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

OC.T-1 1 ':: 'D ' 1 c::=' FROt,,l FL:'H LEG I SLAT I' )E AFFAIR
TO

F..4

(tJEIJT{N N. BURDICK CQMMJ'EE A%,-N~-s 'tQ
NORTH OAKOTA AP~VUQiAt,1".,
TNV'RONMENT ANO F'SC, v S.
$1 WART ENATE OFFICE BUILDING SPECIAL COMMIT-TEE ON AGiNG
PHONE [phone] P 4SELECT COMMITTEE ON NDIAN AFFAIRS
It 4dItatS LInat SENATE RURAL HEALTH CAUCUS
WASHINGTON DC 20510-3401
May 6, 1991
Gerald V. Quinnan, Jr., M.D.
Acting Director
Center for Biologics Evaluation
and Research
HFB-230
8800 Rockville Pike
Bethesda, Maryland 20892
Dear Dr. Quinnan:
I am interested in the requirements the Food and Drug
Administration (FDA) has or will set for the human clinical
efficacy trials for product licensing of preventive AIDS
vaccines to stop the spread of the epidemic to uninfected
individuals.
I have been informed that there is some concern that it may
only be possible to run one AIDS vaccine efficacy study on
humans in the United States. In order to evaluate this
conclusion, I would like to get the Food and Drug
Administration's perspective on the following questions:
1. What are the appropriate numerical size and demographics
of the population or populations, if there is more than one,
that would be subjects of an AIDS vaccine efficacy test? How
long would the subjects be followed before there would be
sufficient results to determine if a preventive AIDS vaccine
was effective?
2. How many different human efficacy trials could be run in
the United States?
3. Given that the epidemic is spreading to other groups
(i.e., from homosexuals to intravenous drug users to spouses of
bisexuals and drug users to infants born of infected mothers to
college students), what would prevent subsequent tests from
being run on groups which may be at higher risk in the future?
Is it possible that some populations which could be included in
efficacy tests within the next 12 months will become so
infected that they could not be included in future efficacy
tests?

111111 5111111111 0III IIIIIIIIIIIIIII
5571095.0462.001