[Email to David Baltimore from Bruce Weniger with Draft of PACHA Recommendations]

research in order to better understand the human
immune response to HIV; (2) product development of
vaccine candidates suitably manufactured and approved
for human testing; (3) small-scale (phase I and II) clinical
studies in humans to determine the safety and immune
response of candidate vaccines; (4) large-scale (phase
III) longitudinal field trials to determine efficacy; and
(5) resolution of various supporting issues, such as
product liability, incentives for private research and
development investment, and financing mechanisms to
ensure access to successful vaccines worldwide.
Leadership
It has also become obvious that strong, visible,
high-level leadership is desperately needed to accelerate
the vaccine effort by overseeing the development and
implementation of a comprehensive plan, and by
elevating the vaccine effort to the highest priority in
order to stop an epidemic that continues to infect
8,000 - 10,000 people every day world-wide. The
Vice President has the necessary interest and
standing to engage the cooperation and collaboration
of the private sector, the international community, and
the appropriate federal agencies in order to oversee
the development of an effective plan. The Office of
the Vice President also has the authority to hold the
relevant Federal agencies accountable for their
vaccine efforts and their willingness to collaborate
with other essential agencies, organizations and
participants.
To complement the Vice-President's role, the
President should appoint a respected and
accomplished leader in public health/medical science
as the National Director for AIDS Vaccine Development.
This should be a full time position in a semi-autonomous
environment sufficiently high in the Government hierarchy
to: (1) be an advocate for AIDS vaccine development,
(2) have fiscal authority over all government AIDS vaccine
efforts, (3) provide strong leadership and coordinate all
government organizations involved in this field,
(4) maintain close relationships with vaccine developers
in the private sector, and (5) martial the resources and
cooperation of other nations, international organizations,
and the philanthropic community.
Planning Process and Goals
The development and implementation of a
comprehensive plan for accelerated AIDS vaccine
development will require a systematic, coordinated
process, with defined timelines, and must include all
appropriate constituencies representing relevant federal
agencies/institutions [e.g. National Institutes of Health
(NIH), Centers for Disease Control and Prevention
(CDC), Department of Defense (DOD), United States
Agency for International Development (USAID)], the
private sector (biotechnology and pharmaceutical
industries), and the international community [e.g. United
Nations Programme on AIDS (UNAIDS), International

AIDS Vaccine Initiative (IAVI), World Bank, G-7
countries]. The first phase would include a series of
focused meetings, with establishment of working groups
and committees, each with specific objectives and
deadlines for action and performance.
The comprehensive plan must include not only
the vision and process for vaccine development but also