Smallpox:  Germany Has Immunization Plan, 100 Million Vaccine Doses

Germany has 100 million doses of smallpox vaccine on hand and German officials have prepared an emergency plan to quickly immunize the population in case of a biological attack, according to the German weekly magazine Focus, Agence France-Presse reported yesterday (see GSN, Oct. 24).

The plan calls for 500,000 firefighters and 800,000 clinical workers to quickly distribute the vaccine to the country’s 82 million residents (Agence France-Presse, Nov. 17).

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BWC:  Conference Approves BW Nonproliferation Work Plan

By David Ruppe
Global Security Newswire

GENEVA — Guided by the persistent and patient diplomacy of a Hungarian diplomat, parties to the Biological Weapons Convention unanimously agreed today to continue meeting over the next three years to discuss ways of addressing biological weapons proliferation (see GSN, Nov. 14).

The United States, among the celebrants, was cast by some delegations as the villain of the conference for discouraging the creation of an inspections mechanism to check compliance with the treaty, and for reportedly insisting on no changes to the plan offered this week.

The parties approved a final decision of the 1972 treaty’s fifth review conference unamended, laying out a plan for annual meetings until the next review conference in 2006 to discuss a list of possible actions.

“Thank you very much, this is a happy moment, said conference chairman Tibor Toth, after receiving unopposed support for the proposal and gaveling it into existence.

Until the final hour of this conference, delegates and observers were on edge to see whether countries that had urged amendments to the plan might oppose it or possibly try to amend it when finally submitted for approval.  A collection of developed countries, known as the Western Group that includes the United States, had indicated they would oppose the plan if amended (see GSN, Nov. 13).

Toth, who during three days of closed discussions strove to develop a consensus, urged delegations that it was likely to pass only if submitted without changes (see GSN, Nov. 11).

“I cannot hand out last minute goodies because all of those compromises have been built into the draft decision as it stands now,” Toth told Global Security Newswire.

Toth was heartily applauded by delegates and reappointed to the presidency.

“He’s done a fantastic job, presiding over this,” said U.S. Assistant Secretary of State for Arms Control Stephen Rademaker, the senior member of the U.S. delegation.  “I’ve been watching him for the last several months and he has the patience of a saint and the victory today is in no small measure due to his extraordinary efforts.”

The seeming inability of parties to agree to any kind of plan for cooperation for more than a year was seen by many diplomats and outside experts as a sign that the international community was unable to address biological weapon proliferation multilaterally.  Many have said they were troubled by such a shortcoming in light of certain developments in the biotechnology field, the anthrax attacks in the United States and other high-profile terrorist attacks.

The subjects that will be discussed at the meetings include:

*         adopting national measures to implement treaty prohibitions, including penal legislation;

*         creating national mechanisms to establish and maintain the security and oversight of pathogenic microorganisms and toxins;

*         enhancing international capabilities for responding to, investigating and mitigating the effects of cases of alleged use of biological or toxin weapons or suspicious outbreaks of disease;

*         strengthening and broadening national and international institutional efforts and existing mechanisms for the surveillance, detection, diagnosis and combating of infectious diseases affecting humans, animals and plants; and

*         developing, promulgating and adopting codes of conduct for scientists.

U.S. Painted as Bad Guy

Despite its adoption by consensus, Toth’s work plan was considered by most delegations, including other Western Group members, to be a poor alternative to a protocol negotiated over seven years that would have created a mechanism for assessing treaty compliance through inspections.

Though not named specifically in statements following the vote, the United States was widely viewed as criticized by a collection of developing states known as the Nonaligned Movement and other states for its opposition to the protocol.  Following the conference, those countries issued a statement criticizing the conference for not adopting “initiatives to strengthen the implementation of the convention.”

“While standing at the verge of success, we were prevented from achieving a successful conclusion of the BWC Review Conference at our meeting in 2001,” it said (see GSN, Dec. 10, 2001).

The NAM and others also referenced an April NAM statement expressing concern about “the growing resort to unilateralism and unilaterally imposed prescriptions.”

The United States had withdrawn its support for the protocol mid-2001, and concerned about re-emerging discussions of a compliance mechanism, opposed a closing resolution for the conference last December, forcing Toth to suspend the conference until this week.

This past September, U.S. diplomats told Western Group members they opposed holding any meetings before the next review conference in 2006 and preferred a “very short” resumed conference this week (see GSN, Sept. 6).

In supporting the Toth proposal today, U.S. officials appeared to have taken a step back from that position.

Toth, at a press conference today, said he and “many, many states’ parties, including close allies of the United States,” appealed to U.S. diplomats at the September meeting, saying “we might be able to do it in a way where we focus on not what was dividing us but what was bridging us.”

Toth’s plan closely mirrored a U.S. proposal for discussions last year.

A U.S. official disputed the NAM that characterization of unilateralist, observing the United States had joined in supporting the Toth proposal.

“I heard those same comments ... I thought they were misdirected,” said Rademaker during a press conference.

He cited successful U.S. efforts to gather U.N. support for pressing Iraq to allow weapons inspectors in (see GSN, Nov. 8). “It’s very difficult to accuse the United States of unilateralism,” Rademaker said.

He also cited U.S. support for the Toth proposal today saying, “It’s nothing if not multilateral.”

Bioweapons Development “Unverifiable”

With other Western Group members apparently unwilling to pursue an inspection mechanism absent support from the United States, which has by far the world’s largest and most advanced biotechnology sector, the U.S. position effectively set the direction of the consensus-ruled treaty meeting.

Rademaker explained U.S. opposition to the protocol, saying it is the U.S. view the treaty is “inherently unverifiable” using traditional arms control mechanisms.

“It was the view of the United States a year ago that the inspection mechanism that was developed in the context of the protocol would not be effective in detecting the violations of the biological weapons convention,” he said. 

“At the same time, it was our conclusion that it would put at considerable risk intellectual property rights of pharmaceutical and biotechnology firms who might be subject to inspections under the protocol.  It would put at risk legitimate biodefense activities carried out by the United States and other governments consistent with the Biological Weapons Convention,” he said.

Rademaker said there was a concern that inspectors would misinterpret defensive biological research and development allowed by the treaty for an offensive program.

“To conduct biodefense, you basically have to create a biological weapon to figure out how to defend against it,” he said.  Later, when asked whether the United States was building biological weapons for defensive research, he clarified it was not weapons necessarily created for defensive purposes, but “agents” allowable by the treaty.

The Bush administration has received some criticism from experts over secret programs officials said were defensive, including one to develop genetically altered variant of the anthrax bacteria to replicate a suspected Russian model, revealed by the New York Times last year.

Rademaker also said the protocol would require nations to declare the agents they created for biological defense research, the release of which could tip off potential attackers.

Perhaps anticipating criticism the United States had turned its back on biological weapons control, the U.S. team passed out to reporters a release describing U.S. efforts to combat the biological weapons threat.

It cited the USA Patriot Act, major legislation increasing law enforcement capabilities, measures to improve national and global health system detection and response capabilities, and initiatives with other countries to prevent the spread the of technologies that could be used to make biological weapons.

“The principal point that I hope you take away from this sheet is that the Biological Weapons Convention is not the only place that we can make progress … There are more ambitious ideas that we think can be pursued in other venues,” Rademaker said.

Alternatives to Inspections

Asked what mechanism could be used to confirm suspected biological weapons activities without treaty inspections, Rademaker said, “It’s the view of the United States that there is no formula that will work in all cases.”

Rademaker called “prevention” the “single most effective step to combat the threat of biological weapons.”

“In other words, not to discover biological weapons once they are in existence, but to prevent such programs from getting off the ground in the first place, and central to that policy is the effective enforcement of export controls,” he said.

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Smallpox:  Targeted Vaccination is Key, Study Says

The best way to conduct a vaccination campaign during a smallpox outbreak would be to find and target everyone who comes into contact with anyone who has been infected with the disease, says a study published today in Science magazine (see GSN, Nov. 7).

The study lends support to the strategy known as targeted vaccination, and it provides some evidence against the competing strategy known as mass vaccination, which Yale University public health specialist Edward Kaplan and two colleagues supported in a study in July, according to the magazine (see GSN, July 8).

Both studies draw their conclusions from computerized models that use information such as how contagious smallpox is and for how long it is transmittable to calculate how the disease would spread through a population.  The two studies reach different conclusions, however, partly because they make different assumptions about how the disease might be transmitted, Science reported.

Kaplan assumed that any population is similar to a continuous block of people so that disease spreads through it in a way similar to the way that electricity might spread through a sheet of metal.  The study published today, authored by M. Elizabeth Halloran and three colleagues, takes into account the individuality of each member of a population, which allows the disease to die out if contacts among people are limited by where they live or with whom they socialize, Science reported.

Many scientists are beginning to believe that the model that Halloran used is probably more accurate, according to Science.  The Kaplan model can only calculate an overall level of vaccination that health workers might need to accomplish, the magazine reported.  Halloran’s model, however, illustrates that it is important to focus on transmission chains rather than wasting resources on people who are not at risk, according to the magazine.

Mass vaccinating a population before anyone is infected would not completely prevent a smallpox outbreak, Halloran said, because a massive campaign would still miss a significant number of people, including those unable to receive the vaccine for health reasons and those who may not be able to reach a clinic to receive the vaccine.  Additionally, mass vaccinating after an outbreak is ineffective because it is difficult, unnecessary  and possibly unsafe to persuade everyone seek inoculation.

Given Halloran’s study, many analysts believe that vaccinating some people before any outbreak and then stopping any chains of transmission before they become widespread is the most effective way to snuff out an outbreak, Science reported.  One possible disadvantage of a targeted strategy, however, is that it might take less time to automatically vaccinate a mass of people than to follow chains of at-risk individuals one-by-one for targeted vaccinations, according to Science (Jim Koopman, Science, Nov. 15).

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BWC:  Diplomats Expect Conference Agreement Today

By David Ruppe
Global Security Newswire

GENEVA — Parties to the Biological Weapons Convention are expected to approve a final decision of the treaty’s fifth review conference later today.  Delegates said countries that were seeking to change the text of a draft decision proposed by the conference chairman have relented, and the draft will most likely be approved by consensus with no changes (see GSN, Nov. 13).

Chairman Tibor Toth has scheduled a plenary meeting for late today to submit the plan for approval without any of the changes that some states had advocated.  He had offered a draft decision to the conference Monday (see GSN, Nov. 11).

“I cannot hand out last minute goodies because all of those compromises have been built into the draft decision as it stands now,” Toth told Global Security Newswire this morning.

Approving review conference decisions has traditionally required consensus among the parties, but until now consensus has eluded the current conference, which Toth suspended in December 2001 after parties failed to agree on a final declaration.

The inability of parties to agree to any kind of plan for cooperation for more than a year is seen by many diplomats and outside experts as a sign that the international community is unable to address biological weapon proliferation multilaterally.  Many have said they are troubled by such a shortcoming in light of developments in the biotechnology field, the anthrax attacks in the United States and other high-profile terrorist attacks.

“Facing a threat that is ubiquitous means multilateral measures are needed,” said a Western diplomat at the conference.  While the Toth proposal does not create any multilateral measures, it could promote needed international cooperation, the diplomat added.

The Toth plan calls for holding annual meetings until the next review conference in 2006.  Discussion at these meetings would be limited to five subjects primarily addressing ways that individual countries could improve domestic measures to control and penalize biological weapons activities.  Virtually every state is believed to support such meetings in principle.

Without Changes

Toth’s decision to submit his proposal without any changes should be a disappointment to some delegations.  Since the chairman formally proposed the text Monday, some diplomats from a collection of developing states known as the Nonaligned Movement have attempted to expand the scope of the proposed annual meetings.

A collection of developed countries known as the Western Group has opposed broadening the proposal, and the United States reportedly supports that position.  For instance, it has opposed discussions to create a global inspection mechanism for checking compliance with the treaty.  Citing commercial interests and national security, it withdrew from efforts to create such a mechanism last year, disappointing Western Group and NAM members alike.

Toth has said that he opposes allowing changes because parties are unlikely to reach agreement if the text of his draft decision is opened for negotiation.

“I have not promised last-minute compromises because all of the compromises were embedded in the draft decision,” he said.  “I explained to delegations what compromises were required by others and what compromises were required by them,” he said.

Toth also cited precedents for taking a gradual approach to developing a major nonproliferation treaty, he said.

Implied in Toth’s proposal, though not specifically addressed in it, is that an ad hoc group that had been negotiating a treaty protocol would not be abolished or have its mandate terminated.  That protocol, under negotiation for more than seven years, would create verification and monitoring systems for the treaty, which currently has none.  In the past, U.S. officials have sought to end the group’s existence.

Some Optimism

The Western Group diplomat said there is cause for optimism that delegates will accept the proposal.  NAM delegations that had proposed changes said explicitly on Wednesday that they would not veto the proposal, the diplomat said.

“I think that no country wants to stand up and deny the will of all the other states,” the diplomat said.  “Countries will want to join in and support the decision for the common good.”

Toth was slightly more cautious this morning.  “We are very, very close to consensus and we shouldn’t let the process drift in a negative way and turn it into an agonizing exercise.”  He said he is motivated to bring the proposal forward today because a delay might decrease the chances of a successful outcome.

U.S. Support Anticipated

Diplomats have said that the United States has indicated it plans to support the proposal.  U.S. officials appear to have taken a step back from their previous position, stated in September to other developed countries, of opposing any meetings preceding the next review conference in 2006 (see GSN, Sept. 6).

“I think [it was] the vocal, unanimous views expressed in September by all of its allies that their position was unacceptable,” said the Western diplomat.  “I think they heard that and I think they were listening.”

Toth said his proposal is similar to one proposed by U.S. delegates late last year, and that that U.S. proposal was built upon elements already approved in previous review conference final declarations.

“It would be very difficult at this time for the U.S. not to support it,” Toth 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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Smallpox:  Homeland Bill Includes Smallpox Vaccine Liability Protection

Removing a large roadblock to smallpox immunizations, U.S. legislators have included language in the homeland security bill to limit lawsuits against medical workers administering smallpox vaccine (see GSN, Oct. 24).

Senators are expected to vote by next week on the bill, which the House of Representatives passed yesterday.  If the bill passes intact, the U.S. government would pay damages to those who are injured or to the families of those who are killed by the vaccine, but victims would not receive punitive damages, the Associated Press reported.

“Because of risks associated with the smallpox vaccine, many health professionals may be unwilling to give the vaccine without some measure of liability protection,” Senator Bill Frist (R-Tenn.) said.  “The threat of lawsuits mustn’t be a barrier to protecting the American people,” he added (Laura Meckler, Associated Press, Nov. 13).

Meanwhile, scientists in New York are leading a study on residual immunity from old smallpox vaccinations, and how it might affect any new inoculation.  U.S. health officials have said that the existing batch of smallpox vaccine — some doses are more than 40 years old — can be diluted and remain effective.  For people who were vaccinated long ago, existing immunity could be too weak to be effective against smallpox, but such immunity might still resist a diluted dose of vaccine, scientists have said.

If this theory is correct, people with existing immunity would now need full-strength doses of the vaccine.

“It’s likely the body may tamp down the diluted vaccine; we don’t know,” said John Treanor, a medical professor at the University of Rochester who is leading the study.  “The subjects in this study are people who were vaccinated as children, and for some people that may have been 30, 40, 50 years ago,” he added.

Researches plan to use 1,000 volunteers — ranging in age from their early 30s to 75 years old — and to administer either a full dose of the vaccine or a diluted dose (Delthia Ricks, Baltimore Sun, Nov. 14).

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BWC:  States Dispute Plan for Future Meetings

By David Ruppe
Global Security Newswire

GENEVA — Negotiations at the resumed fifth annual review conference of the Biological Weapons Convention continue to hang in the balance, as member states quarrel over a proposal to meet annually for the next three years (see GSN, Nov. 11).

Delegations are disagreeing over recommendations to change language in the plan that might allow members to discuss topics that U.S. officials have said they are opposed to discussing, diplomats and observers said.

The review conference, which meets every five years, serves as a forum for treaty parties to discuss and modify the treaty and other tools to address the proliferation of biological weapons.  Experts and diplomats said they are concerned that this meeting might now end without any common declaration of intentions or plans to prepare for the next conference.

This week’s meetings were scheduled when the review conference could reach no decision last year and conference Chairman Tibor Toth called for reconvening the meeting one year later (see GSN, Dec. 10).  The next full review conference is scheduled for 2006.

Toth, who authored the draft conference decision that is now under consideration, has been shuttling between two groups of countries passing messages and trying to encourage consensus.  One U.N. source described the activity as “pingpong” diplomacy.

If at some point Toth believes he has achieved consensus, a general committee would be convened to consider forwarding the plan to a final plenary meeting.  If no state speaks up in opposition, the plan would then be adopted.

“Western Group” Adamant Against Changes

The Toth plan calls on treaty parties to discuss five subjects involving possible national and international controls for discouraging proliferation and use of biological weapons.  Virtually every state is believed to support such meetings.

Nevertheless, some developing states, part of a group known as the Nonaligned Movement (NAM), are pressing for certain changes to the proposal that would allow for a broader range of subjects to be considered. 

A collection of developed states known as the Western Group, on the other hand, continues to push for approving the plan strictly as it is written.  The United States has supported that position, diplomats said, and one Western diplomat said all group members support it.

“It is a view that is shared by all,” the diplomat said.  “We have been unwilling to countenance any change” to the Toth proposal, the diplomat said.

U.S. Concerns

Some NAM members, including Iran, have argued for introducing the language into a key phrase specifying the subjects that might be discussed at the annual meetings, diplomats said.  Such language would open the door to discussing treaty issues not specifically identified in the draft decision.

The U.S. delegation reportedly opposes such a change over concerns that it might allow discussions to create an inspections mechanism for the treaty, which the Bush administration opposes.  U.S. officials declined to discuss their positions until a resolution is achieved.

Some NAM members have also proposed another change that might allow discussion of export control regimes.  That might lead to discussions at the meetings on separate Australia Group restrictions, which limit transfers of certain biological and chemical technologies to developing countries, said Ed Hammond, co-director of the Sunshine Project.

Some NAM members have complained that the United States should not be allowed to dictate the terms of the process or proposal, diplomats said.  Others complained that “the way the topic has been framed is meant to accommodate U.S. sensitivities and nobody else’s,” the U.N. source said.

“It’s not clear whether they [the NAM] have difficulty in accepting the proposal based on substance or on procedural grounds, as it was presented as a ‘take it or leave it’ proposition,” said Alexander Kelle, a research associate at the University of Bradford.

Western diplomats said nonspecific language regarding the topics of discussion could cause the annual meetings to be occupied with debates over the agenda rather than substance.

Time a Possible Factor

There is a general concern among participants that if discussions become protracted the United States may walk out and effectively end the conference.  Toth has been trying to convince member delegations that “his proposal represents one shot,” said the U.N. source, to “keep the United States involved in the process.”

At a September meeting, U.S. officials told Western Group members that they preferred an extremely short meeting at this resumed conference and no further meetings until 2006 (see GSN, Sept. 6).

The fact that U.S. Assistant Secretary of State for Arms Control Stephen Rademaker is involved in these negotiations, observers said, suggests the administration has reconsidered its opposition to holding annual meetings.

A Second Best Alternative

While possibly all treaty parties are believed to support Toth’s proposal in some form, most also see it as a second-best alternative to creating a legally binding protocol that would create an inspections mechanism to investigate treaty compliance.

U.S. officials indicated before the review conference opened last November they were withdrawing U.S. support from just such a protocol that had been negotiated over a seven-year period. 

All non-U.S. Western Group states still favor adopting a protocol to create such a mechanism, but are unwilling to do so without U.S. participation, according to a Western group diplomat.

Oliver Meier, an Arms Control Association analyst following the proceedings here, said states now have maneuvered themselves into positions where they are unable to address substantive issues. 

“The Western Group is holding the line of the Americans and not moving at all. In the nonaligned movement, there are deep divisions about how and whether to address substantive issues and to approve the proposal that is on the table.”

“The real danger is if such empty exercises in diplomatic procedure are continued over the next three years and such mechanisms not used to talk about real issues, this convention runs the danger of becoming more and more irrelevant,” Meier said.

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Anthrax:  Postal Officials Postpone Brentwood Fumigation

The U.S. Postal Service has decided to wait to fully decontaminate the anthrax-tainted Brentwood Road postal facility in Washington because technicians have found cracks in the plastic piping that was to carry the toxic decontaminant, the Washington Post reported today (see GSN, Oct. 7).

The cracks were found last week among 7,000 feet of piping that was to be used to pump chlorine dioxide gas into the facility, postal officials said.  The cause of the cracks is still unknown, but officials think they occurred during the regular course of manufacturing, delivery or on-site handling, said Postal Service spokeswoman Kristin Krathwohl.

Officials plan to replace the damaged section of the piping, according to Krathwohl.  The remaining sections have been examined and no additional leaks were discovered, she said.

The piping cracks caused postal officials to delay a planned Nov. 9 test of the fumigation procedures and equipment and to postpone the full decontamination of the facility, which Postmaster General John Potter had hoped would begin at the end of the week, the Post reported.  Officials might conduct the test Saturday after replacement piping is installed, postal officials said.  While no new date for the full fumigation has yet been set, officials said they anticipate a delay of approximately one week.

“We are doing constant quality-control assurance testing and reviewing, and we are going to do this safe and right, not fast,” Krathwohl said (Manny Fernandez, Washington Post, Nov. 13).

For further information, see:

GSN Anthrax Attack Chronology (Dec. 12, 2001)

Journal of the American Medical Association Background on Anthrax

CDC Frequently Asked Questions About Anthrax

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Smallpox:  United States Needs More Vaccine Antidote

U.S. officials are contracting with two companies for thousands of doses of vaccinia immune globulin, the only clinically tested antidote for many reactions to the smallpox vaccine, the New York Times reported today (see GSN, Nov. 7).

If U.S. officials were forced to begin mass inoculations against smallpox today, they would not have enough of the globulin, known as VIG, according to the Times.  Regardless of which smallpox immunization plan U.S. President George W. Bush chooses, the United States will need substantial quantities of VIG, which is produced from plasma extracted from the blood of people who have been recently immunized against smallpox (see GSN, Oct. 17).

Health officials have told the Defense Department’s VIG producer to expect one case of severe adverse effects from the vaccine for every 8,000 immunizations (see GSN, Nov. 8).

“Given the uncertainties here, that may not be a bad estimate,” said Raymond Strikas, an epidemiologist at the U.S. Centers for Disease Control and Prevention.

In October, the United States had less than 700 doses of VIG, but U.S. health officials hope to have 5,000 doses by the end of the year, enough to treat the complications of 40 million immunized people.  It might take as long as two years to produce enough VIG to protect the entire country safely.  Officials are unsure exactly how much they need because conditions that cause adverse reactions — including suppressed immune systems and a variety of skin rashes — have increased substantially since the last study on side effects in the 1960s (see GSN, Oct. 18).

VIG Production Underway

The United States has ordered VIG from DynPort Vaccine Company in Maryland and Cangene Corporation of Winnipeg, Canada.  Using stored plasma from immunized soldiers, DynPort has produced VIG to treat 660 reactions, according to David Smith, the company’s chief scientist.  DynPort has tested the antidote on volunteers, and no adverse side effects have arisen, even with dramatically increased dosages, Smith said.

The U.S. government has tasked Cangene with producing as many as 100,000 doses over the next five years, the Times reported.  The company plans to immunize 10,000 volunteers — who must be previously immunized and are medically screened — and use their plasma to produce the VIG.  The company has found 1,300 donors to date and has not experienced any adverse reaction to the immunization (McNeil/Altman, New York Times, Nov. 12).

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