Smallpox:  Panel Supports 500,000 Pre-Emptive Vaccinations

A U.S. Centers for Disease Control and Prevention advisory panel recommended yesterday that 500,000 health care workers be immunized with the smallpox vaccine, revising a stance it took earlier this year (see GSN, Oct. 16).

In June, the Advisory Committee on Immunization Practices supported the pre-emptive vaccination of only 20,000 health care and emergency workers (see GSN, June 21).

The committee has been at odds with the CDC and U.S. health officials, who want a farther-reaching inoculation plan.  The final decision rests with the White House, and that should come “in the next couple weeks,” according to D.A. Henderson, the Bush administration’s senior biological terrorism expert (M.A.J. McKenna, Atlanta Journal-Constitution, Oct. 17).

Some officials had supported a plan that would inoculate up to 10 million people, including paramedics, firefighters and police (Anita Manning, USA Today, Oct. 17).

The 500,000-person plan would include lab workers, security guards and cleaning staff at hospitals.  Several members of the panel opposed the new plan, including Paul Offit, chief of infectious diseases at Children’s Hospital of Philadelphia, who said the panel members were avoiding their responsibilities by changing their recommendation.

“We shirk our responsibility by throwing it back onto the public to make a decision that we should help make,” Offit said (McKenna, Atlanta Journal-Constitution).

Meanwhile, Harvard scientists have produced antibodies that could attack the smallpox germ, the Journal-Constitution reported today.

The antibodies are designed to attack the surface of the smallpox virus and destroy it, according to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

The antibodies — developed by Ellis Reinherz, an immunologist at Harvard — would be given to a patient after they contracted the disease.  In addition to their use on smallpox outbreaks, the antibodies might be effective on illnesses caused by the smallpox vaccine, Fauci said (Jeff Nesmith, Atlanta Journal-Constitution, Oct. 17).

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Anthrax:  Pentagon Ready to Begin Limited Vaccination Program

The U.S. Defense Department is ready to begin a limited anthrax vaccination program, vaccinating only those soldiers heading to high-risk areas rather than the previous mass vaccination campaign, Stars and Stripes reported today (see GSN, May 20).

“What changes between the way we did things in the past and the way we’re going to do things now is there’s going to be better control about who gets it and who needs it,” said Navy Lt. Cmdr. Dale Baker, director for community health at the U.S. Navy Hospital at Camp Lester in Okinawa, Japan.  “As a result of that, many of the groups have dropped off now because the mass immunization that we once thought was necessary, the folks have gone back and decided that probably might have been overkill.”

Each of the four branches of the armed services — the Army, Navy, Air Force and Marines — was instructed to develop an anthrax vaccination plan.  Those plans, however, have not yet been completed.  Instead, military medical personnel are using interim Pentagon guidelines to determine who is to be vaccinated and how the vaccine is to be administered, according to Stars and Stripes.

According to the interim guidelines, U.S. military personnel heading into a high-risk area for anthrax for 15 days or more will be vaccinated, Baker said.  The vaccine regimen is the same as it was before vaccinations were suspended in June 2001 — three shots administered in three-week intervals, then a final three shots administered in five- to six-month intervals.  Personnel who had already begun the vaccination regimen will resume where they left off, Baker said.

Once a soldier receives all six anthrax vaccinations, he is immunized against both inhalation and skin anthrax.  Annual booster shots are needed to maintain immunity.

“They may change it once there’s an actual event but ... once you’re immunized, you shouldn’t need any other attention,” said Navy Lt. Cmdr. Annette Von Thun, head of population health at the Navy hospital.

Anthrax vaccinations administered under the new program will be more carefully monitored than they were in the past, Stars and Stripes reported.  Each vaccine dose lot number and each individual dose will be recorded and logged.

“Basically, every single shot is accounted for,” Baker said.  “We know exactly who got it, and how many and it will be electronically monitored” (Mark Oliva, Stars and Stripes, Oct. 17).

For further information, see:

CDC Frequently Asked Questions About Anthrax

Journal of the American Medical Association Background on Anthrax

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Smallpox:  U.S. Officials Push Mass Vaccination

U.S. health officials this week will present their argument for a mass, nationwide smallpox vaccination campaign to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (see GSN, Oct. 15).

The committee has earlier recommended immunizing only 20,000 health care workers (see GSN, June 21); the officials are expected to try to persuade them otherwise today in Atlanta (see GSN, Sept. 27).

“We’ve taken the ACIP’s recommendations and expanded upon it,” said Bill Hall, spokesman for the Health and Human Services Department.

The department is also distributing information to doctors on recognizing smallpox symptoms and administering the vaccine, as well a list of people who cannot be inoculated.  Jerry Hauer, assistant Health and Human Services secretary for public health preparedness, announced the department plans to hire a psychiatrist trained in communication and mass panic.

“The ‘worried well’ can bring the health care system to its knees,” he said (Daniel Yee, Associated Press/Yahoo.com, Oct. 16).

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Anthrax:  CDC Vaccine Research Program Needs Additional Studies, Report Says

By Mike Nartker
Global Security Newswire

WASHINGTON — The U.S. Centers for Disease Control and Prevention anthrax vaccine research program is generally appropriate, but a number of research studies should be canceled and others added, a group of U.S. scientific advisers said in a report released yesterday (see GSN, Oct. 4).

The CDC has proposed a number of research studies to evaluate the efficacy, safety and the acceptability by the public of the current anthrax vaccine — Anthrax Vaccine Adsorbed (AVA).  It is primarily used by the military, which began an anthrax vaccination program in 1998 (see GSN, May 20).  The vaccine is administered through a series of six injections over an 18-month period and requires annual boosters.

The CDC studies include both human clinical trials and primate studies for a number of factors such as required vaccine dosage and potential side effects, according to the report by the National Academy of Sciences Institute of Medicine.  While the report praised a number of these studies, it found that several could be canceled due to their low priority.  The CDC also needs to conduct more research into the passive protection offered by the vaccine in primates in order to determine the level of antibody needed to protect against anthrax, the report says.

As part of its research on the anthrax vaccine, the CDC should examine its effect on children, the elderly and persons with chronic illnesses, the report says.  This study should become a high priority once the CDC determines how the vaccine should be optimally administered to healthy adults, the report says.  The CDC should also increase its research into the use of the anthrax vaccine as a post-anthrax exposure treatment, the report says (see GSN, March 7).

“With some additions to its research portfolio, CDC could make further contributions to understanding the safety and efficacy of AVA as it is currently used or of new uses of AVA or a new anthrax vaccine,” the report says.

The CDC needs to establish clearly defined senior leadership for the vaccine research program in order to provide authority and accountability, with one senior biomedical scientist put in charge of the entire program, according to the report.  An external advisory group for the vaccine research program should also be created in order to help determine which studies should be continued and what new research projects should begin.

“In the absence of authoritative centralized senior leadership, individual projects within programs can sometimes gain a momentum of their own and become difficult to modify or stop, even if they are no longer appropriate,” the report says.

For further information, see:

CDC Frequently Asked Questions About Anthrax

Journal of the American Medical Association Background on Anthrax

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U.S. Response:  Army, NIH Plan USAMRIID Upgrade

The U.S Army and the National Institutes of Health presented a plan yesterday to build a new campus at the U.S. Army Medical Institute of Infectious Diseases. The Fort Detrick, Md. facility houses both civilian and military scientists to develop better biological weapons defenses (see GSN, April 11).

The first stage of the national Defense Biomedical Research Consortium plan involves the construction of a $105 million NIH building near USAMRIID, according to the Associated Press.  Funding for the building, expected to begin construction in 2004, is almost guaranteed, said John La Montagne, deputy director of the NIH National Institute of Allergy and Infectious Diseases.

The building will house a Biosafety Level 4 laboratory, used to conduct work on the most dangerous pathogens, La Montagne said.  NIH also plans to build a similar laboratory at its infectious-disease research facility in Hamilton, Mont., AP reported (see GSN, July 18).

The Army also plans to upgrade USAMRIID facilities as part of the consortium project, said Maj. Gen. Lester Martinez-Lopez, commander of Fort Detrick.  The Army plans to replace the 32-year-old main USAMRIID building with a larger facility expected to cost “close to a billion dollars” that will be connected to the new NIH facility, Martinez-Lopez said.  The Army hopes to begin construction of the new USAMRIID facility in 2007, but could begin earlier depending on public and congressional support, he said.

The new USAMRIID building is expected to have improved security measures, such as constant video monitoring of facilities, Army officials said (see GSN, July 29).  The security upgrades will also include a personnel reliability program the Army is developing to check the backgrounds and certifications of scientists working with biological agents, said USAMRIID commander Col. Erik Henchal (see GSN, Aug. 8; David Dishneau, Associated Press, Oct. 16).

The USAMRIID expansion will help create a “ brain trust” of both civilian and military scientists to develop better defenses against biological weapons, La Montagne and Martinez-Lopez said yesterday.

“We’re in the middle of a war,” Martinez-Lopez said.  “We want to build the best biotechnology center in the country.”

Meanwhile, a university consortium including the Johns Hopkins University and the University of Maryland at Baltimore plan to apply for NIAID funding to become a “Regional Center of Excellence for Biodefense,” according to the Baltimore Sun (see GSN, Aug. 16).  The consortium might also apply for funding to build a Biosafety Level 4 laboratory, according to sources.

Some scientists and arms control experts, however, have criticized the expansion and new construction of biological research facilities.  Such an expansion could lead to an increase in biological attacks by increasing access to knowledge and biological agents, they said, adding that some investigators believe last fall’s anthrax attacks were carried out by someone with access to the U.S. biological defense program.

“These laboratories might become a pathogen-modification training academy or biowarfare agent ‘superstore,’” wrote Eileen Choffnes of the National Academy of Sciences in a recent article in The Bulletin of the Atomic Scientists (Scott Shane, Baltimore Sun, Oct. 16).

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Smallpox:  Defense Officials Recommend Mass Military Vaccination

The U.S. Defense Department may soon begin to vaccinate as many as 500,000 military personnel against smallpox, the New York Times reported Saturday (see GSN, Oct. 7).

Leading defense officials have recommended that Defense Secretary Donald Rumsfeld approve the vaccination plan, under which 350,000 to 500,000 troops would be immunized as soon as food and drug officials license the vaccine.  The White House must also approve the plan.

The recommendations have come at the end of a Pentagon study on the risk that smallpox poses to U.S. military forces (see GSN, Oct. 8).

“If you’re talking about potentially sending troops to areas where they could be exposed to smallpox,” a Pentagon official said, “aren’t you negligent if you don’t give them every possible protection?”

The Food and Drug Administration is expected to license 1 million doses of vaccine early in November and another million later in the month.  Last week Rumsfeld directed Pentagon officials to assist U.S. allies in obtaining the vaccine to protect themselves against an attack, the Times reported (Miller, Schmitt, New York Times, Oct. 12).

Debates within the Bush administration, meanwhile, have delayed important decisions needed to shape a response to potential biological terrorism attacks, the Times reported.

Some White House officials, including Vice President Dick Cheney, reportedly support widespread vaccinations without evidence of a terrorist attack.  President George W. Bush and others, however, have been more cautious in light of the vaccine’s potential dangerous side effects (William Broad, New York Times, Oct. 13).

Israel Vaccinates Key Personnel

In Israel, health officials Sunday began inoculating thousands of key security and emergency response personnel against smallpox (see GSN, Aug. 21; Dawn, Oct. 14).

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