Long delays between the development of a new vaccine and its extensive use is often occasioned by the disparate regulatory requirements of the countries to which it is being offered.
Michael Isbell of the International AIDS VCCINE Initiative (IAVI) presented some recommendations aimed at removing or at least reducing these delays.
The objectives are to expedite comprehensive safety, efficacy and quality assessments; to standardise and make more uniform countries’ risk-benefit considerations, and to ensure timely, effective review of new vaccines.
IAVI has proposed that global meetings should be held to clarify methodologic issues, and to promote agreement on regulatory pathways.
Regulatory capacity should be built, so that the country needing the vaccine can make the initial assessment. Under an export licence, a receiving country can perform its own regulatory function. Increased harmonization of regulatory systems could be facilitated by the WHO, and increased regional collaboration for those countries with similar demographic profiles.
Bridging studies are needed to determine the applicability of vaccines in multiple circumstances: funding will be required for these investigations.
Donor countries should fund WHO’s capacity-building activities.
Flexibility is required from high-income countries to avoid delays.
AIDS 2002 Conference News produced by Health & Development Networks/Key Correspondent Team