Summary of Vaccine Panel’s
Deliberations and Recommendations
As part of an ongoing series of updates in scientific areas of emphasis and
opportunity, an expert panel was convened to discuss issues ranging from the
feasibility and safety of developing and testing a vaccine against dental caries
to marketplace realities. The panel heard latest findings from scientific experts
in this area and then identified and deliberated on the issues. They concluded
that NIDCR should continue to support basic research on mucosal immunology
and suggested that priority be given to the passive immunization approach.
The panel also raised several scientific, ethical and economic considerations
related to the active immunization approach for the prevention of dental caries.
The panel pointed out the need for additional longitudinal data documenting
the relationship among S. mutans levels, antibody levels and caries. One approach
could involve studying all innate immune factors in children not colonized
by S. mutans, despite having mothers with high caries levels. They questioned
whether organisms other than S. mutans cause caries, since current vaccine
strategies have targeted this organism. The possibility of other pathogenic
organisms moving into the niche vacated by S. mutans was considered. Some concern
was expressed about the safety of some of the antigens being proposed by the
caries vaccine research groups. The panel raised the question of whether immunization
of children, ages 1-2 years, whose immune systems are still developing, would
present unique safety issues relative to older children or adults. They pressed
for more precise identification of the target population for a caries vaccine
and the rationale.
The panel noted public perception that vaccines (in general) alter normal
development. This concern would have to be overcome for the public to accept
a caries vaccine. Also explored was whether acceptance would be achieved if
only “high-risk” populations were immunized.
The panel offered that a caries vaccine would have little chance of making
it to marketplace. The biggest hurdle would be getting a CDC Advisory Committee
on Immunization Practices (ACIP- http://www.cdc.gov/nip/ACIP/default.htm) recommendation
for routine use in all children. Without that, the panel said, industry will
not make the vaccine. An ACIP recommendation is tied to economic-risk benefit,
making it necessary to prove that a caries vaccine would be cost saving. More
information about the burden of caries over time in terms of both economics
and quality of life will be required.
In summary, the panel recommended that if NIDCR does pursue research supporting
the development of a caries vaccine, we should re-frame our end goal to aim
for proof of principle, stopping short of Phase 3 trials. Given the real-world
barriers to a caries vaccine, the panel suggested that NIDCR consider using
its resources to develop alternative means of solving the caries problem.
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