A US presidential ethics panel has opened the door to testing
an anthrax vaccine on children as young as infants, bringing an angry response
from critics who say the children would be guinea pigs in a study that would
never help them and might harm them.
The report, however, released by the Presidential
Commission for the Study of Bioethical Issues, said researchers would have to
overcome numerous hurdles before launching an anthrax-vaccine trial in
It now goes to Secretary of Health and Human Services
Kathleen Sebelius, who will decide whether to take the steps the commission
The one anthrax vaccine approved in the United States,
called BioThrax, is made by Emergent BioSolutions Inc of Rockville, Maryland.
The company reported $215.9 million in sales of BioThrax, its only licensed
product, in 2012.
Anthrax vaccine tested
The ethics commission took up the issue after a biodefense
panel recommended in 2011 that the anthrax vaccine be tested in children. That
endorsement, by the National Biodefense Science Board, came with the caveat
that such a study also get the go-ahead from a bioethics panel.
It did, albeit conditionally."We have to get this
precisely right," panel Chair Amy Gutmann, president of the University of
Pennsylvania, said at a news conference. "Many significant steps would
have to be taken" before a pediatric anthrax vaccine trial could be
considered, she said.
But she added that it is important "to develop the
knowledge needed to save children's lives" in the event of an anthrax
Balancing the need to protect children against the need to
know, for instance, the safe dose of the vaccine, made this "one of the
most difficult ethical reviews a bioethics board has ever conducted,"
Experts warned public
of moral harm
Activists said the board was wrong not to oppose
unequivocally testing the anthrax vaccine in children. Vera Sharav, founder of
the Alliance for Human Research Protection, predicted that such a study would
cause "moral harm for us as a nation and suffering for the children.
They should have said, 'thou shalt not.'"'DARK
ZEPHYR'The idea of testing an anthrax vaccine in children arose when a 2011 war
game, called Dark Zephyr, presented to policy makers a scenario in which
terrorists released anthrax on a city modeled on San Francisco.
Doctors did not know
what dose of the vaccine to give children. That presented a dilemma: should
children be vaccinated anyway, or should the government test the vaccine on
them first to establish a safe dose?
Information about safety has come from giving the vaccine to
some 2.9 million adults, mostly members of the armed forces who were thought to
be at risk of exposure to biological weapons in Iraq.
Information about efficacy has come from animal studies, as
it is unethical to expose someone to anthrax intentionally to see if the
vaccine works, and from measurements of the anthrax-fighting antibodies a
vaccinated person produces.
Federal regulations set a high bar for research on kids. If
the chance of their benefiting is minuscule or nil, and the potential risk even
minimal, children are usually off-limits.
The presidential bioethics panel conceded that "there
is no prospect of direct benefit to children" who participate in an
anthrax-vaccine study, Gutmann said.
Side effects still
According to the biodefense board, children in such a study
would face more than minimal risk (defined as a risk no greater than that in
daily life or at a check-up), mostly because the side effects of the vaccine in
children are unknown.
Because the vaccine poses more than minimal risk to
children, any proposal for testing it in them would have to clear several
hurdles, the commission said. One pre-requisite for such a study is rigorously
testing the vaccine in the youngest adults, starting at age 18.
"You'd work your way down from 18-year-olds," said
Dr. John Parker, a retired army major general and chairman of the biodefense
board. "If it were safe you'd go to 17-year-olds, then 16-year olds."
After each round showing minimal harm, "you'd ask permission to move on to
younger children."The youngest age for testing is not clear, said Parker,
"but the immune system of very young children is different from older
Results in the study
16-year-olds or even 5-year-olds might not reveal whether the vaccine is safe
in babies, who would therefore have to be studied, too. HATCHING SPORESTo
critics, the combination of no benefit and some risk to children means a
pediatric anthrax-vaccine study should be prohibited.
"We have to wonder if, after all the data collected by
the US Army on the side-effects experienced by soldiers, we would want to
subject children to skin ulcers symptoms of the disease," said Jeanne
Guillemin, a senior fellow in the Massachusetts Institute of Technology's
Security Studies Program and author of a 2011 book about anthrax attacks,
titled "American Anthrax."
In the largest study of the anthrax vaccine, the US Centers
for Disease Control and Prevention reported in 2008 that in 1 563 adults who
received the vaccine, there were 229 "serious adverse events" such as
cardiovascular disease, intracranial aneurysm and seizure, though only nine
were blamed on the vaccine.
Much more common were milder reactions such as soreness near
the injection site, itching, fever and malaise. Opponents of testing the
anthrax vaccine in children argue that antibiotics would be sufficient to
protect kids in an anthrax attack.
Antibiotics worked following attacks in 2001 that were
traced to an Army scientist who committed suicide in 2008 as investigators
People died after
The five people who died after inhaling anthrax spores sent
through the mail did not receive antibiotics before developing symptoms.
Everyone who was exposed and received antibiotics in time survived, noted MIT's
Proponents of testing the anthrax vaccine in children argue
that antibiotics are not enough."The point of vaccinating is that anthrax
spores can hatch at different times and stay dormant for days to months,"
said Dr Daniel Fagbuyi of Children's National Medical Center in Washington, DC,
and a member of the biodefense board.
Vaccination, he said, would prevent disease long after
victims' 60-day course of antibiotics is finished. Under a 2005 law, children
in an anthrax-vaccine study would be prohibited from seeking damages through
the legal system. The presidential commission, said Gutmann, "strongly
recommended that a plan be in place to compensate any children" who are