WSJ: Search for Better Anthrax Vaccine Increases

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Search for Better Anthrax Vaccine Increases

By 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 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.

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 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. "