Research Subcommittee Minutes

Revised
12-6-97
1:00 p.m.
Research Subcommittee Minutes
December 4, 1997
Helen Miramontes, Chair, asked for public comment on the Vaccine Report. In attendance were
the following Subcommittee members: Jerry Cade, Phyllis Greenberger, Scott Hitt, Ron Johnson,
Bruce Weniger, and a representative for Debra Fraser-Howze. Others attending included Bob
Rohr(?), San Francisco Chronicle; Donald Burke, Johns Hopkins University; Bonnie Mathieson,
Office of AIDS Research (OAR), NIH; Wendy Wertheimer, OAR, NIH; and representatives
from U.S. Medicine and The Blue Sheet.
Dr. Mathieson provided an update on NIH vaccine activities. She reported that the Master
Agreement that had been sent to the Subcommittee was now on the NIH homepage as contract
98-15 and lists an RFP with a 2/28/97 due date. Contract planning had begun for the Vaccine
Research Center. The pool of applicants for director for the Center have been narrowed to five or
six people. She clarified that the Vaccine Research Center will have AIDS vaccines as its initial
focus, but the scope of the Center will be broadened to include other diseases.
The Subcommittee asked for comments from NIH on the PACHA draft. Although Jack
Whitescarver had spoken with Subcommittee members, the group's perception was that these
comments were off the record and that no formal NIH response had been received.
Discussion ensued around the coordination of vaccine efforts and appropriations since the
Vaccine Research Center is only a portion of the vaccine effort. Dr. Wertheimer replied that the
OAR's goal is to ensure that resources are appropriated where needed throughout NIH. OAR was
given budgetary authority by Congress and the funds go directly to the Institutes. Special study
sections are housed in the Center for Scientific Review (formerly the Division of Research
Grants). The AIDS research scientific peer review sections are being reorganized, and there is a
proposal for a separate vaccine study section. Innovative vaccine grants are currently reviewed
internally by NIAID since these grants are being fast tracked. OAR has given discretionary funds
to assist this effort.
The issue of NIH support for testing vaccines in phase III efficacy trials was raised. Dr.
Mathieson replied that phase I/II trials have been funded. Although phase III trials could be
proposed, the funds available were probably not sufficient. HIVNET supports phase III trials and
new awards have increased the HIVNET domestic sites from 8 to 11 and the international sites
from 9 to 10 or 11. When asked if NIH would consider cosponsoring phase III trials in Thailand
with the Army, Dr. Mathieson replied that those with NIH operational functions would be more

appropriate to address this question.
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