Part 1. U.S. Government’s History of HIV Vaccine Development

AUG-04-97 12:00 From:14154766042

T-617 P.02/05 Job-316

Part i, U.S. Goyernment's History of HI!V Vaccine Development
* The private sector, not the government, develops vaccines;
* For a variety of reasons, mostly financial, relatively few companies are
seriously attempting to make an AIDS vaccine. (This is in marked contrast to
HIV therapeutic drug development where there is a large incentive and many
players).
* Until the President's declaration, the OAR report and the President's
Commission hammering, the government's commitment (e.g., policy, funding,
structure) for AIDS vaccine has been small;
* The lead government organization for an AIDS vaccine is NIAID;
* NIAID is excellent at encouraging basic research in Universities. But it is
not a public health institution with extensive vaccine application experience
and has limited experience in working with the private sector to make
vacoines.
* NIAID's vaccine program has been mediocre at best;
* NIAID leaders and Division of AIDS staff, while well intended, have little
experience in developing other vaccines;
* The 1994 NIAID decision (against its expert committees' advice) not to
conduct promised Phase Ill trials of the envelope-based vaccines chilled the
entire AIDS vaccine field;
Part 1: A new structure for the President's AIDS vaccine initiative (see figural
I have made a figure to help put this new structure into perspective with
existing structures.
The essentials:
* Keep NIH in basic vaccine research and Phase I and Phase II clinical research;
* Move Phase Ill's control out of NIH to an experienced public health oriented
agency (e.g., CDC or the Army. I prefer CDC since it seems a bit strange to
give the Army the lead, though it should be deeply involved);