Protecting Our Forces Improving Vaccine Acquisition and Availability in the U.S. Military (2002) / Chapter Skim
Currently Skimming:
3 Current Status of Vaccines for Military Personnel
3 Current Status of Vaccines for Military Personnel
Pages 39-54
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 39... ...
, or is in development. It is an incomplete list of potential threats and does not include a number of infectious diseases or infectious disease agents for which a vaccine is neither available nor in development, but against which the military might have a need for a vaccine, such as Crimean-Congo hemorrhagic fever, West Nile encephalitis, Nipah virus, Norwalk virus, Lassa fever, and other common infections or infectious disease agents, such as gonorrhea, chlamydia, and tuberculosis.
|
From page 40... ...
Hantavirus Hepatitis A Hepatitis B Hepatitis C Hepatitis E Human immunodeficiency virus Influenza Japanese encephalitis Leishmaniasis Lyme disease Malaria Measles Meningococcal groups A, C, Y andW-135 Meningococcal group B Mumps Plague Pneumococcal X Poliovirus types I, II, and III X Q fever Rabies Rift Valley fever Rubella Scrub typhus Shigella XC XC XC XC XC X X X xa xb X X X X X X X X X X X X X X continued
|
From page 41... ...
. DynPort Vaccine Corporation, DoD's prime vendor contractor through the Joint Vaccine Acquisition Program, has linked with BioReliance to produce 300,000 doses of a smallpox vaccine (Brownlee, 2001; JohnsonWinegar, 2001)
|
From page 42... ...
Market factors, such as inadequate sustained demand, are obstacles as are a lack of interest or monetary incentive for industry to participate in the development or scale-up of the production process, the lack of an adequate physical infrastructure to meet the regulatory requirements for manufacture of the 1DynPort Vaccine Corporation, DoD's prime vendor contractor through the Joint Vaccine Acquisition Program, has linked with BioReliance to produce a smallpox vaccine. The vaccine is being evaluated at the University of Kentucky, and Phase I clinical trials began in April 2002 (Gay, 2002; Johnson-Winegar, 2001)
|
From page 43... ...
and W-135 Mumps virus vaccine, live Pneumococcal 7-valent conjugate vaccine Pneumococcal polysaccharide polyvalent vaccine Poliovirus vaccine, inactivated Rabies immune globulin Rabies vaccine Rubella virus vaccine, live, attenuated Smallpox vaccines Tetanus and diphtheria toxoid, adsorbed Tetanus immune globulin Tetanus toxoid Tetanus toxoid, adsorbed Typhoid vaccine, Vi, polysaccharide Typhoid vaccine, live, oral Ty21a Varicella vaccine, live, attenuated Yellow fever vaccine, live, attenuated GlaxoSmithKline Biologicals Merck & Co., Inc. Aventis Pasteur, Inc.
|
From page 44... ...
Military Personnel as IND Products Product Manufacturer Botulinum toxoid vaccine, pentavalent Tick-borne encephalitis vaccine, inactivated BioPort Corporation Baxter-Immuno Vertriebs GmbH*
|
From page 45... ...
Brief descriptions of the current status of the select vaccine research programs supported by the Military Infectious Diseases Research Program (MIDRP) 3 appear in the following paragraphs.
|
From page 46... ...
Priority Malaria vaccines 5.8 1 Malaria drug discovery program 4.8 2 Diarrheal vaccines 4.4 3 Flavivirus vaccines 2.9 4 (includes vaccines against tick-borne encephalitis and dengue viruses) Common diagnostic systems 0.5 5 Malaria genome project 1.4 6 Identification and control of insect vectors 1.6 7 Hepatitis E virus vaccine 0.9 8 Polyvalent meningococcal vaccine 0.5 9 Vaccine tech 1.1 Hemorrhagic fever and tick-borne encephalitis virus 0.8 10 Hantavirus vaccine 0.7 10 Rickettsial diseases 0.7 11 Leishmania research 1.5 Not rankeda Human immunodeficiency virus research 15.0 Not rankedb Walter Reed Army Institute for Research overhead 11.0 Total 53.6 Total for Vaccines 31.3 NOTE: Program priorities in boldface type represent vaccine-related research.
|
From page 47... ...
Phase III clinical trials measure the vaccine's safety, efficacy, and immunogenicity. This phase should generally include thousands of patients and should provide sufficient benefit to risk data to ensure licensure and "provide an adequate basis for product labeling" (FDA, 2001c)
|
From page 48... ...
, and a Small Business Innovation Research program grant from the National Institute of Allergy and Infectious Diseases to develop oral microbead vaccines against diarrhea. Antex Biologics, Inc.
|
From page 49... ...
A Phase II clinical trial of the vaccine with 2,000 adult volunteers is under way in Nepal (Genelabs Technologies, 2001~. Meningococcal Group B Vaccine The efforts of investigators at WRAIR led to the development of a quadrivalent polysaccharide meningococcal vaccine that has been recommended for use by selected civilian populations, such as college students (AAP, 2000; CDC, 2000b)
|
From page 50... ...
Significantly, as described in the note to Table 3-8, live, attenuated vaccines against chikungunya virus, Junin virus, and Rift Valley fever virus that were previously available as INDs through SIP no longer have active IND status and thus are not available even for very specialized uses within DoD. TABLE 3-7 FDA-Licensed Vaccines Used by SIP as of March 2002*
|
From page 51... ...
SIP administered as an IND a tick-borne encephalitis vaccine to U.S. military personnel deployed to Bosnia in 1996.
|
From page 52... ...
It states that "FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that drug product has an effect on a surrogate endpoint." To detect relatively low frequency adverse events related to vaccine administration, tests need to be conducted with substantial numbers of subjects, making the demonstration of safety and efficacy not only difficult but also costly. Several published estimates from the pharmaceutical industry and others indicate that approximately 60 to 75 percent of vaccine development costs occur in the late stage of product development (Greco, 2001; Monath, 2000~.
|
From page 53... ...
Congress passed an amendment to the Defense Authorization Act for FY 199912 that vests solely with the president the authority to waive the informed consent requirement. Accordingly, FDA revoked the 1990 interim rule and established a new interim final rule outlining the limited circumstances in which the president could waive the informed consent requirement: "if the President finds obtaining informed consent (1)
|
From page 54... ...
The sequence of events outlined above highlights the difficulties inherent in complying with FDA rules related to an IND product and conducting welldocumented clinical trials of investigational vaccines among military personnel engaged in combat or participating in peacekeeping duties under hazardous conditions. They also point out the difficulties that commanders face when they must confront the rules and regulatory practices that are in place when they are deploying forces into situations that are likely to expose those forces to infectious disease threats for which licensed vaccines may not be available.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.