AEGiS-14IAC: Minimizing Regulatory Delays in the Approval and Licensure of New HIV/AIDS Vaccines.

14th International AIDS Conference


Barcelona, Spain - July 7-12, 2002

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Minimizing Regulatory Delays in the Approval and Licensure of New HIV/AIDS Vaccines.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. WeOrD1302)

Isbell MT, Widdus R, Williams L, Gold D
International AIDS Vaccine Initiative, New York NY, United States

ISSUE: A generation or more is currently required before new vaccines receive extensive use in the world's poorest countries, even though these products could prevent substantial morbidity and mortality. To reduce the likelihood that such a situation will occur with respect to HIV/AIDS vaccines, IAVI released at the Durban AIDS Conference a blueprint entitled "AIDS Vaccines for the World: Preparing Now to Ensure Access." According to this IAVI analysis, fragmented and often-inconsistent regulatory requirements in multiple jurisdictions threaten to delay by many years effective use of new HIV/AIDS vaccines when these products emerge.

DESCRIPTION: To clarify potential regulatory delays and to devise strategies for overcoming them, IAVI has initiated a worldwide consultation of leading experts, including research scientists (public and private sectors), regulatory officials (in developing and developed countries), and lawyers, policy experts, and multilateral agencies. Lessons Learned/

RECOMMENDATIONS: IAVI will present the findings of its global consultation, including recommendations for policy reform. Issues addressed will include: -- What fast-track mechanisms may be developed in advance to facilitate swift, comprehensive assessment of the safety, efficacy and quality of new vaccines? -- What policies and practices are needed to address the fact that the societies in which key regulatory agencies exist often have widely varying risk-benefit considerations with respect to new HIV/AIDS vaccines? -- How may capacity be enhanced in developing countries to ensure their timely, effective review of new vaccines?

Keywords: AEGIS, AIDS Vaccines, HIV Infections, Acquired Immunodeficiency Syndrome, HIV Seropositivity, Licensure, Developing Countries, Vaccines, Private Sector, legislation & jurisprudenceKWDaegis,aidsvaccines,hivinfections,acquiredimmunodeficiencysyndrome,hivseropositivity,licensure,developingcountries,vaccines,privatesector,legislation&jurisprudence

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Copyright © 2002 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.