1. Name of activity: Global Vaccine Policies

2. Project leader and email address:     Thomas N. Denny at dennytn@umdnj.edu

3. Brief statement of mission and/or vision:

Within the last 100 years, vaccination has been credited with tremendous reduction in the incidence of some infectious diseases. For example, in the US, since 1950 the use of vaccines reduced the number of cases of diphtheria from 6,000 to 3 or 4 per year by 1990. During the same period of 1950 to 1990 cases of pertussis dropped from 120,000 to 4,500 per year and huge reductions were also observed for mumps, polio, rubella, hemophilus influenza and measles.

However, barriers to increased global vaccine coverage include an unfavorable climate for vaccine production that includes less than adequate product liability coverage, reasonable returns on investment (e.g., compared to a hypertension drug), stable delivery system, discordance in global vaccine administration schedules (e.g., multiplicity of schedules that takes place in different countries) and lack of harmonization in global regulatory approaches.

4. Collaborators, staff and faculty by name and email:

5. Specifics about activity:

Three policy areas of focus are relevant to assess solutions to global vaccine shortages:

1. Financial analysis of disharmonization. How does the lack of regulatory harmonization impact vaccine costs? This could include assessment of direct cost related to the increased costs associated with GMP (e.g., GMP spiral) or what it actually costs to put an application through the regulatory process. For example, do we need to have 70,000 people in a clinical trial or would 20,000 or even 1,000 be enough for a trial. What are the costs associated with administration schedule divergence? For example, in some areas where most of the countries are resource poor there is little divergence in terms of schedules and vaccine products being used. However, in contrast, if you look at the 45 countries in Europe you would find that 25-30 different vaccine administration schedules are currently used.

2. Narrow the gap among regulatory authorities. The International Conference on Harmonization (ICH) which deals with the United States, Europe and Japan. Despite the contribution that this effort has made a large degree of variability remains between US FDA and the European regulatory authorities regarding requirements and practices. And, there is even greater variability between the regulatory authorities of the industrialized countries and those of resource poor or developing nations as a group.

3. Address the impact of risk/benefit calculations on the regulatory process. US or European regulatory agencies may develop risk/benefit calculations that effect the regulatory approval process. Many times these decisions are exported to other settings as a policy though it may not be appropriate for that setting since they may operating in a different disease risk environment. For example, if you have a higher incidence of disease you may be willing to accept greater risks associated with a vaccine that would not be relevant if your setting had a lower disease burden (e.g. current debate on use of high risk smallpox vaccine vs . risk of bio terror event).

6. Publications from project:

7. Other related websites:

www.CDC.gov

www.NIH.gov

www.Sabin.org

8. Opportunities for students:

Opportunities are available for students to work on questions related to the above three areas that impact global vaccine policies.

9. Opportunities for volunteers:

Opportunities are available for volunteers to participate in activities related to this project. Those interested should contact Mr. Thomas Denny at dennytn@umdnj.edu

10. Hidden text and keywords

Date revised: 3/30/05