The
American College of Pediatricians has come out with a statement against
the forced vaccination of 12 year old girls with the HPV vaccine
as a requirement to attend school for the following reasons:
1. the vaccine is tested but long
term immunity is not known yet. The College suggests establishing data
banks to trace how effective the vaccine is, on the long term. As the
college stated "waning protection is an issue with almost every vaccine"
2. parents rights should be
respected as to whether they want their girls to receive the vaccine or
not. It may not be appropriate for MOST young girls unless it is known
that they are very sexually active and having unprotected sex.
Receiving the vaccine should be totally voluntary on the part of the
individual, states the ACP and medical providers should inform parents
that the ONLY TOTAL protection from infection is abstinence.
3. 30 percent of HPV is caused by
strains NOT covered in the vaccine
4. the trials were only 2-4 years
long - but the average time from infection with HPV to cervical cancer
is 20 years (probably why some experts have opined that the vaccine may
not be needed because pap smears identify atypical cells long before the
person is in danger of cervical cancer and it can be treated at that
time)
5. Basically the position of the
ACP is that there are far too many questions yet to be answered about
this vaccine, that cervical cancer can be prevented through regular
pap smears and treatment of HPV long before there is a danger of
cervical cancer and that parents rights and the right of the
individual to make the decision whether or not to get the vaccine,
should be respected.
It should be noted that in the
double blind trials with the HPV vaccine, individuals in the
vaccinated cohort showed 16.5 percent fewer procedures for cervical
problems involving HPV and 25 percent fewer genital warts.... this is
not exactly total protection considering that this vaccine can cause
some rather serious repercussions like Guillian Barre' etc.
We should also remember that
these trials were run by the manufacturer of the vaccine - and in the
Phen Fen trials, Ayrest-Wyeth admitted that removing negative results
was "common practice in the pharmaceutical industry thus the less than
impressive results from the Merck trials might have been
"sanitized"....
>>>>College
States Position on HPV Vaccine
The American College of Pediatricians commends the researchers,
prelicensure study participants, and vaccine manufacturers for
bringing the Human Papilloma Virus (HPV) vaccine to fruition.
Despite the monumental contribution of Dr. George N.
Papanicolaou, who developed the “Pap” test in 1928 and published
a description of its use in diagnosing uterine cancer in 1943,
cervical cancer is still a major health problem for women. It is
the 2nd most common cancer worldwide, and the 11th most common
cancer in American women. Despite a 70% reduction in deaths from
cervical cancer with the routine use of Pap smears, in 2005 it
still took the lives of 3710 women in the United States, and
290,000 worldwide. While the average age of death from
malignancies in general is 72 years, the average age of women
dying of cervical cancer is 57 years. The cost of cervical
cancer screening and treatment has been calculated to be as high
as 6 billion dollars per year in the United States alone.
Currently, an HPV vaccine is approved for children and adults
ages 9-26. Despite encouraging results in
prelicensure studies, research definitively establishing the
duration of HPV vaccine protection, degree of protection and
spectrum of side effects remain to be determined.
As of 2006, HPV vaccines have been tested on 25,000 people in 33
countries. The Merck trials involved 20,541 women 16 to 26 years
of age, and 1121 girls between 9 and 15 years of age.1,2 Vaccine
recipients were given 3 doses over a 6 month period. About half
of the 16 to 26 year olds in the Merck studies received that
manufacturer’s HPV vaccine (Gardasil, which targets HPV types 6,
11, 16, and 18) and the other half was given placebo. Compared
to those given placebo, study participants immunized with
Gardasil had significantly fewer genital warts and Pap smear
abnormalities. Vaccine recipients had 16.5% fewer definitive
procedures for HPV cervical problems, including local
electrosurgery, laser treatment, or “cold knife” local surgery,
and 26.5% fewer excisions for external genital warts. The
average length of follow up in the 4 studies conducted by Merck
ranged from 2 to 4 years. Blood antibody levels against HPV in
the vaccine group peaked at 7 months after immunization,
declined through the 2nd year, and stabilized at 36 months,
remaining at levels above pre-immunization. For the girls aged 9
to15 years immunized with Gardasil, blood antibody levels showed
a good response and “the efficacy of Gardasil in 9 to 15 year
old girls is inferred.”3 The number of 9 year old girls
vaccinated in all trials has been reported to be 250. Also,
according to the Merck published report on Gardasil, the
“duration of immunity following a complete schedule of
immunization with Gardasil has not been established.”4 The Glaxo
Smith Kline trials include some data on crossprotection against
HPV types not included in the vaccine. Their Cervarix vaccine,
which includes only HPV material targeted at HPV types 16 and
18, also provided protection against types 45 and 31.
To help resolve the questions left by these limited, short term
data, the American College of Pediatricians recommends that HPV
vaccine manufacturers establish vaccine registries for HPV
vaccine recipients. The registries should be designed to assure
patient privacy and collect long term data. Because the average
time between initial HPV infection and death from cervical
cancer is 20 years, definitive conclusions about HPV vaccine
efficacy will take years to establish. Future research should
also address the use of the vaccine in males.
Until further research is completed, HPV vaccine recipients
should be fully informed as to the current limits of knowledge
regarding the vaccine’s potency and duration of protection.
Waning protection is an issue with almost every vaccine in
existence. In the 1980’s it became clear that a single
mumps-measles-rubella (MMR) vaccine was insufficient to offer
complete protection against measles. When approved in 1995 a
single dose of chickenpox vaccine was expected to offer
long-lasting protection, now we know a booster is needed. It may
be years before we know with certainty the duration of
protection afforded by HPV vaccines. Delaying the administration
of the vaccine until the recipient is sexually active and
therefore at risk of HPV exposure should be considered. Parents
and adolescents should also be reminded that 30% of cervical
cancers are not caused by HPV strains included in the current
HPV vaccines. They should also understand that this vaccine
offers no protection against other forms of sexually transmitted
diseases.
Cervical cancer causing HPV infection is spread only by
penetrating vaginal sexual intercourse with direct
penile-to-cervix contact. Although DNA from HPV was detected on
the external genitalia of up to 20% of virginal women in one
study, it was not found on the cervix in any of the same women
in the absence of a history of vaginal sexual intercourse. Not
all adolescents engage in penetrating vaginal sexual
intercourse. Families with firmly enforced restrictions on
sexual conduct, whose children do not participate in penetrating
vaginal sexual intercourse outside of marriage, should have
those values respected; it should be acknowledged that the child
will not require HPV vaccination prior to marriage. There are
other adolescents, who will engage in vaginal sexual
intercourse, but do so with advanced planning without
impulsivity. Because the duration of protection offered by HPV
vaccination is uncertain, these adolescents should be offered
the option of deferring immunization until the age of initiation
of sexual intercourse. Whatever their views on sexual conduct,
all families deserve equal respect and should be offered
affordable HPV vaccination. They should be counseled, however,
that HPV vaccination is not completely protective against
cervical cancer. Special cellular characteristics of the
developing adolescent cervix make it especially susceptible to
infection with STDs. Condom use provides some but not complete
protection against cervical HPV infection. Parents and
adolescents must understand that receiving this vaccine does not
make all sexual activity "safe." The most medically safe sexual
conduct for adolescents is abstinence until marriage, and they
should be counseled accordingly.
The American College of Pediatricians is opposed to any
legislation which would require HPV vaccination for school
attendance. Excluding children from school for refusal to be
vaccinated for a disease spread only by penetrating vaginal
intercourse is a serious, precedent-setting action that
trespasses on the right of parents to make medical decisions for
their children as well as on the rights of the children to
attend school. In addition, this vaccine prevents a disease
which is exclusively sexually transmitted; mandating it as early
as 9 years of age places the medical provider in an ethical
dilemma. First, the administration of the vaccine requires
explanation to both the parent and the child. Parents may have
chosen not to introduce the subject of sexual activity to their
nine year olds due to their physical and emotional immaturity.
Also, most 9-12 year old children are not sexually active; many
have not entered puberty. Forcing a parent to forsake his/her
better judgment and discuss this information with the child
would be inappropriate and unnecessarily intrusive.
The American College of Pediatricians recommends that parents
use the availability of this vaccine to usher in a discussion of
human sexuality in a way consistent with their culture and
values at a time when they determine their child is ready to
receive the information. Parents should closely monitor their
children’s activities, reinforce their values, and consent to
vaccination when appropriate. At that time, physicians should
introduce the value of sexual abstinence as the only way to
completely eliminate the risks associated with sexual activity.
January 12, 2007
References
1. Zacharyczuk, Colleen. “HPV vaccine shows good prevention
against cervical pre-cancers.” Infectious Diseases in Children
2005 November:19.
2. Villa LL, Costa RL, Petta CA, et al. Prophylactic
quadrivalent human papillomavirus (types 6,11,16, and 18) L1
virus-like particle vaccine in young women; a randomized
double-blind placebo-controlled multicentre phase II efficacy
trial. Lancet Oncology 2005; 6:271-8.
3. Merck & Company, Inc. Product Information on Gardasil (Quadrivalent
Human Papillomavirus(types 6,11,16,18) Recombinant Vaccine,
accessed at www.merckvaccines.com on 7-31-06.
4. Merck & Company, Inc. Product Information on Gardasil (Quadrivalent
Human Papillomavirus(types 6,11,16,18) Recombinant Vaccine,
accessed at www.merckvaccines.com on 7-31-06.
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