U.S. Response:  Official Urges Funding for Project Bioshield

By David Ruppe
Global Security Newswire

WASHINGTON — A senior U.S. official today encouraged Congress to fund Project Bioshield, the Bush administration plan to spur biological weapons vaccine research, development and procurement (see GSN, May 23).

A House bill proposed by the White House, the Project Bioshield Act, would authorize $5.6 billion in funds to be spent over 10 years to induce the U.S. pharmaceutical industry to increase investment in vaccines and treatments for biological weapons diseases through multiyear authorization of funding and liability-limiting provisions (see GSN, April 7).

“The intent of asking for mandatory funding is to provide assurance to big industry that large dollar amounts would be there,” according to Philip Russell, senior adviser for vaccine development and production in the Health and Human Services Department’s Office of Public Health and Preparedness.

In using the term “mandatory,” Russell was referring to bill language designating the $5.6 billion as a “special reserve fund,” from which the homeland security secretary could draw through 2013 to procure vaccines and other medical products after declaring a state of emergency.

He told a conference here today that the purchase of vaccines and drugs would require “very large numbers” of dollars, so “we opted for mandatory funding because we thought it was the best way to assure industry that we were truly serious and that the money would be there.”

The bill, notably, would permit the homeland security secretary to declare a national emergency and authorize release of a drug or device not approved by the Food and Drug Administration for use in an emergency, would provide government compensation for injuries resulting from smallpox vaccinations, and would guarantee procurement of certain vaccines.

The House Government Reform Committee approved a version of the legislation last month and the bill will now be considered by the Homeland Security Committee.  A Senate version awaits floor action. 

The legislation has been criticized by some lawmakers who have questioned the need and the wisdom of atypical multiyear funding authority, and whether the bill’s focus on developing vaccines and drugs for anthrax, smallpox and botulinum toxin might drive potential terrorists to focus on agents that cause other diseases.

The Congressional Budget Office, furthermore, published a report in April concluding the bill’s cost could actually be $2.5 billion more than the $5.6 billion the Bush administration has estimated and the bill would authorize (see GSN, May 9).

DynPort Vaccine Company, attending the conference, provided a chart showing that most progress has been made developing vaccines for smallpox and anthrax, which are considered by officials to be the potentially most dangerous bioterrorism diseases.  Two anthrax vaccines are available in the U.S. stockpile and a smallpox vaccine and treatment for complications should be ready in three to four years, it indicated.

The chart indicated the length of time it takes to develop, test and bring a vaccine into production.  Vaccines for plague, tularemia, botulinum toxin, and multivalent Venezuelan equine encephalitis, and a next generation anthrax vaccine, are in the technology development stage, which could last four to eight years before moving into a system development and demonstration phase prior to production that could take three to four years, it said.

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Iraq:  U.S. Intelligence Agencies Call Recovered Trailers “Strongest Evidence” of Biological Program

By Mike Nartker
Global Security Newswire

WASHINGTON — Two trailers recently recovered by coalition forces in Iraq are “the strongest evidence to date” that Iraq had attempted to conceal a biological weapons program, the CIA and the U.S. Defense Intelligence Agency said in a report yesterday (see GSN, May 21).

The trailers — one captured by Kurdish forces near the northern Iraqi city of Mosul and turned over to U.S. troops in late April and a second discovered by U.S. troops at the al-Kindi Research, Testing, Development and Engineering site in Mosul early this month — have long been suspected of being mobile biological production plants.  In an address before the U.N. Security Council in February, U.S. Secretary of State Colin Powell cited the existence of such mobile plants as evidence that Iraq had continued to attempt to develop weapons of mass destruction (see GSN, Feb. 6).

In their report, the two intelligence agencies compared the layout and inventories of the trailer recovered last month with information provided by an Iraqi chemical engineer who had managed one of Iraq’s mobile plants.  The engineer was able to recognize pictures of the trailer as being similar to the mobile plant he had managed, including specific pieces of identical equipment, the report says. 

An analysis of the trailers has determined that they are likely to be a second- or third-generation design of the mobile facilities described by the Iraqi engineer, according to the report.  The equipment discovered within the trailers, such as fermenters and systems to capture exhaust gasses, were installed in such a way as to create an “ingeniously simple, self-contained bioprocessing system,” the report says. 

The trailers were likely meant to be components in a two- or three-trailer unit, with both recovered trailers likely intended to produce biological agents in liquid slurry, the report says.  It adds that the third trailer in such a unit would likely be equipped with equipment to prepare growth media and for post-harvest processing. 

According to the report, coalition experts have been unable to determine any legitimate uses for the recovered trailers that would justify the effort and cost of a mobile production capability.  “We … agree with the experts that BW agent production is the only consistent, logical purpose for these vehicles,” the report says.

Several theories, however, have been put forth as to possible alternative uses for the trailers, according to the report.  For example, a May 13 New York Times article reported that experts have suggested the trailers might have been used to produce biopesticides or to refurbish Iraqi anti-aircraft missiles.  The report dismissed such theories, however, saying the exhaust collection systems and the size of the equipment found in the trailers are unnecessary for biopesticide production.  In addition, U.S. missile experts have been unable to determine how the trailers could refurbish anti-aircraft missiles, the report says.

The report was less critical, but sill dismissive, of claims made by senior al-Kindi officials that the trailers were used to produce hydrogen for artillery weather balloons.  While some of the equipment found in the trailers could be used to produce both biological agents and hydrogen, the trailers’ design would be “inefficient” for hydrogen production, the report says. 

The report’s assessment of the trailers helps to verify claims made by the United States concerning Iraq’s WMD efforts prior to the war, U.S. State Department spokesman Richard Boucher said yesterday.

“It’s very important to recognize that programs that we had said existed do exist; that the kind of equipment that we had said existed does exist,” Boucher said.

Some independent experts, however, have criticized the CIA-DIA report’s findings.  In an issue brief released yesterday, the Institute for Science and International Security criticized the intelligence agencies for determining that the recovered trailers were used to produce biological agents by eliminating other possible uses.  The institute said the use of such a methodology was “controversial … under any circumstances.”

“Given the high stakes for the United States to prove the existence of weapons of mass destruction (WMD) in Iraq, this methodology is particularly suspect,” the institute said.

The institute also criticized the report for relying so heavily on information gathered from the Iraqi chemical engineer, saying that much of the information recovered from human sources on Iraqi weapons of mass destruction has been “flawed.”  In addition, the institute raised the possibility that the report might have been written with “a preferred conclusion” in mind. 

In its brief, the institute called for an independent investigation of the trailers, adding that a “logical group” to conduct such an investigation would be the U.N. Monitoring, Verification and Inspection Commission.  Such an investigation is needed to improve the credibility of the U.S. findings, the institute said.

“Because the United States has such a vested interest in proving the existence of WMD in Iraq, the report’s findings cannot be trusted without independent confirmation,” the institute said.

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Anthrax:  Hundreds In Military Disciplined For Refusing Vaccine in Past Five Years

In the five years since the U.S. military made anthrax vaccinations mandatory for all members of the armed forces, hundreds have faced disciplinary action or discharge for refusing to be inoculated, the Associated Press reported today (see GSN, May 21).  Since 1998, at least 37 members of the armed forces have been court-martialed for refusing the vaccine

An Army reservist was found guilty by a military panel yesterday for disobeying an order to be vaccinated against anthrax, according to AP. Army Reserve Pvt. Kamila Iwanowska could be sentenced to up to 12 months in jail and receive a bad-conduct military discharge, reduction in rank and forfeiture of pay (Associated Press/New York Post, May 29).

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International Response:  WHO Governing Body Approves New Powers

The governing body of the World Health Organization yesterday approved a new resolution to significantly expand its powers to combat international epidemics that could be caused by biological terrorism, according to the New York Times (see GSN, May 19).

The resolution, approved by the World Health Assembly, would give the WHO the authority to establish an instant communications network with member countries and to use nonofficial sources of information, such as media reports, when there is an international public health threat, according to the Times.  The resolution also gives the WHO the authority to issue global alerts for international health threats and authorizes the organization’s director general to send an inspection team to determine if a country has taken adequate measures to combat an international public health threat.

While the resolution lacks “legal teeth,” it does provide the WHO with “leverage” in compelling countries to address international public health threats, said WHO spokesman Iain Simpson.

The resolution is expected to be approved today by the full WHO because members routinely approve committee decisions, Simpson said.  Once approved, the resolution will be incorporated into a new version of WHO international health regulations, said David Heymann, WHO executive director for communications.  Members will have an opportunity to comment on the new regulations before they are presented for formal approval in 2005 (Lawrence Altman, New York Times, May 28).

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Smallpox:  Panel Says Smallpox Campaign Needs Review, Thwarted SARS

By David McGlinchey
Global Security Newswire

WASHINGTON — A U.S. Institute of Medicine committee yesterday recommended that health officials pause and evaluate the sluggish national smallpox immunization effort before expanding the pool of vaccine recipients (see GSN, Jan. 16).

Institute officials said, however, that the Centers for Disease Control and Prevention has so far taken a thorough and deliberate approach to prepare for a smallpox bioterrorism attack.  That preparation might have helped prevent an outbreak of Severe Acute Respiratory Syndrome in the United States, according to a letter yesterday from the IOM’s Committee on Smallpox Vaccination Program Implementation.

“The committee heard from program administrators that the effective response to SARS both at the national and local level was at least in part facilitated by smallpox preparedness efforts,” the letter said.

The improved communication between health officials most likely aided the U.S. response to the worldwide emergence of SARS, according to the letter.

Pause, Review Program

Health officials should investigate all adverse effects to the vaccine and ensure the four-month-old program is integrated with the overall effort to combat bioterrorism, the letter says.

The CDC is currently focusing the immunization effort on health workers who would respond to a bioterrorism attack with the smallpox virus.  When the plan was originally announced, health officials expected to immunize 450,000 health workers — “phase one” — and then expand the program to include 10 million emergency workers, law enforcement officials and firefighters, known as “phase two.”

Widespread concerns about the safety of the vaccine have hampered the overall effort, and only 36,000 health workers have received the vaccine so far.  Some states and localities, however, are beginning phase two.

“The committee would like to reaffirm the need for a pause in the program, before the vaccine is offered more widely,” yesterday’s letter says.  The committee acknowledged the program’s low turnout, but said that a pause and evaluation is vital to “safely building smallpox preparedness.”

Specifically, the committee recommended new educational material for volunteers who lack a medical background.  The CDC has attempted to screen out some volunteers — such as those with eczema or suppressed immune systems — who are vulnerable to adverse side effects and should not receive the vaccine.

Health officials have said that more thorough safety material is needed once the program moves beyond immunizing nurses and emergency room personnel.

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Anthrax:  U.S. Company Receives FDA Approval to Begin Testing New Vaccine

A U.S. company has received Food and Drug Administration approval to begin testing a new anthrax vaccine (see GSN, Oct. 4, 2002).

VaxGen plans to conduct Phase I human clinical testing of its vaccine on 100 volunteers beginning next month, according to the company.  The trials will be carried out at four medical centers — Baylor College of Medicine, Emory University School of Medicine, Johns Hopkins University and St. Louis University Health Sciences Center. 

The tests will compare the safety of VaxGen’s new vaccine with that of the existing anthrax vaccine.  The tests are also intended to evaluate the efficacy of the new vaccine by comparing human immune responses with those immune responses shown to protect animals from inhalation anthrax, company officials said.

“The ability to begin Phase I clinical trials advances our ultimate goal of supplying the next-generation anthrax vaccine to the U.S. and foreign governments, as well as private markets,” company Chief Executive Officer Lance Gordon said in a statement (VaxGen release, May 27).

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United States:  Army Finds Buried Bacteria Vials in Waste Dump

Officials have discovered several vials of biological agents buried at the U.S. Army’s former biological weapons research facility at Fort Detrick, Md., the Washington Post reported today (see GSN, May 23).

Fort Detrick officials believed they were removing industrial waste from a former biological weapons research center, but workers have discovered more than 100 vials, some containing Brucella melitensis, Klebsiella pneumoniae and Bacillus anthracis, a nonvirulent form of anthrax.

“You find it, contain it, and try to figure out what it is,” said Col. John Ball, Fort Detrick’s garrison commander.  “We’re learning, but it’s expensive,” he added.

Workers are operating in a sealed tent at the excavation site and wear biohazard suits.  Piles of buried debris occasionally explode, and Army officials have equipped bulldozers with blast shields, the Post reported.  Technicians remove large waste from the soil, mash the remaining dirt and waste and then douse it with bleach to kill bacteria.

Hubert Kaempf, an 83-year-old who supervised Fort Detrick’s waste haulers decades ago, defended the facility.

“We had one of the finest safety departments in the world,” he said.  “But what was in keeping with safety and sanitary laws then would now be very much forbidden,” he added (Elizabeth Williamson, Washington Post, May 27).

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Anthrax:  U.S. Postal Service to Expand Testing of Anthrax Detection System

The U.S. Postal Service plans next week to expand testing of a new system designed to detect the presence of biological agents, according to the Washington Post (see GSN, April 10).

The biohazard detection system (BDS) has been successfully tested over the past nine months in Baltimore, said Thomas Day, vice president of engineering for the Postal Service.  Beginning June 1, the system will be tested at 14 additional postal facilities throughout the country for 30 days, after which time postal officials will decide whether the system should be deployed at all postal sites, the Post reported.

“In approximately 30 days, we’ll have the results of various test sites and hopefully, this will lead to the validation of the new BDS system, Day said.

The BDS works by testing the air surrounding mail-handling equipment for anthrax particles using a rapid on-site DNA test, Day said.  If a positive match is detected, the network computer will provide immediate notification and an emergency response plan would then be activated (Michael Zimmerman, Washington Post, May 26).

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