IAVI Report Vol. 2, no. 2

US. President Sets Goal... continued from page 1
While the idea of setting a goal for
development of anAIDS vaccine had been
discussed in a White House meeting in
December, 1996 by Clinton,
Vice President Al Gore and in t e
a number of NIH officials, I
many researchers appeared many the
to have been caught off
guard by the U.S. President's success of
decision to publicly declare
such a goal. vaCCine ce
Nevertheless, leading NIH depend
researchers, including National
Institute ofAllergy and director
Infectious Diseases (NIAID)
DirectorAnthony Fauci and selected e
Office ofAIDS Research (OAR)
Director William Paul, voiced amount
strong support for Clinton's
speech. According to Pat Fast,
associate director of NIAID's
Vaccine and Prevention Research Program, the
Presidential goal provides "great support to those
working on HIV vaccine research from the highest
level. It has already improved the mood and
morale of people quite a bit.'
Others were more cautious. Robert Gallo,
director of the Institute of Human Virology in
Baltimore, described Clinton's declaration as "a
good gesture, but only a gesture." He called for
"focused HIV vaccine developments efforts to
be conducted at multiple centers." This
competition, Gallo suggested,"would spur
research and development activity to move
at a much faster pace.'
Even Fauci noted that, while researchers have
made dramatic advances in understanding and
treating HIV in recent years,"there are no
absolute guarantees that we can produce a
vaccine within 10 years!'
Plans for New NI H Lab
Perhaps the most tangible part of the
speech was the announcement that NIH would
establish a separate laboratory for AIDS vaccine
research. Details of what the center will look
like are now beginning to emerge. To be called
the Vaccine Research Center at the NIH, the lab
will be jointly administered by NIALD and the
National Cancer Institute (NCI). It will begin as

a "laboratory without walls", centralizing work
already being done by NIH scientists in HIV
immunology, virology and vaccine research.
At the start, the center will include approximately 30 to 50 researchers.

Physical, financial and human resources for
the center will 6e provided by both NCI and
NIAID.While lab space will be sought in the

view of
ultimate
the NIH
'nter will
on the
that is
" "d hA
vicinity of NIH, construction of.
a building on the NIH campusQ
is being considered.
In terms of funding, the OAR
has proposed a US$10 million
budget for fiscal year 1998 for
the new center. According to
Paul, who first proposed the
center, the budget allocation is
"new funding" which will not
be taken from other HIVrelated research.

Lab Director
Of new to be Hired
In the view of many
rovided researchers, the ultimate
success of the center will
depend on who the NIH is
able to attract as its director and the new
resources that are provided. Gallo, a former
NIH researcher himself, warns that "NIH is
not filled with great vaccinologists." He
believes that the center's success will be
based on the person selected as director and
the amount of authority that person is given.
According to Fauci, a search committee is
being named to recruit a top level manager
from the outside to head the center. The
committee will conduct a broad nationwidesearch and will seek a director with "specific
expertise in vaccine development." The search
will be fast-tracked and, in a best-case scenario,
a director will be hired by fall.NIH Director Harold Varmus appears to be
actively involved in the overall effort and will
head an executive committee that oversees the
center.The AIDS Vaccine Research Committee,
headed by David Baltimore, will be the
scientific advisory committee to the center.
Questions also emerged as to the specific
work that the center will undertake. NIH
officials suggest that the lab will oversee
everything from basic research to preparing
pilot lots of candidate HIV vaccines. According
to Paul, the center may have GMP (good
manufacturing practices) and/or GLP (good
laboratory practices) facilities, which would
enable it to play a far greater role in producing
candidate vaccines.To date, the NIH has relied
almost exclusively on private industry to
prepare candidate vaccines for Phase I trials.

Can a U.S. government agency conduct
vaccine research and manufacturing in a rapid,.
timely, and efficient manner? "I certainly hope
so, says Paul.
Summit of the Eight Action
Clinton also vowed to "enlist other nations
to join in a worldwide effort to find a vaccine!'
These efforts, the U.S. President vowed, would
begin at the Summit of the Industrialized
Nations in Denver, Colorado.
To increase support for these efforts, IAVI
organized an "International Call for Action on
HIV Vaccine Development' The declaration,
which attracted the support of 68 leading AIDS
organizations from 23 different nations in little
more than one week, called on the industrialized
nations to support a global effort to develop safe
and effective HIV vaccines for use throughout
the world and to expand this effort to other
international forums,'including the G-77 nations.
The full text of the Call for Action was submitted
to the leaders of all participating countries at the
summit (see page 12).
At the summit, which was held on 20-22 June,
1997, the participating nations agreed on a final
communique which stated that "in the long term
the development of safe, accessible, and effective
vaccines againstAIDS holds the best chance of
limiting, and eventually eliminating the threat of
this disease!' The participants added that "we
will work to provide the resources necessary to
accelerate AIDS vaccine research, and together
will enhance international scientific cooperation
and collaboration" and that "collaboration among
scientists and governments in the developed and
developing world and international agencies will
be critical." The communiquf concluded by
calling on other states to join in the effort.
IAVI Interim President Seth Berkley voiced
strong support for President Clinton's efforts and
the actions taken at the Denver Summit, but
noted that they were only a start. "The real work
in implementing these agreements has just
begun,' Berkley stated. "It will take a global
commitment of resources, leadership and goaloriented multilateral efforts to insure that rapid
progress is made in HIV vaccine development."*

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