http://dailynews.yahoo.com/h/nm/20011015/hl/vaccine_1.html
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Monday
October 15 2:34 PM ET
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By Louis Charbonneau
VIENNA (Reuters) - Michigan Governor John Engler said on Monday he strongly
supported the re-licensing of Lansing, Michigan-based BioPort Corp., the only
laboratory in the United States authorized to produce an anthrax vaccine.
``We strongly support their re-licensing by the Food and Drug Administration
(news
- web
sites) (FDA),'' Engler told Reuters in an interview during an official
visit to Austria. ``We think they have a very competent and very talented
management.''
BioPort produced the vaccine for US armed forces personnel under an
exclusive contract with the Department of Defense (news
- web
sites).
However, the private firm halted production of its anthrax vaccine in 1998
amid FDA concerns about the safety of its facilities. Last week, BioPort
submitted the final materials necessary for a re-licensing inspection of its
renovated plant.
The FDA has said it is encouraged by BioPort's efforts to improve its
manufacturing process.
Engler expressed optimism about the FDA re-licensing process. He said after
the September 11 attacks in the US, his concern had been the security of
BioPort facilities.
``Our initial concern was limited to their security and safety, making sure
that that site is safe and secure. And we believe that it definitely is,'' he
said.
On October 5, the photo editor of the Florida-based Sun supermarket tabloid
died from anthrax after receiving mail containing the odorless and invisible
anthrax spores.
Since then, several anthrax-contaminated letters have reached people in the
United States. The number of Americans who have tested positive for anthrax in
what authorities have called bioterrorism has reached double figures.
CIVILIAN ANTHRAX VACCINATION
Once it has been re-licensed, BioPort has said it would be prepared to
supply the vaccine, currently reserved for the armed forces, to civilians.
``I think that would be their hope, though right now they're just trying to
finish their re-licensing with the FDA,'' Engler said. ``I'm sure they will
look for developing the (civilian) market, though I'm also sure they hope that
won't be necessary.''
BioPort could only take advantage of increased civilian demand for the
vaccine once it had fulfilled its obligations to the Department of Defense and
produced enough vaccine.
``We'd like them to fulfill their military obligations. After that, it would
be a (good) opportunity to provide for the civilian population.... We'd be all
for that.''
Engler said he did not know when BioPort would begin manufacturing the
vaccine again.
In June this year, the Department of Defense curtailed its anthrax
vaccination program as the vaccine started to run out.
However, in a press release issued at the time, the department said BioPort
could be ready to re-start production of the anthrax vaccine by around the
first quarter next year.
BioPort officials were not immediately available for comment.
The FDA first approved manufacture of the anthrax vaccine in 1970.
ALL
INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.