Here is a news release I received from the NVIC which outline concerns over this new vaccine by a vaccine safety group. I've bolded a few of the more interesting passages.
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.
Hybrid Mode
