DduRqc\
cDH7eTPQ51VoluXKQwWxNfRdQVY0HlUXdhwFdlNs4-zaYLDNizbZh2N_o1W7WwySU0FtYBFi8Va4HFOy\
h5RywKIYDUA==):NVIC President Barbara Loe Fishersays governmentdenies Gardasil
risks and calls
fortransparency.~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~...October 24, 2008
10:10 AM Eastern Daylight
Timehttp://www.businesswire.com/news/home/20081024005429/en(http://rs6.net/tn.js\
p?e=001GlwGCQ5YLjyBDE_SugYWF_LwrbBc3oGF2mr5HPSxBOFlMoO3YS_71SqVCiwisBS31_hTfiHCQ\
gpfvj57Cg31TcIlq4Qjlo_bIeAOB1hj-GZE-NU94izBP5yYHHnVRRll-JZZcH8GSc9XgWqtIn_yLux1Y\
197HuGc)NVIC Says Government Denies Gardasil RisksVaccine Watchdog Group Calls
for TransparencyWASHINGTON--(BUSINESS WIRE)--The National VaccineInformation
Center
(NVIC)(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjyWDxZaexF1trJWR11bxh-uX7yRwncLdIDFON\
gLH35xK2HQNMFN0WY13Fzoxz26cp3KC69XnhBmDHsomgZhSaeJdLnuH_3jYhg=) is calling
ontheCenters for Disease Control (CDC) and Food andDrug Administration (FDA) to
publicly release thestudy design, data and names of principalinvestigators
involved in a
statement(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjys8otT5rv00cWZpW69WVE105d3knTphuB\
gq6XE5MHGnNm1N-Qv4lFMqsGoEKfEp_bBB0aQH_dWwgwYT9stzkKVL9Qz-r_Bpt8rPDUTD8fpxyEwgsy\
xjuxHzXBpbcAu1-T1mhQWXPvKQ2iwKEjW2iPC) this week maintaining thatGardasil
vaccine is safe with no serious side effects.NVIC will also be calling on the
newly electedPresident and members of Congress to remove thenation's vaccine
safety monitoring system from theDepartment of Health and Human Services
(DHHS)and place it in a separate entity reporting directly toCongress to restore
trust in the nation's public healthlaws based on federal mass vaccination
policies.The CDC and FDA are alleging that the vastmajority - if not all - of
the approximately 9,000 HPVvaccine adverse events, including 27 deaths,
reportedto the federal Vaccine Adverse Event ReportingSystem (VAERS) are not
causally related to theGardasil vaccine based on internal analysis,
includingreview of medical records of girls and womenvaccinated in HMO's
participating in the federalVaccine Safety Datalink (VSD) Project and
otherclosed government operated databases."Transparency in government is
essential to trustin government and replication is the hallmark of goodscience,"
said NVIC co-founder and president Barbara
LoeFisher(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjzSGp8EoKD9PNp-HVAhqaDptJ2htlsj1AT\
xy7Gw2PvcDdpURDNfSMpDjfikZuXgsXTlEj1c3f4NUf726UnTgr6HWQ68H9ARWG1s4Hv3D0rKx1yvChB\
q1TuF). "Parents of young girls and women cutdown in their prime - some of them
paralyzed or deadwithin hours or days of getting Gardasil vaccine -deserve
better answers than a whitewashing of thisvaccine's very serious side effects.
Until there is anindependent confirmation of these unverified findingsby
individuals and companies without financial ties tothe government or industry,
it is not credible." * In June
2006(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjxEb5ZoicnNYvvNoZ3P8rO_G-zjVfwngGSW0pXX\
qwFGk7p1awlouecbM4LLlAk_s6gQ0CI0fxk-kup0qQqm0_CJ4PvT7-ThZUP2PQAy3ihxSOhkzQ-TnhPr\
1pArbHbTpKQQyXiGwnBKxNm2FfpJzPhl) NVIC questioned the qualityand quantity of
Merck's pre-licensure Gardasil vaccinesafety data in girls under age 16 and, in
2007, issuedthree
reports(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjyhfYCul6GJFNsL7yVVf8VjU0zyk0AxBXOsX\
8De_RAeKCcGUDqGPJXnGd-P1I70bwixFAN9OZXYsHp_-NeP5izjtSIPvrWFSRKsQGm6XWLdyF5xHR2q2\
qOh34ZeexPDACvtfi73n9bMyo6Wvg_oD_erdy4_MeXCGUVwdSonKgETgKccUaWfEclIK_McMA9JVp2fU\
M5XnnLHcAJG2-iT6mwB) analyzing serious Gardasiladverse events reported to VAERS;
* In 2007, Merck lobbied in many states for Gardasil
vaccinemandates(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjyjWhQzrqr898r0iL994FU9bbRW4\
b5F48147oPvTacUHpB6N3-SjOx00M5t33qj3Evtfrp_FBSuREiks9cHdkd8reGRmvMbAkHaUes7pS-2V\
A4zwntx5tqrflKU7Oo0yMbHuN-7QFkrz7WV6lk6gRzcwZKYNR9gZ81dyawwplyfVF_icZAIDAu_oP9PU\
iC_Nog=)but failed in most; * During 2008, about 20 percent of all
vaccineadverse event reports to
VAERS(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjyvk-UGS8WyUMW7vyW_lTRXkF9Rh2Cjz35kF5b\
ww7jyFl3e8plOoTg9xNpeZBIiwTgTShGNfM6ASHSVq6-FvMaYsI6vmQ7gC9rWdlROgpBErwciVExs6Dr\
0etxmnspCKAU=)were related to Gardasil eventhough it is not a mandated vaccine
like mostothers; * Last week, reports that Merck's Gardasil sales are
falling(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjxKKfR7kb6P9wl5c1K6-1trTcqKABixt3dcf\
XmcaHuhC3u6msUJJMn7HqfSzyU4P_AikXeYU9zXOyhwsv74M3NeeBATqFpAzjw9_4FoIZKMdcz68t3on\
1CnOg0yL4KjzUwbH6M1yHHoCGUcr8COPHgfcf9ciX-3Bg4vkFROYYNlflSEbKM6aYIQdQWXKaw7auk=)\
dramatically and are notoffsetting similar declining sales of other
drugsassociated with safety concerns prompted Merck tolower profit projections
and layoff employees.NVIC
(www.nvic.org(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjxS1kJT_qvoejYsvL4yV235wpnMXl6\
QZDtcauONHIHJbabYz8OkVv7Ui0Bf9w14lf28ePrzFmX8cb0sGIsgK-xuD9Rg6nxn-Jg=))
wasfounded in 1982 and worked with Congress on the1986 National Childhood
Vaccine Injury Act. The non-profit watchdog group advocates for safer
vaccinepolicies and the legal right for Americans to makeinformed, voluntary
decisions about vaccination.ContactsNational Vaccine Information CenterBarbara
Loe Fisher,
703-938-0342Permalink:http://www.businesswire.com/news/home/20081024005429/en(ht\
tp://rs6.net/tn.jsp?e=001GlwGCQ5YLjyBDE_SugYWF_LwrbBc3oGF2mr5HPSxBOFlMoO3YS_71Sq\
VCiwisBS31_hTfiHCQgpfvj57Cg31TcIlq4Qjlo_bIeAOB1hj-GZE-NU94izBP5yYHHnVRRll-JZZcH8\
GSc9XgWqtIn_yLux1Y197HuGc)~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~Hi. My
name is Christina RichelleTarsell,but people call me Chris. I celebrated my 21st
birthdayin November 2007. I did not live to see my 22nd.Suddenly, unexpectedly,
and inexplicably, I died in bedin June. After an extensive autopsy, the cause of
deathis still a mystery. My family wants to know whathappened to me. My family
has concerns about theHPV vaccine, Gardasil, which I had received only
daysbefore my death. They are researching the VaccineAdverse Event Reporting
System for accounts of suchdeaths. Can you help us find
answers?http://www.gardasilandunexplaineddeaths.com(http://rs6.net/tn.jsp?e=001G\
lwGCQ5YLjx5ZtGa0pcZgnjFgzJcbe8MsQZUaU1hoUlaL1Aw2mWRdEDVEwDylTpSIKWGisbSOjnSy5yCP\
J4h__V5cznPcFLUAThSzDyGD1h7lvtoqCRhoaUMuIs-Sbd4ykGtcSkOdHw=)~~~~~~~~~~~~~~~~~~~~\
~~~~~~~~~~~~~~~~~~~~~~~~~Reports of Health Concerns Following
HPVVaccinationCenters for Disease ControlOctober 21,
2008http://www.cdc.gov/vaccinesafety/vaers/gardasil.htm(http://rs6.net/tn.jsp?e=\
001GlwGCQ5YLjys8otT5rv00cWZpW69WVE105d3knTphuBgq6XE5MHGnNm1N-Qv4lFMqsGoEKfEp_bBB\
0aQH_dWwgwYT9stzkKVL9Qz-r_Bpt8rPDUTD8fpxyEwgsyxjuxHzXBpbcAu1-T1mhQWXPvKQ2iwKEjW2\
iPC)HPV Vaccine SafetyThe safety of the HPV vaccine was studied in
7clinicaltrials before it was licensed. There were over 21,000girls and women
ages 9 through 26 in these clinicaltrials.Since it was licensed, CDC and FDA
have beenclosely monitoring the safety of the HPV vaccine.There are 3 systems
used to monitor the safety ofvaccines after they are licensed and being used in
theU.S. These systems can monitor side effects alreadyknown to be caused by
vaccines as well as detect rareside effects that were not identified during a
vaccine'sclinical trials. The 3 systems are: * The Vaccine Adverse Event
Reporting System(VAERS)--a useful early warning public health systemthat helps
CDC and FDA detect possible side effectsor adverse events following
vaccination.* The Vaccine Safety Datalink (VSD) Project--aproject between CDC
and 8 health care organizationsto study patterns in reports detected by VAERS
anddetermine if a vaccine is causing a side effect.* The Clinical Immunization
Safety Assessment(CISA) Network--a project between 6 academiccenters in the U.S.
which conduct research onadverse events that might be caused by vaccines.Reports
to VAERS Following HPVVaccinationAs of August 31, 2008, there have been
10,326VAERSreports of adverse events following Gardasilvaccination in the United
States. Of these reports, 94%were reports of events considered to be
non-serious,and 6% were reports of events considered to beserious.Based on all
of the information we have today,CDCand FDA have determined that Gardasil is
safe to useand effective in preventing 4 types of HPV. As with allapproved
vaccines, CDC and FDA will continue toclosely monitor the safety of Gardasil.
Any problemsdetected with this vaccine will be reported to healthofficials,
healthcare providers, and the public, andneeded action will be taken to ensure
the public'shealth and safety.Non-serious adverse event reportsVAERS defines
non-serious adverse events asthoseother than hospitalization, death, permanent
disability,and life-threatening illness.The vast majority (94%) of the adverse
eventsreportsfollowing Gardasil have been non-serious. Reports ofnon-serious
adverse events after Gardasil vaccinationhave included fainting, pain and
swelling at theinjection site (the arm), headache, nausea and fever.Fainting is
common after injections and vaccinations,especially in adolescents. Falls after
fainting maysometimes cause serious injuries, such as headinjuries, which can be
easily prevented by keeping thevaccinated person seated for up to 15 minutes
aftervaccination.Serious adverse event reportsVAERS defines serious adverse
events asadverseevents that involve hospitalization, death, permanentdisability,
and life-threatening illness. As with allVAERS reports, serious events may or
may not havebeen caused by the vaccine.All serious reports (6%) for Gardasil
have beencarefully analyzed by medical experts. Experts havenot found a common
medical pattern to the reports ofserious adverse events reported for Gardasil
thatwould suggest that they were caused by the vaccine.The following is a
summary of the serious adverseevent reports that were submitted to VAERS
betweenJune 8, 2006 and August 31, 2008.Guillain-Barré Syndrome
(GBS)Guillain-Barré Syndrome (GBS) has beenreportedafter vaccination with
Gardasil. GBS is a rare disorderthat causes muscle weakness. It occurs in 1-2
out ofevery 100,000 people in their teens. A number ofinfections can cause GBS.
There has been noindication that Gardasil increases the rate of GBS ingirls and
women above the rate expected in thegeneral population, whether or not they
werevaccinated.Blood ClotsPeople have reported blood clots after
gettingGardasil. These clots have occurred in the heart,lungs, and legs. Most of
these people had a risk ofgetting blood clots, such as taking oral
contraceptives(the birth control pill).DeathsAs of August 31, 2008, there have
been 27 U.S.reports of death among females who have receivedthe vaccine. There
was no common pattern to thedeaths that would suggest that they were caused
bythe vaccine. Of the 27 U.S. reports: * 3 reports were related to diabetes or
heartfailure * 3 reports were related to viral illnesses ormeningitis (an
infection in the brain) * 2 reports were related to drug use * 2 reports
were related to blood clots * 5 reports are being evaluated (attempting to
followup/identify case) * 1 report is still under review or VAERS is
stillwaiting for additional medical records, such as anautopsy report or death
certificate * 1 report of seizure disorder (history of seizures) * 3
reports had an unknown cause of death * 7 reports that could not be evaluated
because theydid not have enough information to identify the person,or to verify
that a person had diedReports of adverse events after getting avaccinecanbe
submitted to VAERS by fax at 1-877-721-0366,online
athttps://secure.vaers.org/VaersDataEntryintro.htm(http://rs6.net/tn.jsp?e=001Gl\
wGCQ5YLjxPidsSepZ5N2defM0x7oXwvJugpluDBGBH186PrN9R3NFLJNHPx9j6w1iaNkL0EJiAt3rHnH\
T3rt-13q7cKOL7fQVxkVuVBK7XMMVjO5AX_I0QS3jvNaTKBAhiLnNl89R9DxC5n0QpzQ==), or
bymail to Vaccine Adverse Event Reporting System, P.O.Box 1100, Rockville, MD
20849-1100.~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~Cervical Cancer Vaccine
Called SafeWednesday, October 21, 2008Health
Dayhttp://www.washingtonpost.com/wp-dyn/content/article/2008/10/22/AR20081022030\
58.html(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjyoTrb80eFRe3Xd-d78Q-rh8kp3DrnQXejyA\
kFjov9sPrBAzPkJlFwCZGKFhx1Gdh9xmsCkGWsfuNr0q5XZUUWWliE0EcEIBuzEYJbONg5aQ3RimxrWS\
TAn2Uy-ugmUf9ejm3nEv_e6pkCPFms6H9A1GwGgofxOAuo_I-YSAbUbdrxVQfc8rRqSxYTgVXnXTdVRU\
W3QpNyjBA==)WEDNESDAY, Oct. 22 (HealthDay) -- Gardasil, the two-year-old vaccine
that's designed to prevent cervicalcancer, is safe, U.S. officials said
Wednesday.The U.S. Centers for Disease Control andPrevention's Immunization
Safety Office said a study of370,000 doses given to girls and young women
overthe past two years found no evidence that the vaccinecauses an increased
risk of blood clots or otherserious conditions,Bloomberg Newsreported.The CDC,
which recommends the vaccine forgirls starting at ages 11 and 12, based its
findings onstatistics from the Vaccine Safety Datalink, which usesmedical data
to test hypotheses about vaccine safety,the news service said."There were no
associations found thatsuggested an elevated risk," said John Iskander,acting
director for the Immunization Safety Office,toldBloomberg.Critics of the
vaccine, including some groups thatworry that the inoculation could promote
promiscuity,have contended that Gardasil may not be safe andcould give women a
false sense of security aboutsexually transmitted diseases.Gardasil protects
against four types of genitalhuman papillomavirus, HPV, which is spread
throughsexual contact and can cause cervical cancer inwomen.The U.S. study
covered 190,000 girls and youngwomen who received at least one dose of
thevaccine's three-shot regimen. The CDC researcherscompared medical data on
those girls who got thevaccine with data for girls and young women whoreceived
other vaccines or none."The results are really reassuring," said Dr. PaulOffit,
chief of the infectious diseases division atChildren's Hospital of Philadelphia.
"There's a publicperception that the vaccine is not safe. This isimportant for
countering negative information."CDC officials had announced earlier this
monththat an estimated 25 percent of girls aged 11 to 17have gotten the
vaccine."This is very good for a first-year measurement ofa new vaccine," Dr.
Lance Rodewald, director of theDivision of Immunization Services at the
CDC'National Center for Immunization and RespiratoryDiseases, said during a Oct.
9 teleconferenceannouncing the survey. "It usually takes six to nineyears to
achieve the desired 90 percent coverage."Rodewald noted that because the survey
coveredonly young teens, many more young women haveprobably received the
vaccine. The vaccine has beenvery well-tolerated, and its protection, especially
whengiven at a younger age, is expected to last at least sixyears, he noted.
Whether a booster shot will beneeded isn't known yet.The hope for the vaccine is
that it will reduce thealmost 4,000 cervical cancer deaths each year in
theUnited States. Barriers to getting the vaccine includecost, which is about
$375, although it is covered undermany health insurance plans.One side effect
associated with the vaccine,fainting, resulted in the U.S. Food and
DrugAdministration last month requiring that vaccinemanufacturer Merck & Co. add
a warning to thepackage insert, advising doctors to watch patients for15 minutes
after the shot to be sure they don'tfaint.In July, news stories said that almost
8,000reports of adverse reactions to Gardasil -- includinginjection site pain
and nausea -- had been filed withthe CDC.The reactions included 15 reports of
death and10 confirmed deaths, but none of the deaths has beentied to the
vaccine, according to aCNNreport.After the CDC study results were
releasedWednesday, Merck issued the followingstatement: "Gardasil is an
important tool to helpprevent cervical cancer caused by HPV types 16 and18 for
girls and young women. About 30 women everyday are diagnosed with cervical
cancer in the UnitedStates. An estimated 8 out of 10 women will becomeinfected
with HPV in their lifetime. For most people,HPV clears on its own. But for some
women who don'tclear certain types of the virus, cervical cancer candevelop. And
there's no way to predict who will or won'tclear the virus."For more on
Gardasil, visit the
CDC(http://rs6.net/tn.jsp?e=001GlwGCQ5YLjx3n9bvFAxf69YDgxFhbqiouNaD1_HnyjwVcY8xO\
8DnKUPyq92Q218B0iQSYWKNM6JTQiUtO_iGSaXgqbyWiuBQIzqI0qtFCYXqUwr9XLAjTP9gXuEMgjW8Z\
YFBhfoQPU3go8jrg5Kfq4O6ku_vgeis).SOURCES: U.S. Centers for Disease Controland
Prevention, Atlanta;Bloomberg News; Oct. 22,2008, news release, Merck &
Co.~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~Side Effects Not Linked to
Gardasilby Jennifer Corbett DoorenWall Street JournalOctober 23,
2008http://online.wsj.com/article/SB122471132565059959.html(http://rs6.net/tn.js\
p?e=001GlwGCQ5YLjyPxIDiH8_ztOIPcYDDt1HHJi-ua6yEztnTZstrIVsCXx54oLMaYzMKy6wUDNDUf\
E1k8Izojpw2OTzOxfQyw1L68NrrDRekhSULtZEu41CISxeNoQzy17iwGdlgp-DsS6igOHZ1a6Gnpykx_\
ehQ9Zmu)Reports of serious adverse events and deaths inyoung girls and women
following administration withMerck & Co.'s Gardasil are likely not related to
thecervical-cancer vaccine, federal health officials saidWednesday.Data from the
first post-marketing safety study ofthe vaccine, Gardasil, were presented to a
CDCvaccine panel Wednesday, along with a tally of reportsfiled to the vaccine
adverse events reporting system,which is run by the Food and Drug Administration
andthe Centers for Disease Control and Prevention.Gardasil was approved in June
2006 and isdesigned to protect against four strains of the humanpapillomavirus,
or HPV, two of which account for about70% of cervical-cancer cases. It's
recommended thatgirls ages 11 to 12 receive the vaccine in a three-doseseries
before they are sexually active, and it coincideswith recommendations on other
vaccines.CDC said findings from its Vaccine SafetyDatalink program, which uses
data from severalmanaged-care organizations, found no increased riskof a
pre-specified set of possible side effects -- suchas Guillain-Barre Syndrome, a
neurological disorder,stroke, blood clots, fainting, appendicitis and aserious
allergic reaction known as anaphylaxis --among vaccine recipients compared to a
similargroup of patients who didn't receive the vaccine. Thestudy looked at
375,000 doses of the vaccine fromAug. 20, 2006, to July 20, 2008, in girls and
womenages 9 to 26."Based on all of the information we have today,CDC and FDA
have determined that the HPV vaccineis safe to use and effective in preventing 4
types ofHPV," the CDC said.CDC also said it had received more than 10,000adverse
event reports, including 27 deaths, as of Aug.31, 2008. Of the reports, 94% were
reports of eventsconsidered to be non-serious and 6% were reports ofevents
considered to be serious. Most vaccines havereported serious adverse events
rates between 10%and 15%, CDC said.Non-serious events include fainting, pain
andswelling at the injection site, headache, nausea andfever. Serious adverse
events, defined as thosecausing hospitalization, death, permanent disability
orlife-threatening illness included blood clots andGuillan-Barre Syndrome.Write
to Jennifer Corbett Dooren
atjennifer.corbett-dooren@...~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~\
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