Fw: How do you test that a human Ebola vaccine works? You don't

[Guest guest]

http://www.sciam.com/article.cfm?chanID=sa006 & articleID=000B0B7E-6C63-1150-ABFD8\

3414B7F0000 & colID=5

An Uncertain Defense

How do you test that a human Ebola vaccine works? You don't

By W. Wayt Gibbs

The Ebola virus is among the deadliest on earth; in outbreaks last

year in the Republic of Congo, 157 of the 178 people infected with it died

of hemorrhagic fever. Because it can be exceedingly contagious in aerosol

form, the Ebola virus ranks with smallpox and anthrax as one of the most

worrisome potential biological weapons. Although there is no effective

treatment, recent tests have shown a new vaccine able to prevent infection

in monkeys. Clearly, researchers could never intentionally expose human

volunteers to the lethal virus. And there are no populations at especially

high risk for Ebola, as there are for HIV. So how can doctors determine

whether the vaccine works in people?

That question, which applies as well to experimental vaccines for

smallpox and anthrax, took on new significance on July 21, when President

W. Bush signed the Project Bioshield Act. The law authorizes the U.S.

Department of Homeland Security to spend up to $5.6 billion over 10 years to

increase its stockpile of antibioweapons medicines, including drugs that the

U.S. Food and Drug Administration has not yet approved as safe and

effective.

The secretary of health and human services can now recommend that the

president order the distribution of experimental drugs to the armed forces

or even to the general populace, should the secretary perceive " a

significant potential for a domestic emergency, involving a heightened risk

of attack. " Although scientific evidence of some kind must suggest that the

drugs will do more good than harm, human clinical trials--for decades, the

only evidence that has mattered--are no longer strictly required.

The prospect of treating thousands of people with a vaccine or drug only

proved to work on animals may seem risky. But the realities of the

pharmaceutical market and the lethal character of many bioweapons leave few

alternatives. The pharmaceutical industry has already all but abandoned work

on vaccines for many of the world's major infectious diseases, such as

malaria and tuberculosis, because the people most vulnerable to such

illnesses tend to be least able to afford expensive medicines. There is

virtually no natural market for vaccines to prevent smallpox (which has been

eradicated) or anthrax (which is not contagious) or Ebola (which occurs in

vicious but sporadic outbreaks).

So federal agencies are creating a market. " The Project Bioshield law

specifies initial stockpiling of Ebola vaccine at about $90 million and a

long-term procurement of about $260 million, " Vijay B. Samant, president of

Vical, observed in an August conference call with investors. Vical is a

biotech firm based in San Diego; both it and Crucell, a Dutch company, have

won potentially lucrative contracts to manufacture the genetically

engineered ingredients in the new vaccine.

" To gain FDA approval, we will have to gather safety data on perhaps 5,000

people, " says J. Nabel, director of the Vaccine Research Center at the

National Institutes of Health. Nabel's group designed the immunization to

have two stages: a DNA primer and a viral booster shot. Both parts contain

only minute fragments of Ebola virus, so the vaccine itself could not cause

infection. Small human safety trials of just the primer portion, made by

Vical, are now under way at the NIH. But recent experiments on macaques have

shown that the booster alone led to full immunity against Ebola in less than

four weeks. Jaap Goudsmit, chief scientific officer at Crucell, says it

remains to be seen how long the protection will last.

That is a question typically answered by a large-scale clinical trial. But a

special rule passed in 2002 allows FDA approval even without direct evidence

that it works in humans, in cases where subjecting humans to clinical trials

would be unethical or infeasible.

A company must first show that the vaccine works in monkeys (or another

animal similar to humans). Researchers then have to figure out how the

animals' immune systems respond to the optimal dose and find an equivalent

dose in humans that generates a similar immune response. Project Bioshield

allows the president to waive even that lowered regulation when the nation

faces " heightened risk of attack. "

It may be years before scientists can determine an optimal human dose for

the new Ebola vaccine. That does not mean, however, that it won't soon enter

the national stockpile. The Bush administration says that next year it

expects to purchase 75 million doses of a new anthrax vaccine that has not

yet even completed human safety trials.

Of course, Nabel says, " you can bet there would be follow-up studies if the

Ebola vaccine was used in a real outbreak. " He acknowledges, however, that

" if the vaccine is so good that it aborts infection before the virus induces

an immune response, we might not be able to tell who was exposed and who

wasn't. "

[Guest guest]

http://www.sciam.com/article.cfm?chanID=sa006 & articleID=000B0B7E-6C63-1150-ABFD8\

3414B7F0000 & colID=5

An Uncertain Defense

How do you test that a human Ebola vaccine works? You don't

By W. Wayt Gibbs

The Ebola virus is among the deadliest on earth; in outbreaks last

year in the Republic of Congo, 157 of the 178 people infected with it died

of hemorrhagic fever. Because it can be exceedingly contagious in aerosol

form, the Ebola virus ranks with smallpox and anthrax as one of the most

worrisome potential biological weapons. Although there is no effective

treatment, recent tests have shown a new vaccine able to prevent infection

in monkeys. Clearly, researchers could never intentionally expose human

volunteers to the lethal virus. And there are no populations at especially

high risk for Ebola, as there are for HIV. So how can doctors determine

whether the vaccine works in people?

That question, which applies as well to experimental vaccines for

smallpox and anthrax, took on new significance on July 21, when President

W. Bush signed the Project Bioshield Act. The law authorizes the U.S.

Department of Homeland Security to spend up to $5.6 billion over 10 years to

increase its stockpile of antibioweapons medicines, including drugs that the

U.S. Food and Drug Administration has not yet approved as safe and

effective.

The secretary of health and human services can now recommend that the

president order the distribution of experimental drugs to the armed forces

or even to the general populace, should the secretary perceive " a

significant potential for a domestic emergency, involving a heightened risk

of attack. " Although scientific evidence of some kind must suggest that the

drugs will do more good than harm, human clinical trials--for decades, the

only evidence that has mattered--are no longer strictly required.

The prospect of treating thousands of people with a vaccine or drug only

proved to work on animals may seem risky. But the realities of the

pharmaceutical market and the lethal character of many bioweapons leave few

alternatives. The pharmaceutical industry has already all but abandoned work

on vaccines for many of the world's major infectious diseases, such as

malaria and tuberculosis, because the people most vulnerable to such

illnesses tend to be least able to afford expensive medicines. There is

virtually no natural market for vaccines to prevent smallpox (which has been

eradicated) or anthrax (which is not contagious) or Ebola (which occurs in

vicious but sporadic outbreaks).

So federal agencies are creating a market. " The Project Bioshield law

specifies initial stockpiling of Ebola vaccine at about $90 million and a

long-term procurement of about $260 million, " Vijay B. Samant, president of

Vical, observed in an August conference call with investors. Vical is a

biotech firm based in San Diego; both it and Crucell, a Dutch company, have

won potentially lucrative contracts to manufacture the genetically

engineered ingredients in the new vaccine.

" To gain FDA approval, we will have to gather safety data on perhaps 5,000

people, " says J. Nabel, director of the Vaccine Research Center at the

National Institutes of Health. Nabel's group designed the immunization to

have two stages: a DNA primer and a viral booster shot. Both parts contain

only minute fragments of Ebola virus, so the vaccine itself could not cause

infection. Small human safety trials of just the primer portion, made by

Vical, are now under way at the NIH. But recent experiments on macaques have

shown that the booster alone led to full immunity against Ebola in less than

four weeks. Jaap Goudsmit, chief scientific officer at Crucell, says it

remains to be seen how long the protection will last.

That is a question typically answered by a large-scale clinical trial. But a

special rule passed in 2002 allows FDA approval even without direct evidence

that it works in humans, in cases where subjecting humans to clinical trials

would be unethical or infeasible.

A company must first show that the vaccine works in monkeys (or another

animal similar to humans). Researchers then have to figure out how the

animals' immune systems respond to the optimal dose and find an equivalent

dose in humans that generates a similar immune response. Project Bioshield

allows the president to waive even that lowered regulation when the nation

faces " heightened risk of attack. "

It may be years before scientists can determine an optimal human dose for

the new Ebola vaccine. That does not mean, however, that it won't soon enter

the national stockpile. The Bush administration says that next year it

expects to purchase 75 million doses of a new anthrax vaccine that has not

yet even completed human safety trials.

Of course, Nabel says, " you can bet there would be follow-up studies if the

Ebola vaccine was used in a real outbreak. " He acknowledges, however, that

" if the vaccine is so good that it aborts infection before the virus induces

an immune response, we might not be able to tell who was exposed and who

wasn't. "

[Guest guest]

I only read the first couple paragraphs, but OH NO!! An ebola vaccine?? Makes me

wonder if everyone gets the vaccine except us non-vax'ers, then we could

potentially catch Ebola from the vaccinated!! Couldn't we??

-

Angelina due: 10/26/04

Fw: How do you test that a human Ebola vaccine works?

You don't

http://www.sciam.com/article.cfm?chanID=sa006 & articleID=000B0B7E-6C63-1150-ABFD8\

3414B7F0000 & colID=5

An Uncertain Defense

How do you test that a human Ebola vaccine works? You don't

By W. Wayt Gibbs

The Ebola virus is among the deadliest on earth; in outbreaks last

year in the Republic of Congo, 157 of the 178 people infected with it died

of hemorrhagic fever. Because it can be exceedingly contagious in aerosol

form, the Ebola virus ranks with smallpox and anthrax as one of the most

worrisome potential biological weapons. Although there is no effective

treatment, recent tests have shown a new vaccine able to prevent infection

in monkeys. Clearly, researchers could never intentionally expose human

volunteers to the lethal virus. And there are no populations at especially

high risk for Ebola, as there are for HIV. So how can doctors determine

whether the vaccine works in people?

That question, which applies as well to experimental vaccines for

smallpox and anthrax, took on new significance on July 21, when President

W. Bush signed the Project Bioshield Act. The law authorizes the U.S.

Department of Homeland Security to spend up to $5.6 billion over 10 years to

increase its stockpile of antibioweapons medicines, including drugs that the

U.S. Food and Drug Administration has not yet approved as safe and

effective.

The secretary of health and human services can now recommend that the

president order the distribution of experimental drugs to the armed forces

or even to the general populace, should the secretary perceive " a

significant potential for a domestic emergency, involving a heightened risk

of attack. " Although scientific evidence of some kind must suggest that the

drugs will do more good than harm, human clinical trials--for decades, the

only evidence that has mattered--are no longer strictly required.

The prospect of treating thousands of people with a vaccine or drug only

proved to work on animals may seem risky. But the realities of the

pharmaceutical market and the lethal character of many bioweapons leave few

alternatives. The pharmaceutical industry has already all but abandoned work

on vaccines for many of the world's major infectious diseases, such as

malaria and tuberculosis, because the people most vulnerable to such

illnesses tend to be least able to afford expensive medicines. There is

virtually no natural market for vaccines to prevent smallpox (which has been

eradicated) or anthrax (which is not contagious) or Ebola (which occurs in

vicious but sporadic outbreaks).

So federal agencies are creating a market. " The Project Bioshield law

specifies initial stockpiling of Ebola vaccine at about $90 million and a

long-term procurement of about $260 million, " Vijay B. Samant, president of

Vical, observed in an August conference call with investors. Vical is a

biotech firm based in San Diego; both it and Crucell, a Dutch company, have

won potentially lucrative contracts to manufacture the genetically

engineered ingredients in the new vaccine.

" To gain FDA approval, we will have to gather safety data on perhaps 5,000

people, " says J. Nabel, director of the Vaccine Research Center at the

National Institutes of Health. Nabel's group designed the immunization to

have two stages: a DNA primer and a viral booster shot. Both parts contain

only minute fragments of Ebola virus, so the vaccine itself could not cause

infection. Small human safety trials of just the primer portion, made by

Vical, are now under way at the NIH. But recent experiments on macaques have

shown that the booster alone led to full immunity against Ebola in less than

four weeks. Jaap Goudsmit, chief scientific officer at Crucell, says it

remains to be seen how long the protection will last.

That is a question typically answered by a large-scale clinical trial. But a

special rule passed in 2002 allows FDA approval even without direct evidence

that it works in humans, in cases where subjecting humans to clinical trials

would be unethical or infeasible.

A company must first show that the vaccine works in monkeys (or another

animal similar to humans). Researchers then have to figure out how the

animals' immune systems respond to the optimal dose and find an equivalent

dose in humans that generates a similar immune response. Project Bioshield

allows the president to waive even that lowered regulation when the nation

faces " heightened risk of attack. "

It may be years before scientists can determine an optimal human dose for

the new Ebola vaccine. That does not mean, however, that it won't soon enter

the national stockpile. The Bush administration says that next year it

expects to purchase 75 million doses of a new anthrax vaccine that has not

yet even completed human safety trials.

Of course, Nabel says, " you can bet there would be follow-up studies if the

Ebola vaccine was used in a real outbreak. " He acknowledges, however, that

" if the vaccine is so good that it aborts infection before the virus induces

an immune response, we might not be able to tell who was exposed and who

wasn't. "

[Guest guest]

You probably should read it in its entirety, more specifically:

Snip 1: " Project Bioshield allows the president to waive even that lowered

regulation when the nation faces " heightened risk of attack. "

Snip 2: " The law authorizes the U.S. Department of Homeland Security to

spend up to $5.6 billion over 10 years to increase its stockpile of

antibioweapons medicines, including drugs that the U.S. Food and Drug

Administration has not yet approved as safe and

effective. "

Snip 3: " The secretary of health and human services can now recommend that

the

president order the distribution of experimental drugs to the armed forces

or even to the general populace, should the secretary perceive " a

significant potential for a domestic emergency, involving a heightened risk

of attack. " Although scientific evidence of some kind must suggest that the

drugs will do more good than harm, human clinical trials--for decades, the

only evidence that has mattered--are no longer strictly required.

Onto your question though, it's a good question. In the cases with the

smallpox vaccine, the disease was actually spread via physical contact and

by a breast feeding mother, because the vaccine was live. In the article

below (ebola) it's stated that it cannot be spread because the disease

that's in the vaccine is " minute " . It doesn't stand to reason however that

if you're using something " live " , the risk of someone else catching it via

transmission of some sort is none - that however is just my opinion.

----------------------------------------------------

Message: 18

Date: Tue, 28 Sep 2004 22:50:33 -0500

From: " " <ashnickel82@...>

Subject: Re: Fw: How do you test that a human Ebola vaccine works? You don't

I only read the first couple paragraphs, but OH NO!! An ebola vaccine??

Makes me wonder if everyone gets the vaccine except us non-vax'ers, then we

could potentially catch Ebola from the vaccinated!! Couldn't we??

-

Angelina due: 10/26/04

Fw: How do you test that a human Ebola vaccine

works? You don't

http://www.sciam.com/article.cfm?chanID=sa006 & articleID=000B0B7E-6C63-1150-ABFD8\

3414B7F0000 & colID=5

An Uncertain Defense

How do you test that a human Ebola vaccine works? You don't

By W. Wayt Gibbs

The Ebola virus is among the deadliest on earth; in outbreaks last

year in the Republic of Congo, 157 of the 178 people infected with it died

of hemorrhagic fever. Because it can be exceedingly contagious in aerosol

form, the Ebola virus ranks with smallpox and anthrax as one of the most

worrisome potential biological weapons. Although there is no effective

treatment, recent tests have shown a new vaccine able to prevent infection

in monkeys. Clearly, researchers could never intentionally expose human

volunteers to the lethal virus. And there are no populations at especially

high risk for Ebola, as there are for HIV. So how can doctors determine

whether the vaccine works in people?

That question, which applies as well to experimental vaccines for

smallpox and anthrax, took on new significance on July 21, when President

W. Bush signed the Project Bioshield Act. The law authorizes the

U.S.

Department of Homeland Security to spend up to $5.6 billion over 10 years

to

increase its stockpile of antibioweapons medicines, including drugs that

the

U.S. Food and Drug Administration has not yet approved as safe and

effective.

The secretary of health and human services can now recommend that the

president order the distribution of experimental drugs to the armed forces

or even to the general populace, should the secretary perceive " a

significant potential for a domestic emergency, involving a heightened

risk

of attack. " Although scientific evidence of some kind must suggest that

the

drugs will do more good than harm, human clinical trials--for decades, the

only evidence that has mattered--are no longer strictly required.

The prospect of treating thousands of people with a vaccine or drug only

proved to work on animals may seem risky. But the realities of the

pharmaceutical market and the lethal character of many bioweapons leave

few

alternatives. The pharmaceutical industry has already all but abandoned

work

on vaccines for many of the world's major infectious diseases, such as

malaria and tuberculosis, because the people most vulnerable to such

illnesses tend to be least able to afford expensive medicines. There is

virtually no natural market for vaccines to prevent smallpox (which has

been

eradicated) or anthrax (which is not contagious) or Ebola (which occurs in

vicious but sporadic outbreaks).

So federal agencies are creating a market. " The Project Bioshield law

specifies initial stockpiling of Ebola vaccine at about $90 million and a

long-term procurement of about $260 million, " Vijay B. Samant, president

of

Vical, observed in an August conference call with investors. Vical is a

biotech firm based in San Diego; both it and Crucell, a Dutch company,

have

won potentially lucrative contracts to manufacture the genetically

engineered ingredients in the new vaccine.

" To gain FDA approval, we will have to gather safety data on perhaps 5,000

people, " says J. Nabel, director of the Vaccine Research Center at

the

National Institutes of Health. Nabel's group designed the immunization to

have two stages: a DNA primer and a viral booster shot. Both parts contain

only minute fragments of Ebola virus, so the vaccine itself could not

cause

infection. Small human safety trials of just the primer portion, made by

Vical, are now under way at the NIH. But recent experiments on macaques

have

shown that the booster alone led to full immunity against Ebola in less

than

four weeks. Jaap Goudsmit, chief scientific officer at Crucell, says it

remains to be seen how long the protection will last.

That is a question typically answered by a large-scale clinical trial. But

a

special rule passed in 2002 allows FDA approval even without direct

evidence

that it works in humans, in cases where subjecting humans to clinical

trials

would be unethical or infeasible.

A company must first show that the vaccine works in monkeys (or another

animal similar to humans). Researchers then have to figure out how the

animals' immune systems respond to the optimal dose and find an equivalent

dose in humans that generates a similar immune response. Project Bioshield

allows the president to waive even that lowered regulation when the nation

faces " heightened risk of attack. "

It may be years before scientists can determine an optimal human dose for

the new Ebola vaccine. That does not mean, however, that it won't soon

enter

the national stockpile. The Bush administration says that next year it

expects to purchase 75 million doses of a new anthrax vaccine that has not

yet even completed human safety trials.

Of course, Nabel says, " you can bet there would be follow-up studies if

the

Ebola vaccine was used in a real outbreak. " He acknowledges, however, that

" if the vaccine is so good that it aborts infection before the virus

induces

an immune response, we might not be able to tell who was exposed and who

wasn't. "