December 2003

Below is a listing of bioterrorism-related events this month, part of an ongoing bioterrorism chronology that begins with Sep 11, 2001. To see events from other months, go to the Bioterrorism Watch index page.

Dec 30

FDA says anthrax vaccine safe for all routes of exposure
Addressing a federal judge's recent ruling that mandatory anthrax shots be halted for American military personnel because the vaccine was being used investigationally (see Dec 22 and Dec 23 items), the FDA issues a statement saying the vaccine is safe for use against inhalational anthrax as well as cutaneous. (See CIDRAP News item.)

Research could point the way to new anthrax treatment
Researchers from Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, announce a discovery that could lead to a new treatment for anthrax. The six chemicals they have discovered are believed to prevent anthrax lethal factor, an anthrax toxin, from entering cells. The research is reported in the January 2004 issue of Nature Structural & Molecular Biology. The discovery, the authors say, could result in a treatment for anthrax that could reduce the need for mass vaccinations, thereby reducing vaccine side effects and improving cost-effectiveness.

Dec 29

New Chinese regulations on WMD-related exports issued
China's Commerce Ministry and General Administration of Customs issue new regulations on registration and licensing of weapons of mass destructionrelated exports. The Xinhau News Agency reports that the Commerce Ministry will issue export licenses and Customs will oversee procedures for businesses required to provide relevant licenses. The regulations make China's control list of dual-use items and technologies public and require exporters to apply for a license if an item being exported could pose a proliferation risk, even if the item is not on the control list. The regulations go into effect January 1.

Dec 28

Renewed concern about anthrax attack
The Bush administration has a renewed concern about US vulnerability to an anthrax attack based on results of a secret exercise carried out several weeks ago and on information obtained from captured al-Qaeda members, according to a New York Times report. The secret exercise, named Scarlet Cloud, involved simulated anthrax attacks in several US cities simultaneously. While results showed that detection and response systems have improved greatly in the past 2 years, they also showed that flaw remained in antibiotic distribution systems and in plans to control and monitor potentially contaminated people and food. Captured al-Qaeda operatives have told interrogators that the terrorist organization was conducting an anthrax program in Kandahar before Afghanistan before the US invasion of that country.

Dec 23

Pentagon halts anthrax vaccinations for military
The Department of Defense issues a statement saying it is suspending the mandatory military anthrax vaccination program until the legal situation is clarified (see item just below and CIDRAP News item).

Dec 22

Judge rules mandatory anthrax shots for military should be stopped
US District Judge Emmet G. Sullivan, acting on a class action suit lodged by unidentified active duty, National Guard, and civilian defense cmployees, says military personnel should not be used as "guinea pigs for experimental drugs" and ordered the Pentagon to stop their program of mandatory shots for certain personnel. He stated that the drug is being "used for an unapproved purpose," referring to the fact that the vaccine label does not state that the drug is for inhalational as well as cutaneous exposure. The Department of Defense and the Food and Drug Administration did not immediately comment. (See CIDRAP News story.)

Brentwood mail facility reopens
The Brentwood mail-processing facility in Washington reopens after being closed since Oct 21, 2001, when letters containing anthrax were found there. The facility, renamed the Joseph Curseen Jr. and Thomas Morris Jr. Processing and Distribution Center in honor of two postal workers who died after exposure to anthrax-containing letters, will house 1,700 employees by the end of January. During the 2-plus year hiatus, Brentwood employees were moved to other regional facilities. About 100 have chosen to not return. Costs of the sanitation and renovation ran about $130 million.

Dec 21

Alert level raised to orange
The Bush administration raises the nation's antiterrorism alert status to orange, or "high" alert, from yellow, or "elevated," on the basis of a substantal increase in intelligence suggesting the potential for terrorist attack during and/or after the holiday season. Department of Homeland Security Secretary Tom Ridge said at announcement of the change that the threat is "the most significant" seen since Sep 11, 2001. Intelligence indicates that terrorists may again use aircraft as weapons; also of special conern to authorities are the possibliity of attack on such public facilities as dams, bridges, and nuclear and chemical plants. The alert level has not been raised for 6 months. The criteria for raising the level were tightened in September.

Dec 18

Topoff 2 indentified many vulnerabilities, says administration report
The 5-day Topoff 2 exercise held last May in Chicago and Seattle, the largest counterterrorism exercise held since Sep 11, 2002, showed multiple areas of shortcomings, says a classified Bush administration report. An unclassified summary of the report made available to the New York Times notes communications problems, shortages of medical supplies and hospital rooms, and confusion over the area affected by a radiological attack. Topoff 2 tested the preparedness of federal and local response teams to simultaneous attacks involving biological agents and a "dirty bomb." A Department of Homeland Security spokesman pointed out that the department had existed for only 4 months prior to the exercise, that the exercise was intended to find and address weakensses in preparedness planning, and that numerous new systems have been established in response to the findings.

Dec 17

New homeland security directives signed
President Bush signs two directives considered to be the cornerstone of the country's homeland security strategy. They order the Department of Homeland Security (DHS) to assess, prioritize, and protect the country's critical infrastructure and to establish a "national all-hazards domestic preparedness goal." The directives replace former President Clinton's PDD 63 directive, which focused mainly of the economic consequences to critical infrastructure of a terrorist attack. DHS is to deliver a "comprehensive, integrated national plan for critical infrastructure and key resources protection" with a year.

Dec 16

Bush administration presents UN with draft resolution on WMDs
The Bush adminstration announces at the UN Security Council a draft resolution that would outlaw transfer of weapons of mass destruction to individuals and groups instead of to countries. By doing so, the administration makes good on its stated intention to lead international efforts at the UN to restrain trafficking of WMDs. The resolution, unlikely to be voted on before the end of the year, includes no enforcement mechanism to empower the council to impose sanctions against countries that do not comply.

HHS announces research funding aimed at agroterrorism
Funding in the amount of $33 million for two university-based "Homeland Security Centers" is announced by the Department of Homeland Security. The centers are to research ways of combatting potential terrorist attacks on the US livestock and food supply. One center will do preharvest research and the other postharvest research. Applications for the grants are due in early February.

Dec 15

Federal "Biodefense End-to-End Assessment" nears completion
Gen. John Gordon, President Bush's homeland security advisor, issues a statement confirming that a classified "Biodefense End-to-End Assessment" he is heading up is nearing completion, according to a Washington Post story. The project is planned to systematically catalog the gaps in the nation's safeguards against biological attack and begin to develop strategies for filing them. Said Gordon, "This assessment will enable us to evaluate the wide range of biodefense activities throughout the government and further improve our ability to protect the American people against this threat.

Dec 12

Common security strategy for? EU members
The European Union's 15 member nations approve a security strategy they say will enable them to "share in the responsibility for global security, and in building a better world," according to a New York Times report. Also approved is a plan for a joint military planning staff that is separate from NATO. Washington has been resistant to the latter, fearing it has the potential to duplicate parts of NATO and to disrupt relations EuropeanNorth American cooperation on defense matters. Javier Solana, chief European foreign affairs official, states that "the trans-Atlantic relationship is irreplaceable," however.

Smallpox vaccination compensation implementation plan unveiled
HHS Secretary Tommy Thompson announces an interim final rule implementing the Smallpox Vaccine Injury Compensation Program passed earlier this year. The law outlines the compensation package for individuals injured by receiving a smallpox vaccination and individuals injured by coming into contact with a vaccinated person. Information and claim forms are available at www.hrsa.gov/smallpoxinjury. (See CIDRAP News story.)

FDA food import rules take effect
The FDA's new food import requirement, in which prior notification must be received of all imported human and animal foods, drink, and dietary supplements, takes effect today. Also required is registration with the FDA of all foreign enterprises that export food items to the United States. The requirements are in accordance with the Bioterrorism Act of 2002. Compliance will be worked toward over the next 8 months, primarily through education of affected firms and individuals. (See CIDRAP News story.)

Report ranks states on bioterrorism preparedness
The Trust for America's Health releases a report evaluating the states' efforts in bioterrorism preparedness efforts since distribution of federal funding for the work. States were "graded" on 10 criteria. States judged to be best prepared were California, Florida, Maryland, and Tennessee. Those ranking worst were Wisconsin, Arkansas, Kentucky, Mississippi, and New Mexico. (See CIDRAP News story.)

Dec 9

FDA clears anthrax-detection kit
A test kit that allows clinical labs to distinguish between Bacillus anthracis and other organisms is cleared by the FDA. Called the Redline Alert test, it is to be used only in Biosafety Level 2 labs. The test is manufactured by Tetracore, Inc., Gaithersburg, Md.

Dec 8

USAMRIID makes progress on Ebola vaccine
A research paper from the US Army Medical Research Institute of Infectious Diseases is published in the Proceedings of the National Academy of Sciences reporting successful immunization of mice against Ebola virus. The vaccine uses virus-like particles (VLPs), which are noninfectious but which trigger a strong response from the immune system. A protection rate of 100% was achieved in mice given VLPs three times at 3-week intervals and exposed to Ebola virus 6 weeks after the last vaccination. Ebola, which carries a death rate of up to 80% in infected individuals, has killed thousands of people in Africa and is considered a viable agent for use by bioterrorists.

Dec 7

UK company to work on oral anthrax vaccine
Microscience, a UK-based biotech company, announces that it has entered a cooperative agreement with the Naval Medical Research Centre to evaluate preclinically what the company believes is the first oral anthrax vaccine to enter human testing, according to a press release.? Microscience claims that because their vacine induces both systemic and mucosal immune response, it will protect the body sites most vulnerable to anthraxthe lung, intestine, and skin. Immunity is conferred within days with just one dose.

Dec 4

Tularemia vaccinenew challenge for Albany Medical College
Albany Medical College officials announce that a highly secure research laboratory will be built there for the purpose of developing a vaccine for tularemia. The program is to be funded by an $8.3 million grant from the National Institute of Allergy and Infectious Diseases. Francisella tularensis, the causative agent, was engineered and stockpiled by the United States and Soviet Union during the Cold War in a form that could kill a person if even 10 grains were inhaled. (See CIDRAP News story.)

Georgia to distribute federal funds across state
The Georgia Department of Public Health announces that it will distribute $4.2 million in federal grant money to all hospital and emergency medical services in the state to equip them for disaster, according to a story in the Macon Telegraph. Funds are to be divided according to how many emergency department patients a hospital sees each year.

Dec 3

FDA and Customs to work together on food security
The FDA furthers its implementation of the Bioterrorism Act by signing with the US Customs and Border Protection (CBP) a memorandum of understanding (MOU) that strengthens the safety and security of imported foods. The MOU allows FDA to commission CBP agents to conduct examinations and investigations of imported foods on FDA's behalf. (See CIDRAP News story.)

China details its WMD nonproliferation plans
China unveils a detailed white paper on its plans for nonproliferation of weapons of mass destruction, according to a New York Times article. It is thought that assurance of the international community, especially the United States, that no weapons technology is being exported by China and is one motivating factor behind the paper. Expressed in the paper is the message that nonproliferation be a cooperative efforts between nations, a reproof of US unilateralism.

Dec 2

Attenuated smallpox vaccine looms on horizon
An American company, VaxGen, and a Japanese company, Kaketsuken, announce finalization of the commercial terms of their collaboration to develop a safer smallpox vaccine for use in the United States and elsewhere. The vaccine, LC16m8, is the only attenuated smallpox vaccine licensed for use in humans: It was licensed in Japan in 1980 and has been administered to more than 50,000 Japanese children. VaxGen is carrying out an animal study and plans other such studies as well as human clinical trials next year subject to FDA approval. The US Congressional Budget Office estimates that the United States government will spend $1.9 billion over the next 10 years for purchase of an attenuated vaccine.

Action on Hatfill lawsuit could raise national security concerns
Documents are filed by the FBI in response to a lawsuit by Steven Hatfill, a "person of interest" in the 2001 anthrax investigation (see August 26 item), saying that disclosure of FBI information on the investigation could harm the ongoing investigation and could be a national security concern. The Justice Department is working to delay the lawsuit.

CDC buys laboratory systems aimed at improving bio-chem preparedness
The CDC agrees to spend $9 for the purchase of 36 devices aimed at upgrading state and local laboratories' capabilities of preparing for and responding to bioterror and chemical attacks, outbreaks of infectious diseases, and other public health threats and emergencies. The devices, called ELAN DRC, are inductively coupled plasma-mass spectrometer systems developed by PerkinElmer, Inc. The purchase is being made as part of the Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism.

Dec 1

New multinational WMD battalion announced by NATO
NATO announces that a multinational battalion put together by NATO to respond to attacks involving weapons of mass destruction is now operational. The group, called the Chemical, Biological, Radiological and Nuclear Defense battalion, is considered to be at "initial operational capability" and lab training and field and command-post exercises will be fully operational in July 2004. Capabilities of the battalion include nuclear, biological, and chemical (NBC) reconnaissance operations; identification of NBC substances; biological detection and monitoring operations; NBC assessments and advice for NATO commanders; and NBC decontamination operations, according an American Forces Press Service story. The first rotation involves about 500 people and then next is expected to involve 700; 15 NATO countries and two of the invited member are part of the first two rotations.

Texas scientist convicted in plague case
Leading plague expert Thomas Butler, arrested in January in the case of missing vials of plague bacteria (see January 15, 16, and 26 and September 4 items), is convicted of illegally exporting plague samples and of defrauding Texas Tech University over research contracts. He was found not guilty on charges of lying to FBI agents, illegally importing and transporting plague samples, and filing false tax returns. A sentencing hearing is set for mid-January. His lawyers are planning to appeal, according to a Washington Post article, and they note that disputes are common between academics and their universities.

Smallpox drill held in Tokyo
Tokyo holds a drill to prepare for biological attack, reports the Japan Times. About 170 city government officials took part in the exercise, which unknown ahead of time to the participants, involved hypothetical release of the smallpox virus in the subway system. The reactions of officials, firefighters, and rescue workers was evaluated, as was the level of cooperation among government departments. The city plans to produce a manual detailing plans for nuclear, biological, or chemical attack by the end of March. Tokyo is the site of a 1995 attack by the Aum Shinrikyo cult in which sarin was released into subway trains.

Self-contained system for battlefield detection of biological agents unveiled in UK
The first six Integrated Biological Defence Systems (IBDS) are rolled out at a ceremony of the United Kingdom Armed Forces, according to the UK Ministry of Defence. Each self-contained system, which is a box mounted on a 4-ton truck, comprises a detection suite; environmental conditioning, communications, and meteorological equipment; and a rest suite for the crew of four. It is a highly sensitive system, capable of detecting tiny traces of biological agents on the battlefield.

For other months' installments, go to the Bioterrorism Watch index page