Smallpox Vaccine Decision Due Today (FREEPER QUOTED)

After months of public meetings, and with less than 24 hours to reach a decision, the group that will decide how many Americans receive smallpox vaccine still faces profound uncertainty.

Meeting in Atlanta on Wednesday, the Advisory Committee on Immunization Practices heard almost 12 hours of testimony on a single theme: whether to allow some segment of the public to be vaccinated before any potential bioterror attack begins.

But the 15-person group, which makes vaccine policy recommendations to the federal government and is expected to announce a decision today, could not answer a key question underlying every argument pro or con: How great is the risk of an attack?

"The key piece of information that we don't have is the actual risk of disease," said Dr. Paul Offit, a committee member from the Children's Hospital of Philadelphia. "Should we be making this decision in the absence of that information?"

There have been no U.S. smallpox cases since the 1940s, and no smallpox vaccinations have been given in the country since the 1980s, except to staff of the Centers for Disease Control and Prevention.

If a smallpox attack occurs, the CDC has committed to vaccinating people in the path of the disease, using a search-and-containment strategy that resembles the rings around a bull's-eye.

The agency has argued against vaccinating before an attack because the vaccine carries a high risk of side effects. But a desire to be protected from smallpox has been growing among the public and emergency workers who would be the first to take care of victims.

The committee agreed several months ago to explore alternatives, including whether to offer "pre-event" vaccination to state disease-detection teams, health care workers, emergency personnel and citizens. Since then, it has held meetings for scientists, emergency workers and the public in New York, Washington, St. Louis, San Francisco, San Antonio and Atlanta.

The panel will submit its recommendation to the CDC's acting director and to the secretary of Health and Human Services. HHS usually accepts the committee's recommendations, but the group seldom rules on subjects this sensitive.

A plea for immediate widespread vaccination came Wednesday from one impassioned citizen: William Tell, a hospital industry consultant who traveled from Washington to ask the group to release smallpox vaccine to the public.

"We know there are risks, but we also know that we would rather assume the risk and be vaccinated now, rather than in the terror of a national emergency," Tell said.

"My wife wishes to inform this committee that she does not want to become pregnant again until she has been vaccinated for smallpox," the father of two added. "I think that is prudent thinking in these forever-changed times."

On the other side of the debate, the group heard comments from a range of nonprofit organizations opposed to wider use of the vaccine. They included two groups normally on opposite sides of debates over shots: the Immunization Action Coalition, which supports vaccinations in childhood, and the National Vaccine Information Center, which alerts families to potential adverse vaccine reactions.

Dr. J. Donald Millar, who led the CDC's smallpox program in the 1960s, silenced the gathering with a speech criticizing the government for not giving the public a reasonable estimate of the bioterror threat.

"In my opinion, the risks of vaccination are insignificant compared to the risks of the disease," he said. "The policy to withhold vaccine should either be defended, which it has not been, or it should be changed in favor of a policy which makes the vaccine available, now, to those who want it."

Dr. Michael Lane, a CDC smallpox veteran who did not voice support for mass vaccination, defended the vaccine against the agency's portrayal of its side effects.

"It worries me that we are painting such a horrific picture of adverse events that we are going to scare an awful lot of people," he said.

And Douglas Holtz-Eakin, chief economist for the White House Council of Economic Advisors, upset what looked like a dawning consensus --- against mass immunizations, but in favor of protection for some emergency workers and bioterrorism teams --- by arguing for vaccination of "economic first responders" such as truck drivers and airplane pilots. Failing to vaccinate widely before an attack, he predicted, could shut down 90 percent of the U.S. economy.

The meeting, which is open to the public, continues today at the Marriott Century Center, 2000 Century Blvd. N.E., Atlanta.

Related information:

Not for commercial use. Solely to be used for the educational purposes of research and open discussion.

The Deseret News (Salt Lake City, UT)
June 16, 2002, Sunday
Pg. A09

'71 accident piques smallpox fears
By Scott Shane The Baltimore Sun

U.S. bioterrorism experts are studying a previously unknown 1971 accident in which a secret Soviet military test of smallpox in aerosol form infected a woman on a ship 10 miles away.

The resulting outbreak, which killed three people and sickened seven others, has implications for the potential of smallpox as a terrorist weapon, said Dr. Alan Zelicoff, a senior scientist at Sandia National Laboratories in New Mexico who has studied a classified Soviet report on the outbreak and interviewed two victims.

The long-distance infection provides the first solid evidence that Soviet scientists succeeded in aerosolizing smallpox, creating a cloud of virus particles that could cause illness miles downwind, he said.

In addition, Zelicoff said, the pattern of cases suggests that the strain was especially lethal and relatively resistant to smallpox vaccine. The seven survivors all got sick despite having been vaccinated against smallpox, according to the Soviet report. The three who died -- including two infants -- had not been vaccinated. "It's now legitimate to ask the question: Is there a vaccine-resistant strain?" Zelicoff said.

But Dr. Donald A. Henderson, a senior adviser to the Bush administration on bioterrorism and a smallpox expert, said it was not unusual for vaccinated people to develop smallpox.

Henderson did acknowledge that the incident, confirmed by an interview with a former Soviet official in a Russian newspaper, is the only known outbreak to have been caused by a smallpox bioweapon.

The strain that caused the outbreak could not have been engineered genetically, because that was not possible in 1971, but it might have been a natural strain selected by the Soviets for its virulence. The three fatalities all contracted the hemorrhagic form of smallpox, a relatively large proportion, Zelicoff said.

He is to present his findings at the National Academy of Sciences in Washington, D.C., where a panel of experts convened by the Institute of Medicine will discuss smallpox vaccination strategies.

Health authorities are debating whether smallpox vaccinations should be offered to emergency personnel or to the general public to protect against a possible terrorist attack. Current policy is to contain any outbreak by rushing to vaccinate people in a ring around the first reported case.

The decision is important, because mass vaccination likely would result in serious or lethal side effects for a small number of people. And the risk of a smallpox attack is considered small, as the disease has been eradicated in nature and the only known supplies of the virus are in high-security labs in Novosibirsk, Russia, and at the Centers for Disease Control and Prevention in Atlanta.

Still, many experts believe some other countries, including Iraq, have kept secret stocks. They also fear that smallpox created in the old Soviet bioweapons program, of which 20 tons were stockpiled, might not have been destroyed and might fall into the hands of terrorists.

The details of the 1971 accident are likely to be studied very carefully by U.S. scientists. U.S. smallpox researchers are interested in obtaining from the Russians a sample of the strain released in the 1971 accident so that it can be compared with previously known strains.

Zelicof believes the existing vaccine might not provide adequate protection against all strains of smallpox and advocates development of an improved vaccine and anti-viral drugs. Last week, U.S. Army and Centers for Disease Control resumed experimental work in infecting monkeys with smallpox to test new remedies.

The 60-page secret Soviet report describing the outbreak was obtained recently from a disease research institute in Kazakhstan by the local office of the Monterey Institute of International Studies. Raymond Zilinskas, a bioterrorism expert at the institute, asked Zelicoff to study the report, which was prepared in 1971 by a local health official and sent to the Central Asian Anti-Plague Research Institute in Almaty, the Kazakh capital.

Zilinskas said the episode shows the Soviets had smallpox weapons for at least 20 years before the United States found out about them in 1989 from a defector. "It seems like a real intelligence failure," he said.

He also said the report gives credence to the possibility that terrorists could infect large numbers of people simultaneously by releasing an aerosol cloud rather than spreading the disease more slowly by infecting themselves and exposing others in crowded locations.

The 1971 accident was mentioned by a Kazakh speaker at a conference last year on the Soviet bioweapons program in Almaty, but he had no details, Zelicoff said. It was also mentioned in a November interview in the Russian newspaper Moscow News with retired Gen. Pyotr Burgasov, 86, a former top bioweapons official.

Burgasov said the research ship was supposed to stay 40 kilometers from the island but approached to 15 kilometers. When the outbreak was discovered in Aralsk, he ordered that the Almaty-Moscow trains not stop in the town.

"Thus a nationwide epidemic was prevented," Burgasov said. "I called ( Yuri) Andropov, KGB head at the time, and told him about the exceptionally potent smallpox formula developed on Vozrozhdeniye Island.

"He ordered me to keep mum," Burgasov said.

Not for commercial use. Solely to be used for the educational purposes of research and open discussion.

Federal News Service
March 19, 2002, Tuesday
CAPITOL HILL HEARING

HEADLINE: PANEL II OF A HEARING OF THE SENATE FOREIGN RELATIONS COMMITTEE
TOPIC: THREAT REDUCTION OF CHEMICAL AND BIOLOGICAL WEAPONS

CHAIRMAN: SENATOR JOSEPH BIDEN (D-DE)
LOCATION: 419 DIRKSEN SENATE OFFICE BUILDING, WASHINGTON, D.C.

WITNESSES:

MICHAEL MOODIE, PRESIDENT OF THE CHEMICAL AND BIOLOGICAL ARMS CONTROL INSTITUTE;
AMY SANDS, DEPUTY DIRECTOR FOR THE CENTER FOR NON-PROLIFERATION STUDIES IN MONTEREY; AND
ALAN P. ZELICOFF, SENIOR SCIENTIST, SANDIA NATIONAL LABORATORY

(snip)
SEN. FRIST: And I'm reinforcing what you're saying. But my colleagues don't realize that when smallpox comes to a community, or anthrax is in the community here, if you are physician and you see a wide -- (inaudible) [probably "widened mediastinum"] -- in a clear chest X-ray, you haven't been trained to think anthrax, period. That pattern recognition you need to report to somebody so that the pattern can be picked up. And it becomes even more important -- you said anthrax is easy -- that's easy stuff. We knew the powder was here, you could draw a perimeter around it, you could treat everybody. But what about smallpox, which can travel across the country. And as a physician, if you've never -- you are board-certified in internal medicine, I see from your bio, have you see active smallpox?

MR. ZELICOFF: No, I haven't even seen a case of measles. And I don't think I would be able to make that diagnosis --

SEN. FRIST: No, you wouldn't. But a lot of children get chicken pox. And if smallpox is in your community, somebody -- the doctors are going to see it, and they have not been trained --

MR. ZELICOFF: Correct.

SEN. FRIST: -- to make that diagnosis. Well, if you miss it, and every moment does count, right now how infective smallpox? Right now, if I had smallpox sitting around me right now, left and right, people would be infected after about an hour, if I had lesions in my mouth. People don't really understand how infective and communicable it actually is. I just take your presentation -- and then, Dr. Sands, in your testimony you mention Italy, in your written testimony -- what if Italy is the site of a smallpox attack? We may be planned in some way -- smallpox's germs know no boundaries. They don't care if it's the United States, Tennessee, California, New Mexico -- smallpox travels, and it travels on an airplane pretty easily, and it doesn't have to be to stay. That's when I ask who has this smallpox -- smallpox has killed 500 million people. We have eradicated the disease, but there are a bunch of people running around with the virus in their pocket somewhere. And from an intelligence standpoint we need to figure that out, which comes into this whole panel, in terms of why we are discussing it. But going from the front line, we are trained to recognize smallpox, we don't have the communication to address the smallpox today. So we have a long, long, long way to go.

MR. ZELICOFF: Right. And also add with regard to smallpox, and I quite agree with you it's a highly significant problem that's overlooked because it almost falls into the too-hard-to-do category -- that once we have our vaccine supply of 300 million doses, that will not be adequate to solve the problem or address it. Increasing work in genetic alteration of the organism may in fact result in a vaccine- resistant strain. We have to have at least one other tool in our toolbox. There is a small program being run at the CDC with folks at U.S. AMRID to look for antibiotics. They have succeeded in probably coming up with an animal model. That's an enormous breakthrough, because for the first time we can now test other non-traditional means of treating the disease -- not only if there is an antibiotics or a vaccine-resistant strain; but, more to the point, for the 15 or 20 percent of the population that cannot tolerate the existing vaccine for smallpox because of other conditions.
(snip)

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