September 28, 2002
Smallpox Vaccine to be tested in
children — why hasn't CDC released their vaccine data?
FYI
WHOSE CHILDREN ARE BEING USED
TO TEST THE HIGHLY CONTROVERSIAL,SMALLPOX VACCINE?
According to Newsday (below),
the tests will be conducted at Cincinnati's Children's Hospital Medical
Center and Harbor-UCLA Medical Center, marking "the first time the vaccine
has ever been tested in children, using the rigors of modern science."
Below, AHRP board member,
Meryl Nass, MD, an expert on biological terrorism, and a board member of
AHRP, reports that the Center for Disease Control allegedly stopped it
smallpox vaccine inoculation program because the adverse reactions were
greater than anticipated.
Given the serious adverse
reactions in adults, it is all the more astonishing that the government is
giving its blessing to "an unprecedented clinical trial in which the
smallpox vaccine will be tested in a small number of children."
~~~~~~~~~~~~~~
CDC began inoculating staff
with smallpox vaccine about a year ago, but allegedly stopped, because the
adverse reactions were greater than anticipated.
What the public and medical
professionals require in order to make a reasoned risk-benefit decision
about using this vaccine, are modern data using the currently available
vaccine in the recommended dilution. This means obtaining the following
information:
a) the "take" rate
b) information on whether the
presence of inflammation at the site truly corresponds to development of
protective immune markers
c) the rate of local and
systemic reactions, their type and duration
d) the period of time during
which the vaccinee remains contagious for vaccinia.
If CDC provided this simple
and straightforward information from the smallpox vaccinations they
conducted in-house, an awful lot of speculation could be avoided and
intelligent decision-making with respect to this vaccine could commence.
Come to think of it, with
mandatory anthrax vaccinations beginning in the Persian Gulf on October 1,
if CDC would release the results of their observational study of
vaccinations conducted with the anthrax vaccine last winter, the public
would similarly benefit.
Meryl Nass, MD
http://www.researchprotection.org/about/Nass.html
http://www.redflagsweekly.com/nasspubhlth.html
http://www.anthraxvaccine.org/response.htm
~~~~~~~~~~~~
Posted on Wed, Sep. 25, 2002.
Full story at:
http://www.newsday.com/news/health/ny-hssmal252939369sep25.story
Doctors Planning Clinical
Trial
Hope to test smallpox vaccine on children in two states
By Delthia Ricks
NEWSDAY
Doctors are planning an
unprecedented clinical trial in which the smallpox vaccine will be tested
in a small number of children in two states, federal health officials
confirmed yesterday.
The idea is to establish
vaccine dosages suitable for children in the event that mass vaccination
is needed because of a bioterrorist attack.
Tests, which will be
conducted at Cincinnati's Children's Hospital Medical Center and
Harbor-UCLA Medical Center in Southern California, will mark the first
time the vaccine has ever been tested in children, using the rigors of
modern science.
Though doctors administered
the vaccine successfully in children for two centuries before the
disease's eradication, a formal controlled clinical trial had not been
performed even in the 1960s, a period well within the era of
evidence-based medicine.
Doctors involved in the
design of the trial hope testing will begin before the end of the year.
Fewer than 50 children are expected to be entered into the trial in both
states.
"We're just waiting for the
final word, to hear that it's a go. All of the pieces seem to be in
place," said Dr. David Bernstein, director of the division of infectious
diseases at Cincinnati Children's Hospital and Medical Center. Bernstein
will be the chief investigator of the study's Ohio arm.
He does not foresee trouble
enrolling children into the trial and is discussing the test with
Cincinnati pediatricians. Because test subjects must be closely monitored
and wear special bandages after their inoculation, neither site will
accept enrollees from out of state.
"This is a good vaccine and
millions of children have been safely immunized with it," said Dr. Michael
Lane, a smallpox expert now retired from the Centers for Disease Control
and Prevention.
Medical researchers plan to
test the Dryvax vaccine, Bernstein said, which was the same one used to
eradicate smallpox in an aggressive global campaign in the 1960s and '70s.
It is also the same vaccine administered in a nationwide adult clinical
trial that began late last year. Findings announced in March showed that
Dryvax could be diluted and still maintain its effectiveness.
But Dryvax is not
problem-free. Although doctors think current medical knowledge may make
the vaccine safer, it is a live-virus vaccine that has caused encephalitis
and potential brain damage in some recipients. It also carries a 1 in 1
million chance of death, a ratio worked out by Lane and colleagues in a
series of groundbreaking studies on the vaccine conducted at the CDC in
the 1960s.
