Vaccine anthrax

Schneerson R, Kubler-Kielb J, Liu TY et al (2003) Poly(y-D-glutamic acid) protein conjugates induce IgG antibodies in mice to the capsule of Bacillus anthracis a potential addition to the anthrax vaccine. Proc Natl Acad Sci USA 100 8945-8950... 

Rhie GE, Roehrl MH, Mourez M et al (2003) A dually active anthrax vaccine that confers protection against both bacilli and toxins. Proc Natl Acad Sci USA 100 10925-10930... 

The lack of financial profit of the production of orphan drug production is the main obstacle in achievement of the protection task. NBC orphan drugs (NBC-OD) are necessary in large amount, only in critical situations (war, natural or technological disaster, terrorist attack etc ). Practically all NBC-OD, with very few exceptions, like anthrax vaccine, have no civil use, as drugs. 

An anthrax vaccine contains 0.0025% benzethonium chloride as preservative. When a subcutaneous injection of 0.5 mL is given as a booster dose, how many micrograms of the preservative does the patient get ... 

Anthrax vaccines Bacillus anthracis-duenwedu antigens found in a sterile filtrate of cultures of this microorganism Active immunization against anthrax... 

Our initial expectations were that we would interview far more FDA officials than we did. However, we ended up interviewing more DoD officials, at all levels of policy and operations. Officials were interviewed in the following DoD offices Anthrax Vaccine Immunization Program (AVIP) J-4 Eogistics Directorate Office of the ASD(HA) JPO-BD the Defense Supply Center in Philadelphia Office of the Assistant to the Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs U.S. Army Soldier Biological and Chemical Command U.S. Army Medical Materiel Development Activity and U.S. Army Medical Research Institute of Infectious Diseases... 

Third, as the anthrax vaccine experience reveals, both DoD acquisition personnel and the contractors hired by DoD have not always possessed the technical and managerial expertise for working with FDA. Interactions with FDA, especially in licensing-related efforts, involve a complicated three-way relationship among DoD, the private contractor, and FDA. This relationship is quite unlike either the two-way relationship between DoD and defense contractors involved in the procurement of weapon systems or the two-way interaction between FDA and a private drug firm. The policy and operational issues about how to manage these three-way relationships have yet to be worked out. 

In addition to anthrax vaccine, the organization was a licensed producer of diphtheria and tetanus toxoids and pertusis vaccines, adsorbed immune serum globulin (human) pertusis vaccine adsorbed rabies vaccine adsorbed and tetanus toxoid, adsorbed. See Plotkin and Orenstein (1999), Appendix2, pp. 1190-1193. 

In December 1997, Secretary of Defense William Cohen announced a departmentwide anthrax immunization program for high-risk military personnel. Implementation began in March 1998. On May 18, 1998, the Secretary authorized the vaccination of all military forces (Cohen, 1998). Almost 2.5 million troop-equivalent doses of vaccine were required to implement the Secretary s decision, much more than had ever been produced by the licensed manufacturer in its entire history. Prior to Desert Storm, the primary vaccine users had been veterinary, laboratory, and industrial workers at risk of infection, for whom an estimated 60,000 doses of Anthrax Vaccine Absorbed (AVA) were distributed between 1974 and 1989, an average of 4,533 doses per year (foellenbeck et al., 2002). During Desert Storm, approximately 150,000 troops received 300,000 doses of AVA, without accurate recording of recipients or adverse reactions. 

FDA provided DoD officials customized E T in Fehmary 2000, which was considered useful hy many of those we interviewed in both DoD and FDA. CBER s Office of Commimication, Training and Manufacturers Assistance presented a basic course on FDA-CBER for both DoD and the Centers for Disease Control and Prevention in response to the problems associated with the anthrax vaccine. FDA officials indicated to RAND that it was both possible and desirable for FDA to provide E T programs responsive to DoD needs. The lack of a central point of contact in DoD to discuss needed and available E T was viewed as a limiting factor. ... 

AVIP has three main responsibilities to monitor the services exeention of the program and facilitate its exeention (other than anthrax acquisition) to act as the focal point for information on the anthrax vaccine, the program, etc. and to lead surveillance of adverse effects from the anthrax vaccine (according to Colonel Randy Randolph, Director of AVIP, interviewed July 12,2001). 

Clayson, Edward T., Lieutenant Colonel, U.S. Army, Program Director, Anthrax Vaccine Adsorbed Production Program, JPO-BD, telephone interview, August 22, 2001. 

Marano, Nina, Coordinator, Anthrax Vaccine Research Program, Centers for Disease Control and Prevention, telephone interview, July 11, 2001. 

Cohen, W., Implementation of the Anthrax Vaccination Program for the Total Force, Office of the Secretary of Defense memorandum. May 18,1998. 

U.S. Food and Drug Administration, FDA Approves License Supplements for Anthrax Vaccine Lots from Renovated Facility Can Be Released and Distributed, press release FDA News), January 31, 2002a, available at www.fda.gov/bbs/topics/NEWS/2002/ NEW00792.html (accessed July 2003). 

The threat of a bioterrorist attack with smallpox is especially disturbing since the eradication of smallpox remains one of the great achievements in human history. Unfortunately, since routine vaccination against smallpox was discontinued in 1978, few people retain immunity today. Although there are only two official repositories of the smallpox virus today, it is still possible that terrorists will be able to obtain the virus. Thus, the government has had to stockpile supplies of the vaccine, and there is some debate about whether to resume routine smallpox vaccinations. Although the smallpox vaccine was discovered by accident, the story of how Louis Pasteur developed the first anthrax vaccine and his use of unvaccinated animals as controls remain as excellent lessons about the process of science (Trachtman 2002). 

Anthrax. At this time, anthrax vaccine adsorbed (AVA) is licensed for use in individuals 18 to 65 years of... 

An anthrax vaccine is available but its use is currently reserved for laboratory personnel who may come in contact with the disease and for military personnel. The vaccine currently in use by the United States military is a sterile, acellular vaccine known as AVA (Anthrax Vaccine Adsorbed). It is not currently licensed for use with civilian populations, although there are protocols under investigation. 

Postexposure prophylaxis is not recommended for contacts of patients infected with B. anthracis, or for health care workers who may treat anthrax patients. It is also not recommended for the prophylaxis of cutaneous anthrax. It is currently only indicated for persons who may have been exposed to airspace contaminated with aerosolized B. anthracis (Bell, Kozarsky, Stephens, 2002). The duration of therapy is generally determined to be 60 days of either ciprofloxacin or doxy-cycline, with amoxicillin as an option for children and pregnant or lactating women. The U.S. Department of Health and Human Services has recently announced additional options for prophylaxis of inhalational anthrax, especially for those in whom inhalational exposure may have been significant. These options include 60 or 100 days of prophylaxis, as well as 100 days of prophylaxis plus anthrax vaccine as an investigational agent (GDG, 2001a Nass, 2002). 

Nass, M. (2002). The Anthrax Vaccine Program An analysis of the CDC s recommendations for vaccine use. American Journal of Public Health, 92, 715-721. 

Ciprofloxacin or doxycycline, 60-100 d course, anthrax vaccine THERAPY... 

Anon (Anonymous) (2000). Use of anthrax vaccine in the United States. Recommendations of the advisory committee on immunization practices (ACIP). MMWR 49. 

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