Smallpox:  Doctors Plan Vaccine Tests on Children

Doctors have begun preparing a clinical trial to test smallpox vaccine on children, U.S. health officials said yesterday (see GSN, Sept. 24).

The purpose of the trial — which will mark the first time the smallpox vaccine is tested on children — is to determine the suitable vaccine dosage for children in the event of a mass vaccination campaign, according to Newsday.  The tests are to be conducted at the Children’s Hospital Medical Center in Cincinnati, Ohio, and the Harbor-UCLA Medical Center in California.

Since subjects will have to be carefully monitored following inoculation, neither site will accept subjects from other U.S. states, Newsday reported.  The tests are expected to involve fewer than 50 children in both states, according to Newsday.

“We’re just waiting for the final word, to hear that it’s a go.  All of the pieces seem to be in place,” said David Bernstein, director of the division of infectious diseases at Cincinnati Children’s Hospital Medical Center.

The trial is expected to use the Dryvax vaccine, the same vaccine that was used in worldwide smallpox inoculation campaigns in the 1960s and 1970s, Bernstein said.  A nationwide adult clinical vaccine trial that began last year used the same vaccine, according to Newsday (see GSN, July 9).

“It’s obvious that we should study this in children if we’re going to use it in children,” Bernstein said.  “Children are not small adults.”

The child trial will address some of the same issues as previous adult tests, said Carol Heilman of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.  Heilman is one of the chief designers of the pediatric tests.

“We would like to know, for example, if a dilution (of the vaccine) can be effectively administered and still have it maintain its potency,” she said (see GSN, March 29).

No starting date for the study has been set, Heilman said, adding that there are still several technical issues that must be resolved.  One unresolved issue is the age of the children that should participate.

Meanwhile, researchers are planning a separate smallpox vaccine study for the elderly, Heilman said.  In that study researchers also plan to examine problems associated with declining immunity, she said (Delthia Ricks, Newsday, Sept. 25).

For further information, see:

CDC Smallpox Information

Journal of the American Medical Association Background on Smallpox

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U.S. Response:  Former Soviet BW Programmer Developing Immune System Boosters

Ken Alibek, a former top official in the Soviet biological weapons program, is working to develop immune system boosters that could be administered through an inhaler to help strengthen the body’s early stages of immunity, the Wall Street Journal reported today.

By improving the reaction of the early stages of the immune system, known as “innate immunity,” a person might be better prepared against a biological weapon attack, when the identity of the pathogen is not immediately known, according to the Journal.

Alibek, vice chairman and chief scientist at Advanced Biosystems Inc., has tested two prototype immune-boosters against pathogens similar to anthrax and smallpox.  Each immune-booster contains a cytokine — a natural infection-combating agent — such as interferon.  Each also contains muramyl dipeptide, which boosts the effectiveness of vaccines, according to the Journal.  Alibek hopes to be able to administer the immune-boosters in a device similar to an asthma inhaler.

“We realized the system we needed to protect is the respiratory tract, and the faster the better,” Alibek said.

The immune-boosters have been tested on mice both before and during exposure to pathogens, the Journal reported.  In studies Alibek said he hopes to publish soon, the immune-boosters protected 60 percent of mice against a nonlethal strain of anthrax and 96 percent of the mice against a cousin of smallpox.  The next step will probably be to test the effectiveness of the immune-boosters after exposure, according to the Journal.

Funding

Alibek said that when he first sought funding for work on the immune-boosters in 1996, “nobody wanted to discuss it.  They wanted to laugh.”  In 1999, however, the U.S. Defense Advanced Research Project Agency provided the first in an eventual $10 million in grants.  DARPA assisted the project “when no one else would give us the time of day,” said Charles Bailey, a partner of Alibek at Advanced Biosystems.  The U.S. Army later provided an additional $5 million in funding.

The hope is that the immune-boosters could be provided to soldiers entering areas where they could be exposed to biological weapons agents, as well as to exposed civilians, said John Carney, director of DARPA’s biological defense grants program.  The agency “makes high-risk investments, and many could fail,” he said.

Scientists are divided on how effective Alibek’s research will be on humans, according to the Journal.  Alibek’s experiments could lead to the development of innate immunity boosters, according to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.  NIAID has provided Alibek with $1 million in funding, as well as supporting other efforts.

“It’s a majestic leap between the concept and being able to do it,” Fauci said.  “But it’s not necessarily unattainable.  That’s why we welcome (such) research.”

Peter Jahrling, a smallpox researcher at the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md., said he was skeptical that a universal immune-booster could be developed (see GSN, Aug. 19).

“It’s like cold fusion:  a great idea, but where is the experimental basis?" Jahrling said.  Alibek, however, “has a ton of U.S. government dollars to prove me wrong,” he added (Marilyn Chase, Wall Street Journal, Sept. 24).

 For further information, see:

CDC List of Bioterrorism Agents

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Smallpox:  Public Health Officials Concerned Over Mass Vaccination

Public health officials welcomed U.S. guidelines for mass smallpox vaccinations but the plan’s logistics are causing some concern, the Washington Post reported today (see GSN, Sept. 23).

The plan, released yesterday, calls for 1.3 million volunteers to work at health clinics 16 hours a day for a week in the event of a biological terrorist attack (Ceci Connolly, Washington Post, Sept. 24).

“I’m astounded at the number of people it takes to actually make this happen,” said Maryland Secretary of Health Georges Benjamin. “I would hate to try to do this tomorrow.”

In addition, the plan does not address the issue of vaccinating public health workers before an attack takes place.  Some medical officials are in support of such a move but the issue is complicated; people with skin disorders and immune system deficiencies are at risk from being inoculated or from coming in contact with those who have been inoculated.

“It’s very hard to say without a clear threat who should and who shouldn’t be vaccinated,” said Tara O’Toole, director of the Johns Hopkins Center for Civilian Biodefense Strategies.  “Some analyses suggest that if you have ever had eczema or live with someone who has, you shouldn’t get vaccinated, and by some estimates that eliminates 30 million Americans” (Stolberg/Altman, New York Times, Sept. 24).

The plan does provide details on such topics as refrigeration of the vaccine, trash collection and security, but the number of people involved could prove to be impossible to vaccinate in a week, according to some officials.

“The paperwork alone” in giving an unlicensed vaccine “will take a minimum of an hour per person,” said Oklahoma health director Leslie Beitsch (Connolly, Washington Post).

“This is a huge and massive undertaking, the likes of which we’ve never seen in our history,” said Mohammad Akhter, executive director of the American Public Health Association (William Broad, New York Times, Sept. 23).

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Smallpox:  U.S. Releases Vaccination Plan

U.S. health officials issued guidelines to states today on conducting a mass smallpox vaccination campaign within five days of an outbreak (see GSN, Sept. 19).

The guidelines, which officials have distributed to public health officials in all 50 states and the District of Columbia, provide information on how to operate mass vaccination clinics, according to the Washington Post (see GSN, Sept. 4).  The guidelines offer suggestions on using the National Guard, building data systems and dealing with extreme weather conditions.

Currently, the Bush administration has no plans to conduct a mass vaccination campaign prior to any signs of an outbreak, the Post reported.  The vaccination guidelines would only be used if a smallpox outbreak were detected.

“This is a very detailed, thoughtful recipe for response” to a terrorist attack involving biological weapons, said Michael Osterholm, a public health expert at the University of Minnesota who is advising the Bush administration.  Using the guidelines, states and cities should be able to create plans “for vaccinating the largest amount of people in the shortest time possible,” he said.

Under the guidelines, at the first signs of a smallpox outbreak, the Centers for Disease Control and Prevention would send emergency teams to the site to confirm the outbreak and begin vaccination, according to the Post.

The threat that terrorists could release the virus in several locations “would require us to be in many, many places simultaneously,” a U.S. planner said.  “That would completely deplete our assets.”

Instead of sending its staff throughout the country, the CDC plans to send vaccine supplies to the states and let them conduct vaccinations, Osterholm said.  The National Pharmaceutical Stockpile “can be at any hamlet in this country in 12 hours,” he said.  Each state would have to decide where to set up vaccination clinics, who would run them, how to inform people about the risks of the vaccine and how to conduct large numbers of vaccinations quickly, the Post reported.

States must develop plans to conduct vaccinations within five days of an outbreak because it is believed that immunity can be provided within that time even after exposure to the disease, said Jerome Hauer, acting assistant secretary for the Health and Human Services Department’s Public Health Emergency Preparedness.

According to Health and Human Services, even if air traffic were stopped as it was after the Sept. 11 attacks, air shipments of vaccine would be allowed to continue, the Post reported.

Previously, the CDC recommended that a smallpox outbreak be contained through a ring vaccination strategy — inoculating those people who have come into immediate contact with those infected (see GSN, July 29).

Experts have begun to believe, however, that while the ring vaccination plan would work to contain a naturally occurring outbreak, it would not be effective against one caused intentionally by terrorists who have the ability to unleash the disease at several locations at once, Hauer said.

“You begin with ring vaccination, but in a big outbreak obviously mass vaccination would be part of the plan,” he said (Ceci Connolly, Washington Post, Sept. 23).

Israel Continues Vaccinations

Meanwhile, Magen David Adom, Israel’s emergency response service, is expected to begin vaccinating its medical personnel against smallpox today (see GSN, Aug. 15).  About 2,500 Israeli health care workers have been vaccinated so far, according to Yehuda Danon, head of the Immunology Institute at Schneider Children’s Hospital (see GSN, Aug. 21).

Israel’s emergency response personnel vaccination campaign is expected to be completed by October, according to Ha’aretz (see GSN, Sept. 18).  If vaccinations continue at the current rate, the program should be completed on schedule, Danon said (Haim Shadmi, Ha’aretz, Sept. 22).

For further information, see:

CDC Smallpox Information

Journal of the American Medical Association Background on Smallpox

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Threat Assessment:  Report Says National Food Supply Vulnerable

A new report from a National Academy of Sciences panel of experts says the United States is not prepared to prevent, detect or respond to a biological terror attack on the country’s food supply or farms, the Philadelphia Inquirer reported today (see GSN, Feb. 27).

The current agricultural inspection system focuses on the accidental arrival of diseases and pests, not on a terrorist attack, the report says.  The federal government also does not have enough knowledge of foreign pests and diseases, does not understand how a biological attack would affect wildlife and does not have enough laboratories and officials to spot an attack quickly, according to the report.

It is impossible, however, “to be specifically prepared or have all the scientific tools for every contingency,” the report says.  A biological terrorist attack is also a “low-probability thing,” according to panel member R. James Cook, a professor of wheat research at Washington State University.

The 14-member panel of experts recommended that officials draw up a national plan to deal with a potential attack on the country’s crops or livestock (Seth Borenstein, Philadelphia Inquirer, Sept 20).

The report also recommends establishing communication between intelligence agencies and agriculture experts and establishing a network of laboratories to quickly identify and diagnose biological attacks (Tim Friend, USA Today, Sept. 20).

Security concerns prompted the panel to remove eight hypothetical case studies before publicly releasing the report, according to Science magazine.  “The academy doesn’t want to provide any information that will help terrorists,” NAS Executive Officer William Colglazier said (Science, Sept. 20).

The academy gave the report to the Bush administration this spring with the case studies intact.

Since the administration received the report, it has taken steps to address some holes that the study identified, an official said.

“Because of these aggressive efforts, our nation’s food and agricultural infrastructure is stronger today than a year ago,” Agriculture Secretary Ann Veneman said in a written response to the report (Borenstein, Philadelphia Inquirer).

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Anthrax I:  Brentwood Cleaning Equipment Is Ready, Postal Service Says

The U.S. Postal Service conducted a successful test Wednesday of the equipment with which it plans to neutralize chlorine dioxide gas used to decontaminate the anthrax-tainted Brentwood Road postal facility in Washington (see GSN, Aug. 23).

Over a 17-hour period, workers drained 7,000 gallons of chlorine dioxide gas through industrial scrubber equipment, successfully neutralizing the gas that had filled a trial area in decontamination tests, according to the Associated Press.  Air monitoring systems reported a leak 50 feet away from the facility, but it was at only 0.5 percent of the level that would have caused an automatic shutdown.

“The chlorine dioxide is effective against the anthrax, and it’s easily cleaned up,” said Dennis Baca, Postal Service manager of environmental policy.

The full decontamination of the Brentwood facility is expected to involve 40,000 gallons of chlorine dioxide gas pumped through the facility for 36 hours, AP reported.  The information gathered during the successful test of the scrubber equipment will be submitted to the Environmental Protection Agency, and the full decontamination effort might begin within a month, Baca said (Derrill Holly, Associated Press, Sept. 18).

For further information, see:

GSN Anthrax Attack Chronology (Dec. 12, 2001)

CDC Frequently Asked Questions About Anthrax

Journal of the American Medical Association Background on Anthrax

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Anthrax II:  Justice Department Charges Waagner with Hoax Letters

The U.S. Justice Department announced yesterday that it intends to try Clayton Lee Waagner on federal terrorism charges in connection with mailing more than 550 anthrax hoax letters to abortion providers (see GSN, April 19).

The department has decided to consolidate all of the potential federal charges against Waagner in 24 states into a single case, U.S. Attorney Patrick Meehan said yesterday.  The 79-count indictment against Waagner includes charges of threatening to use weapons of mass destruction, violating the Freedom of Access to Clinic Entrances Act, extortion and making and mailing threatening communications, according to the Philadelphia Inquirer.  If convicted, Waagner might face life in prison.

Meehan labeled Waagner’s alleged actions as “terrorism, emotional violence,” and said Waagner “used a climate of fear to unleash his own horrific assault.”  The anthrax hoaxes forced authorities to divert emergency response personnel and FBI agents when they were needed in investigations of the Sept. 11 attacks and last year’s anthrax attacks, Meehan said.

Waagner has been in U.S. custody since a Dec. 5 arrest and was sentenced in January to more than 30 years in prison on federal and state charges from Illinois, according to the Inquirer.  A U.S. judge in Ohio has sentenced Waagner to 19 years in prison, to be served after the Illinois sentence, for illegally possessing firearms and a stolen car.  Waagner still faces federal bank robbery charges in Philadelphia and West Virginia as well as car theft charges in Mississippi and possession of a pipe bomb in Tennessee (Joseph Slobodzian, Philadelphia Inquirer, Sept. 20).

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BWC:  United States Opposes Treaty Protocol Discussion

The United States has decided to oppose any further work to strengthen the Biological Weapons Convention at a review conference scheduled for November and wants no further meetings until 2006, the Washington Post reported today (see GSN, Sept. 6).

Bush administration officials believe that convention revisions supported by the European Union and other parties are ineffective and should be left out, administration officials said yesterday.  U.S. diplomats have told allies that the Bush administration’s position toward the current enforcement protocol is so different from the positions of the protocol’s supporters that any meeting would break down into pointless arguments, administration officials said.  It is better instead to end discussions, they said.

“It’s based on an incorrect approach,” a U.S. State Department official said of the protocol.  “Our concern is that it would be fundamentally ineffective.”

As reported Sept. 6 in Global Security Newswire, many experts believe the United States is making a mistake.

“It sounds to me as though they’ve thrown the baby out with the bath water,” said Amy Smithson, an analyst at the Henry L. Stimson Center.  “The contradiction between the rhetoric and what the administration is actually doing — the gulf is huge.  Not a day goes by when they don’t mention the Iraq threat.”

The Stimson Center is expected today to release a report that is critical of U.S. policy toward the convention, according to the Post.  Biological weapons inspections as called for in the enforcement protocol could be effective with the right amounts of time and science, the report says.  It urges the Bush administration to develop stronger enforcement measures.

“We’re denying ourselves useful tools,” said Matthew Meselson, a Harvard biologist who helped draft a treaty to criminalize biological weapons violations.  “To argue that this wouldn’t be a useful remedy would just be a mistake.  I think it’s because they’re looking through the wrong end of the telescope” (Peter Slevin, Washington Post, Sept. 19).

For further information, see:

BWC Text and Associated Documents (U.S. Defense Department)

BWC States Parties (U.S. State Department)

U.N. Background on BWC

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Anthrax:  Senator Questions Justice Department Decisions

A U.S. senator has asked Attorney General John Ashcroft to explain why he has publicly designated former U.S. Army biologist Steven Hatfill as a “person of interest” in the FBI’s investigation into last fall’s anthrax attacks, USA Today reported today (see GSN, Sept. 12).

In a letter to Ashcroft, Senator Charles Grassley (R-Iowa) asked for Justice Department documents that describe what a “person of interest” is and explain the term’s use, according to USA Today.  Grassley also asked Ashcroft to provide previous examples in the past three years of the term’s use.

Senior FBI agents have said they are unfamiliar with the term “person of interest,” USA Today reported.  Ashcroft, however, has used it publicly on several occasions to describe the FBI’s focus on Hatfill in the course of its “Amerithrax” investigation (Toni Locy, USA Today, Sept. 19).

Grassley also requested information on polices that allow the government to order a grant recipient to dismiss an employee, and he requested previous examples of the Justice Department having done so.  Louisiana State University fired Hatfill following a Justice e-mail that said Hatfill could not work on any department-funded projects.  LSU said the decision to terminate Hatfill was not based on the Justice e-mail (see GSN, Sept. 5).

Grassley requested that Ashcroft provide answers to his questions by the end of the month (Washington Post, Sept. 19).

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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Smallpox:  Supplier Packs First Doses of Vaccine for Stockpile

British drug company Acambis has packaged the first finished doses of smallpox vaccine for U.S. government stockpiles, the Washington Post reported today (see GSN, Aug. 9).  The company, which has been contracted to produce 209 million doses of the vaccine, reported a 100 percent success rate in human testing (see GSN, Aug. 7).

“I am delighted to report that the first doses of final, filled and kitted smallpox vaccine have been produced for the U.S. stockpile,” Acambis Chief Executive Officer John Brown said (Justin Gillis, Washington Post, Sept. 19).

The company, however, has strict confidentiality obligations under its contract with the Centers for Disease Control and is prohibited from revealing the “status, quantity or timing of delivery of smallpox vaccine... for security reasons,” according to an Acambis release (Acambis release, Sept. 18).

Brown indicated that the company might be able to provide the entire order by the end of this year. 

Acambis might bill the government for large amounts of vaccine in December, Brown said.  Billing for government contract work such as this would not usually take place until the vaccine is delivered and in the stockpiles, according to the Post (Gillis, Washington Post).

The progress that Acambis has made could lead to vaccine orders from other governments, the London Daily Mail reported today.

“We’ve made incredible progress,” Brown said.  “Going from concept to putting the vaccine in a bottle in 10 months” (Cliff Feltham, Daily Mail, Sept. 19).

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