Smallpox:  U.S. Licenses Stockpiled Smallpox Vaccine

The U.S. Food and Drug Administration licensed a diluted version of the 30-year-old U.S. smallpox vaccine late last month, paving the way for broad immunizations.

“The license will allow the vaccine to be distributed and administered in a more efficient manner,” said John Modlin, a Dartmouth University professor who chairs the government advisory panel on immunizations.  

Administering an unlicensed vaccine is difficult process that requires monitoring, education and consent, according to Modlin.  “The only legal way to administer an unlicensed vaccine would be under Investigational New Drug regulations,” he said.

Defense personnel will probably receive the first 1.7 million doses of the vaccine, according to Jerome Hauer, biological defense chief at the Health and Human Services Department.  Emergency responders are in line to receive some of the remaining 13.7 million doses, which could also be used to respond to an attack (see GSN, Oct. 17).

The vaccine was licensed when it was produced in the 1970s but bifurcated needles and a liquid additive called a diluent required supplemental approval.  Food and Drug Administration officials made the licensing decision Oct. 25 but waited until Friday to announce it (Ceci Connolly, Washington Post, Nov. 2).

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Anthrax:  FBI Attempts to Recreate Spores Used in Attacks

U.S. investigators and scientists have been working for months to recreate the anthrax spores used in last year’s attacks, FBI Director Robert Mueller said Friday (see GSN, Oct. 29).

“We’re replicating the way or ways it might be manufactured, but it is not an easy task,” Mueller said.  “We are going into new territory in some areas.”

Personnel from several U.S. agencies are conducting the experiments at the Dugway Proving Ground in Utah, sources said (see GSN, May 21).  FBI officials refused to say whether investigators are using live anthrax bacteria in the research project and whether scientists are producing spores from scratch.

The FBI might be trying to determine how difficult it would have been to produce the spores used in last year’s attacks, according to some experts.

“They’d probably want to look at several methods of doing it — try to make it several different ways to reproduce the end result,” said David Franz, head of the Chemical and Biological Defense Division of the Southern Research Institute and former commander of the U.S. Army Medical Research Institute for Infectious Diseases at Fort Detrick, Md.  “It doesn’t seem like an unreasonable idea” (Eggen/Gugliotta, Washington Post, Nov. 2).

Simple Spores

Two scientists with knowledge of the FBI’s “Amerithrax” investigation believe it would have been relatively easy to manufacture the anthrax spores used in last fall’s attacks with only tabletop equipment costing a few thousand dollars, the Baltimore Sun reported yesterday (see GSN, Oct. 28).

While experts initially believed that the spores were treated with an additive such as silica to help them disperse more easily, many now believe that no additive was used and that the spores were made through a relatively simple process, the scientists said.

“There’s really nothing all that special about it,” one of the scientists said.  “There are many ways to do it.”

The confusion over the possible addition of silica could have occurred because X-ray studies of the spores used in the attacks detected evidence of the chemical element silicon, a component of silica, said Matthew Meselson, a Harvard University biologist.  Other studies have shown, however, that silicon exists naturally in anthrax, Meselson said.

The powder in the tainted letters was almost pure anthrax, with about 1 trillion spores per gram.  Such a high level of purity was believed to be another indication of the anthrax’s sophistication, according to the Baltimore Sun.

The purity level can be reached, however, through relatively simple production methods such as repeatedly processing the mixture in a centrifuge and removing nonspore materials, said one of the two scientists with knowledge of the FBI’s investigation.

While the anthrax produced in the former U.S. biological weapons program had a much lower purity level, that was because the methods used were meant for large-scale production, the scientist said.  The program could have produced a mixture with a higher purity level on a smaller scale, the scientist said (Scott Shane, Baltimore Sun, Nov. 3).

FBI Director Unsatisfied With Progress

Mueller also said Friday that he is not satisfied with the current status of the FBI’s inquiry into last year’s anthrax attacks, but investigators are making progress.

“Am I satisfied?  No, because we don’t have the person or persons responsible identified, and charges being brought against them,” Mueller said.  “Are we making progress?  Yes.  And we continue to make progress.  We continue to have a number of individuals that we are looking at” (Reuters/Los Angeles Times, Nov. 2).

For further information, see:

FBI Amerithrax Investigation

GSN Anthrax Attack Chronology (Dec. 12, 2001)

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U.S. Response:  States Need Better Plans for Biological Attack

Most U.S. states are not prepared to handle government medicine and vaccines stockpiled for potential biological weapons attacks, the Associated Press reported today (see GSN, Oct. 30).

The deadline for states to report their preparations for biological attack passed yesterday, but most do not have sufficient hospital beds, medical isolation areas or comprehensive plans to deal with vaccine stockpiles (see GSN, April 19).

“Our biggest concern is we will get to a location and a state or a city will not be ready,” said Jerome Hauer, assistant secretary for public health preparedness at the Department of Health and Humans Services.

States must have detailed plans for vaccinating their entire populations by Dec. 1, but that may prove difficult.  To date, only 20 of the 62 states, cities and territories receiving U.S. funding to prepare for a biological attack have submitted plans (see GSN, Sept. 23; Laura Meckler, Associated Press/Philadelphia Inquirer, Nov. 2).

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Smallpox:  Public Comment Period Begins for Children’s Smallpox Tests

The U.S. Food and Drug Administration yesterday began a month-long public comment period on pediatric tests of smallpox vaccine (see GSN, Sept. 25).

Health officials have proposed tests in which researchers would inoculate 40 children between the ages of 2 and 5 — the first children immunized for smallpox since the 1970s.

Officials presented the opportunity for the public to voice its views after research oversight boards expressed mixed reactions to the tests.  Any tests that pose risk to a child and fail to provide benefits require special government oversight.

“It is a very challenging issue because there is no smallpox circulating right now,” said Karen Midthun, FDA’s head of vaccine research.  “There is great concern that there be a lot of safeguards for studies being conducted in children.”

One concern is that children might tear the bandage off the inoculation site and spread the live vaccine virus — vaccinia — to family members who are not immunized, but researchers believe they might have solved this problem.  The bandage used for children is extremely adhesive, “very, very hard to get off,” Midthun said (Associated Press/Baltimore Sun, Nov. 1).

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Anthrax:  Scientists Criticize FBI’s Theory on Lone Culprit in Attacks

Some experts have said the spores used in last fall’s anthrax attacks required technical knowledge and production capabilities beyond that of a lone individual, contrary to the FBI’s views, the Washington Post reported today (see GSN, Oct. 23).

Instead of pursuing a “lone individual” theory, investigators might want to examine if state-sponsored terrorism played some role in the attacks, or if the person responsible obtained the spores from a foreign biological defense program, experts said. 

“In my opinion, there are maybe four or five people in the whole country who might be able to make this stuff, and I’m one of them,” said Richard Spertzel, chief biological inspector for the U.N. Special Commission from 1994 to 1998.  “And even with a good lab and staff to help run it, it might take me a year to come up with a product as good.”

An FBI profile released last November described the person believed to be responsible as a “lone individual” with “some” scientific knowledge who could have made the spores in a primitive laboratory for as little as $2,500 (see GSN, Aug. 15).  The FBI also said there appeared to be no “direct or clear link” between the attacks and foreign terrorism. 

That profile, however, clashed with what was known about the complexity of the spores used in the attacks, according to experts.  The profile was issued three weeks after U.S. Army scientists examined spores taken from a tainted letter sent to U.S. Senate Majority Leader Tom Daschle (D-S.D.).  The scientists found that the spores were processed to a size of 1 trillion per gram — 50 times finer than the spores made through the now-closed U.S. biological weapons program and 10 times finer than known Soviet-made anthrax, the Post reported (see GSN, June 13).

“Just collecting this stuff is a trick,” said Steven Lancos, executive vice president of Niro Inc., a leading manufacturer of spray dryers, viewed by several sources as the likeliest tool needed to weaponize anthrax.  “Even on a small scale, you still need containment.  If you’re going to do it right, it could cost millions of dollars.”

Silica

The FBI had initially ruled out the possibility that Iraq might have been behind the anthrax attacks because the spores used were coated in silica to aid in their dispersion, rather than mineral bentonite, believed to have been used in Iraq’s anthrax weaponization program.  That belief, however, appears to be based on a single sample taken by U.N. authorities in the mid-1990s, according to the Post.  As early as 1989, the U.S. Defense Intelligence Agency reported that Iraq was acquiring silica to use in chemical weapons and in 1998, Iraq informed the United Nations that it had conducted an artillery test of a live biological agent that used silica as a dispersant, the Post reported (see GSN, April 24).

“Iraq almost certainly had their anthrax spores in a powdered form,” Spertzel said.  “They had used silica gel to aid in dispersibility of (wheat) smut spores, and also indicated they were looking at it as a carrier for aflatoxin,” a carcinogen, he said.

The silica-coated spores used in the attacks were probably produced through mixing fine glass particles, known as “fumed silica,” with the spores in a spray dryer.  “I know of no other technique that might give you that finished product,” Spertzel said.

Fumed silica particles are tiny and will stick to larger particles, such as an anthrax spore.  Fumed silica particles also absorb moisture and can acquire an electric charge, both of which keep the particles from clumping together and aid in their dispersion, according to the Post.

“This concept of using something that would serve as a dessicant and a carrier at the same time is new,” said Harvard University chemical engineer David Edwards.  “It’s a diabolically brilliant idea.”

While some fumed silicas are difficult to produce, two brands — Aerosil and Cab-O-Sil — are internationally available for purchase in bulk, according to the Post.  The Soviet Union used Aerosil in producing biological agents, said Ken Alibek, former deputy director of the Soviet biological weapons program.  A 1991 Pentagon memo said Iraq had “imported approximately 100 MT (metric tons) of Aerosil during the last 8-9 years.”  The United Nations also reported in the 1990s that Iraq possessed about 10 metric tons of Cab-O-Sil, Spertzel said.

Equipment

The anthrax production would also require expensive and specialized equipment — several hundred thousand dollars worth, according to experts.  Niro’s least expensive spray dryer costs about $50,000.  An electron microscope, needed to examine the results of the production process, also costs hundreds of thousands of dollars, the Post reported.

The United Nations discovered three Niro spray dryers in Iraq during inspections conducted in the 1990s, according to the Post.  Two of the spray dryers were destroyed and the third was sterilized before it could be inspected, Spertzel said.

Whoever produced the anthrax spores used in the attack would “need some experience” with aerosols and “would have to have a lot of anthrax, so you could practice,” Edwards said.  “You’d have to do a lot of trial and error to get the particles you wanted.”

All together, “you would need (a) chemist who is familiar with colloidal [fumed] silica, and a material science person to put it all together, and then some mechanical engineers to make this work . . . probably some containment people, if you don't want to kill anybody,” Lancos said.  “You need half a dozen, I think, really smart people”(Gugliotta/Matsumoto, Washington Post, Oct. 28).

For further information, see:

CDC Frequently Asked Questions About Anthrax

FBI Amerithrax Investigation

Journal of the American Medical Association Background on Anthrax

GSN Anthrax Attack Chronology (Dec. 12, 2001)

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