Priorities for the National Vaccine Plan (2010) / Chapter Skim
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1 Development of New and Improved Vaccines
1 Development of New and Improved Vaccines
Pages 31-50
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. In this chapter, the committee briefly describes vaccine research and development and major themes that emerged at a meeting with stakeholders about this goal in the draft National Vaccine Plan.
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also in HHS.2 NIH funds basic and clinical vaccine research totaling an estimated $1.675 billion in 2009. The majority of vaccine-related research at NIH takes place in the National Institute of Allergies and Infectious Diseases (NIAID)
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. The vaccine regulatory process is also complex and difficult, requiring a high level of scientific expertise and sustained funding for its maintenance and enhancement.
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the potential desirability of expanding the scope of the National Vaccine Plan to transcend the 1986 definition of vaccines as limited to prevention of infectious disease vaccines. REGULATORY ENHANCEMENTS TO SUPPORT INNOVATION WHILE PROTECTING HEALTH One topic not addressed by the existing Goal 1 objectives is the regulatory system that licenses vaccines and has the potential to facilitate or inhibit innovation.7 The importance of addressing regulatory issues in the National Vaccine Plan was discussed at the committee's meeting with stakeholders on Goal 1 in the plan, and NVAC and the National Vaccine Program Office (NVPO)
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. The great, overarching challenge in bringing new and improved vaccines to market is that new vaccine development and regulation are closely linked processes that tend to be risk-averse.8 Although there are examples of both industry innovation and agile, flexible regulatory approaches, including development of vaccines supported by BARDA and recent development of pandemic influenza vaccines, a considerable proportion of vaccine production and regulation is shaped by an old paradigm of what vaccines are and how they should be studied and regulated.
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Randomized controlled trials have been the gold standard in the regu 9 For example, the European Medicines Agency licensed an HPV vaccine adjuvanted with ASO4 in September 2007 and an H5N1 pandemic influenza vaccine adjuvanted with AS03 in September 2009.
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Such occurrences are not only a regulatory and administrative matter, but may also negatively affect the public perceptions of the effectiveness of influenza vaccine in general. Some of the regulatory barriers to vaccine development are not related to problems of vaccine quality, safety, or efficacy.
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. Because the topic of vaccine research and development is linked with issues in the goals pertaining to vaccine safety and vaccine use, several themes emerged from meetings of the committee with expert stakeholders on those goals in the draft National Vaccine Plan.
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Based on input from stakeholders, a review of pertinent literature, and its own deliberations, the committee found that there are aspects of vaccine development and regulation that can impede innovation without improving safety, efficacy, or immunogenicity, although recent changes at FDA suggest that the regulatory environment is strengthening its scientific foundations. Recommendation 1-1: The National Vaccine Plan should incor porate improvements in the vaccine regulatory process that reflect current science and encourage innovation without compromising efficacy and safety.
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The other candidate vaccines remain at various points in the pipeline. More than a decade later, NIH requested that IOM convene a new committee to assess the progress made since publication of the 1985 reports, to "discuss important barriers to vaccine research and development, and develop another quantitative framework for prioritizing vaccine development" (IOM, 2000)
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report on priorities for vaccines is a signal example of what can be done, but to my knowledge it has never been discussed by the ACIP, nor has the ACIP indicated which of the priorities given by the IOM it agrees with. The 2000 IOM report identified major gaps in data and research relevant to some infectious diseases of public health importance (e.g., Treponema pallidum, Clostridium perfringens, enterococci)
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The committee concurs with the draft plan's attention to prioritization of candidate vaccines and offers the following recommendation. Recommendation 1-2: The National Vaccine Plan should incorpo rate the development of an evidence-based approach for prioritiz ing new and improved vaccine candidates by targeted disease and develop specifications for high-priority vaccines to accelerate their development.13 Such an approach would ideally involve government agencies and all relevant stakeholders and take place under the aegis of NVAC or a similar entity.
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Based on comments received at its December 2008 meeting on developing new and improved vaccines and on a review of relevant literature, the committee understands that barriers to coordination remain, although interactive dialogue has, indeed, been fostered among the relevant federal agencies, advisory committees, and industry. 14 Quality-adjusted life years, or QALYs, have been suggested for use in the United States for priority setting in vaccine development (IOM, 2000)
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Recommendation 1-3: The National Vaccine Plan should incorpo rate creation of a strategy for accelerating development of high priority vaccines17 that (a) engages all relevant institutes within NIH and the Department of Defense, academic investigators, and private sector partners; and (b)
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THE MEANING OF "VACCINE" IN THE 21ST CENTURY The committee believes that the scope of the National Vaccine Plan could be broadened to include classes of vaccines other than vaccines intended to prevent infectious diseases. Such an expansion would recognize the fact that vaccines against infectious diseases are already benefiting from research and development efforts on other vaccine or vaccine-like entities, and that common immunologic platforms may be useful for different types of vaccines.
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The committee does not believe that there is a federal government agency that currently oversees or coordinates work on other types of vaccines. Recommendation 1-4: Future iterations of the National Vaccine Plan should include classes of vaccines (such as therapeutic vac cines and vaccines against non-infectious diseases)
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. It is important that the National Vaccine Plan includes objectives and strategies attentive to this challenging area.
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. Challenge and opportunity on the critical path to new medical products.
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. Draft Strategic National Vaccine Plan.
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2009. Summary Report for Comments on the National Vaccine Plan.
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