Biological Threats and Terrorism Assessing the Science and Response Capabilities: Workshop Summary (2002) / Chapter Skim
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3 Vaccines: Research, Development, Production, and Procurement Issues
3 Vaccines: Research, Development, Production, and Procurement Issues
Pages 85-112
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From page 85... ...
Even among the four major vaccine manufacturers, there is insufficient production capacity. It was suggested during this session that in order to move animal and clinical testing forward, incentives need to be established to reduce the current challenges of vaccine development, vaccine production priorities need to be set and a central office or leader authorized to declare top priorities, and the role of the major vaccine manufacturers needs to be facilitated by clear directions and active collaboration between industry and government.
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From page 86... ...
But there is an urgent need for more anthrax vaccine for the immunization of high risk civilian populations, as well as for use in medical management of exposed individuals in conjunction with antibiotics. Currently, there is only one manufacturer of licensed anthrax vaccine, but production is limited because of regulatory problems.
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From page 87... ...
. The need for ways to accelerate vaccine FDA licensure without compromising product safety, for example use of the proposed animal efficacy rule for products that are either not feasible or ethical for human efficacy trials.
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From page 88... ...
Both smallpox and anthrax vaccines would be very useful in the medical management of exposed individuals, if the vaccines were readily available and placed in geographic proximity to multiple centers for distribution. Less important to the civilian populations are vaccines against bacterial agents that can be managed with antibiotics and viral agents which, at least for the present, seem to be lesser threats.
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From page 89... ...
anthrax vaccine is a filtrate of culture media that contains a high level of PA (protective antigen) absorbed to alum, it probably contains small amounts of the other factors as well.
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From page 90... ...
Efforts are underway to gather all available information on ongoing or planned development efforts for a second generation anthrax vaccine, and compile the information in a systematic fashion and convene several advisors to review the resulting data, findings, and policy options. This may involve a major research and development contract program similar to what exists for smallpox vaccine and which will hopefully build on the work that has been done by DoD and DoD-DHHS collaboration.
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From page 91... ...
This paper will address the following topics: Current medical biological defense research and development efforts, Current biological defense vaccine capabilities, Proposed national biological defense vaccine production facility, and, Issues related to the use of biological defense vaccines. In accordance with Congressional direction, DoD established a Joint Service Chemical and Biological Defense Program in 1994.
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From page 92... ...
The recombinant production technology would eliminate need for spore-forming anthrax, and hence the need for a dedicated production facility. Overall, the next generation anthrax vaccine would decrease production cost, allow a greater range of potential vaccine production facilities, and potentially allow for streamlining of the regulatory approval process.
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From page 93... ...
Current Biological Defense Vaccine Capabilities Joint Vaccine Acquisition Program (JVAPJ In order to enable the transition of candidate biological defense vaccines developed under the MBDRP or from other sources, a Prime Systems Contract was awarded in November 1997 to DynPort Vaccine Production Corporation, LLC. The JVAP was established for the purpose of developing, testing, and Food and Drug Administration (FDA)
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From page 94... ...
Implementation of the vaccination continues to designated special mission units, to vaccine manufacturing and DoD personnel conducting anthrax research, and others conducting Congressionally mandated anthrax vaccine research. Detailed information on the status of the AVIP is available at www.anthrax.osd.mil.
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From page 95... ...
The vaccine production industrial base is nearly at full capacity to meet public health priorities. This will pose a challenge for the production of biological defense vaccines if production of biological defense vaccines results in the deferral of production of public health vaccines.
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From page 96... ...
Proposed National Biological Defense Vaccine Production Facility Following years of research, development, and efforts to produce biological defense vaccines in sufficient quantities to meet DoD needs, a different approach is currently being planned. In July 2001, DoD submitted a report to Congress detailing biological defense vaccine efforts within DoD.
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From page 97... ...
The report recognized that in order for the GOCO to be successful, it would require long-term government commitment, increased resources, innovative DoD business and program management practices, and effective participation by established pharmaceutical industry leaders in vaccine discovery, licensure, and manufacturing. The design concept for a GOCO biological defense vaccine production facility would accommodate three bulk vaccine production suites, each with different processes: spore-forming bacteria (for which FDA requires separate facilities)
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From page 98... ...
Malaria . Diphtheria Tetanus Poliovirus Biological Defense Vaccines Anthrax Vaccine Adsorbed (licensed)
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From page 99... ...
As cases of polio have been virtually eliminated in the United States, the risk of rare occurrences of adverse effects of the vaccine has exceeded the risk of the occurrences and effects of the disease. If biological defense vaccines are produced and planned for use especially among civilians populations vaccine development criteria may place greater emphasis on vaccine safety than on vaccine effectiveness.
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From page 100... ...
A second factor limiting the availability of biological defense vaccines is that they are similar to orphan drugs. There is no commercial incentive for manufacturers to produce vaccines.
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From page 101... ...
M.D., Ph.D. Director, Vaccine Research Center National Institute for Allergy and Infectious Diseases in recent years, increasing attention has been focused on the Ebola virus as a potential public health problem, either from natural or deliberate outbreaks.
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From page 102... ...
This glycoprotein enables the Ebola virus to recognize and introduce its viral contents into the endothelial cell lining of the blood vessels, as well as monocytes/macrophages, thereby resulting in the cellular damage that is associated with the devastating symptoms of Ebola infection. Antiviral Targets Detailed analyses of the mechanisms of viral entry, replication, and cell damage have identified the Ebola glycoprotein 2 (GP2)
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From page 103... ...
Thus, one of the important challenges for developing an effective DNA vaccination platform technology is to improve immune responses in non-human primates and humans. The first successful studies of a DNA vaccine for Ebola virus were carried out in guinea pigs (Xu et al., 1999~.
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From page 104... ...
exhibited rapid increases in their viral antigen levels and succumbed to infection within seven days. In striking contrast, all animals immunized with the combination DNA-adenovirus vaccine survived Ebola virus challenge (4 out of 4~.
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From page 105... ...
This statement reflects the professional view of the author and should not be construed as an official position of the Food and Drug Administration.
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From page 106... ...
This complicates many decisions about product use. For example, a vaccine, such as the licensed anthrax vaccine, which may have been originally studied and used in a limited population effectively and without major safety concerns may raise more significant public concerns about uncommon adverse events, whether coincidental or due to the vaccine, if and when it is administered for similar reasons to hundreds of thousands of people or when unanticipatedly used for post-exposure prophylaxis.
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From page 107... ...
(Although this is presently more difficult in many cases to engineer than antibacterial resistance.) The potential complications of live vaccine administration to increasing immunocompromised populations.
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From page 108... ...
Such studies are critical because civilian populations often include vulnerable or pharmacokinetically variable subsets. Finally, similar to the fast track and accelerated approvals, the animal rule has post-marketing and labeling commitments and restrictions.
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From page 109... ...
. Day-to-day participation in what it takes to develop a product, including clinical trials, quality assurance, adverse event monitoring, timelines, etc.
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From page 110... ...
Medical and Scientific Consultant Aventis Pasteur, Inc. The vaccine industry is highly concentrated with only four major manufacturers providing more than three quarters of the market.
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From page 111... ...
With regard to the development of a new smallpox vaccine, for example, efficacy is an important issue that requires the use of monkey models for which the vaccine industry must turn to DoD or NIH. Development of biodefense vaccines requires better adverse reaction surveillance.
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From page 112... ...
, 49(RR15) ;1-20 "Use of Anthrax Vaccine in the United States Recommendations of the Advisory Committee on Immunization Practices." G
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