16. Access and Availability of Vaccine

Consensus:

Those who have participated in an HIV vaccine trial, and the population of a host country in which the trial was conducted, must have access to the vaccine being studied if it is proven efficacious. Access for other groups (such as high-incidence populations in other countries, other developing countries) should be negotiated prior to the trial being conducted.

Discussion:

Those who should be involved in negotiating availability include government (health, finance, and justice), investigators, sponsors, the pharmaceutical industry and international organizations such as UNAIDS.

The level of assurance of availability that can be made prior to the results of a trial becoming available, and how this assurance can be guaranteed, is difficult to define. Without knowing the level of effectiveness, cost of production and appropriate target populations, detailed formulae for ensuring availability may not be achievable. This issue was not discussed in detail.

If a more effective vaccine is discovered than that being studied in the host country, the host country must have the option to use the more effective vaccine.