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

Product development refers to the translation of
promising concepts from laboratory and animal
experiments to actual vaccine products made according
to "good manufacturing practices" (GMP) under Food
and Drug Administration (FDA) guidelines before they
are approved by the FDA for human testing under
"investigational new drug" (IND) protocols.
Product development requires the infrastructure
and expertise residing primarily in the private sector
(pharmaceutical and biotechnology industries) and is an
area in need of leadership and innovation. Government
leadership may be required to effectively subsidize
private industry needs. Such support would ideally
involve the commissioning of targeted applied research,
the facilitation of cooperative agreements for pilot
manufacture of new vaccine candidates, and the support
of Phase 1, II, and III trials. This could be accomplished
by experienced companies or non-governmental
research institutes working with a minimal amount of
governmental interference. Federal leadership will also
be required to address a host of essential related issues,
such as intellectual property rights, financial incentives
for the government vaccine purchase market,
international vaccine development and purchase funds,
tax rebates, subsidies for vaccine approaches not
commercially attractive, patent extensions, and liability
issues. These are issues which are not within the
traditional role of NIH, but are essential to the
development of an effective vaccine.
Phase III Field Efficacy Trials
A third major area of concern relates to the
implementation of large scale field trials to determine
vaccine efficacy. It will be important to conduct multiple
field trials of various candidate vaccines concurrently,
not waiting for the results of one before starting others.
Many such trials will likely occur in developing countries,
where the incidence of new infections is higher. As a
result, true partnerships with investigators in these
countries must be developed. Critical to the success
of large field trials in developing countries will be the
involvement and "ownership" of the testing program
by scientists living in these developing countries.
Agencies such as CDC, DOD, and USAID have
extensive experience and expertise in field epidemiology,
surveillance, and the conduct of vaccine efficacy trials,
especially in developing countries. In addition, DOD
and CDC currently maintain several long term overseas
field research infrastructures operating through
government-to-government collaborations with foreign
ministries of health and other agencies. These ongoing
field research stations can provide tremendous capacity
for the multiple vaccine trials which are likely to extend
over decades. To facilitate this process, the
comprehensive plan must address the complex issues
of communication, cooperation, and collaboration among
the diverse agencies and organizations which will be
required in this international effort.
PACHA Research Subcommittee Members:

Alexandra Levine, Chairperson
Jerry Cade
Debra Fraser-Howze
Phyllis Greenberger
Bob Hattoy
R. Scott Hitt
Ronald Johnson