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Companies to Make Smallpox Vaccine
AP | 10/24/01 | PAUL RECER AP Science Writer

Posted on 10/24/2001 12:53:53 AM PDT by kattracks

WASHINGTON (AP) - Drug companies plan to answer the government's call to make about 250 million doses of smallpox vaccine by the end of next year, but may need regulatory concessions to meet the deadline.

Health and Human Services Secretary Tommy Thompson said Tuesday that the government's goal was to produce enough smallpox vaccine ``so every American will be assured there is a dose with their name on it if it is needed.''

Thompson asked Congress for $509 million to pay for a crash program to produce the vaccine. He said HHS sent a letter on Oct. 19 to vaccine makers asking about their ability to bring the nation's smallpox vaccine stocks up to 300 million doses by the end of 2002.

``Seven companies have indicated they would like to get involved,'' Thompson told Congress.

The companies had until Wednesday to respond to the request, but some said they would not meet the deadline. Others said that to achieve such rapid production of smallpox vaccine - currently not made in the United States - would be possible only if some federal regulations are waived or modified.

The government has about 15.4 million doses of smallpox vaccine stockpiled. A British company, Acambis, is making 54 million doses for delivery next year under a previous contract. The government will need about 250 million more doses to meet its goal, Thompson said.

Dr. Tony Fauci, head of the National Institute of Allergies and Infectious Diseases, said the number of stockpiled doses may be expanded if a dilution experiment is successful.

Researchers are now inoculating volunteers with diluted doses to see if a weaker vaccine will still provide protection. Fauci said the results should be known by February. If the experiment is successful, it could expand the stockpiled doses to at least 75 million, he said.

No American company has made smallpox vaccine since the 1980s, when smallpox was considered eradicated from the world. Most said they would have to start from scratch - installing equipment and developing the expertise - to begin production. The vaccine would have to meet standards set by the Food and Drug Administration.

Doing all that by the end of 2002 could be difficult without some close cooperation with government health agencies, including ``breaking down some barriers'' in regulation, said Nancy Pekarek, a spokeswoman for GlaxoSmithKline.

``Under ordinary circumstances, we're not able to gear up that quickly,'' she said. But Pekarek said GlaxoSmithKline has ``made a commitment to do whatever we can to meet the needs.''

A spokesman for Aventis Pasteur said it was uncertain if his company would even participate. ``We are one of the companies that got a letter, but we have not decided if we will respond,'' said Len Lavenda.

He said Aventis last made smallpox vaccine in the 1970s. ``We don't even have the technique to quickly produce smallpox vaccine by today's standards, (and) we don't know what standards would apply.''

FDA spokesman Larry Bachorik the agency would not cut corners in safety or quality.

``The FDA is committed to work long and hard if that is what is required,'' he said. ``But the FDA will still uphold its same high standards.''

Baxter International spokeswoman Tanya Tyska said Baxter - which has a commercial alliance with Acambis - would commit only to offer ``assistance to accelerate'' vaccine production. ``Baxter's role has not really been determined,'' she said.

Eilene Underkoffer of Merck & Co. would say only that her firm ``was in discussion'' with HHS.

Wyeth-Ayerst Laboratories spokesman Doug Petkus said the letter was still being evaluated. ``We are in discussions with the government about how we can be helpful,'' he said.

--

On the Net:

Department of Health and Human Services: http://www.hhs.gov/

Smallpox facts: http://www.bt.cdc.gov/Agent/Smallpox/Smallpox.asp

Copyright © 2001 Associated Press. All rights reserved.



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1 posted on 10/24/2001 12:53:54 AM PDT by kattracks
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To: kattracks
the end of next year may not be soon enough. maybe they shouldn't put out that kind of info.
2 posted on 10/24/2001 12:59:40 AM PDT by blondee123
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To: kattracks
it would be stupid to attack Americans with smallpox. we can handle the disease better than anyone else. but imagine if someone infected with smallpox visited Mecca or Indonesia? millions of muslims would be wiped out. the poor muslim countries won't be able to treat it
3 posted on 10/24/2001 1:17:44 AM PDT by arielb
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To: arielb
but, and that's a big but, our government won't do it. still politically correct, you know. but the american people are getting restless with each new anthrax diagnosis.
4 posted on 10/24/2001 1:26:26 AM PDT by blondee123
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To: arielb
Well maybe we can enlist the "Dirty Dozen" like in the movie to take a vacation to the middle east should they get afflicted here.
5 posted on 10/24/2001 1:27:20 AM PDT by rolling_stone
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To: kattracks; *Smallpox List
Index bump. To search for smallpox articles, click here: Smallpox List. Please ping all articles relating to smallpox to the list.
6 posted on 11/06/2001 6:08:54 AM PST by Dixie Mom
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