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Access

Aeras is dedicated not only to developing new tuberculosis vaccines, but also ensuring that they are made available as quickly as possible to all who need them at an affordable price. Aeras will do this by reducing as many barriers as possible on the front end of vaccine development, and by speeding distribution of the vaccine once it is licensed.

To ensure future access, Aeras:

  • Obtains rights and/or licenses to distribute vaccines in resource-poor countries
  • Partners with vaccine developers that agree to adequate supply and affordable production and distribution costs
  • Shares financial risk to spur investment by outside vaccine developers
  • Develops manufacturing capacity to accelerate production and distribution at the lowest possible cost

Affordability and Availability

The concept of future access is considered at every stage of our work. A key determinant for Aeras to commit resources to a particular vaccine candidate is our ability to obtain intellectual property rights to vaccine candidates or a license for distribution in resource-poor countries where the tuberculosis epidemic is most severe. Alternatively, Aeras will enter into agreements with vaccine development partners who agree to distribution terms that include sufficient vaccine production and affordable prices. In all cases, guarantee of adequate supply at the lowest possible cost is a condition of Aeras's financial and clinical trial support.


Spurring Investment

To encourage pharmaceutical and biotechnology companies to invest their time, resources and scientific knowledge to develop a new TB vaccine, Aeras shares the financial risks associated with the large-scale vaccine process development and clinical trials needed for commercial licensing. This financial and scientific support by Aeras removes the highest initial risk, much like a venture capital investment in a new technology.


Expanding Manufacturing Capacity

Another important aspect of the Aeras approach involves manufacturing the vaccine for widespread distribution at the lowest possible cost. It takes four to five years to build a vaccine manufacturing facility and prepare it for commercial production. So as not to lose this amount of time after a license has been obtained, Aeras has already developed manufacturing capacity at our headquarters in Rockville, Maryland, in the U.S., and with partners in China, India and Korea. The Aeras manufacturing facility, in combination with its manufacturing partners, can supply the entire world's need for a new rBCG vaccine. By establishing this capacity, Aeras could move a new TB vaccine could from pre-clinical testing to full-scale distribution within seven to nine years.

To ensure the lowest cost for future vaccines, Aeras will not consider vaccine candidates that will be costly to manufacture on a large scale.


PDP Access Steering Committee

Product Development Partnerships (PDPs) focused on the development of new technologies against under-addressed infectious diseases created a steering committee in 2008 to facilitate information sharing, particularly in the area of product access. The group aims to lay the groundwork to ensure future access for those who need them most to health products currently under development by member groups. The committee facilitates interaction across PDPs and among representatives from endemic countries, donors, the WHO and implementing organizations.

Seven topics addressed by the group are addressed in a new series of discussion papers developed from interviews with PDPs, donors and other stakeholders:

Since the formation of the PDP Access Steering Committee, representatives of the PDPs have convened once in 2008 and again in 2010, with the support of the Rockefeller Foundation and the Concept Foundation, and of the Netherlands Directorate-General for International Cooperation (DGIS). Further information can be found at the Concept Foundation website.


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