Evening star., 1955-06-10
Continued From First Page

OOutiuuc0 EEUm HIST = age
as investigations are completed.
Polio cases among many chill
d-en inoculated with vaccine
from some lots produced by the
Berkeley tCalif.) firm led to a
withdrawal of the company's
product last April 26.
Although DR.. Scheele dis
closed essentially no more than
he did in his Atlantic City talk,
he went somewhat further in
the report today by listing sew
eral possible causes Of the Cut
ter difficulty.
This occurrence, he said,
"may have been due to vaccine
which, by deficiency in the tests
themselves or by error in the
performance Of the tests, passed
the established safety procedures
and contained sufficiently large
amounts Of live virus to infect a
small number of recipients.
"It may also have been due
to some break in manufacturing
which led to contamination after
testing had been completed
He added that all Of the six
licensed manufacturers expert
enced some testing problems. But
the PHS investigation, he said,
wants to determine especially
what. if any. problems were
uniquely Cutters"
Caused Halt in Program
In any event. the Cutter Incl
dent and other "unanticipated"
difficulties caused a halt in the
mass immunization program,
the report said. This long pause
was necessary. it explained, so
that PHS authorities, polio ex-
perts, and manufacturers could
make a systematic review of
production and testing processes.
The review has resulted in un-l
expected findings that neceSSi-
tated a delay in the vaccination
program which had been planned
on a Nationwide basis. But it
also led to adoption of more rigid
safety requirements and other
moves that should make the pro-
gram much more effective. DR..
Scheele stated.
AS mentioned earlier this week
by DR.. Scheele. the intensive in
vestigationS revealed that "the
records which manufacturers
were required to submit Ito
PHS) did not include certain
data which are essential for an
adequate assessment of con-
siStency in performance" The
report said the manufacturers at
the outset provided information
only on lots which passed tests
but not on various defective lots
discarded in the course of pro-
duction.
While the report did not
specifically say so, it indicated
that PHS itself may have been
at fault in not requiring such
complete processing and testing
information at the start from all
manufacturers.
Some Lots Cleared
Finally, the release of vaccine
has been resumed with clearance
Of some lots in accordance with
the sitter standards and under
the close supervision of a special
review advisory panel, the re-
port related.
But as a result of the overall
inquiry" the repSrt noted, "the
current supply of vaccine is con-
siderably less than anticipated. I"
DR.. Scheele previously had an
nounced in TV and radio talk
this week that manufacturers
would not be able to provide
sufficient vaccine for all young
sters this summer.
PHS spokesmen said this ap-
piled to all children up to and
including those 19 years old. It
does not conflict with a state
ment by President Eisenhower
last week that enough vaccine
would be on hand for second
round shots to all first and Sec
ond graders.
Aided by Experience
Experience, particularly in
learning. the need for more
stringent criteria in testing and
production methods concerning
Salk vaccine, has been a good
teacher despite the confusion
and begging down of the pro-
gram, the report implied.
The Salk vaccine story already
has provided valuable lessons
and new practices in the pro-
duction of viral vaccines in gen.
eral, it said. But ever there, it
cautioned. such developments
are certain to face difficult and
perhaps other novel problems.
The Salk vaccine has pro-
gressed from the experimental
level to large-scale production
with unprecedented rapidity, ("
the report continued. This
speed, rejecting the increased
tempo of all medical research
created problems in biologics
control amenable to solution only
with the accumulation of knowl-
edge and experience. 1t is likely
that other problems of equal
complexity will be raised by the
development of new viral vac
cines."
Recent Moves Made
The report summarized the
following moves made during the
past four or five weeks ito deal
with both the current and the
lAtarr ,.n