Mon, Jun. 27, 2005

Plans to test anthrax shot on children questioned

Safety of vaccine first must be proven on adults

The Star's Washington Correspondent


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 Pennsylvania.

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 Hopkins University.

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.”

To reach David Goldstein, Washington correspondent, call 1-(202) 383-6105 or send e-mail to