Chemical and Biological Defense Program, Annual Report to Congress March 2000

[Guest guest]

I have extracted anthrax-related information from the Report. One

thing caught my eye was one of the " Advanced Developments " for AVA:

" (2) to license the vaccine to provide protection against aerosol

exposure to anthrax. "

Unless I am misreading this this is a tacit admission by DOD THAT THE

VACCINE IS _NOT_NOT_NOT_ LICENSED FOR THE INDICATION FOR WHICH IT IS

BEING ADMINISTERED. If FDA accepts this IND THEY ARE ADMITTING THAT

TOO.

Here are the full quotes from the report. (Available from

http://www.defenselink.gov )

D.1 MEDICAL CHEMICAL DEFENSE RESEARCH PROGRAM

D.2.2 Biological Defense Research and Development Accomplishments

Conducted a comparative serological study of five different species

of laboratory animals

immunized with the licensed anthrax vaccine, using both ELISA and

toxin neutralization

assays, in support of studies to understand and differentiate among

the different animal

models.

· Characterized the isoelectric point of the three protein components

of the two anthrax

toxins (PA-EF and PA-LF) in order to better understand various

genetic classifications

of different isolates and their virulence patterns.

· Initiated studies on the ability of CpG oligonucleotides to protect

animals from B.

anthracis challenge, and found a small level of non-specific

protection in mice.

· Completed aerosol challenge study in rabbits and rhesus monkeys of

B. anthracis strains

which were highly virulent in AVA-immunized guinea pigs, and found

that the licensed

vaccine provided excellent protection in both the monkey and the

rabbit model.

· Completed studies in immunized rabbits comparing the virulence of

B. anthracis spores

with that of vegetative cells, and found that rabbits were completely

protected against

challenge with either form of the organism.

· Inserted the C-terminus of the heavy chain of the botulinum

neurotoxin gene into the

genome of B. anthracis by transposon-mediated mutagenesis in order to

explore a live,

attenuated, multivalent vaccine vector system.

· Characterized the DNA sequence for two genes involved in

replication of B. anthracis,

and which are essential for further development of cloning systems

for expressing

homologous and heterologous antigens in B. anthracis.

· Screened representative samples of Ames and V1B B. anthracis

variants for vrrA type,

which appears to be stable in these strains, and may potentially be

useful as a marker to

indicate the presence of discrete strains.

· Continued studies on the anti-spore activities of antitoxin

antibodies to determine their

role in protection early in infection; the antibodies stimulated

phagocytosis of spores by

macrophages and inhibited spore germination in vitro.

D.2.3 Advanced Development Accomplishments

D.2.3.3 Anthrax Vaccine Human Adsorbed

· The sale of Michigan Biologic Products Institute (MBPI) by the

state of Michigan was

finalized. MBPI was purchased by BioPort, which consists of the

management team from

MBPI and outside capital; it is a private sector entity without state

of Michigan

affiliation.

· Managed and funded efforts leading to the submission of a Biologic

Licensure

Application amendment to the FDA for Anthrax Vaccine Adsorbed. Data

submitted to

the FDA supports two separate efforts for the vaccine:

(1) to reduce the current six-dose schedule to a five-dose schedule,

and

*******************

(2) to license the vaccine to provide protection against aerosol

exposure to anthrax.

*******************

· Managed the anthrax vaccine production and stockpile to ensure

sufficient vaccine is

available to support the Secretary of Defense's anthrax immunization

efforts.

· DoD continued to provide technical assistance to BioPort to

identify and correct FDA

compliance issues.

· Funded and provided oversight of production facility upgrades and

ancillary support

function renovation at BioPort that are critical to maintaining

anthrax vaccine

availability.