15. Availability of Vaccine

Consensus:

The sponsor has an obligation to the host regarding availability and pricing of the vaccine. Availability should be negotiated prior to the protocol being approved, with a statement of assurance of availability included in the contract, even if details are not yet possible.

Discussion:

Negotiating availability might include consideration of claim to the patent.

First priority for providing vaccine following the trial goes to those who received the placebo. Mechanisms were discussed such as transfer of technology to the host to ensure the ability to produce the vaccine, tiered pricing, an international loan fund, or partial responsibility for production by the host (product refinement or packaging).

UNAIDS should promote international activity around resource allocation, and should begin this soon.

There should be an agreement that if, for any reason, the sponsor decides not to produce the vaccine following trial completion, another country could produce it for its own use.