October 26

Will 2 to 5 year old Amer. kids be exposed to Smallpox Vaccine? Israeli Intelligence says "No immediate threat"

Will 2 to 5 year old Amer. kids be exposed to Smallpox Vaccine? Israeli Intelligence says “No immediate threat”

Sat, 28 Dec 2002

What is the Administration’s final decision regarding the proposed smallpox vaccine trial that would expose 40 children aged 2 to 5 years old to a controversial live virus smallpox vaccine?

According to Dr. Yehuda Danon, professor of immunology and pediatrics at Tel Aviv University, Israeli intelligence reports say “there is no immediate threat, and we don’t see the possibility of Iraq attacking us with smallpox.” [See below]

On Sept 25, 2002, Newsday reported the plan to test the controversial, 30-year old, live virus vaccine, Dryvax, in 40 children. Dr. David Bernstein, director of the division of infectious diseases at Cincinnati Children’s Hospital and Medical Center, the principle investigator, was quoted saying: “We’re just waiting for the final word, to hear that it’s a go. All of the pieces seem to be in place.” Dr. Michael Lane, formerly with the Centers for Disease Control, was quoted saying: “This is a good vaccine and millions of children have been safely immunized with it.”

But contrary to these doctors’ rosy spin, other experts noted publicly that Dryvax vaccine is linked to very real, severe–even life-threatening risks for some recipients–including encephalitis and brain damage. The adverse reactions led to the suspension of smallpox vaccination–even though there were cases of smallpox reported in the world. Those who witnessed the array of severe adverse reactions to the vaccine–especially in children–are dismayed by the proposed trial.

Dr. Paul Offit, a pediatrician at Children’s Hospital, University of Pennsylvania, a member of the Advisory Committee on Immunization Policy, which makes vaccine recommendations to federal health agencies, says he has seen babies who suffered reactions to smallpox vaccine. Dr. Offit said that, in the absence of a single case of smallpox anywhere on earth, the vaccine is too risky to use.

And as the Washington Post reported, the severity of the adverse reactions to the vaccine today have jolted experts. See: Ceci Connolly. Smallpox Vaccine Reactions Jolt Experts. From Rashes to Fevers, Array of Side Effects Is Uncommon Today Washington Post Thursday, December 5, 2002; Page A01 http://www.washingtonpost.com/ac2/wp-dyn/A11192-2002Dec4?language=printerwas hingtonpost.com

Following the announcement of the proposed trial on 2 to 5 year old children, The Alliance for Human Research Protection (AHRP)launched a campaign to raise public awareness about the proposed trial, the potential harm for some of the 40 children, and the questionable ethics of conducting such a trial. https://ahrp.org

On Oct. 30, The Secretary of Health and Human Services invited public comments in accordance with federal regulations (45 CFR 46.407). The overwhelming response of more than 700 citizens who sent in comments–among them, physicians and other healthcare workers, parents, grandparents, brothers and sisters–unequivocally rejected the proposed trial, many calling it “inhumane.”

See: AMA News: http://www.amaassn.org/scipubs/amnews/pick_02/hlsc1202.htm


Unlike representatives of the research / pharmaceutical industry establishment, professional and lay citizens recognize a public responsibility to protect children from medical experiments that are not in their best interest:

“Subjecting children to something you don’t know the long term effects to should be illegal!” L. Moratto, 12/10/2002 http://www.fda.gov/ohrms/dockets/dockets/02n0466/02N-0466_emc-000249.txt

“In about 1960 my sister, age 3, received the smallpox vaccine. Although the details are somewhat muddy, via my parents, my sister spiked a fever, and went into a coma When she emerged from her coma a few days later, she had lost all motor and vocal skills. She had to relearn to walk and talk. She still suffers till this day” Gary McCready DDS 11/18/2002 https://ahrp.org/children/smallpoxpubcomments.php

“We feel there is no sound scientific reason to pursue this trial of the dangerous smallpox vaccine.” Timmothy Bessett, D.C. Illinois Prairie State Chiropractic Association (IPSCA) http://www.fda.gov/ohrms/dockets/dockets/02n0466/02n-0466-c000048-01-vol5.pdf

“Throughout the past month I have been reading a lot about the study dealing with the administration of the smallpox vaccine to 40 children from the ages 2 to 5.” “Is it worth it to put these 40 children in danger for something that we aren’t even sure about? Do we know the probability of a bioterrorist attack occurring with the smallpox virus? The most unethical part of this study is that the children may not even be benefiting from it.” Lindsay Roome 12/10/2002 http://www.fda.gov/ohrms/dockets/dockets/02n0466/02n0466.htm

“one of the panelists and a number of parents (in the public comments) have said that they approved of the trial, but would not themselves be willing to enter their patients (in the case of the panelist) or their own children (the parents) into such a trial. These views offer a strong ethical argument against testing on 2 to 5 year olds. If the trial is too risky for your own children, then it is too risky for anyone’s children.” Carol A. Tauer, Ph.D. Emeritus Professor of Philosophy, http://www.fda.gov/ohrms/dockets/dockets/02n0466/02N-0466_emc-000120-01.doc

See: http://www.fda.gov/ohrms/dockets/dockets/02n0466/02n-0466-c000033-01-vol5.pdf [For easier access to public comments, See: https://ahrp.org/children/smallpoxpubcomments.php

I’ve practiced family medicine for 23 years. I am opposed to this vaccine study. This study, in my opinion, crosses the line of proper medical ethics. Dr. Kenneth Unice

See also, smallpox vaccine comments by AHRP: https://ahrp.org/ahrpspeaks/smallpox1202.php

Among the very few endorsers of the smallpox vaccine trials was The American Academy of Pediatrics which erroneously referred to the smallpox vaccine as “the currently licensed vaccine,” when it is not. http://www.fda.gov/ohrms/dockets/dockets/02n0466/02n-0466-c000033-01-vol5.pdf Philadelphia

Shouldn’t the public be informed before the New Year about the Administration’s final decision?


http://www.nytimes.com/2002/12/26/international/middleeast/26ISRA.html?pagew anted=print&position=top December 26, 2002 Israel Will Expand Its Smallpox Vaccinations, but Not to Everyone By DEXTER FILKINS

JERUSALEM, Dec. 25 – Israeli officials said today that they had decided against vaccinating the entire population against the smallpox virus. But they said they were expanding the number of soldiers and health care workers who would be vaccinated to 40,000 or more.

The officials said they made the decision after concluding that the likelihood of a smallpox attack, by terrorists or another country, was slim. A more realistic goal, they said, was to ensure that the country’s doctors and nurses could carry out a crash program to inoculate the entire population quickly if a single case of smallpox were discovered. The officials said they hoped they could vaccinate the entire population of six million Israelis in about four days if the need arose.

“Intelligence reports are saying there is no immediate threat, and we don’t see the possibility of Iraq attacking us with smallpox,” said Dr. Yehuda Danon, professor of immunology and pediatrics at Tel Aviv University. “But everything could change once we have the first case.”

The decision was announced amid a flurry of press reports here speculating on the dangers of a biological or chemical weapons attack in the event of a war with Iraq. The Israeli smallpox program has been closely watched in the United States, where the Bush administration recently started a campaign to vaccinate as many as 10 million health care and emergency workers and 500,000 soldiers. The American program has prompted concerns that the vaccines will kill or harm a number of people, but Israel uses a less virulent strain and officials say they have kept the vaccine’s side effects to a minimum. The Israeli government has already vaccinated about 17,000 people, and so far only two people have suffered ill effects from the vaccines. Both of them recovered, the officials said.

Israeli officials said they decided to expand the pool of those receiving vaccinations to include more health workers, police and soldiers. The larger group of people receiving the vaccine, the officials said, would provide a larger supply of plasma with which to treat those who suffer complications.

“The first single case of smallpox would change the daily life of the whole country and probably the whole world,” Dr. Danon said. “Air and sea transportation would stop. We have to make sure that we have a population who can treat the sick people and immunize healthy people.”

Smallpox was declared eradicated by the World Health Organization in 1980. Until then, it killed about a third of those it infected.

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