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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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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