Smallpox:  Study Says Immunizations Safer Than Expected

Military immunization results have shown that it is safe to speed up the U.S. national effort to vaccinate health and emergency workers against the smallpox virus, according to a study published yesterday by the Journal of the American Medical Association (see GSN, June 24).

The Defense Department immunized almost 500,000 military personnel without any deaths and with fewer complications than were expected, the report said.

Some health care worker groups were still skeptical about President George W. Bush’s plan to immunize up to 10 million emergency workers by the end of this summer.  The plan began in February, but fewer than 38,000 civilians have received the vaccine.

The immunization effort is failing partly because there is no clear threat, according to Charles Idelson, a spokesman for the 50,000-member California Nurses Association.

The immunizations are a “massive diversion of public resources for badly needed health care toward a program that has, to this date, been demonstrated to be totally unnecessary.  Any of the adverse reactions that have occurred as a result of this immunization program have been too many,” he said.

The study was completed by John Grabenstein of the Army Medical Command’s Military Vaccine Agency and William Winkenwerder, the assistant defense secretary for health (Susannah Rosenblatt, Los Angeles Times, June 25).

“Our experience suggests that broad smallpox vaccination programs may be implemented with fewer serious adverse events than previously believed,” the report says (Reuters/New York Times, June 25).

Military researchers did determine, however, that cardiac inflammation should be added to a list of potential side effects of the vaccine.  The inflammation, also known as myopericarditis, occurred at a rate of 78 cases for every million vaccine recipients.  That rate is triple the occurrence in the unimmunized population (Associated Press/Baltimore Sun, June 25).

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Anthrax:  U.S. Biotechnology Company Receives FDA Approval to Begin Human Testing of New Treatment

A U.S. biotechnology company announced today that it has received Food and Drug Administration approval to begin human testing of a new drug that has been found to both prevent and treat anthrax (see GSN, March 18).

Human Genome Sciences is now set to begin enrolling adult volunteers into a Phase 1 placebo-controlled clinical trial to evaluate the safety and tolerability of its new drug, ABthrax.  Adults enrolled into the study will be administered different dose levels of intramuscularly and intravenously administered ABthrax, the company said in a press release.  Under the Bioterrorism Act of 2002, the company can use the results of animal testing to demonstrate the drug efficacy for the purposes of licensing and marketing approval, the company said.

“We are pleased to be able to proceed with a clinical trial to evaluate the safety, tolerability and pharmacology of ABthrax in healthy adults,” Human Genome Sciences Senior Vice President David Stump said in a statement.  “Positive results from such a human study, along with our preclinical proof of efficacy data, would support the further development of ABthrax as a new means to prevent and treat anthrax infections,” Stump said.

ABthrax is a human monoclonal antibody that works by countering protective antigen — a toxin released by the anthrax bacterium.  Animal testing has found that a single dose of the drug can protect against anthrax infection once an appropriate level of the antibody is built up in the blood, the company said.  The drug also works against the toxins produced by anthrax bacterium, making it suitable as a treatment.

Large-scale production of ABthrax is dependent on government funding, which could be provided through the pending “Project Bioshield” legislation, the company said (see GSN, June 24; Human Genome Sciences release, June 25).

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U.S. Response:  Area Residents Oppose New Biosafety Level 4 Laboratories

U.S. plans to build at least six new Biosafety Level 4 research facilities, able to work with the most dangerous pathogens to help prevent against biological terrorism, are facing opposition from residents near the proposed laboratory sites, the Los Angeles Times reported today (see GSN, Feb. 24).

The United States has four Biosafety Level 4 facilities, located at the Centers for Disease Control and Prevention in Atlanta, the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md., the Southwest Foundation for Biomedical Research in San Antonio, Texas, and the National Institutes of Health in Bethesda, Md.  The NIH facility, however, currently only works with Biosafety Level 3 organisms, according to the Times.

Several new Biosafety Level 4 laboratories are set to be open, with one to be installed at the CDC and another at the University of Texas in Galveston.  In addition, the National Institute of Allergy and Infectious Diseases plans to open large-scale facilities at the Rocky Mountain Laboratories near Hamilton, Mont., and at Fort Detrick.  Several other academic institutions and the New York state Health Department are competing to construct two additional facilities.

The plans to construct the new laboratories, however, have raised concerns and opposition among area residents worried about possible consequences of an accident.  Area residents have been able to block a Homeland Security Department plan to upgrade the Plum Island Animal Disease Center off the coast of Long Island, N.Y., and have also sued to block a laboratory proposed by the University of California at Davis, the Times reported.

“The risk is low, but the outcome is total devastation,” said Linda Perry, a Hamilton veterinarian.  “If there is an accident, people here are going to lose everything,” she said.

NIAID Deputy Director John La Montagne denied that the new laboratories pose increased risks to the public.

“Safety is a nonissue,” La Montagne said.  “These are highly safe facilities,” he added (Charles Piller, Los Angeles Times, June 25).

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Smallpox:  Report Says Threat of Vaccine Was Exaggerated

By David McGlinchey
Global Security Newswire

WASHINGTON — U.S. health officials crippled the national smallpox immunization campaign by exaggerating the threat of the smallpox vaccine, according to a report to be released this week by the CATO Institute (see GSN, June 23).

Beginning in late January, U.S. officials had hoped to immunize 10 million emergency first responders by the end of the summer.  As of early June, only 37,000 civilians had received the vaccine.

“The perception of vaccine risk by many medical and public health practitioners, as well as by the public, is far greater than the actual risk,” says the report from William Bicknell, a Boston University professor and an authority on immunization planning, and Kenneth Bloem, a former chief executive of Stanford University Hospital and a veteran of smallpox eradication programs in Central Africa and Bangladesh.

The report says the information distributed by the Centers for Disease Control and Prevention was “inadequate and confusing.”  The CDC did not respond to Global Security Newswire’s requests for an interview by press time, but health officials have said that one or two people could die from the vaccine for every million that are inoculated.  Health officials also warned that up to 50 people per million could suffer serious side effects.  Many more were expected to suffer annoying but nonlife-threatening side effects.

Bicknell and Bloem say the U.S. vaccination effort — which focused on health workers and emergency responders — was primarily aimed at healthy adults.  The report says that the historical sickness rates used by the CDC include children, the elderly and those with illnesses.

The vaccine’s fatality rate for healthy adults is approximately one in 15 million, according to the report.

Since the program began in February, health officials have investigated several deaths among the 37,000 civilian volunteers, but none was found to be related to the vaccine.  In addition, about 10 vaccine recipients have suffered from cardiac inflammation that has been linked to the immunizations.  The Defense Department inoculated more than 450,000 military personnel, and no military deaths have been directly attributed to the immunizations.  Approximately 40 Pentagon personnel experienced the heart inflammation.

The report also criticized the lack of high-level leadership for the program and the absence of compensation for those sickened by the vaccine early on in the immunization process.  U.S. President George W. Bush signed a bill to provide compensation April 30, but the program was already floundering at that point and it has failed to be revived (see GSN, May 1).

Given the allegedly exaggerated threat, as well as the lack of compensation and leadership, the report says that “far too many people reasonably and understandably, but erroneously, are prone to conclude that vaccination before an attack is too dangerous, its complications may not be paid for, and it probably isn’t very important anyway.”

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U.S. Response:  Bush Asks for Lobbying Help on Project Bioshield

By David McGlinchey
Global Security Newswire

WASHINGTON — U.S. President George W. Bush appealed to the pharmaceutical industry yesterday to lobby Congress to support Project Bioshield, a $6 billion, 10-year effort to stockpile medicines and technologies to respond to a bioterrorist attack (see GSN, June 23).

In a speech to the Biotechnology Industry Organization convention here, the president called Project Bioshield a “great scientific effort” and “a key part of our all-out effort to prepare for the threat of bioterror.”

Bush proposed the plan during his January State of the Union speech, but the legislation is still being considered in the House Select Committee on Homeland Security.  Republican and Democratic lawmakers have criticized Project Bioshield as being ineffective, poorly structured and too narrowly focused (see GSN, May 16).

In May, Representative Harold Rogers (R-Ky.) said the $5.6 billion project is “chicken feed to this [pharmaceutical] industry.”

Bush asked conference attendees to lobby members of Congress, saying that under the plan Washington would spend more money on pharmaceutical research.

“If you’re interested in seeing more flexibility and more research dollars for the sake of national security, I need your help in lobbying the members of the United States Congress,” he said.

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Smallpox:  Immunization Program Falters, But Threat Remains

By David McGlinchey
Global Security Newswire

WASHINGTON — The national smallpox immunization campaign has slowed to a nearly complete halt, but the threat of a smallpox terrorist attack has not been significantly diminished, according to a Republican lawmaker (see GSN, June 20).

“I don’t think there is any question that the need is still there for us to have a plan in place,” said House Select Intelligence Committee member Richard Burr (R-N.C.), who sponsored legislation in April designed to jumpstart the faltering vaccination effort.

Some public health experts agreed that the United States must continue to prepare for a possible smallpox attack.

“The threat is there … until the intelligence committee tells us it’s gone I’m unwilling to say it is gone, or decreased,” said William Bicknell, a Boston University professor and an authority on immunization planning.

In December, U.S. President George W. Bush announced the immunization campaign, which was intended to inoculate 500,000 civilian health care workers in “phase one” and another 10 million emergency workers in the second phase.  Health officials said they wanted to reach the 500,000 mark by the end of February, but only 37,000 health workers had been immunized by early June.  The campaign has not yet officially moved into phase two.

Burr sponsored a bill to compensate those sickened by the potentially harmful vaccine, a long unresolved issue that was keeping volunteers away from the program (see GSN, May 1).  Bush signed the bill into law last month, and lawmakers were hopeful for a swell in volunteers, but a quick end to the war in Iraq took momentum away from the effort, according to some officials.

The threat of a smallpox attack goes beyond Iraq, according to Bicknell and Kenneth Bloem, a senior fellow at the Johns Hopkins University Center for Civilian Biodefense Strategies.  In a soon-to-be-released paper from the CATO Institute, the two say that health officials should not allow the vaccination campaign to die.

“The smallpox risk has never been thought to be limited to the [Saddam] Hussein regime … as was true before the Iraq war, the decision regarding post-Iraq smallpox risk is for the intelligence community to assess, not for medical and public health personnel,” the paper says.

Last week, the New York Times reported that only 100 volunteers, nationwide, are receiving the vaccine each week and Burr said the program had stumbled out of the gates and had never recovered.

“Clearly we are not going to have the pool that we first thought we would,” Burr said.

Faced with low numbers of immunized health workers, Bicknell and Bloem called on the Bush administration to rejuvenate the campaign.  They also recommended the establishment of an advisory panel “to assure that bioterrorism response plans are adequate,” according to their report.

Burr said the United States must explore new technologies to improve biological defenses.

“We need to continue to look at alternatives that allow us to address an attack in a timely fashion, I don’t want us to look at the vaccination program as the only method to prepare for an attack,” he said.

Burr offered strong support for Project Bioshield — a $6 billion, 10-year effort to stockpile medicines and technologies to respond to a bioterrorist attack.  He said that the effort, proposed by Bush in his January State of the Union address, could advance promising new efforts.  The bill is currently in the House of Representatives (see GSN, May 23).

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Anthrax:  Washington Postal Facility Set to Reopen By Late November

By Mike Nartker
Global Security Newswire

WASHINGTON — The Brentwood Road postal facility here, which was contaminated during the 2001 anthrax attacks and has since been the focus of a major decontamination effort, is expected to resume full operations by the end of November, a U.S. Postal Service spokesman told Global Security Newswire today (see GSN, March 5).

Preliminary tests conducted in early March indicated that decontamination of the Brentwood Road facility had been a success.  An Environmental Clearance Committee — consisting of scientific experts from a number of agencies, including the Washington Health Department, the U.S. Environmental Protection Agency and the Occupational Health and Safety Administration — then reviewed the results and declared the facility to be clean, Postal Service spokesman Bob Anderson said.

The Postal Service is now in the process of renovating the facility in preparation for resuming full operation, which postal officials have set for “the holidays” — meaning by the end of November, Anderson said.  The decontamination process, which involved filling the facility with chlorine dioxide gas to kill lingering anthrax spores, resulted in the creation of salt and water byproducts that caused some corrosion that needs to be cleaned, he said. 

The renovation work is being performed by contractors and former Brentwood Road employees working as volunteers, Anderson said, adding that the former employees working at the site are “enthusiastic and ready to get back to work.”  Community meetings are set to be held once the facility is fully operational to address lingering concerns, Anderson said, noting that no such meetings have yet been scheduled.

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Smallpox:  Panel Warns Against Expanding Immunizations

An influential health advisory board yesterday cautioned against expanding the national smallpox immunization campaign to millions of emergency workers, the Washington Post reported (see GSN, June 19).

Meeting yesterday in Atlanta, officials from the Advisory Committee on Immunization Practices — which counsels the Centers for Disease Control and Prevention on vaccine issues — said it would be “unwise to expand beyond its current, pre-event smallpox vaccination recommendations.”

The move comes as many health officials are saying that the immunization program has effectively stopped well short of U.S. President George W. Bush’s goals, the Post reported.  In December, Bush said he wanted 500,000 civilian health care workers immunized by the end of February and another 10 million emergency workers immunized by this summer.  Approximately 37,000 civilian health workers have been immunized to date.

The committee cited “new and unanticipated safety concerns” in cautioning against expanding the program.  During the civilian and military immunization campaigns, an unexpected number of people experienced cardiac difficulties, particularly tissue swelling in and around the heart.

The CDC is reviewing the program at the six-month mark, according to Joseph Henderson, the top bioterrorism official there.

Henderson said that focusing completely on vaccinations “is not a practical approach right now,” but maintained that the centers are “committed to the president’s decision.”

CDC Director Julie Gerberding said U.S. health officials would review the committee recommendation, but it was doubtful that immunizations would stop.

“The more people we have vaccinated, the better off we’ll be, and the fact that we have almost 40,000 people vaccinated is, I think, a tremendous step forward compared to where we were just six months ago,” Gerberding said.  “So we’ve made enormous progress, but we have more to do,” she added (Ceci Connolly, Washington Post, June 20).

The committee said the heart inflammation issue needed further exploration before inoculations can continue.

“The committee has believed from the beginning that we need to put safety above and beyond any other issue,” said John Modlin, committee chairman and professor at Dartmouth Medical School.  “This will allow us to buy some time, and to perhaps better understand both sides of the equation,” he added (Catherine Shoichet, Atlanta Journal-Constitution, June 20).

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International Response:  Global Biological Security Guidelines Needed, Expert Says

By Mike Nartker
Global Security Newswire

WASHINGTON — Nations with scientific research facilities must develop new security guidelines to prevent terrorists from acquiring dangerous pathogens that could be used to develop biological weapons, a leading nonproliferation specialist said yesterday (see GSN, June 12).

Without improved security measures, terrorists could try to obtain pathogens by stealing them from research facilities or by purchasing them under false pretenses, according to Jonathan Tucker, a senior fellow at the U.S. Institute of Peace.  During a presentation at the institute’s Washington headquarters, Tucker cited several examples of poor security at research facilities, such as those found by a U.S. Agriculture Department investigation that found that many of the department’s 124 laboratories were vulnerable to theft (see GSN, May 13, 2002).

While the United States and other countries have sought to domestically improve laboratory security with new regulations (see GSN, Jan. 29), an international system of biological security guidelines is needed to avoid gaps of weak enforcement that terrorists might attempt to exploit, according to Tucker.  Such guidelines should address physical security, pathogen accountability and facility personnel concerns, he said. 

At a minimum, according to Tucker, a new system of international guidelines should include the registration and licensing of research facilities that work with an agreed list of pathogens.  The new guidelines should also include physical security requirements for facilities based on the perceived levels of theft risk, as well as pathogen inventory and collection audit procedures to prevent diversion, he said.  Tucker warned, however, that quantitative inventory control procedures would not fully guarantee security because a potential terrorist could steal a minute sample of a pathogen and use it to produce large amounts.

In addition, new security guidelines should also focus on facility personnel concerns, such as periodic background checks, Tucker said, adding that scientists and technicians should receive security education and training.  Regulations concerning the transfer and export of pathogens should also be included in the new system, he said.

Tucker said his proposal mainly focused on preventing terrorists from illegally obtaining pathogens for use in weapons.  It would do little to prevent state proliferation of biological agents or to prevent states from providing terrorists with such agents, he said.

An August meeting of the Biological Weapons Convention experts group, scheduled to be held in Geneva, could be used as a launching point for the development of new international security guidelines, Tucker said.  Convention members should create a technical experts group — which could include representatives from international organizations and scientific organizations — to develop the guidelines, which could then be individually implemented through national legislation, he said.  An international oversight mechanism may also be needed to ensure uniformity and to prevent security gaps, Tucker added.

New guidelines should be developed with a focus on the inclusion of those developing countries with the least secure research facilities into the system, according to Tucker.  To this end, a minimum-standards level should be created that countries could meet either through labor-intensive measures for developing countries and more capital-intensive measures for industrialized nations, he said.  Standards should also have an appropriate level of flexibility to be tailored to individual facilities, Tucker said.  The system should also focus on compliance via incentives, not through punishments, he said.

Once the guidelines are created, states that choose to implement them could also agree to participate in annual review meetings that could be organized by an international secretariat, Tucker said.  At these meetings, countries could report on the implementation of the guidelines at a national level, as well as participate in information exchanges to aid the implementation of new biological security standards, he said.

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Smallpox:  Smallpox Immunization Programs Stalled

U.S. officials said yesterday that the national smallpox immunization campaign had come to an effective halt, the New York Times reported (see GSN, June 13).

The civilian smallpox immunization program, which was intended to inoculate 500,000 civilian health care workers by the end of February, has so far immunized only 37,608 volunteers.  Health officials said 100 more are being immunized each week.

The U.S. Defense Department has immunized 454,856 military personnel, and is inoculating 1,000 each week as a “maintenance” effort, according to Col. John Grabenstein, who ran the defense immunization effort.

Raymond Strikas, who directed the civilian immunization program for the Centers for Disease Control and Prevention, said that volunteer interest had dropped off after March and the program was now paused.

The U.S. military victory in Iraq, a long delay in the compensation plan for sickened volunteers (see GSN, May 1) and other public health concerns hampered the program, according to Strikas.  U.S. President George W. Bush originally indicated the vaccine would eventually be available to the general public, “but there’s been relatively little clamoring for that,” Strikas said.  “We accept where we are, given the circumstances.  We can make this work,” he added (Donald McNeil, New York Times, June 19).

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