September 28, 2002
Smallpox Vaccine to be tested in children – why hasn’t CDC released their vaccine data?
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
Posted on Wed, Sep. 25, 2002. Full story at:
Doctors Planning Clinical Trial
Hope to test smallpox vaccine on children in two states
By Delthia Ricks
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.