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close this bookUNAIDS-Sponsored Regional Workshops to Discuss Ethical Issues in Preventive HIV Vaccine Trials (UNAIDS, 2000, 52 p.)
close this folderWORKSHOP REPORTS
close this folderENTEBBE, UGANDA, 27-29 APRIL, 1998
View the document1. Phase I/II (Safety and Immunogenicity) Trials
View the document2. Phase III Trials
View the document3. Vulnerability to Harm and Exploitation
View the document4. Community
View the document5. Ethical Review
View the document6. Intellectual Property
View the document7. Control Arm in Trials
View the document8. Informed Consent
View the document9. Counselling
View the document10. Gender, Pregnancy and Breast-Feeding
View the document11. Children
View the document12. Discrimination
View the document13. Treatment and Care
View the document14. Endpoints in Vaccine Trials
View the document15. Compensation for Injury or Harm
View the document16. Access and Availability of Vaccine

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.