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Secretary
103
DREW
5246 HEW Bldg
HUNTER--EX 3-6300
Ext. 3178
ROSS - --Ext. 2125
U. S. DEPARTMENT OF
HEALTH, EDUCATION, AND WELFARE
Public Health Service
Bethesda, Maryland
The
uwiaht
FOR IMMEDIATE RELEASE
D.
Saturday, April 30, 1955
HEW-C15
The Public Health Service, U. S. Department of Health, Education, and
Welfare, made public late today a summary of conclusions and recommendations of
an advisory group of experts in the fields of poliomyelitis and immunology which
has just concluded a two-day meeting at the National Institutes of Health,
Bethesda, Maryland.
The meeting was called by Surgeon General Leonard A. Scheele to advise on
an investigation of the poliomyelitis vaccine produced by the Cutter Laboratories
of Berkeley, California, which was withdrawn from distribution this week.
In addition to the consulting group and staff members of the Public Health
Service, today's meeting included technical representatives of the six pharma-
ceutical houses manufacturing the vaccine. Dr. Scheele said they were included
so that the Service might benefit from their special knowledge regarding the
production and distribution of vaccine.
In arriving at its conclusions and recommendations, the group was guided
by last minute data obtained by telephone from health officials in various parts
of the country concerning cases of paralytic poliomyelitis occurring among
children who have been vaccinated.
As of Noon Saturday, the number of cases reported to the Public Health
Service was as follows: California, 16; Idaho, 8; Louisiana, 2; Illinois, 1;
Colorado, 1; and Georgia, 1.
(More)
- 2 -
HEW-C15
The vaccine manufactured by the Cutter Laboratories had been used in all
but 3 of these cases.
In releasing the latest tabulation, the Surgeon General pointed out that
as of the present moment this represented a total of only 29 cases.
Approximately 4 million children have been vaccinated.
"It is important to remember," Dr. Scheele said, "that the field trials of
the vaccine indicated that it was from 60 to 90 percent effective. It must be
anticipated that additional cases will inevitably occur among some of those for
whom the vaccine is not effective."
The Surgeon General reiterated the belief of the Service that the mass
inoculations now under way should be continued.
It was emphasized in the advisory group!s report that at the present time
there is no reason to suggest that vaccine of manufacturers other than Cutter
should be withheld.
The
Dwight
D.
A summary of the recommendations follows:
The consultants agreed that the data presented on reported cases of
paralysis following infection with vaccine manufactured by the Cutter Laboratories
justify the action of the Public Health Service in ordering discontinuance of the
use of Cutter vaccine pending necessary investigations.
The group said that the failure of significant numbers of cases to occur
following the administration of vaccine prepared by manufacturers other than
Cutter warrants the continuation of vaccination with products prepared by other
manufacturers.
The group's discussion of the Cutter vaccine centered around three basic
questions, upon which continuing studies were recommended:
(More)
- 3 -
HEW C15
(1) Is the appearance of poliomyelitis among people inoculated with the
Cutter vaccine merely coincidental?
(2) Could the injection of the vaccine have provoked the appearance of
paralysis in a manner similar to the provocative effect which has been
observed after the use of other immunizing agents?
(3) Was a live virus introduced by the injection of vaccine?
The consultant group agreed that the incidence and distribution of polio-
myelitis in the next several weeks would shed light on these questions.
The
D.
The group recommended that every effort be exerted to stay abreast, on
a day-to-day basis, of the incidence of poliomyelitis among those who have
received vaccine--securing both medical and laboratory data on each case reported.
In addition, the group felt that it is particularly important that prac-
ticing physicians themselves should keep careful data on all inoculations they
administer, including manufacturer's name, lot number, site of inoculation, and
general health of the individual and that these data be reported to health
departments.
In addition to obtaining epidemiclogical and physical data, the group
recommended that careful laboratory studies be conducted on affected individuals
who have been injected with vaccine and their families. The group recognized
that this will mean a severe strain on the laboratory facilities of the Public
Health Service and suggested that the Surgeon General investigate the possibility
of enlisting other laboratory resources. The group agreed to serve on a con-
tinuing basis to advise the Surgeon General as necessary.
The names of the scientific consultants follow:
(More)
- 4 -
HEW-C15
Dr. David Bodian, Johns Hopkins University, School of Hygiene &
Public Health, Polio Laboratory
Dr. John Enders, Head, Department of Bacteriology and Immunology,
Harvard University Medical School
Dr. Thomas F. Francis, Jr., University of Michigan School of
Public Health
Dr. W. McD. Hammon, Head, Department of Epidemiology & Microbiology,
University of Pittsburgh Graduate School of Public Health
Dr. Edward Lennette, California State Health Department, Director,
Viral & Rickettsial Disease Laboratory, California
Dr. Ford McGinnes, Medical Consultant, National Foundation for
Infantile Paralysis
The
D.
Dr. H. J. Shaughnessy, Director of Laboratories, Illinois
Department of Public Health
Dr. John R. Paul, Professor, Preventive Medicine, Yale University
Medical School
Dr. Albert Sabin, Fellow-in-Charge, Infectious Disease Division,
Children's Hospital Research Foundation, Cincinnati Department of
Pediatrics, College of Medicine, University of Cincinnati
Dr. Jonas E. Salk, University of Pittsourgh, Virus Research Laboratory
Dr. Joseph Smadel, Chief, Department of Virus & Rickettsial Diseases,
Army Medical Service Graduate School, Walter Reed Army Medical Center.
- 30 -
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"ocrText": "Secretary\n103\nDREW\n5246 HEW Bldg\nHUNTER--EX 3-6300\nExt. 3178\nROSS - --Ext. 2125\nU. S. DEPARTMENT OF\nHEALTH, EDUCATION, AND WELFARE\nPublic Health Service\nBethesda, Maryland\nThe\nuwiaht\nFOR IMMEDIATE RELEASE\nD.\nSaturday, April 30, 1955\nHEW-C15\nThe Public Health Service, U. S. Department of Health, Education, and\nWelfare, made public late today a summary of conclusions and recommendations of\nan advisory group of experts in the fields of poliomyelitis and immunology which\nhas just concluded a two-day meeting at the National Institutes of Health,\nBethesda, Maryland.\nThe meeting was called by Surgeon General Leonard A. Scheele to advise on\nan investigation of the poliomyelitis vaccine produced by the Cutter Laboratories\nof Berkeley, California, which was withdrawn from distribution this week.\nIn addition to the consulting group and staff members of the Public Health\nService, today's meeting included technical representatives of the six pharma-\nceutical houses manufacturing the vaccine. Dr. Scheele said they were included\nso that the Service might benefit from their special knowledge regarding the\nproduction and distribution of vaccine.\nIn arriving at its conclusions and recommendations, the group was guided\nby last minute data obtained by telephone from health officials in various parts\nof the country concerning cases of paralytic poliomyelitis occurring among\nchildren who have been vaccinated.\nAs of Noon Saturday, the number of cases reported to the Public Health\nService was as follows: California, 16; Idaho, 8; Louisiana, 2; Illinois, 1;\nColorado, 1; and Georgia, 1.\n(More)\n- 2 -\nHEW-C15\nThe vaccine manufactured by the Cutter Laboratories had been used in all\nbut 3 of these cases.\nIn releasing the latest tabulation, the Surgeon General pointed out that\nas of the present moment this represented a total of only 29 cases.\nApproximately 4 million children have been vaccinated.\n\"It is important to remember,\" Dr. Scheele said, \"that the field trials of\nthe vaccine indicated that it was from 60 to 90 percent effective. It must be\nanticipated that additional cases will inevitably occur among some of those for\nwhom the vaccine is not effective.\"\nThe Surgeon General reiterated the belief of the Service that the mass\ninoculations now under way should be continued.\nIt was emphasized in the advisory group!s report that at the present time\nthere is no reason to suggest that vaccine of manufacturers other than Cutter\nshould be withheld.\nThe\nDwight\nD.\nA summary of the recommendations follows:\nThe consultants agreed that the data presented on reported cases of\nparalysis following infection with vaccine manufactured by the Cutter Laboratories\njustify the action of the Public Health Service in ordering discontinuance of the\nuse of Cutter vaccine pending necessary investigations.\nThe group said that the failure of significant numbers of cases to occur\nfollowing the administration of vaccine prepared by manufacturers other than\nCutter warrants the continuation of vaccination with products prepared by other\nmanufacturers.\nThe group's discussion of the Cutter vaccine centered around three basic\nquestions, upon which continuing studies were recommended:\n(More)\n- 3 -\nHEW C15\n(1) Is the appearance of poliomyelitis among people inoculated with the\nCutter vaccine merely coincidental?\n(2) Could the injection of the vaccine have provoked the appearance of\nparalysis in a manner similar to the provocative effect which has been\nobserved after the use of other immunizing agents?\n(3) Was a live virus introduced by the injection of vaccine?\nThe consultant group agreed that the incidence and distribution of polio-\nmyelitis in the next several weeks would shed light on these questions.\nThe\nD.\nThe group recommended that every effort be exerted to stay abreast, on\na day-to-day basis, of the incidence of poliomyelitis among those who have\nreceived vaccine--securing both medical and laboratory data on each case reported.\nIn addition, the group felt that it is particularly important that prac-\nticing physicians themselves should keep careful data on all inoculations they\nadminister, including manufacturer's name, lot number, site of inoculation, and\ngeneral health of the individual and that these data be reported to health\ndepartments.\nIn addition to obtaining epidemiclogical and physical data, the group\nrecommended that careful laboratory studies be conducted on affected individuals\nwho have been injected with vaccine and their families. The group recognized\nthat this will mean a severe strain on the laboratory facilities of the Public\nHealth Service and suggested that the Surgeon General investigate the possibility\nof enlisting other laboratory resources. The group agreed to serve on a con-\ntinuing basis to advise the Surgeon General as necessary.\nThe names of the scientific consultants follow:\n(More)\n- 4 -\nHEW-C15\nDr. David Bodian, Johns Hopkins University, School of Hygiene &\nPublic Health, Polio Laboratory\nDr. John Enders, Head, Department of Bacteriology and Immunology,\nHarvard University Medical School\nDr. Thomas F. Francis, Jr., University of Michigan School of\nPublic Health\nDr. W. McD. Hammon, Head, Department of Epidemiology & Microbiology,\nUniversity of Pittsburgh Graduate School of Public Health\nDr. Edward Lennette, California State Health Department, Director,\nViral & Rickettsial Disease Laboratory, California\nDr. Ford McGinnes, Medical Consultant, National Foundation for\nInfantile Paralysis\nThe\nD.\nDr. H. J. Shaughnessy, Director of Laboratories, Illinois\nDepartment of Public Health\nDr. John R. Paul, Professor, Preventive Medicine, Yale University\nMedical School\nDr. Albert Sabin, Fellow-in-Charge, Infectious Disease Division,\nChildren's Hospital Research Foundation, Cincinnati Department of\nPediatrics, College of Medicine, University of Cincinnati\nDr. Jonas E. Salk, University of Pittsourgh, Virus Research Laboratory\nDr. Joseph Smadel, Chief, Department of Virus & Rickettsial Diseases,\nArmy Medical Service Graduate School, Walter Reed Army Medical Center.\n- 30 -"
}