Children Won't Be Used In Anthrax Vaccine Test Trials

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Children Won't Be Used In Anthrax Vaccine Test Trials

Tue, 19 Jul 2005 18:17:18 +0100

 

 

 

 

BL Fisher Note;

 

NVIC http://www.nvic.org publicly protested NIH's plan to test

anthrax vaccine in children. NIH was wise to revise the plan and

refrain from subjecting young children to the risk of injury or death

from adverse responses to anthrax vaccination.

 

http://www.courant.com/news/local/hc-vaccines0712.artjul12,0,763580.story

_ Hartford Courant July 12 2005

 

Children Won't Be Used In Vaccine Test Trials

National Institutes of Health says it made a mistake

 

By THOMAS D. WILLIAMS Courant Staff Writer

 

 

 

The National Institutes of Health says it made a mistake in

announcing it would be using children to conduct anthrax vaccine test

trials.

 

But the agency has not ruled out using children in future tests.

 

" Approval was not granted to enroll children in [the anthrax testing

trial]. The Web announcement ... was in error. It has since been

corrected, " said Robert Bock, a NIH spokesman. " Any planning to test

anthrax vaccine on children in [that trial] can be viewed only as a

contingency. "

 

The NIH was sharply criticized in June when it posted an Internet

announcement that 350 healthy adults and 100 healthy children in the

first and second grades were being sought as volunteer test subjects.

 

A new vaccine NIH is developing and the one currently in use by the

military, manufactured by BioPort Corp. of Lansing, Mich., are being

compared in the NIH test trials.

 

Days after news stories surfaced on the NIH's announcement, Sen. Jeff

Bingaman, D-N.M., wrote Mike Leavitt, secretary of the U.S. Department

of Health and Human Services, to express " grave concern " about

clinical anthrax vaccine trials for children.

 

" Surely considerable information regarding the safety of the new

vaccine, as well as about its potential effectiveness, should be

obtained in adults long before any consideration is given to providing

it to children, " Bingaman wrote. " And, based on what already is known

about the adverse event profile of the older vaccine, it should not

be `tested' in children at all. "

 

The NIH does do trials on children for other vaccines, Bock said.

" [it] is currently conducting a study of a vaccine for typhoid fever

in infants, in Vietnam. The institute is also conducting a study of a

vaccine for shigella among 1- to 4-year-olds in Israel. "

 

In its initial announcement, posted on its website, the NIH stated:

 

" Adults who are in good health and children who are in good health

may be eligible for this study. ... On a random basis, patients will

receive either the rPA dose or the licensed vaccine, for comparison

of the properties of both vaccines.

 

" Rare but severe reactions could occur if there is extreme

sensitivity to a vaccine. However, such an occurrence is extremely

rare following a vaccine, and if there are any dangerous symptoms,

they can be effectively treated by medications available to patients

while they are at the clinic. "

 

BioPort's vaccine, used almost exclusively on soldiers, has shown an

adverse reaction rate 100 times the figure initially stated on the

label. Adverse reactions include immune disorders, muscle and joint

pain, headaches, rashes, fatigue, nausea, diarrhea, chills and fever.

At least half a dozen deaths and a number of birth defects have been

attributed to its use.

 

The six-shot vaccine plus annual booster is being used to eventually

protect all 2.4 million in the armed services against anthrax spores

that can be inhaled after being spread or fired by terrorists or

enemies of the United States.

 

The NIH and U.S. Health and Human Services Department are calling for

development of the vaccine to protect civilians from terrorist or

other attacks. Hundreds of millions of dollars have been spent on

developing a new vaccine, in addition to the new one NIH is testing.

 

 

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