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Health & Science: Volunteers receiving experimental doses of smallpox vaccine
http://www.nando.net ^ | 7 10 02 | By PAUL ELIAS, AP Biotechnology Writer

Posted on 07/10/2002 12:17:47 AM PDT by ATOMIC_PUNK

Health & Science: Volunteers receiving experimental doses of smallpox vaccine

SAN FRANCISCO (July 10, 2002 1:18 a.m. EDT) - With the jab of a needle, volunteers are being injected with a smallpox vaccine as part of government-sponsored experiments that come amid heightened fear of biological terrorism.

About 330 volunteers will be inoculated with diluted doses of the vaccine over the next two weeks at four sites across the nation. On Monday, the Oakland Medical Center began vaccinating 50 volunteers.

Researchers will test two vaccines. One, known as Dryvax, was made 20 years ago and consists of 15 million doses. The other is more than 70 million doses that Aventis Pasteur Inc. donated to the government, which now must determine whether the vaccines are still useable.

For decades, Aventis' doses sat nearly unnoticed in a walk-in freezer at a remote mountainside lab in Pennsylvania. The firm thought the contents of their freezer were so worthless they were planning to destroy the stockpile.

Then came Sept. 11 and the ensuing anthrax attacks.

Suddenly the nation's available supply of vaccine for smallpox, a disease that had been declared eradicated worldwide in 1980, was deemed crucial.

"In the past year, I think we've all become more aware of the possibility of a bioterrorist attack in the United States," said Steve Black, co-director of the Vaccine Research Center at Oakland Medical Center.

"I hope we never need to use this vaccine again, but it's important to make certain that if we do it will be available and it will work," Black said. "If we can show that this vaccine stock is still effective, it will go a long way toward making a dose of smallpox vaccine available for everyone in the U.S."

Volunteers have already begun receiving the vaccine at Vanderbilt University in Nashville, Tenn., and the University of Iowa. Baylor College of Medicine, in Houston, also is enrolling volunteers. Results are expected by mid-August.

The tests are part of a $12.6 million National Institutes of Health grant awarded last year to Vanderbilt, which is overseeing the experiment and will enroll about 90 volunteers of its own.

Federal officials at the Centers for Disease Control and Prevention now are considering vaccinating as many as 500,000 health care workers and emergency personnel who would be first to see any smallpox cases. Because the vaccine carries significant risks - including death - officials do not want to resume mass vaccinations.

Bioterrorism experts consider the possibility of a smallpox attack one of the most frightening, albeit unlikely, threats because one infected patient could infect many others.

Health workers will inject the vaccine, the area will be bandaged and the area will be checked. Subsequent blood tests will determine whether the test subjects develop the antibodies needed to fight off the disease.

Two studies released in March by The New England Journal of Medicine found that out of the 700 previously unvaccinated young adults who received some of the Dryvax vaccine, one-third had pain bad enough to miss school, work or other activities after being inoculated. While no one in the study fell seriously ill, some experienced fever, headache, nausea, muscle aches, lesions and swelling.


TOPICS: Breaking News; Culture/Society; Government; News/Current Events
KEYWORDS: biowarfare; smallpox

1 posted on 07/10/2002 12:17:47 AM PDT by ATOMIC_PUNK
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To: ATOMIC_PUNK
Israel announced a new vaccine for smallpox that does not have the traditional side effects six months ago. They do not use eggs to raise the vaccine but rely on a new patented process. Why are we not purchasing the product from Israel, but are diluting old vaccines that have been proven to be inferior to the new product? Is our FDA red tape strangling us or what? Strange world this...
2 posted on 07/10/2002 2:53:48 AM PDT by American in Israel
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To: American in Israel
Excellent question. I wish I knew the answer. I wish I could get the new vaccine for my family.
3 posted on 07/10/2002 3:57:45 AM PDT by FreedomPoster
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To: American in Israel
>>Why are we not purchasing the product from Israel, but are diluting old vaccines that have been proven to be inferior to the new product?<<

In what sense has conventional smallpox vaccine been "proven to be inferior" to this new vaccine?

Have head-to-head clinical trials been done?

Have they been published?

Where?

Or can you post the data?

4 posted on 07/10/2002 4:25:36 AM PDT by Jim Noble
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To: Jim Noble
I searched for It and have not been able to find it yet. I will look again. All I know is an article I read announcing the new freeze dried vaccine had passed its trials and was readying for commercial production. The article mentioned IIRC that they used a new process that avoided a lot of the alergic reactions of the old method. It did not however spell out what the new process was. If I find someting I will post a link. It is far more revelant now than it was then...

5 posted on 07/10/2002 4:49:49 AM PDT by American in Israel
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To: American in Israel
I did a google search, and came up with some interesting results. I started with "israel smallpox vaccine" which led to using "MRC-5 smallpox vaccine".

It appears that the new vaccine is based on a human cell culture, and a controversial element is the use of the MRC-5 line of cells...which, as nearly as I can tell, came from an aborted fetus.

So it may be that this is being kept low-key so as to avoid the controversy such a state of affairs might create.

Anyone interested in the disease might wish to look at a powerpoint presentation (this from Google) at

www.fda.gov/cber/summaries/120600bio05MM.ppt

6 posted on 07/10/2002 5:37:47 AM PDT by neutrino
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To: American in Israel
>> All I know is an article I read announcing the new freeze dried vaccine had passed its trials and was readying for commercial production<<

In other words:

Your statement that conventional smallpox vaccine had been "proven to be inferior" to this product was false.

Is it an error that you woud like to retract, or do you think we should believe it just because you made it up?

7 posted on 07/10/2002 5:55:58 AM PDT by Jim Noble
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To: American in Israel
This doesn't seem to make sense. If the dose is diluted then how is it different from the diminished efficacy of protection for those vaccinated many years ago?
8 posted on 07/10/2002 6:24:55 AM PDT by OldFriend
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To: Jim Noble
>>Your statement that conventional smallpox vaccine had been "proven to be inferior" to this product was false.

>>Is it an error that you woud like to retract, or do you think we should believe it just because you made it up?

Ewwww! I detect a cow pie!

I did not "make it up" the article cited that the vaccine was superior because it did not cause the side effects that lead to nerve damage and or death like the vaccine from the good old days.

If you feel that dying is not worse than good health then why are you taking a vaccine in the first place? I will retract my statement in your direction, but personaly I feel that a vaccine that is cheaper, has no listed side effects and is more effective is superior. But if you insist, call a Whamblance...

However I think also that your statement that the vaccine is not superior is false, and where does that leave us? I do not demand a retraction however. Your statement stands or falls on it own weight just like mine.

-grin-

9 posted on 07/10/2002 6:56:37 AM PDT by American in Israel
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To: *Bio_warfare
Index Bump
10 posted on 07/10/2002 8:33:17 AM PDT by Free the USA
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To: OldFriend
The diluted vaccine produces the typical skin lesion which correlates with antibody production and is a surrogate for protection in almost everyone who receives it. The few who do not get the typical "wheal" can be vaccinated with a higher concentration of vaccine.

Any vaccination that "takes" will provide protection for a finite time period. Eventually, the body's ability to respond decreases. This is why tetanus vaccines must be periodically given, because the protection is not indefinite. Likewise, smallpox vaccinations given many decades ago probably have little, if any, protection, but may decrease the virulence of the illness.

11 posted on 07/10/2002 8:46:36 AM PDT by SC DOC
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To: SC DOC
My question is how the diluted vaccine will be any more effective than the vaccine I got as a child.
12 posted on 07/10/2002 10:53:40 AM PDT by OldFriend
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To: FreedomPoster
The hospital doing the study is accepting volunteers; unfortunately for you it is in CA:

Kaiser (CA HMO) testing smallpox vaccines (on non-medical volunteers)

(I guess I didn't flag my article properly.)

13 posted on 07/10/2002 11:15:24 AM PDT by jiggyboy
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To: OldFriend
It won't be any more effective, but it won't be any less effective either.
14 posted on 07/10/2002 2:59:23 PM PDT by SC DOC
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