Dangerous Smallpox vaccine testing

[Guest guest]

From Meryl Nass MD...

60 people are enrolled in the smallpox vaccine efficacy study discussed

below. I imagine it would surprise them to read the following, from the

April 1999 issue of Nature Biotechnology, page 324. Dr. Philip ,

from whom the remarks below were taken, is a former director of

USAMRIID, Fort Detrick, and is now at s Hopkins' Center for Civilian

Biodefense Studies.

"...stockpiles of the conventional smallpox vaccine, maintained in the

United Staes and Europe, are considered "inadequate and deteriorating."

They are associated with nasty side effects, particularly among

immunocompromised recipients, says .

The Defense Department, which plans to reintroduce smallpox vaccinations

(and is already inoculating its forces with available anthrax vaccine)

is developing a second-generation smallpox vaccine produced on cell

culture, according to . However, to validate this vaccine through

means of limited human trials, officials face another "obstacle" because

of the short supply of smallpox-specific immunoglobulin, a product that

helps to protect vaccine recipients against side effects. "We can't do

clinical testing without this," he says."

There exist millions of doses of old smallpox vaccine in storage in the

US. It seems to me that some additional primate safety testing is in

order first. If the vaccine cannot pass rigorous safety tests, the

stockpile should be destroyed. Efficacy studies should ONLY be started

after safety studies are completed; but because smallpox vaccine is

licensed, they are not legally required to be performed on this old

stockpile. (IND vaccines similarly have no expiration date and can be

used indefinitely!) However, the current vaccine has obviously expired,

since the last case of smallpox on earth occurred 25 years ago. How was

this vaccine released by FDA for the test protocol described below? And

will the vaccinees be scrupulously observed for adverse effects?

Meryl Nass, MD

Jeff Jeffords wrote:

> From: "Jeff Jeffords" <lisamichelleearthlink (DOT) net>

> SMALLPOX VACCINE TESTING

> ************************

>

>

> Date: Tue 14 Mar 2000

> From: M. Cosgriff <mcosgriffhotmail>

> Source: media reports, 13 Mar 2000

>

>

> Researchers at St. Louis University said Monday they had been asked to

>

> study a smallpox vaccine because of fears the deadly virus could be

> spread

> or revived through terrorist attacks. Smallpox was officially

> eradicated

> through a mass vaccination program 20 years ago but could be used in

> bioterrorist attacks, requiring governments to quickly find an

> antidote for

> the deadly virus.

>

> The U.S. Centers for Disease Control and Prevention (CDC) in Atlanta

> has

> asked the St Louis University School of Medicine Center for Vaccine

> Development in Missouri, to determine the safety and effectiveness of

> some

> of the small, remaining supply of the smallpox vaccine known as

> Dryvax.

>

> "Because of the recent concerns of terrorism throughout the world, the

>

> United States government is making efforts to improve its ability to

> protect its citizens in the event of an attack," said associate

> professor

> of infectious diseases and immunology at the university's Medicine

> Center

> for Vaccine Development, Sharon Frey. Frey, who is leading the study,

> said

> in a telephone interview that the main aim of their research was to

> measure

> the effectiveness of diluted doses of Dryvax, which is no longer

> produced.

>

> Of the 60 people enrolled in the study, one third will receive a

> vaccine

> diluted 10 times, the second a vaccine diluted 100 times, and the

> remainder

> will get the full undiluted dosage.

>

> "Being able to dilute the vaccine would potentially increase the

> available

> stock by 10 to 100 fold," said Frey. Frey estimated there were about

> seven

> million Dryvax doses available in the United States -- far short of

> what

> would be needed to inoculate the current U.S. population of 270

> million in

> the event of a smallpox outbreak. "There is a limited amount of supply

> and

> the point of this is to see how much we can dilute the vaccine to see

> how

> many available doses we could really have in the event of an attack,"

> Frey

> said. She added that the United States government, the military and

> others

> were doing research to find other vaccines against smallpox. "Our

> research

> will be an interim step between what we have now in terms of stocks

> and

> finding a new vaccine," she said.

>

> The nightmare scenario would be if the smallpox virus were released

> via an

> aerosol at a crowded place such as a sports stadium or a political

> campaign

> event. "We guesstimate that if one person is infected they can, in

> turn,

> infect 25 people...You can imagine with air travel how easily we could

> have

> a pandemic on our hands."

>

> With smallpox, it takes about two weeks before people begin to show

> their

> symptoms and by that time the virus would be on its way to being

> spread

> nationwide and beyond. The World Health Organization declared the

> world

> free of the smallpox virus in 1980 after routine vaccinations

> eradicated

> the disease. Last year, experts from the WHO recommended further

> research

> on the virus before the world's only known remaining stocks of

> smallpox in

> the United States and Russia were destroyed. The stocks, kept in

> high-security laboratories at the CDC in Atlanta and at the Russian

> State

> Center for Research on Virology and Biotechnology in Novosibirsk, were

> to

> have been destroyed last June 30. Both the United States and Russia

> were

> among 30 states at WHO's annual assembly last May who sponsored a

> resolution calling for more international research into antiviral

> agents

> and improved vaccines.

>

> President Clinton announced last April that he would seek a delay in

> destroying the stocks because of fears the disease may be spread

> through

> terrorist attacks.

>

> --

> ProMED-mail

> <promedpromedmail (DOT) org>

>

> [D.A. has been preaching to everyone who will listen that

> there

> is insufficient smallpox vaccine available. Now we will find out

> whether

> even that inadequate supply is effective. - Mod. CHC]

> .................................chc/ds

60 people are enrolled in the smallpox vaccine efficacy study discussed below. I imagine it would surprise them to read the following, from the April 1999 issue of Nature Biotechnology, page 324. Dr. Philip , from whom the remarks below were taken, is a former director of USAMRIID, Fort Detrick, and is now at s Hopkins' Center for Civilian Biodefense Studies.

"...stockpiles of the conventional smallpox vaccine, maintained in the United Staes and Europe, are considered "inadequate and deteriorating." They are associated with nasty side effects, particularly among immunocompromised recipients, says .

The Defense Department, which plans to reintroduce smallpox vaccinations (and is already inoculating its forces with available anthrax vaccine) is developing a second-generation smallpox vaccine produced on cell culture, according to . However, to validate this vaccine through means of limited human trials, officials face another "obstacle" because of the short supply of smallpox-specific immunoglobulin, a product that helps to protect vaccine recipients against side effects. "We can't do clinical testing without this," he says."

There exist millions of doses of old smallpox vaccine in storage in the US. It seems to me that some additional primate safety testing is in order first. If the vaccine cannot pass rigorous safety tests, the stockpile should be destroyed. Efficacy studies should ONLY be started after safety studies are completed; but because smallpox vaccine is licensed, they are not legally required to be performed on this old stockpile. (IND vaccines similarly have no expiration date and can be used indefinitely!) However, the current vaccine has obviously expired, since the last case of smallpox on earth occurred 25 years ago. How was this vaccine released by FDA for the test protocol described below? And will the vaccinees be scrupulously observed for adverse effects?

Meryl Nass, MD

Jeff Jeffords wrote:

> From: "Jeff Jeffords" <lisamichelleearthlink (DOT) net>

> SMALLPOX VACCINE TESTING

> ************************

>

>

> Date: Tue 14 Mar 2000

> From: M. Cosgriff <<mailto:mcosgriffhotmail>mcosgriffhotmail>

> Source: media reports, 13 Mar 2000

>

>

> Researchers at St. Louis University said Monday they had been asked to

> study a smallpox vaccine because of fears the deadly virus could be spread

> or revived through terrorist attacks. Smallpox was officially eradicated

> through a mass vaccination program 20 years ago but could be used in

> bioterrorist attacks, requiring governments to quickly find an antidote for

> the deadly virus.

>

> The U.S. Centers for Disease Control and Prevention (CDC) in Atlanta has

> asked the St Louis University School of Medicine Center for Vaccine

> Development in Missouri, to determine the safety and effectiveness of some

> of the small, remaining supply of the smallpox vaccine known as Dryvax.

>

> "Because of the recent concerns of terrorism throughout the world, the

> United States government is making efforts to improve its ability to

> protect its citizens in the event of an attack," said associate professor

> of infectious diseases and immunology at the university's Medicine Center

> for Vaccine Development, Sharon Frey. Frey, who is leading the study, said

> in a telephone interview that the main aim of their research was to measure

> the effectiveness of diluted doses of Dryvax, which is no longer produced.

>

> Of the 60 people enrolled in the study, one third will receive a vaccine

> diluted 10 times, the second a vaccine diluted 100 times, and the remainder

> will get the full undiluted dosage.

>

> "Being able to dilute the vaccine would potentially increase the available

> stock by 10 to 100 fold," said Frey. Frey estimated there were about seven

> million Dryvax doses available in the United States -- far short of what

> would be needed to inoculate the current U.S. population of 270 million in

> the event of a smallpox outbreak. "There is a limited amount of supply and

> the point of this is to see how much we can dilute the vaccine to see how

> many available doses we could really have in the event of an attack," Frey

> said. She added that the United States government, the military and others

> were doing research to find other vaccines against smallpox. "Our research

> will be an interim step between what we have now in terms of stocks and

> finding a new vaccine," she said.

>

> The nightmare scenario would be if the smallpox virus were released via an

> aerosol at a crowded place such as a sports stadium or a political campaign

> event. "We guesstimate that if one person is infected they can, in turn,

> infect 25 people...You can imagine with air travel how easily we could have

> a pandemic on our hands."

>

> With smallpox, it takes about two weeks before people begin to show their

> symptoms and by that time the virus would be on its way to being spread

> nationwide and beyond. The World Health Organization declared the world

> free of the smallpox virus in 1980 after routine vaccinations eradicated

> the disease. Last year, experts from the WHO recommended further research

> on the virus before the world's only known remaining stocks of smallpox in

> the United States and Russia were destroyed. The stocks, kept in

> high-security laboratories at the CDC in Atlanta and at the Russian State

> Center for Research on Virology and Biotechnology in Novosibirsk, were to

> have been destroyed last June 30. Both the United States and Russia were

> among 30 states at WHO's annual assembly last May who sponsored a

> resolution calling for more international research into antiviral agents

> and improved vaccines.

>

> President Clinton announced last April that he would seek a delay in

> destroying the stocks because of fears the disease may be spread through

> terrorist attacks.

>

> --

> ProMED-mail

> <<mailto:promedpromedmail (DOT) org>promedpromedmail (DOT) org>

>

> [D.A. has been preaching to everyone who will listen that there

> is insufficient smallpox vaccine available. Now we will find out whether

> even that inadequate supply is effective. - Mod. CHC]

> .................................chc/ds

> ----------

>

>

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

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