WASHINGTON — The government’s effort to develop a new vaccine against
anthrax has raised red flags among critics over plans to eventually test an
experimental version on children.
Robert Bock, a spokesman for the National Institute of Child Health and
Human Development, said the new anthrax vaccine would not be tested on 100
first- and second-graders until it is first tested safely on adults. That is
under way now, he said.
“If that study is successful, there will probably be a protocol to test
the anthrax vaccine in children,” Bock said.
While federal rules govern how children can be used in medical research,
Barbara Loe Fisher, president of the National Vaccine Information Center,
said the threat of anthrax exposure was too remote to subject children to a
possibly dangerous substance.
“There is almost no risk to these children of being exposed to a form of
… anthrax that has been weaponized” so it can be inhaled, said Fisher, whose
nonprofit group has been pushing for vaccine safety since the 1980s. “The
benefits are zero and risk is quite high.”
Several pediatricians involved in bioterrorism issues, however, said that
given the potential threat, it would be irresponsible not to include
children in the test.
“Considering that in a worst-case scenario, this vaccine would have to be
used in an emergency over a very short period of time, we would be in a bad
position medically and ethically if it were not tested beforehand,” said
Stanley Plotkin, emeritus professor of pediatrics at the University of
Plotkin was a consultant on a 2002 study that declared the current
anthrax vaccine to be “effective” and “acceptably safe.”
But government researchers at the National Institutes of Health now are
trying to find a better vaccine. There are ideas the current vaccine, which
has been in use for several decades, causes too many side effects.
They range from simple headaches and muscle pains, to more serious and
complex ailments, such as heart problems, arthritis, multiple sclerosis,
hypertension, diabetes and blood clots.
For decades, the current vaccine was largely given only to people who
worked in the livestock industry, where most exposures occur. But in 1991,
it was issued to some troops during the first Gulf War because of fears
Saddam Hussein had biological weapons.
By 1997, the military was concerned enough about the spread of such
weapons that it made anthrax inoculations mandatory for all troops.
Developing a national vaccine program to protect the public became a
priority after the Sept. 11, 2001, terrorist attacks when five persons died
from anthrax-tainted letters and 13 others were infected. The sender has
never been identified.
The current vaccine is given in a series of six doses over 18 months,
with annual boosters. More than 1.3 million military and civilian personnel
have taken it.
Made by the BioPort Corp. of Lansing, Mich., the vaccine has been
approved only for anthrax exposure through the skin, not through inhalation,
the way it would be disseminated on a battlefield or in a public place.
But numerous soldiers who have taken it under military orders have
reported severe side effects.
In response to a lawsuit by six anonymous service members challenging the
mandatory vaccinations, a federal judge stopped the program last fall
because he said federal regulators had not properly followed rules to
declare it safe.
Secretary of Defense Donald Rumsfeld called the vaccine “safe and
effective” following the ruling. The program has been reauthorized, however,
on a voluntary basis, under provisions of the Project Bioshield Act, which
permits emergency use of unapproved vaccines.
In the new vaccine tests, 350 adults are randomly being given either the
experimental vaccine or the BioPort vaccine to compare their effects.
“No children have been given a licensed or experimental vaccine in the
trial,” according to a statement from the National Institute of Child Health
and Human Development, the division of NIH that is conducting the trial.
“Studies in children will not begin until the safety of the new vaccine has
been demonstrated in adults.”
Meryl Nass, a Maine internist who has treated numerous soldiers who’ve
experienced medical problems after taking the BioPort vaccine, said one of
the primary ingredients in the experimental vaccine — the protective antigen
— is a known toxin.
“There is no good reason to expect that (the experimental) vaccine will
be any safer than the older one,” she said.
BioPort spokeswoman Kim Brennen Root said the company was unaware that
its vaccine was being used in a new NIH trial and could not comment.
Steve Robinson, executive director of the National Gulf War Resource
Center, which helps former soldiers with service-related health problems,
said, “Anybody who gets involved is taking a huge gamble that maybe their
children might become harmed.”
When the NIH conducts a clinical trial, it generally advertises for
participants and asks for referrals from physicians.
Under federal rules governing medical research and children, the research
must not present more than a “minimal risk.”
If the risk is greater, the rules generally require that the research
either directly benefit the children involved, or that it “further the
understanding, prevention, or alleviation of a serious problem affecting the
health or welfare of children.”
The rules also require that parents or guardians must be fully informed
of the risks and benefits, and must give their informed consent before their
children can participate.
“As long as effective safeguards are in place and families and the
children understand the risk, I think that this is the right thing to do,”
said Julia McMillan, a member of the American Academy of Pediatrics
Committee on Infectious Diseases and professor of pediatrics at Johns
Reactions to testing on children
■ From a critic: “There is almost no risk to these children of
being exposed to a form of … anthrax that has been weaponized.… The benefits
are zero and risk is quite high.”
■ From a proponent: “Considering that in a worst-case scenario,
this vaccine would have to be used in an emergency over a very short period
of time, we would be in a bad position medically and ethically if it were
not tested beforehand.”