Book 5: Vaccine availability

Any HIV preventive vaccine demonstrated to be safe and effective, as well as other knowledge and benefits resulting from HIV vaccine research, should be made available as soon as possible to all participants in the trials in which it was tested, and to other populations at high risk of HIV infection. Plans should be formed at the initial stages of HIV vaccine development to ensure such availability.

2.1 Given the severity of the pandemic, it is imperative that there should be sufficient incentives, both through financial rewards in the marketplace and through public subsidies, to foster development of effective vaccines while also ensuring that vaccines are produced and distributed so as to be available to the populations at greatest risk.

2.2 There should be benefits to the host community, including access to the best proven prophylactic method identified by the study (see Book 1, 11.4.4).

2.2.1 A safe and effective HIV vaccine should be made available as soon as possible to all participants in the trials in which it was tested, as well as other populations at high risk of HIV infection.

2.2.1.1 In judging what is reasonable to expect in terms of current and future availability, international human rights standards should be used.

2.2.2 As it will take a long time before a safe and effective vaccine is licensed and distributed, sponsors and investigators in collaboration with other stakeholders must consider how other benefits of HIV vaccine research are to be distributed in the participating community; that is, how research findings could be translated into components of health care (see Book 1, 11.4.4), capacity- building initiatives (see Point 3) and development of health care infrastructure (see Point 16).

2.3 A process of discussion regarding making a safe and effective HIV vaccine reasonably available should begin among relevant parties before a trial commences, and should be carried on through the course of the research. The discussions should:

1. Include representatives of relevant stakeholders, such as the executive, health authorities, relevant scientific and ethical groups, participating communities, people living with HIV/AIDS, and NGOs representing affected communities;
2. Include issues such as payments, royalties, subsidies, technology and intellectual property (see Book 1, 11.4.2. ii), and distribution costs, channels and modalities, including vaccination strategies, target populations, and dosage;
3. Engage international organisations, sponsor governments, bilateral agencies, representatives from wider- affected communities, international and regional NGOs and the private sector;
4. Consider financial assistance regarding making vaccines available; and
5. Build the capacity of government and communities to negotiate and implement distribution plans.