National Institutes of Health Decision Delayed on Anthrax Vaccine Testing on Children
By David Ruppe
Global Security Newswire
WASHINGTON — A plan to conduct safety tests of two experimental anthrax vaccines on children could proceed, despite the recent removal of any reference to such testing from a notice on the National Institutes of Health Web site (see GSN, June 27).
Researchers from the National Institute for Child and Human Development (NICHD) last year proposed including 100 first- and second-graders along with 350 adults in a clinical study assessing the relative safety, safe dosage levels, and side effects of a currently used vaccine and a new one for protection against inhalation anthrax.
A NICHD review board approved the study in July 2004, but directed that a decision on whether to include children be deferred until after the adults, ages 18-30, were tested and the results assessed.
The study formally began Sept. 8, 2004 and its completion is dependent, in part, upon recruiting volunteers. As of last week, 52 adult patients had been vaccinated using either the focal point of the testing, a genetically engineered anthrax vaccine now under development by NIH, or the controversial Anthrax Vaccine Adsorbed, which is now administered to U.S. military personnel deployed to certain regions of concern (see GSN, July 7).
The National Institutes of Health has published advertisements seeking participants for the trials in the Washington, D.C. area, offering compensation totaling $400 for eight clinical visits over the course of a year.
Compensation is not unusual and typically covers expenses and time, said Dr. Stephen Kaler, clinical director of the NICHD intramural research program. The institute would obtain parental consent for children to participate, if that component of the study is approved, he said.
Web Site Notice Changed
Complaints have surfaced in recent weeks that the trial, at least initially, should not include children and that no children should be vaccinated with the older vaccine because of doubts about its safety.
“I have grave concern about any intent to proceed with clinical trials with children at this point,” Senator Jeff Bingaman (D-N.M.) wrote in a July 1 letter to Health and Human Services Secretary Mike Leavitt.
“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. 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,” he added.
Critics have also expressed their doubts in U.S. newspapers.
“There is almost no risk to these children of being exposed to a form of … anthrax that has been weaponized,” Barbara Loe Fisher of the National Vaccine Information Center told the Kansas City Star. “The benefits are zero and the risk is quite high.”
A notice published in 2004 by the NIH Patient Recruitment and Public Liaison Office, which said the trial planned to include 100 children, prompted the criticisms. The institute recently removed that statement from the notice.
Kaler said there was a misunderstanding that children were already part of the trial. He said an additional decision by the Institutional Review Board, following the outcome of testing on adults, would be needed before children might be included.
Whether children would ultimately be included is an “open question, because it hasn’t been approved,” he said
Kaler said some view a perceived benefit from testing the new vaccine on children.
“Whether we do this in children is tempered by the feeling of some that children would be at risk in a bioterrorism attack and it would be unfortunate if children weren’t included in the study,” he said.
Safety Questions
There are uncertainties about the safety of both vaccines.
This trial phase is the first human testing for the NIH vaccine, which is still under development, according to Kaler.
If the vaccine passes, it could then be subjected to two additional phases of trials involving larger numbers of patients, according to Food and Drug Administration regulations. One phase would evaluate its effectiveness and further evaluate its safety, and the second would seek to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that would allow the drug or treatment to be used safely, according to the regulations.
After that, the Food and Drug Administration could determine whether to license the vaccine as safe and effective against inhalation anthrax, the method of contraction of foremost concern from biowarfare or terrorism. The entire process apparently could take years.
The NIH vaccine is distinct from another genetically engineered anthrax vaccine, under development by the company VaxGen. The Health and Human Services Department in November purchased 75 million doses of that vaccine for $878 million, enough to vaccinate 25 million people against inhalation anthrax, according to the company (see GSN, May 6). The department also awarded the company up to $69 million for, among other things, testing on children and the elderly after the Food and Drug Administration has approved the vaccine, according to Vice President of Public Affairs Paul Laland. The VaxGen vaccine is in its second phase of testing.
The older Anthrax Vaccine Adsorbed was licensed in 1970 as safe and effective against anthrax contracted through the skin, the disease form likely to infect textile and farm workers, and veterinarians. The Food and Drug Administration has not yet licensed it effective against inhalation anthrax.
Questions recur about its safety, with rare reports of debilitating reactions after vaccination and experts questioning whether there is a link to multisymptom illnesses effecting soldiers after the first Gulf War (see GSN, Nov. 16. 2004).
The Defense Department insists the vaccine is as safe as other commonly used vaccines, or safer. “Study after study shows: people vaccinated against anthrax are as healthy as unvaccinated people,” according to a statement on the DOD Web site.
It is uncertain how many military and civilian personnel have experienced severe reactions from the existing vaccine. However, of approximately 1.3 million personnel vaccinated against anthrax during 2003 and 2004, hundreds were said to have been treated for “complex” cases following those and other vaccinations at four special vaccine treatment clinics, ranging from muscle and joint weakness and pain to multiple sclerosis (see GSN, May 6).
The military since May has been administering the vaccine to select military personnel on a voluntary basis, after a judge found that the treatment could not be required because the Food and Drug Administration had not yet properly licensed it against inhalation anthrax. About half the civilian and military personnel offered the vaccine have refused the shot. A Food and Drug Administration review for that license is under way, which could allow mandatory vaccinations to resume.
The new vaccine however should be safer, according to an NIH advertisement for trial volunteers, provided by Kaler.
“The vaccine is expected to be as effective as the licensed anthrax vaccine (AVA) but it is purer and should be safer,” it says.
Global Security Newswire
WASHINGTON — A plan to conduct safety tests of two experimental anthrax vaccines on children could proceed, despite the recent removal of any reference to such testing from a notice on the National Institutes of Health Web site (see GSN, June 27).
Researchers from the National Institute for Child and Human Development (NICHD) last year proposed including 100 first- and second-graders along with 350 adults in a clinical study assessing the relative safety, safe dosage levels, and side effects of a currently used vaccine and a new one for protection against inhalation anthrax.
A NICHD review board approved the study in July 2004, but directed that a decision on whether to include children be deferred until after the adults, ages 18-30, were tested and the results assessed.
The study formally began Sept. 8, 2004 and its completion is dependent, in part, upon recruiting volunteers. As of last week, 52 adult patients had been vaccinated using either the focal point of the testing, a genetically engineered anthrax vaccine now under development by NIH, or the controversial Anthrax Vaccine Adsorbed, which is now administered to U.S. military personnel deployed to certain regions of concern (see GSN, July 7).
The National Institutes of Health has published advertisements seeking participants for the trials in the Washington, D.C. area, offering compensation totaling $400 for eight clinical visits over the course of a year.
Compensation is not unusual and typically covers expenses and time, said Dr. Stephen Kaler, clinical director of the NICHD intramural research program. The institute would obtain parental consent for children to participate, if that component of the study is approved, he said.
Web Site Notice Changed
Complaints have surfaced in recent weeks that the trial, at least initially, should not include children and that no children should be vaccinated with the older vaccine because of doubts about its safety.
“I have grave concern about any intent to proceed with clinical trials with children at this point,” Senator Jeff Bingaman (D-N.M.) wrote in a July 1 letter to Health and Human Services Secretary Mike Leavitt.
“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. 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,” he added.
Critics have also expressed their doubts in U.S. newspapers.
“There is almost no risk to these children of being exposed to a form of … anthrax that has been weaponized,” Barbara Loe Fisher of the National Vaccine Information Center told the Kansas City Star. “The benefits are zero and the risk is quite high.”
A notice published in 2004 by the NIH Patient Recruitment and Public Liaison Office, which said the trial planned to include 100 children, prompted the criticisms. The institute recently removed that statement from the notice.
Kaler said there was a misunderstanding that children were already part of the trial. He said an additional decision by the Institutional Review Board, following the outcome of testing on adults, would be needed before children might be included.
Whether children would ultimately be included is an “open question, because it hasn’t been approved,” he said
Kaler said some view a perceived benefit from testing the new vaccine on children.
“Whether we do this in children is tempered by the feeling of some that children would be at risk in a bioterrorism attack and it would be unfortunate if children weren’t included in the study,” he said.
Safety Questions
There are uncertainties about the safety of both vaccines.
This trial phase is the first human testing for the NIH vaccine, which is still under development, according to Kaler.
If the vaccine passes, it could then be subjected to two additional phases of trials involving larger numbers of patients, according to Food and Drug Administration regulations. One phase would evaluate its effectiveness and further evaluate its safety, and the second would seek to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that would allow the drug or treatment to be used safely, according to the regulations.
After that, the Food and Drug Administration could determine whether to license the vaccine as safe and effective against inhalation anthrax, the method of contraction of foremost concern from biowarfare or terrorism. The entire process apparently could take years.
The NIH vaccine is distinct from another genetically engineered anthrax vaccine, under development by the company VaxGen. The Health and Human Services Department in November purchased 75 million doses of that vaccine for $878 million, enough to vaccinate 25 million people against inhalation anthrax, according to the company (see GSN, May 6). The department also awarded the company up to $69 million for, among other things, testing on children and the elderly after the Food and Drug Administration has approved the vaccine, according to Vice President of Public Affairs Paul Laland. The VaxGen vaccine is in its second phase of testing.
The older Anthrax Vaccine Adsorbed was licensed in 1970 as safe and effective against anthrax contracted through the skin, the disease form likely to infect textile and farm workers, and veterinarians. The Food and Drug Administration has not yet licensed it effective against inhalation anthrax.
Questions recur about its safety, with rare reports of debilitating reactions after vaccination and experts questioning whether there is a link to multisymptom illnesses effecting soldiers after the first Gulf War (see GSN, Nov. 16. 2004).
The Defense Department insists the vaccine is as safe as other commonly used vaccines, or safer. “Study after study shows: people vaccinated against anthrax are as healthy as unvaccinated people,” according to a statement on the DOD Web site.
It is uncertain how many military and civilian personnel have experienced severe reactions from the existing vaccine. However, of approximately 1.3 million personnel vaccinated against anthrax during 2003 and 2004, hundreds were said to have been treated for “complex” cases following those and other vaccinations at four special vaccine treatment clinics, ranging from muscle and joint weakness and pain to multiple sclerosis (see GSN, May 6).
The military since May has been administering the vaccine to select military personnel on a voluntary basis, after a judge found that the treatment could not be required because the Food and Drug Administration had not yet properly licensed it against inhalation anthrax. About half the civilian and military personnel offered the vaccine have refused the shot. A Food and Drug Administration review for that license is under way, which could allow mandatory vaccinations to resume.
The new vaccine however should be safer, according to an NIH advertisement for trial volunteers, provided by Kaler.
“The vaccine is expected to be as effective as the licensed anthrax vaccine (AVA) but it is purer and should be safer,” it says.
