Search for Better Anthrax Vaccine Increases

By Laura Johannes and Laurie McGinley

The Wall Street Journal

October 19, 2001

Several scientific teams, their work shrouded in secrecy, are scrambling to
develop anthrax vaccines that they hope will prove more potent -- and safer
-- than the existing vaccine used by the U.S. military.

Two of the vaccines, one developed by the U.S. military and another by the
National Institutes of Health, are expected to enter clinical trials within
the next few months, scientists said. Scant information was available on the
vaccines, but officials said both use modern genetic techniques to create a
purer formulation that is likely to have few side effects.

"We're working night and day," NIH scientist John Robbins says. In addition
to being purer than the existing vaccine, he adds, the new vaccine contains
an added ingredient intended to more quickly and more thoroughly mobilize
the body's immune system against a possible future anthrax infection. He
declined to name the ingredient, saying, "The people who should know about
it do know, but we're not saying much."

The current vaccine, designed in the 1950s and reformulated in the late
1960s, is now made by BioPort Corp., of Lansing, Mich. Quality-control
problems at BioPort's factory have fueled a major controversy over the
vaccine's safety within the U.S. military. Soldiers injected with it have
complained of severe side effects, and six deaths have occurred, though
there is no evidence the vaccine caused them. Even though the military says
the vaccine is safe, more than 100 people have faced court martial for
refusing to get it.

Anthony Fauci, director of the National Institute of Allergy and Infectious
Diseases, says the anthrax-vaccine development effort has been going on for
years, but has been stepped up sharply during the past several weeks.

The U.S. Army also is working on a new vaccine made with modern
genetic-engineering techniques. Human trials, concentrating first on safety,
are expected to begin this fall, says Carl McNair, chairman of the board of
managers of Dynport Vaccine Co., a Frederick, Md., company that has a
contract with the Department of Defense to aid in development of new
versions of 18 vaccines, including anthrax.

Mr. McNair added that one of Dynport's goals is to make a vaccine that will
be effective against as many as possible of the more than 1,000 known
anthrax strains. "It's like the flu," he says. "You can have Asian flus and
many other types of flus. The minute you have a vaccine that takes care of
one type of flu, then boom, someone gets another type of flu."

Dynport, a joint venture of British pharmaceuticals company Porton
International and Dyncorp, a closely held Reston, Va. technology company,
declined to further comment.

The current vaccine manufactured by BioPort is made by purifying a substance
called "protective antigen" from a strain of nonlethal anthrax bacteria. The
antigen is the substance in anthrax that triggers the body's immune
response. The trouble is, vaccine made using this method may contain
contaminants, such as bits of bacterial cell walls, that could cause side
effects.

It is still unclear how soon the new vaccines could be available, in part
because nobody yet knows how rigorous the U.S. Food and Drug
Administration's standards will be for proving efficacy. While safety trials
can be performed in healthy humans, it is unethical to give people anthrax.
In a proposed rule, the FDA has said it will allow animal tests when human
tests would be "unethical."

Meanwhile, Bioport, which closed its plant in 1998 after numerous problems
with sterility and quality control, says it completed its application Monday
to the FDA for permission to reopen it.

At a news briefing, Defense Secretary Donald Rumsfeld said he favored giving
BioPort "one more crack at getting the job done" and said the company would
be working with the U.S. Department of Health and Human Services to get back
in production. He said, however that "things have not been going swimmingly"
for BioPort, adding, "What we're trying to do is figure out a way where we
might get some help so that they might improve their performance."