Anthrax:  Vaccine Makers Hope to Begin Production Next Year

The United States has contracted two pharmaceutical companies to produce 25 million doses of a new anthrax vaccine, health officials said yesterday.  Under a fast-track proposal, production is scheduled to begin by late next year (see GSN, Aug. 8).

“There is an urgent need to devise more effective measures to protect U.S. citizens from the harmful effects of anthrax spores used as instruments of terror,” Health and Human Services Secretary Tommy Thompson said.

British company Avecia and U.S. company VaxGen received the contracts to produce the vaccine, worth a combined $22.5 million.  The contracts call for a vaccine that can be used as a post-exposure treatment and can be administered in three or fewer doses.  The current vaccine, in use by the Pentagon, requires six doses administered over 18 months.

The new anthrax vaccine is also to be produced through more modern techniques than the current vaccine, according to the Washington Post.  Developers plan to use “recombinant” technology to use genetically engineered bacteria and leave out extraneous substances that could cause side effects, according to the Washington Post (Washington Post, Oct. 4).

For further information, see:

CDC Frequently Asked Questions About Anthrax

Journal of the American Medical Association Background on Anthrax

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Anthrax — One Year Later:  Attack Culprit Remains at Large, But Preparedness Spending Increases

By Mike Nartker
Global Security Newswire

WASHINGTON — In October 2001, less than a month after the Sept. 11 attacks in New York and Washington, another act of terrorism hit the United States.  The weapon was anthrax, which ultimately killed five people along the East Coast, infected 13 and scared thousands into stockpiling antibiotics, buying gas masks and taking other defensive measures.

Now, on the first anniversary of the anthrax attacks, the FBI’s “Amerithrax” investigation has yet to determine who is responsible.  The incidents have, however, galvanized U.S. biological defense researchers and public health officials to better prepare responses to any future incidents.

The first reports of the anthrax attacks came Oct. 3, 2001, when Robert Stevens, a photo editor for American Media Inc. in Florida was diagnosed with the inhalational form of the disease.  When Stevens died two days later, he became the first U.S. fatality from anthrax since 1976 (see GSN, Oct. 5, 2001).  Ultimately, a second AMI employee, Ernesto Blanco, became infected, and six other AMI employees tested positive for exposure (see GSN, April 23).  The source of the anthrax in the AMI building has not yet been found.  FBI agents armed with new investigative techniques re-entered AMI headquarters Sept. 3 to try to recover the source — probably a letter or package mailed to the building — but they have released no details about what they found (see GSN, Sept. 11).

The first anthrax victim outside of Florida — an NBC News employee who contracted anthrax on her skin — was reported Oct. 12, 2001 (see GSN, Oct. 12, 2001).  That day, investigators tested a suspicious letter sent to NBC Nightly News anchor Tom Brokaw that was later linked to the attacks.  Two employees at other New York media organizations and a 7-month-old boy who visited the offices of ABC News contracted skin anthrax as a result of the attacks.

In New Jersey, five postal workers contracted anthrax — two inhalation cases and three skin infections.  Investigators have speculated that tainted letters processed in New Jersey mail-handling centers caused these cases.

Anthrax arrived in Washington Oct. 15 with the opening of a tainted letter sent to Senate Majority Leader Tom Daschle (D-S.D.).  The “Daschle letter” ultimately caused officials to close the Hart Senate Office building, where Daschle’s offices are located, until Jan. 23, 2002 (see GSN, Oct. 16, 2001).  While no member of Congress or congressional staff member became infected, four Washington postal workers contracted inhalation anthrax and two died — Thomas Morris and Joseph Curseen (see GSN, Oct. 23).  An employee at a U.S. State Department mail center also contracted inhalation anthrax.

On Oct. 31, New York City hospital worker Kathy Nguyen died from inhalation anthrax (see GSN, Oct. 31, 2001).  Investigators have been unable to find anthrax spores in any locations, such as her home or where she worked, that Nguyen was known to frequent.  Analysts have speculated that she might have contracted the disease through cross-contaminated mail — mail that passed through the same sorting machines as the tainted letters.

The anthrax attacks continued into November, with the discovery Nov. 17 of an unopened tainted letter mailed to Senator Patrick Leahy (D-Vt.).  On Nov. 21, the fifth and final death related to the anthrax attacks occurred — the death of Ottilie Lundgren of Oxford, Conn. (see GSN, Nov. 21, 2001).  Investigators have speculated that Lundgren also died through contact with cross-contaminated mail (see GSN, March 27).

CDC Analysis

The U.S. Centers for Disease Control and Prevention has divided the anthrax cases into two clusters based on exposure to two different sets of tainted mailings, according to a CDC report released this month.  One cluster originated from two letters mailed Sept. 18 to NBC Nightly News and the New York Post.  The other cluster surrounds two letters mailed Oct. 9 to Daschle and Leahy.  All four of those letters were mailed from Trenton, N.J.

Patients in the first cluster of cases were more likely to have developed skin anthrax and to have been exposed at media organizations rather than postal facilities, according to the report.  Patients in the second cluster were more likely to have developed inhalation anthrax and to have been exposed at postal facilities that handled the tainted letters mailed to Daschle and Leahy, the report says.

According to the report, a difference in the consistency of the anthrax spores in the Sept. 18 mailings versus the Oct. 9 mailings might account for the increased number of inhalation cases in the second cluster.  The media employees generally suffered fewer effects than did the postal employees who worked along the paths of the Daschle and Leahy letters, it says.  The report also says that “substantial” death and illness might have resulted among Senate staff members exposed to the Daschle letter if health officials had not distributed preventive antibiotics such as ciprofloxacin (see GSN, Oct. 18, 2001).

“Amerithrax” Investigation

The FBI’s investigation into the anthrax attacks has not yet revealed the person, or people, behind them.  It is difficult to gather evidence in this kind of case, Barbara Hatch Rosenberg, a biologist at State University of New York who has often publicized her views on the anthrax investigation, told Global Security Newswire last week.  She added that she is unsure whether the FBI would move to arrest someone in the absence of final, conclusive evidence.

In January, Rosenberg released a possible profile of the person responsible for the attacks.  According to the profile, the person behind the attacks is probably a middle-aged U.S. resident who worked at the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md., has experience in working with dangerous pathogens such as anthrax and has been questioned by the FBI, among other characteristics (see GSN, Jan. 25).

Throughout the Amerithrax investigation, the FBI has questioned and administered polygraph tests to several U.S. biological defense researchers (see GSN, May 21).  The investigation seems to have focused on many of the traits listed in Rosenberg’s profile.

Some observers have speculated that the anthrax incidents were linked to the Sept. 11 attacks, which were perpetrated by non-U.S. citizens.  Newsweek reported in July, however, that several FBI agents had begun to believe a U.S. scientist is responsible (see GSN, July 8).  Genetic testing has determined that the anthrax spores included in the Daschle and Leahy letters are the same strain as samples at USAMRIID (see GSN, June 13).

Even though the FBI has gathered a large amount of information during its investigation, the longer the case goes on, the less likely the person responsible will be found, said Charles Pena, a senior defense policy analyst at the Cato Institute, a Washington think tank.

The Strange Case of Steven Hatfill

In the course of the FBI’s investigation, only one name has been publicized:  Steven Hatfill, a former U.S. Army biologist who has become a “person of interest” in the case.  Newspapers reported June 25 that the FBI had conducted what became the first search of Hatfill’s Frederick, Md., apartment (see GSN, June 26).  The FBI later searched the apartment two more times and searched the apartment of Hatfill’s girlfriend and a storage unit he rented.  It was later reported that Hatfill had commissioned a study in 1999 examining a possible anthrax attack similar to those carried out last fall (see GSN, June 27).  Suspicions were also raised when it was learned that Hatfill had apparently listed several false qualifications in his resume, including his educational history and military service.

During an Aug. 11 press conference, Hatfill publicly declared his innocence, saying he had nothing to do with the anthrax attacks (see GSN, Aug. 12).

“I am a loyal American and I love my country.  I had nothing to do with the anthrax letters, and it is terribly wrong for anyone to contend or think otherwise,” Hatfill said.

Analysts are unsure what role, if any, Hatfill might have played in the anthrax attacks.  Rosenberg, whose profile Hatfill matches in many respects, said the FBI must have had something they were looking for by the time of the third search of Hatfill’s apartment.  She has never publicly named Hatfill, however, and last week she said it is “unfortunate” that his name was made public.

It would be fair to label the FBI’s interest in Hatfill as “overzealous,” Pena said.  Investigators might have concentrated on Hatfill because he was an easy lead, but not necessarily a good one, he added.

The fact that the FBI continues to publicly focus its investigation on Hatfill might be an indication that it is under pressure itself to find someone responsible, Pena said.  Unless investigators have solid evidence on Hatfill, however, he is probably going to go the way of Richard Jewell, Pena added, referring to a man once suspected, but later exonerated, of being responsible for a bombing at the 1996 Olympics in Atlanta.

If it turns out that Hatfill had no role in the anthrax attacks, the FBI has “essentially ruined someone’s life, and no one seems to care,” Pena said.

Preparations for (A Possible) Next Time

While the investigation into the anthrax attacks has so far had little success, the United States has begun an intensive effort to be better prepared for a future possible attack.  In January, three months after the attack, U.S. officials increased efforts to develop the National Pharmaceutical Stockpile — supplies of treatments and vaccines stored throughout the country to counter biological agents (see GSN, Jan. 29).  Funding for the stockpile jumped this year to $644 million, up from the $50 million spent annually since it was created in 1999.

In June, President George W. Bush signed into a law a bioterrorism bill to provide $4.6 billion for improvements to U.S. defenses (see GSN, June 12).  The bill included $640 million to develop a stockpile of smallpox vaccine and $1.6 billion to help states improve hospital systems.  Last month, the CDC began distributing more than $900 million in grants to state and local public health departments to help improve readiness for a biological attack.

“That money is helping to build better laboratories and better systems for detecting a potential terrorist attack as well as expanded communications systems to get information to public health workers and clinicians quickly,” CDC Director Julie Gerberding said in a Sept. 4 press release.  “These investments will not only pay off in terms of terrorism preparedness, but public health in general will also benefit.”

The increased funding in biological defense research and public health preparedness probably would not have occurred without the anthrax attacks, according to experts.  The attacks were “quite a wake up call,” said Mohammad Akhter, executive director of the American Public Health Association.

The anthrax incidents and the Sept. 11 attacks have demonstrated that terrorists are interested in causing mass casualties and in using weapons of mass destruction — which has led to the increased spending, said Mike Powers, a research associate at the Chemical and Biological Arms Control Institute.

The attacks have led to “unprecedented” biotechnology research including new detection devices and safer vaccines, Akhter said.  The increased biological defense spending has been well focused, addressing areas of concern as well as potential new threats, he added.

Rosenberg has claimed, however, that the United States has rushed to increase funding into research on potential biological weapons agents that might be ineffective and lead to security problems (see GSN, Jan. 22).

“Because of the rush to ‘do something,’ large amounts of government money are being thrown, without sufficient forethought, at research involving potential biological weapons agents,” she wrote in a Sept. 22 commentary for the Los Angeles Times.  “Scientists go where the money is, and we’re now seeing a crowd of biologists lacking in relevant experience trooping to the trough.”

Increased research on biological agents could make it even more difficult to impose regulations and oversight, Rosenberg wrote.  Some have speculated that the anthrax used in the attacks originated from a U.S. research facility (see GSN, Dec. 17, 2001).

Instead of increasing funds for biological defense, the United States should fund improvements in the U.S. public health system to be able to respond to a wide range of naturally occurring diseases, Rosenberg wrote.

“Natural outbreaks of disease, including rapidly emerging new diseases for which we are unprepared, are a far more likely hazard for most people,” she wrote.  “Improving the public health system’s ability to respond would help combat these diseases as well as biological attacks.”

The increased biological defense funding has not appeared to take away from public health spending, according to Akhter and Powers.  Even with the small number of casualties caused by the anthrax attacks, the increased funding is justified, Powers said.  Terrorism has both a physical and psychological effect, he said, noting that the disruptive effect of the attacks has been “quite substantial.”  The appearance of preparedness, through the increased funding and research, can help to reduce the psychological effects of a future attack, Powers said.

Powers did agree that the United States still has “a long way to go” in developing a basic public health capacity.  There is a tendency to focus research efforts on improving response capabilities such as developing a new smallpox vaccine, he said.  The “front-end” public health system, however, provides detection and assessment capabilities in the event of a biological attack, without which it would be hard to determine how to allocate response capabilities, he said (see GSN, Feb. 20).

There is also still a tendency to focus planning and research on high end attacks — ones that could cause mass casualties such as the use of smallpox, Powers said.  While it is important to be prepared for such attacks, an exclusive focus on them could leave the United States unprepared to combat other biological weapons agents, he said.

There are two U.S. public health areas that still need to be improved, according to Akhter.  One is better public preparedness, such as the distribution of treatments and vaccines to the public in the event of an attack.  For example, more research needs to be done on new vaccine delivery methods, he said.  The recently released U.S. smallpox vaccination plan calls for the vaccine to be administered in the same way as it was 30 years ago, Akhter said (see GSN, Sept. 23).

“We don’t do anything the way we did 30 years ago,” he said.

Vaccines and treatments to be distributed to other countries also need more development, Akhter said.  “People over there are basically sitting ducks.”  A global strategy is needed to combat biological terrorism, he said.

“We’ve asked out allies about a war on Iraq” but have not sought their help in combating biological terrorism, he said.

Could It Happen Again?

The possibility of another attack is based largely on the supply of anthrax still in the hands of those responsible for last fall’s attacks, Pena said.  If a non-U.S. terrorist group is behind last fall’s attacks, the chances for a future attack are lower because “real terrorists” tend to alter their methods to retain an element of surprise, he said.

If the person responsible fits the mold of a “Unabomber”-type terrorist, however, the chances of future attacks increases, according to Pena.  These types of terrorists tend to repeat attack methods to taunt authorities — a “catch me if you can” mentality, he said.

Whether or not the anthrax culprit is found, the CDC has said it is now better prepared to respond to any future acts of biological terrorism in the United States.

“The process of preparing for a terrorist attack is a continual one with no real endpoint, but even today CDC’s level of preparedness is very high,” Gerberding said in a Sept. 9 press release.  “We have the plans, the policies, the people, the products, and now we have the practice to make sure we are ready to respond.”

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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U.S. Response I:  CDC Ships Biological Agents Worldwide

The U.S. Centers for Disease Control and Prevention distributes hundreds of different biological agents to a dozens of countries each year for use in research, the Atlanta Journal-Constitution reported today (see GSN, Sept. 27).  The CDC has recently come under criticism for shipments of biological agents to Iraq in the 1980s that some analysts have suspected were used in Baghdad’s biological weapons program.

The shipments are part of a worldwide exchange of agents that is necessary in order to conduct research to combat pathogens, CDC officials said.

“We ship over 300 agents to several dozen countries every year,” said CDC spokesman Thomas Skinner.  “It’s important for the CDC to cooperate with international health authorities on research that ... saves lives.  At the same time it’s equally important to us to work with the U.S. Commerce Department to see that these organisms don’t fall into the wrong hands.”

Commerce has created a list of countries where biological agents cannot be shipped, including Iran, North Korea and Cuba.  In the 1980s, Iraq was not included on that list, but is today, according to the Journal-Constitution.  The department also has a list of pathogens that require U.S. approval before export.

Senator Robert Byrd (D-W.Va.) has called for even stricter controls on the export of biological agents.  Byrd has criticized the CDC and the American Type Culture Collection, a nonprofit firm, for shipping biological samples to Iraq in the 1980s. 

American Type Culture Collection’s shipments to Iraq are “old news” that came up during congressional hearings in 1993, said company spokeswoman Nancy Wysocki.

“The Department of Commerce approved all requests for shipments of biological samples by Iraq,” Wysocki said.

The current situation with Iraq, however, has made the dangers of potentially weak export controls on pathogens more apparent, Byrd said.

“We not only know that Iraq has biological weapons, we know the type, strain, and the batch number of the germs that may have been used to fashion these weapons,” he said.  “We know the dates they were shipped and the addresses to which they were shipped” (Mike Toner, Atlanta Journal-Constitution, Oct. 2).

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U.S. Response II:  CDC Awards Grant to Develop Early Warning System

The U.S. Centers for Disease Control and Prevention has awarded the Harvard Consortium a $1.2 million grant to develop an early warning system for biological terrorism attacks, the agency said today (see GSN, May 20).

The consortium, which includes health care experts in institutions throughout the United States, plans to develop a pilot program to connect 20 million ambulatory care records throughout the country, the agency said in a press release.  The goal of the program is a system that can interconnect information from various health departments to detect disease clusters and alert health care professionals to a biological weapons attack.  If the program is successful officials will use it as a basis for a U.S. monitoring system, the CDC said.

“This system will be able to locate pockets of illness that might represent an intentional attack of terrorism and will give us an early warning of such an attack,” Health and Human Services Secretary Tommy Thompson said (U.S. Centers for Disease Control and Prevention release, Oct. 2).

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Smallpox:  Australia Prepares to Stockpile Vaccine

Australia is expected to soon receive supplies of smallpox vaccine for use in the event of biological terrorism, officials said today (see GSN, May 16).

The Australian Health Department is close to completing contracts with the French pharmaceutical company Aventis Pasteur for an initial shipment of 50,000 doses of the vaccine, the department said.  Officials are set to order an additional supply that should be available early next year from another producer, the department said.

No mass vaccination campaign has been planned and the threat of a smallpox outbreak is “very low,” Commonwealth Chief Medical Officer Richard Smallwood said.

“The current response strategy is to keep the vaccine in a secure location and deploy it to affected areas in the event of the discovery of a case of smallpox in Australia,” Smallwood said (Associated Press/Yahoo.com, Oct. 2).

For further information, see:

CDC Smallpox Information

Journal of the American Medical Association Background on Smallpox

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U.S. Response:  BWC Protocol, Proposed Alternatives Both Fall Short

By Anne Marie Pecha
Global Security Newswire

Inspectors would not have had a “fighting chance” to enforce the Biological Weapons Convention under the draft monitoring protocol that the United States rejected last year, but U.S.-proposed alternatives to the protocol also fall short, industry experts wrote in a report released last month (see GSN, Sept. 19).

Written by 11 industry researchers and executives and published by the Stimson Center, Compliance Through Science:  U.S. Pharmaceutical Industry Experts on a Strengthened Bioweapons Nonproliferation Regime examines the Bush administration’s alternative proposals and offers further suggestions for monitoring and implementing the convention.

According to the report, the Bush administration has proposed two avenues for enforcing the convention — international monitoring plus domestic laws and practices.  Because the monitoring proposals have focused on voluntary inspections, they lack substance, the experts wrote.  Additionally, because the proposals regarding domestic regulations have emphasized national autonomy over international standards, they would probably lead to an “uneven patchwork” of practices that would be difficult “to harmonize,” they wrote.

Monitoring

Bush administration officials have said the U.N. secretary general should maintain responsibility for investigating suspicious biological facilities and incidents.  The industry experts, however, rejected the idea, saying that it has failed many times in the past.

“Industry experts could find little merit in leaving the capability to investigate suspicious disease outbreaks in the hands of the very body that failed to do anything to explore the … charges of BWC violations voiced over the last quarter century,” they wrote.

The Bush administration has also proposed requesting individual governments to voluntarily open sites of concern to inspection, but in such a scenario a violator could hide violations from inspectors and governments could politically misuse the threat of inspections against competing facilities, according to the report.

International officials should agree on detailed monitoring strategies and techniques to “detect and sort out inconsistencies” between practice and stated purpose at manufacturing plants and research laboratories, the experts wrote.  Also, U.S. officials should comply with a 1999 congressional mandate for a cost-benefit analysis based on trial inspections at U.S. facilities that explore various strategies and techniques.

Laws and Practices

The Bush administration has suggested several ways in which countries should unilaterally improve the Biological Weapons Convention.  The suggestions include strengthening procedures to survey disease outbreaks, oversee genetic engineering research, enhance safety for biological researchers, criminalize offensive biological weapons research, secure dangerous pathogens and develop codes of conduct for researchers that work with such organisms, according to the report.  Although none of these suggestions is harmful, alone they would fail to meet the goals of the treaty because they provide no international standards, the experts wrote.

“Many governments will enact measures that fall short of worthwhile standards either unintentionally, because they cannot decipher the existing discrepant regulatory concepts, or intentionally, because they seek to perpetuate illicit activies,” they wrote.

Countries should support disease surveillance through the World Health Organization and negotiate an international treaty to criminalize biological weapons, the report says.  Countries should also adopt standardized safety, security and oversight rules and procedures for relevant biological materials and areas of research, the authors said (see GSN, Sept. 27).  International officials should establish a list of pathogens and toxins that should be subject to controls.

“Allowing governments to set their own arbitrary standards” is not “a constructive step forward,” the authors wrote.  In fact, the United States “needs to get its own house in better order,” they added.  For example, privately funded institutions in the United States are not required to adhere to certain guidelines from the U.S. Centers of Disease Control and Prevention and the National Institutes of Health, the report says.  Additionally, basic training in biological safety and research practices has diminished at U.S. academic facilities in recent decades, according to the experts.

Consequences

Finally, to enforce the Biological Weapons Convention, officials should establish standard penalties for violating it, the report says.  The threat of violators losing jobs, grants or licenses might help prevent some potential violators from making “only a minimal effort to abide by the regulations,” the experts wrote.

Overall, to implement all of the suggested measures for monitoring and strengthening the treaty, officials should create an international body “to coordinate, promote and administer” activities, the experts wrote.

“Singly, research oversight, biosafety and biosecurity enhancement measures will not go far in thwarting nations or terrorists from engaging in wayward research, experiencing leaks at covert weapons facilities or gaining access to dangerous pathogens,” the report says.  “Collectively, however, global adoption of … guidelines … would raise the bar, hampering the ability of aspiring proliferators to achieve an offensive weapons capability.”

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Anthrax:  British Rapid Reaction Troops Volunteer for Anthrax Vaccine

The United Kingdom has inoculated as many as 14,000 elite military personnel with the anthrax vaccine in the last three months, the London Times reported today (see GSN, July 19).

Since the country’s voluntary immunization program was expanded in June, 46 percent of the Joint Rapid Reaction Forces has received the vaccination.  The joint forces — which include personnel from the Royal Navy, Army and Air Force — would be the first British troops sent to Iraq for a conflict there (Michael Evans, London Times, Oct. 1).

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Smallpox:  U.S. Officials Prepare to Offer Vaccine to the Public

In an abrupt change from earlier plans to inoculate only emergency first responders, U.S. officials are preparing to offer an unlicensed smallpox vaccine to all U.S. residents, the Associated Press reported today (see GSN, June 26).

Officials have not yet made a final decision or announcement, but the consensus in the Bush administration is that the vaccine will be offered to hospital workers, then nonhospital health workers and eventually to the general public, AP reported.

“You start with one group and based on their potential risk, you keep expanding,” an administration official said.

As recently as this summer officials were recommending that only emergency responders including 20,000 hospital workers — who are at the greatest risk of encountering an infected patient — receive the vaccine.  The company that is supplying the vaccine to the United States has announced, however, that it is making swift progress and has produced the first doses ordered to add to the U.S. stockpile (see GSN, Sept. 19).  U.S. officials have said they anticipate being able to inoculate a large segment of the population as soon as early next year.

The vaccine poses health risks to many and officials are still weighing who should receive the vaccine before it is licensed (Laura Meckler, Associated Press, Sept. 27).

In an uninoculated community, 30 percent of the population would die in a smallpox outbreak, according to Joshua Epstein of the Brookings Institution, who yesterday presented the results of a simulation.  If the same population were given the vaccine, only five percent would die.

Giving the vaccine to the entire community is not the only option, he said.  Inoculating hospital workers before an attack and giving the vaccine to members of a patient’s family immediately after the disease is detected would “provide substantial protection,” Epstein said (Pascal Barollier, Agence France Presse, Sept. 27).

For further information, see:

Journal of the American Medical Association on Smallpox

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International Response:  Biological Security Convention Needed, Expert Says

By David McGlinchey
Global Security Newswire

A multilateral convention to improve security over biological agents in laboratories would reduce the threat of bioterrorism, former U.N. arms inspector to Iraq Jonathan Tucker said in a recently released proposal.

In Preventing Terrorist Access to Dangerous Pathogens:  The Need for International Biosecurity Standards, Tucker said an agreement that helps countries prevent theft or diversion of biological materials would be an effective and “politically realistic” solution.  Tucker currently directs the Chemical and Biological Weapons Nonproliferation program at Monterey Institute of International Studies.

A biological security convention modeled on the 1994 Nuclear Safety Convention would make acquiring dangerous biological agents more difficult, the proposal said.  The nuclear convention is an “incentive instrument” that does not enforce compliance but relies on member states recognizing the mutual benefit of nuclear safety.

Participants of a biological security convention would recognize that “international standards for the physical protection, control and accounting of dangerous pathogens and toxins would put significant obstacles in the path of would-be terrorists and proliferators,” the proposal says.

Inspecting biological development facilities has proven contentious, as demonstrated last year when the United States rejected an inspection protocol to the Biological Weapons Convention, Tucker argued.  U.S. officials said inspections might expose legitimate military and commercial secrets without uncovering biological weapons activities of rogue regimes (see GSN, Sept. 6).

The proposed convention would be a “simple document because it would lack on-site verification provisions and avoid politically contentious topics such as export controls on dual-use equipment or technology transfer,” according to the proposal.

The convention would include a commitment by member parties, a set of universal controls for the “physical protection, control, licensing, and reporting of dangerous pathogens and toxins” and periodic meetings to review progress on implementing standards.

The convention would also require member states to take other steps such as providing a specific list of agents of concern; establishing guidelines for registering and licensing laboratories that work with listed toxins, although a country could keep its list of such facilities confidential; conducting “personnel vetting” procedures on scientists who work with listed toxins; requiring member states to establish import and export controls and a national body to implement those controls; establishing procedures to help some member states achieve security standards and creating a small international body to organize meetings and perform administrative duties.

If the convention is to be effective, it would need to include “all states involved in ‘germ commerce,’” Tucker said.  It would assist international research cooperation as import and export regulations would be standardized.

The convention would also appeal to U.S. companies, Tucker said.  U.S. firms that deal with biological agents already face tight regulations and the convention would ensure that overseas competitors are on a “level regulatory playing field” enforced by their own governments, according to the proposal.

“The limited number of agents subject to regulation should not impose major constraints on legitimate scientific research and drug development, although academic researchers will have to bear additional costs,” Tucker said.

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

Pentagon Executive Summary of BWC

Fifth Review Conference of BWC

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Botulism:  United States Is Unprepared for Attack

The United States is not prepared for a battlefield or terrorist attack involving botulism, USA Today reported today (see GSN, Aug. 6).

The government has not approved a vaccine for the disease — the most advanced version is about four years away — and the antitoxin for botulinum toxin, which causes the disease, is in short supply.  After the 1991 Gulf War, Iraqi officials told weapons inspectors that they had developed botulinum toxin as a weapon and stockpiled vast amounts.

The toxin is extremely dangerous, about 100,000 times more lethal than sarin, according to USA Today.

The current treatment for those exposed to the toxin is developed by vaccinating horses and removing antitoxin from the their blood.  Officials stockpiled thousands of unprocessed doses of antitoxin after the Gulf War but have not disclosed how much they have.  The Army abandoned that project in 1999 and the horses were sent to the Air Force Academy.  A Maryland firm is processing the remaining doses for $500 each, but that batch will not be ready until next year.

“Unfortunately, there’s nothing really available for people yet, other than the horse serum,” said George Lewis, a retired Army microbiologist involved in the Gulf War antitoxin effort (Kevin Moloney, USA Today, Sept. 26).

For further information, see:

Journal of the American Medical Association Background on Botulinum Toxin

CDC Basic Information About Botulism

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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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