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HPV Vaccine Mandates Risky and Expensive
Vaccine Safety Group Finds Serious Reactions, High Costs
VIENNA, Va., Feb. 1 /PRNewswire-USNewswire/ -- The National Vaccine Information
Center (NVIC), the nation's leading vaccine safety and informed consent advocacy
organization, is urging state legislatures to investigate the safety and cost of
mandating Merck's HPV vaccine (GARDASIL) for all pre- adolescent girls before
introducing legislation amending state vaccine laws. In an analysis of reports
made to the federal Vaccine Adverse Event Reporting System (VAERS) since the
CDC's July 2006 universal use recommendation for all young girls, NVIC found
reports of loss of consciousness, seizures, joint pain and Guillain-Barre
Syndrome. In a separate evaluation of costs for young girls being vaccinated in
private pediatrician offices, NVIC discovered that parents living in the
Washington, D.C. area will be paying between $500 and $900 to have their
daughters receive three doses of GARDASIL.
"GARDASIL safety appears to have been studied in fewer than 2,000 girls aged 9
to 15 years pre-licensure clinical trials and it is unclear how long they were
followed up. VAERS is now receiving reports of loss of consciousness, seizures,
arthritis and other neurological problems in young girls who have received the
shot," said NVIC President Barbara Loe Fisher. "At the same time, parents who
take their daughters to private pediatricians are going to be shocked to find
that they will be paying two to three times the widely publicized $360 cost for
the three-dose series. The cost is going to break the pocketbooks of parents and
break the banks of both insurance companies and taxpayers, when the reality is
that almost all cases of HPV- associated cervical cancer can be prevented with
annual pap screening of girls who are sexually active."
Between July 2006 and January 2007, there have been 82 reports of adverse events
filed with VAERS following receipt of GARDASIL by girls and boys ranging in age
from 11 to 27 years. Reaction reports have come from 21 states, including
Virginia and the District of Columbia. All but three of the reports were for
adverse events which occurred within one week of vaccination and more than 60
percent occurred within 24 hours of vaccination.
"The most frequent serious health events after GARDASIL shots are neurological
symptoms," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "These young
girls are experiencing severe headaches, dizziness, temporary loss of vision,
slurred speech, fainting, involuntary contraction of limbs (seizures), muscle
weakness, tingling and numbness in the hands and feet and joint pain. Some of
the girls have lost consciousness during what appears to be seizures." Debold
added "The manufacturer product insert should include mention of syncopal
episodes, seizures and Guillain-Barre Syndrome so doctors and parents are aware
these vaccine adverse responses have been associated with the vaccine."
VAERS reports also indicate the doctors are administering GARDASIL to girls and
women at the same with Tdap, DT, meningococcal (Menactra), hepatitis A, and
other vaccines, even though the Merck product insert states that, with the
exception of hepatitis B vaccine, "Co-administration of GARDASIL with other
vaccines has not been studied." There is no publicly available information about
how many of the 9 to 15 year old girls in Merck's pre- licensure clinical trials
received GARDASIL simultaneously with hepatitis B vaccine.
Although approximately half of all families in the U.S. select a pediatrician in
private practice to provide their children routine care, including vaccinations,
children can receive government subsidized reduced cost or free vaccinations in
public health clinics through the Vaccines for Children program if they cannot
afford to pay for vaccinations administered by private pediatricians. NVIC's
survey of four private pediatric practices in the Virginia suburbs of
Washington, D.C. found that parents could be charged anywhere from $525 to $930
for three GARDASIL shots depending upon whether the child was a first-time or
current patient. Costs for the vaccine plus an administration fee ranged from
$140 to $275 per shot with an additional office visit charge that fluctuated
between $35 and $185 depending upon whether a nurse or doctor saw the child.
HPV is the most common sexually transmitted infection in the U.S. and most
persons naturally clear the infection from the body without symptoms. However,
many years of chronic HPV infection is associated with a higher risk of pre-
cancerous changes in the cervix that can lead to cancer unless diagnosed and
treated promptly. High risk factors for chronic HPV infection include smoking,
long-term use of oral contraceptives and co-infection with HIV, herpes and
chlamydia. There has been a more than 70 percent drop in cervical cancer deaths
in American women since the 1950's due to routine pap smears and nearly all
cervical cancers can be prevented with regular pap smear screening and
treatment.
In its product manufacturer insert, Merck states 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."
Merck also states that "The duration of immunity following a complete schedule
of immunization with GARDASIL has not been established."
For more information about HPV infection and GARDASIL safety, including NVIC's
five-page report on GARDASIL adverse event reports to VAERS as well as a direct
link to VAERS reports, go to NVIC's website at http://www.nvic.org.
SOURCE National Vaccine Information Center
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