2 articles on the experimental anthrax vaccine post-exposure program

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Tuesday December 18 4:32 PM ET

Officials May Offer Anthrax Vaccine

By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON (AP) - Federal health officials may offer anthrax vaccine or an

extra month of antibiotics, or both, to hundreds, even thousands, of

Capitol Hill and postal workers in case any anthrax still lurks in their lungs.

Some 70 to 75 Capitol Hill employees have been notified they could receive

the first of three vaccine shots as early as Wednesday, a Senate aide told

The Associated Press.

Health and Human Services Secretary Tommy planned to announce

who would be offered extra treatments and when.

Thousands of Americans already have swallowed antibiotics for two months

because they may have inhaled anthrax spores during the attacks-by-mail. The

new precaution comes because some animal studies suggest that in rare cases,

anthrax spores might linger in the body after treatment stops and then erupt

to sicken.

``We are concerned that the risk of infection for those who may have been

heavily

exposed might extend beyond 60 days, perhaps to as much as 90 days,''

Dr. D.A. , the government's top bioterrorism adviser, told a meeting

of federal scientists debating the step.

Anthrax is inhaled in a dormant spore form. People get sick when those spores

germinate deep in the lungs, letting the bacteria break out and multiply.

Antibiotics kill bacteria, not the spores.

In some animal studies, 1 percent of the anthrax spores monkeys inhaled still

lurked in their lungs 75 days later, and one monkey died three months

after spore inhalation.

So while 60 days of antibiotics protection should protect most people, federal

scientists worry about the rare person who unknowingly has anthrax

spores still lodged in the lungs, waiting to infect once antibiotics are

stopped.

People who inhaled only a little anthrax shouldn't get sick if a spore or two is

left

after 60 days, said Dr. Greg , infectious disease chief at the National

Naval

Medical Center.

But for people who inhaled a lot - such as Senate staffers who opened the letter

mailed to Majority Leader Tom Daschle that scientists estimate contained a

trillion spores - ``you may be much more concerned,'' said.

Worse, hundreds of people, mostly postal workers, quit taking their antibiotics

before 60 days passed, and no one yet knows the consequences.

The main options: another 30 days of antibiotics or getting vaccinated, or both.

But anthrax vaccine is proven to work only if given before someone inhales

anthrax,

not after.

One monkey study performed by the U.S. Army during the Gulf War suggests that

vaccination plus antibiotics can protect even after exposure. So the Food and

Drug

Administration has given permission for doctors with the Centers for Disease

Control

and Prevention to offer vaccine to certain high-risk people as long as they are

told the

inoculations are experimental.

Vaccination would require three shots at two-week intervals. Some scientists

caution

that to fully protect, those people should continue taking antibiotics until

they receive

the third shot.

Anthrax vaccine has long been used by veterinarians, scientists and the

military, and

side effects are rare. But there is a complication: only one company makes

anthrax

vaccine, and its newly renovated factory has not passed FDA safety inspections.

FDA

officials say they have tested some 10,000 doses of immediately available

vaccine to

ensure they're usable.

Tuesday December 18 8:53 PM ET

U.S. to Offer Vaccines to People Exposed to Anthrax

By Richwine

WASHINGTON (Reuters) - The U.S. government on Tuesday offered vaccinations

and extra antibiotics to people who were exposed to the anthrax bacterium in

recent

mail attacks as an added precaution to prevent lingering spores from making them

sick.

About 10,000 people, including congressional employees and postal workers,

could be eligible for the vaccines, although many fewer are expected to

opt for them. The first shots could be given as early as Wednesday, officials

said.

Using the vaccine after someone may have been exposed to anthrax is considered

experimental because such treatment has not been approved by the Food and

Drug Administration. Critics also say the vaccine may cause serious side

effects.

The U.S. Department of Health and Human Services said that people recently

placed on a 60-day regimen of antibiotics because of possible exposure to the

anthrax bacterium are eligible for the vaccine as part of a federal study.

Experts are concerned that some anthrax spores may survive for longer than 60

days in the lungs of people who inhaled the highest doses. They hope the

vaccine will boost immunity to fight the potentially deadly spores. So far, no

known anthrax cases have developed in people who recently were

exposed and prescribed treatment with antibiotics for 60 days.

But studies in monkeys found traces of anthrax spores in the animals' lungs up

to 100 days after exposure, raising the question of whether the same thing

could happen in people.

If infection did develop, health officials believe it could be treated

successfully, as

were other inhaled anthrax cases that were caught early, according to an

HHS statement.

Still, officials felt it was necessary to offer people additional options ``out

of an

abundance of caution,'' HHS Secretary Tommy told reporters.

Anthrax-tainted letters were sent to two U.S. senators and to media outlets by

an

unknown perpetrator in the aftermath of the Sept. 11 attacks on the United

States.

Five people have died from anthrax since early October, and 13 others have been

infected.

THREE TREATMENT OPTIONS OFFERED

The department said the approximately 10,000 people who have been placed on

the 60-day regimen have three options.

They can elect to be vaccinated, getting three vaccine doses over a four-week

period, plus 40 additional days of antibiotics. They can skip the vaccine but

get

the 40 additional days of antibiotics. Or they can skip the vaccine and end

their

antibiotic treatment after the original 60-day regimen,

but closely monitor for signs of illness.

HHS said people have to make their own decisions about whether to have the shots

after consulting with a physician. Officials said people who elect to take the

vaccine

would be informed of risks and required to sign a consent form.

``The data that's supporting giving the vaccine are very slim indeed,'' said Dr.

D.A.

, head of the HHS Office of Public Health Preparedness. ``We do not

have a lot of information about this. Anthrax is a rare disease, and this would

represent a different way of using the vaccine.''

Officials said about 3,000 people would be considered at the highest risk for

developing

anthrax because they were close to where a contaminated letter was opened or

worked

near someone who became ill.

That may include workers at the Brentwood central postal facility in Washington

and

staff members for Senate Majority Leader Tom Daschle, whose office in the Hart

Senate Office Building received an anthrax-laced letter.

MIXED FEELINGS

Speaking on condition of anonymity, a congressional aide who had worked in that

building

before it was closed for decontamination said, ``Some folks will say, 'OK, we

will take it

(the vaccine). But I think a lot of others won't.'' The aide added, ``Members of

the armed

services have been reluctant to take this, and if they have been reluctant we

will be, too.''

Military troops who were vaccinated to protect them from a battlefield attack

with the germ

warfare agent have said the shots caused serious, chronic health problems.

Health officials

say the vaccine has not been linked to long-term problems but that studies are

ongoing.

The most common side effects are local reactions such as redness and swelling,

they said.

Daschle said he supported the decision to offer the shots. ''I think it is a

wise course of

action, simply because of the unknowns, because of the uncertainty,'' he told

reporters.

The U.S. Postal Service was ``disappointed'' it did not have more advance notice

that the

vaccines would be offered, spokeswoman Krathwohl said. She said

thousands of

postal workers may be interested in the vaccine.

``Logistically this is a challenge, but we will make it possible for our

employees to get the

medical care they desire,'' Krathwohl said.

Maker Bioport Corp., based in Lansing, Michigan, has had manufacturing problems

that

have delayed regulatory approval for its new plant.

HHS said it has obtained 10,000 doses from the Defense Department. The doses are

from a

lot made recently at Bioport but they have not received full regulatory approval

because the

plant lacks clearance.