The Children's Vaccine Initiative Achieving the Vision (1993) / Chapter Skim
Currently Skimming:
1 Executive Summary
1 Executive Summary
Pages 1-18
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 1... ...
Public health officials in the Americas are now close to declaring victory over another infectious scourge: poliomyelitis. Largely because of the success of the Expanded Program on Immunization (EPl; established in 1974, the EPI is administered by the World Health Organization and is supported by numerous national governments, international organizations, and private foundations)
|
From page 2... ...
And many vaccines require constant refrigeration. The complexity of vaccination schedules in the United States and much of the developing world exacerbates two categories of problems common to many immunization programs: high dropout rates and missed opportunities for vaccination.
|
From page 3... ...
The task forces examine strategic, logistic, and policy issues relevant to the industrial development and introduction of CVI vaccine products, including such areas as quality control, epidemiologic capability in developing countries, and global vaccine supply. The product development groups promote, facilitate, and manage projects leading to the development of vaccines and related products.
|
From page 4... ...
Food and Drug Administration, Health Resources Services Administration, National Institute of Allergy and Infectious Diseases, National Vaccine Program Office, and the Office of International Health) , the Pharmaceutical Manufacturers Association, the United Nations Development Program, and the World Health Organization, Children's Vaccine Initiative embarked in February 1992 on an 18-month study to: · identify and explore major economic, legal, regulatory, policy, and other factors that influence, both negatively and positively, the development, production, introduction, and supply of vaccines; and · recommend ways to enhance cooperation and participation among all relevant U.S.
|
From page 5... ...
Each year, the federal government spends hundreds of millions of dollars conducting research on new and improved vaccines, ensuring the safety of existing vaccines, purchasing and distributing vaccines to the states, and conducting educational and other outreach activities to encourage vaccine use. The majority of basic research in the United States that leads to the development of new or improved vaccines is funded or conducted by the federal government, although a significant amount of basic research is conducted and funded by the private sector.
|
From page 6... ...
Procurement of pediatric vaccines for the developing world tends to be highly concentrated, characterized by purchases of large numbers of doses by national governments or international agencies such as UNICEF or PAHO. UNICEF is the largest single buyer of vaccines for use in the developing world.
|
From page 7... ...
Innovation The research and development of new and improved vaccines by commercial manufacturers exclusively for developing country markets is limited at best. The low prices quoted to UNICEF/PAHO cover the marginal costs of vaccine production, but they do not appear to provide sufficient market incentives for international vaccine companies to invest in research and development for exclusively developing-world vaccines.
|
From page 8... ...
The current vaccine development process in the United States, from basic research through to the production, distribution, and marketing of vaccine products, while poorly integrated, does lead to the development and production of new vaccines for the domestic market, primarily because vaccine manufacturers perceive there to be adequate returns on their investment. The current vaccine development system in the United States rarely leads to the development of vaccines intended for developing-country use, simply because such vaccines are perceived to be without sufficient returns on investment.
|
From page 9... ...
Pilot Production In the committee's judgment, a serious bottleneck to vaccine development is the relative scarcity of facilities that are used to manufacture pilot lots of vaccine according to FDA standards of current "Good Manufacturing Practices," an extensive body of regulations for manufacturing pharmaceuticals and biologics. Many of the vaccines currently under development, including those envisioned by the CVI, involve novel and experimental technologies and are directed against diseases for which there are no suitable animal models for evaluating vaccine efficacy.
|
From page 10... ...
Although a number of private firms have the capability of producing pilot lots of vaccine on a small scale, few are able to produce pilot lots of vaccine that meet current Good Manufacturing Practices, and even fewer are able to scale up to large scale manufacture. Indeed, with the exception of a handful of publicly owned pilot production facilities operating in the United States, the capability of producing pilot lots of vaccine according to current Good Manufacturing Practices rests almost entirely with commercial vaccine manufacturers.
|
From page 11... ...
This is primarily because most CVI vaccines targeted to developing countries lack the market potential of vaccines intended for the domestic market and do not provide adequate returns on investment in research and development. At the same time, the committee recognizes that the scientific base for the development of new and improved vaccines in the United States is extensive and impressive and that new approaches and techniques to vaccine construction currently in research and development will revolutionize the ways that vaccines are made and delivered to children.
|
From page 12... ...
In the committee's view, the development of new and improved vaccines for use in the industrialized countries and the developing world is unlikely to occur unless there is an entity that has the mandate to manage and oversee the process from start to finish. Because the private sector alone cannot sustain the costs and risks associated with the development of many CVI vaccines, the committee recommends that an entity, tentatively called the National Vaccine Authority (NVA)
|
From page 13... ...
; · development of simple, low-cost vaccine manufacturing technologies that could be easily transferred to vaccine manufacturers in developing countries; · exploitation of vaccine technologies that are nonproprietary and therefore of little interest to commercial manufacturers who desire market exclusivity; · adaptation and introduction of currently available vaccines (e.g., pneumococcal conjugates) and new vaccines, including combination vaccines, to developing countries; and
|
From page 14... ...
Vaccines that are developed by the NVA and its partners would be licensed to commercial or public-sector manufacturers in the United States or to public-sector manufacturers in the developing world. The NVA would be an international resource and would work closely with the global CVI and multilateral organizations and institutions to ensure that vaccines developed by the NVA meet international needs.
|
From page 15... ...
Efforts to strengthen U.S and global vaccination efforts should be based on the research and development of new and improved vaccines. This committee forwards the recommendation for a National Vaccine Authority having recognized and struggled with the burden and discomfort that the proposal of creating a new entity brings.
|
From page 16... ...
By providing a market "springboard," this program could support the growth of U.S. biotechnology firms, potentially contributing to expansion in the sources of supply for other types of vaccine products, contributing to the growth of a U.S.
|
From page 17... ...
Vaccine-preventable diseases are an economic drain on developing countries. Developing countries that are able to sustain a healthy and productive work force-through effective disease prevention activities, including immunization-are more likely to become vibrant and full partners in the international community.
|
From page 18... ...
A significant number of scientists working on new and improved vaccines are based in the United States-in universities, in government laboratories, in biotechnology firms, and in vaccine manufacturing companies. Many of the world's most innovative vaccine manufacturers are U.S.-based.
|
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.