[Letter to Gerald V. Quinnan, Jr. from Quentin N. Burdick]

f lT-15-1992 15:33 FROM FI:DA LEG I S'LAT I UE AFFAIR S TO ' 9223329564 F'. 0 5
4. Would we learn more about the efficacy of AIDS vaccines in
humans by testing available vaccines for efficacy in humans,
outside the U.S. if necessary, than by limiting efficacy
testing of vaccine candidates to chimpanzees or other primates?
5. If appropriate study populations are not currently
available in the United States for human efficacy studies of
AIDS vaccines, would FDA use results from such studies
conducted overseas in evaluating a product licensing
application for a preventive AIDS vaccine? Assuming the
vaccine has been proven to be safe for humans in approved Phase
I trials, would positive results from overseas human efficacy
tests be sufficient for product licensing in the United States?
I would appreciate your answers to these questions as soon as
possible. Thank you for your time and attention in this
matter. I look forward to your reply.
With kind regards, I am
Sincerely,
Quentin N. Burdick

QNB:jl