Vaccine Field Trial of 1954 – Chronology of Events (1952-1955)
1952
April NFIP
Committee on Immunization meets; Howard Howe reports on criteria for
the inactivation of
poliomyelitis virus and Jonas Salk reports on laboratory tests using formalin
to make a killed-virus vaccine. The committee recommends that NFIP vigorously
support further investigations of potential vaccines.
Summer-Fall Salk studies antibody responses of 161 children at the D. T. Watson Home and Polk State School following inoculation with experimental vaccines prepared from virus cultures, inactivated by formalin, in aqueous and emulsified forms.
October 22 Dr. William McDowell Hammon issues preliminary report on field trials of gamma globulin in three epidemic areas during the summers of 1951 and 1952. The gamma globulin field trials, sponsored by NFIP and directed by Hammon, involved 54,772 children in four states and were the most elaborately planned and executed field testing of a biological product made up to that time. The results indicated that a small amount of antibodies in gamma globulin imparts temporary protection against polio. This finding was critical in demonstrating the practicality of vaccination with a killed-virus vaccine.
1953
January 23-24 NFIP Committee on Immunization meets in
Hershey, PA to discuss inactivated virus vaccine. Jonas Salk reports on his
work on formalin-inactivated virus.
February 26 NFIP
Committee on Virus Research & Epidemiology holds special meeting in NYC
with additional advisors to discuss plans for laboratory and field tests of
Salk’s experimental vaccine. Salk presents (1) Plan for Laboratory Tests of
Safety in Experimental Poliomyelitis Vaccines before Use in Preliminary Field
Studies, and (2) Plan for Preliminary Field Tests of Experimental Poliomyelitis
Vaccines. In attendance are Louis H. Bauer (President, AMA), Thomas P. Murdock
(Trustee, AMA), David E. Price (Assistant Surgeon General, USPHS), and John D.
Porterfield (Sec-Tr, ASTHO).
March 26 Salk appears on a CBS radio program, The Scientist Speaks for Himself,
introduced by Basil O’Connor, and reports on his preliminary injections of
human subjects.
March 28 JAMA publishes Salk’s Studies in Human Subjects on Active
Immunization against Poliomyelitis (151: 1081-1098) in which Salk first reports techniques of
inactivating poliovirus, injections of 161 individuals, and antibody
responses.
April 4 JAMA publishes letter of Dr.
Thomas Rivers to report NFIP recommendation to support Dr. Salk and the
extension of testing to include a field trial in 1954. JAMA also provides its
own editorial comment, Research on a
Vaccine for the Prevention of Poliomyelitis.
May 18 NFIP organizes Special Advisory Committee on Active Immunization (known as Vaccine Advisory Committee) and
appoints Dr. Thomas M. Rivers (Director, Rockefeller Institute for Medical
Research) as chairman. Members include:
Dr. Thomas P. Murdock,
Trustee, American Medical Association; Meriden, CT
Dr. David E. Price,
Assistant Surgeon General, U.S. Public Health Service
Dr. Joseph E. Smadel,
Director, Dept of Virus & Rickettsial Diseases, Army Medical Ctr
Dr. Ernest L. Stebbins,
Director, School of Hygiene & Public Health, Johns Hopkins
Dr. Norman H. Topping,
VP in Charge of Medical Affairs, Univ of Pennsylvania
Dr. Thomas B. Turner,
Professor of Microbiology, SHPH, Johns Hopkins University
May 25 Vaccine Advisory Committee holds first meeting in NYC to hear
report from Salk and to discuss a proposed field trial. The committee decides
that if a suitable vaccine was available the NFIP should undertake a controlled
study to determine its effectiveness.
September 9 Vaccine Advisory Committee meets in NYC
and Salk reports on nearly 600 human subjects injected with his vaccine, in
both emulsified and aqueous forms. The committee decides that an aqueous
vaccine is preferred and worthy of testing in the winter of 1953-1954. The
committee recommends the National Institutes of Health (NIH) assist in safety
testing the vaccine (in addition to Salk and the manufacturer) before being used
in a field test. NIH Laboratory of Biologics Control agrees to safety test each
lot of vaccine prepared for the field trial.
September 23 Salk addresses the NY State Dept of Health
in Syracuse, NY and meets privately with Basil O’Connor to discuss NFIP plans
for manufacture of polio vaccine.
October 3-7 NFIP Medical Advisory Committee
semi-annual meeting; Committee on Virus Research & Epidemiology reviews
progress of Salk vaccine; Vaccine Advisory Committee reviews the problem of
injected vs. uninjected controls in a field trial.
October 9 Salk reads paper, Recent Studies on Immunization against Poliomyelitis, before the
American Academy of Pediatrics in Miami, FL. He reports on 474 additional
humans safely injected with vaccine and the high antibody levels produced
(total of 635 injected over one-year period).
Oct 23-24 Committee on Immunization meets in
Detroit with authorities in public health and epidemiology to hear Salk’s
report and to discuss plans for a field trial.
November 6 NFIP meets with representatives of leading
national educational organizations in Washington to discuss educational aspects
of the field trial. Organizations include American Association of School
Administrators, National Education Association, National Catholic Educational
Association, and American Association for Health, Physical Education, &
Recreation.
November 6 Association
of State and Territorial Health Officers (ASTHO) holds its annual meeting
in Washington, DC. Basil O’Connor, Hart van Riper, and Jonas Salk outline plans
for proposed field trials and extend an invitation to ASTHO to establish two
committees to advise NFIP on the field trials.
November 11 Basil O’Connor and Jonas Salk meet
representatives of 10 major pharmaceutical and biologics manufacturers in NYC
to discuss production of vaccine.
November 12 ASTHO President appoints seven health
officials to Advisory Committee on
Technical Aspects of Field Trials to advise NFIP on procedures for field
trial.
November 13 NFIP
Vaccine Advisory Committee meets in NYC with Jonas Salk and other leading
pediatricians participating with Dr. Salk. The committee discusses the
manufacture and testing of the vaccine, the question of using injected
controls, and the additional number to be injected by Salk before a field trial
could begin. The Committee members agree that the vaccine is safe and ready for
a field trial and recommends, by a unanimous vote, that the NFIP proceed with
its testing.
November 16 Basil
O’Connor holds press conference (PHOTO) at the Waldorf-Astoria in NYC and
officially announces NFIP plans for vaccine field trial in 1954.
November 17 ASTHO President Harold M. Erickson accepts
NFIP invitation and establishes two committees: (1) Advisory Committee on Administration (Chair: R. H. Hutcheson,
Commissioner of Public Health, Tennessee), and (2) Advisory Committee on the Technical Aspects of Field Trials of
Poliomyelitis Vaccine (Chair: D. G. Gill, State Health Officer, Alabama).
November 30 Basil
O’Connor and NFIP staff meet with two ASTHO advisory committees to discuss
state health officers’ role in the field trial and the possibility of a placebo
study in some states. As a result of the meeting, Dr. Hutcheson issues “Special
Letter to State and Territorial Health Officers” on December 1, 1953.
December NFIP asks Dr. Thomas Francis, Jr.
(Professor of Epidemiology, University of Michigan School of Public Health) to
lead an independent evaluation of the vaccine field trial. Theodore E. Boyd
(Assistant Director of Research, NFIP) publishes Immunization against Poliomyelitis in Bacteriological Reviews (17:339-448) describing critical progress
in gamma globulin treatment and vaccine development.
December
11 NFIP issues press release announcing
start of the field trial on February 8, 1954.
December 15 ASTHO Advisory Committee on Administration
meets in NYC to discuss forms and records for use in field trial.
December 17 NFIP organizes Vaccine Project Committee to
coordinate planning, public relations, and administration of the field trial
program by NFIP staff
1954
January 11 Ad Hoc Advisory Group on Evaluation of
Vaccine Field Trials meets in NYC. The group was called together by Dr. Thomas
Francis (University of Michigan) who was asked by NFIP to head the evaluation
program. The group consisted of 18 leading health officials, clinicians, and
medical statisticians who discussed evaluation techniques and reporting on
diagnosing polio cases.
January 9 To stimulate publicity for the field
trial, March of Dimes poster child Debby Dains, along with Basil O’Connor,
present a symbolic bottle of polio vaccine to President Dwight Eisenhower at
the White House.
January 13-14 Salk holds a conference at the Virus Research
Laboratory at the University of Pittsburgh with representatives of
pharmaceutical companies, NFIP, and NIH to discuss procedures for tissue
cultures used for the field trial.
January 18 NFIP
announces that the vaccine to be used in the field trial will be produced on a
non-profit basis by five pharmaceutical companies. The companies are Cutter
Laboratories (Berkeley, CA), Eli Lilly & Co (Indianapolis), Parke, Davis
& Co (Detroit), Pitman-Moore (division of Allied Laboratories,
Indianapolis), and Wyeth Laboratories (division of American Home Products Corp,
Philadelphia).
January 25 Dr. Thomas Francis and the University of
Michigan agree to establish the Poliomyelitis
Vaccine Evaluation Center at Ann Arbor in order to undertake an independent
and objective evaluation of the vaccine’s effectiveness.
January 30-31 ASTHO Advisory Committee on the Technical
Aspects of Field Trials meets in Atlanta and announces the field trial
postponed until March. The committee decided on the format of a placebo study
and discussed the use of gamma globulin in test areas, the handling of request
forms, and muscle evaluation.
February 1 Vaccine Advisory Committee meets in NYC
with NIH representatives and pharmaceutical companies to discuss minimum
specifications for vaccine manufacture and to review commercial production.
Salk reports on the ability of aqueous vaccine to produce high antibody levels.
The committee authorizes sending minimum specifications to journals and health
officials.
February 10 NFIP announces that Dr. Thomas Francis and
the University of Michigan have agreed to direct the evaluation of the polio
vaccine field trial and to conduct an independent study of the vaccine’s
effectiveness.
February 23-24 ASTHO advisory committees meet in Detroit with
NFIP and health officials from states desiring a placebo study to discuss
techniques and facilities involved in placebo study. The committees draft the
criteria for this program.
February 27 Members of Vaccine Advisory Committee,
Committee on Immunization, and field trial evaluators meet in Baltimore to
discuss blood-sampling procedures.
March 11 Salk reads paper before the New
Orleans Postgraduate Medical Assembly and reports that his inoculations to date
and high levels of antibodies produced made it reasonable to proceed with a
systematic study to determine the effectiveness of the vaccine under natural
conditions.
March 17-18 Dr. Francis meets with group of 28
virologists and epidemiologists in Chicago to discuss handling of blood samples
by laboratories.
March 26-28 Vaccine
Advisory Committee meets in Washington, DC with representatives of U.S. Public
Health Service to review safety test procedures. The committee re-affirmed its
recommendation that Salk complete injections of 2500 children with commercially
prepared vaccine after which Dr. Francis was to observe them for 21 days. Salk
had already injected 4000 children with vaccine produced in his laboratory. He
began using commercial vaccine on February 22.
April NFIP mails special pre-print of Vaccination Against Poliomyelitis by Medical Director Hart van
Riper published in April issue of GP
(American Academy of General Practice) to every practicing physician in the
United States.
April 4 News columnist and radio
personality Walter Winchell opens his Sunday evening radio program with an
announcement that Salk vaccine to be used in the field trial contains live poliovirus
and “may be a killer”, provoking a response from NFIP on the safety of the
vaccine.
April 5-8 NFIP
Medical Advisory Committee meets to discuss all aspects of the field trial.
Vaccine Advisory Committee holds meetings to discuss Salk’s inoculations with
commercial vaccine and the specified observation period.
April 22 Basil
O’Connor issues memo on “Experimentation on Human Subjects” to all grantees of
NFIP requesting ample advance notice of plans for testing vaccines or other
therapeutic agents on human subjects.
April 23 Dr.
Henry F. Helmholz (National Chairman, Committee on Health, National Congress of
Parents and Teachers) issues statement of his full confidence of the safety of
the vaccine to be used in the field trial. Dr. Helmholz was formerly head of
section on pediatrics at Mayo Clinic and former president of both American
Academy of Pediatrics and American Pediatric Society.
April 24-25 Vaccine
Advisory Committee meets in Washington to review all aspects of the field
trial and checked safety tests on each lot of vaccine. Salk reports on 4000+
children who received one or more doses of commercially prepared vaccine
without adverse reaction. The committee
passes unanimous resolution recommending that NFIP begin the field trial.
April 26 Vaccine
Field Trial begins with inoculations given in 19 areas in nine states.
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Six-year-old
Randy Kerr of Fairfax County, Virginia, became Polio Pioneer No. 1 at 9:35 a.m.
on April 26, 1954, the first child to be inoculated in the nationwide vaccine
field trial. Administering the vaccination is Dr. Richard J. Mulvaney along
with Mrs. Earl Purcell and Mrs. John S. Lucas, at the Franklin Sherman School
in McLean, Virginia.
April – July Inoculation phase of the field trial is
conducted in 217 areas in 44 states
and 48 additional areas in 3 Canadian
provinces and Finland. Total participants in U.S. - 1,831,702.
Over 443,000 receive one or more inoculations of vaccine and over 210,000 one
or more inoculations of placebo without significant adverse reaction. Over
73,000 Canadian and Finnish children participate, of whom more than 46,000 are
inoculated.
May 4 NYC Dept of Health announces that more than 21,000
children received polio vaccinations today. Health Commissioner Dr. Leona
Baumgartner praised the work of the more than 1600 volunteers recruited by the
Greater New York Chapter of the National Foundation to assist in the field
trial program in NYC.
May 7 Assistant Surgeon General David E. Price announces
today, “Americans across the nation have taken first steps toward the possible
prevention of poliomyelitis. This is a significant milestone in the history of
preventive medicine.”
May 13 Basil O’Connor meets with
pharmaceutical manufacturers who recommend continued production of vaccine
pending Dr. Francis’ report, looking forward to licensing and commercial
distribution of the vaccine if the evaluation indicates that the vaccine is
effective.
May 20 NIH
Laboratory of Biologics Control issues its minimum requirements for the polio
vaccine, prepared with advice and cooperation of the manufacturers and Dr.
Salk. The specifications are distributed to vaccine manufacturers and
interested parties as a guide to prospective standards of the vaccine later to
be licensed.
May 21 The initial phase of the field
trial inoculation is nearly completed with 651,159 children receiving first
vaccination and 80% of those a second vaccination.
June 21 NFIP announces that about 600,000
children have received the complete series of three vaccinations in the polio
vaccine field study.
June 23 American Medical Association passes
resolution criticizing NFIP for launching vaccine field trials “without
official consultation” with the AMA. NFIP Medical Director Hart van Riper
issues statement on June 24 that the Vaccine Advisory Committee that reviewed
and approved the field trial was composed entirely of AMA members and the
committee’s decision was endorsed by the U.S. Public Health Service, including
safety-testing by its National Institutes of Health.
Summer Preliminary plans formulated for
widespread and immediate use of vaccine among the most susceptible groups if
vaccine is found effective and licensed.
July – Dec Follow-up
phase of field trial is in progress.
August NFIP places orders with six manufacturers for 27 million inoculations
of vaccine. Salk publishes further studies on vaccine and its use.
August 9 NFIP announces that 18 laboratories
have started the study of blood samples from children who participated in the
field trial. NFIP made grants totaling $516,000 for this phase of the
evaluation, in addition to $890,000 to the University of Michigan. The final
cost of the field trial will total $7,500,000
August 16-31 NFIP holds an emergency March of Dimes,
raising approximately one-half of the $20,000,000 needed for 1954 commitments.
September NIH begins inspection of manufacturing
plans and procedures for compliance with standards for licensing vaccine
manufacture.
October NFIP mails publication Report to Physicians – Polio Vaccine to
all practicing physicians in the U.S. to announce preliminary plans for 1955
vaccine program.
October 18 NFIP announces it has contracted to
purchase 25,000,000 cubic centimeters of Salk polio vaccine to provide
9,000,000 vaccinations in 1955 if the vaccine is found effective. The vaccine
purchased is intended for unvaccinated field trial participants, pregnant
women, and all first-grade school children.
Oct – Dec NFIP holds meetings and corresponds with
national health organizations (voluntary, governmental, and professional)
seeking advice and assistance in planing 1955 vaccine program.
November 1-12 The third and final phase of blood sampling of
approximately 40,000 children who participated in the field trial takes place
to measure polio infection during the 1954 epidemic season and the degree of
persistence of antibodies.
November 2-3 Meetings in Pittsburgh with Salk, NIH, and
manufacturers on the preservation of vaccine potency. Deterioration due to
merthiolate is eliminated.
December Manufacturers of vaccine begin limited
use of vaccine (without merthiolate) to obtain additional clinical data on use
of vaccine produced under NIH revised Minimum Requirements. Approximately 9000
additional children inoculated.
December 13 NFIP announces it accepts a recommendation
by ASTHO to offer polio vaccine to children in the second grade in 1955 instead
of to pregnant women. NFIP is purchasing vaccine to inoculate 9,000,000 without
charge.
December 18 Vaccine Advisory Committee and Committee on
Immunization meet to review preliminary plans for 1955 vaccine program.
December 23 NFIP announces that 40,000 nurses
participated in the 1954 field trial
1955
January 10 NFIP holds National Planning Meeting in
NYC with representatives of national medical and health associations to
consider nationwide administrative policies for distribution of the Salk
vaccine in 1955 if it is licensed. Organizations include American Medical
Association, American Public Health Association, ASTHO, American Academy of
Pediatrics, and U.S. Dept of HEW.
January Vaccine manufacturers begin
submitting manufacturing protocols and samples to NIH for testing.
Jan – March Final phase of evaluation is in progress at
Vaccine Evaluation Center at the University of Michigan.
March – April Field preparation for 1955 vaccine program is
in progress in 48 states, Alaska, and Hawaii.
March 22 NFIP announces that the official
report on the Salk vaccine by Thomas Francis will be released on April 12th
at the University of Michigan in Ann Arbor.
March 29 NFIP mails publication Report to
Physicians – Polio Vaccine to all practicing physicians advising of the
forthcoming Francis Report and plans for use of vaccine if evaluation report is
favorable.
April 7 NIH
issues revised minimum requirements and specifications for vaccine manufacture
and license.
April 12 Dr. Francis issues Summary Report of Evaluation of Field Trial, announcing that
the Salk vaccine is “safe, effective, and potent” at Rackham Auditorium at the
University of Michigan in Ann Arbor. Dr. Thomas stated that the vaccine tested
in the field trial was proven up to 80% to 90% effective in preventing
paralytic polio. NIH issues first official Minimum
Requirements for Poliomyelitis Vaccine. The U.S. Secretary of Health,
Education, and Welfare licenses six manufacturers to produce vaccine and 13
lots of vaccine by four manufacturers are approved for use.
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| Dr. Thomas Francis, Basil O'Connor and Jonas Salk. University of Michigan April 12, 1955 |
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| Program cover for the April 12 Field Trial Announcement |
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| Speakers at the April 12, 1954 Field Trial Announcement |
April 18 President Eisenhower announces that he will ask Congress to award Dr. Salk with a medal of Distinguished Civilian Achievement, the highest civilian award that Congress can confer. (VIDEO)
April 27 Approximately
5,000,000 children receive first inoculations between April 16 and April 27.
U.S. Public Health Service orders the temporary withdrawal of vaccine made by
Cutter Laboratories while it investigates cases of paralytic polio caused by
the vaccine.
April 28 U.S. Public Health Service
establishes Poliomyelitis Surveillance Unit at the Communicable Disease Center
in Atlanta.
April 29 U.S. Public Health Service
establishes Advisory Committee on Poliomyelitis Vaccine and holds meeting at
NIH in Bethesda, Maryland.
May 7 U.S. Surgeon General Leonard A. Scheele recommends
cessation of use of all vaccine pending the re-study of manufacturing and
testing procedures.
May 17 NFIP announces that while national
attention has concentrated on the Salk vaccine, the cost for caring for chronic
and new polio patients continues to increase. NFIP has provided more than
$707,000 in emergency aid to polio patients in the first four months of 1955.
May 27 NIH issues Amended Minimum
Requirements.
June 1 Re-clearance of vaccine begins.
June 7 AMA holds panel discussions on
Prospects for the Control of Poliomyelitis at meetings in Atlantic City, NJ.
June 10 U.S. Public Health Service issues
technical report on association of cases of polio and vaccine.
June 18 Vaccine
Advisory Committee meets with representatives of medical groups and public
health officials to discuss the risk of “provocation” of paralytic polio in the
use of the Salk vaccine and makes unanimous recommendation that the risk of
provocation is insufficient to warrant interruption of the vaccine program.
June 22 National Advisory Committee on
Poliomyelitis Vaccine recommends voluntary federal-state distribution program
for polio vaccine and priorities for its use.
June 22 NFIP issues Report to Physicians – Polio Vaccine, Recommendations on the Use of
Poliomyelitis Vaccine during the Summer of 1955 to all practicing
physicians in the U.S.
July 7 Executive Committee of the
Association of State and Territorial Health Officers (ASTHO) recommends
continuation of inoculations during the summer season.
July 8 New federal research and testing
program announced.
July 31 NFIP announces that sufficient
vaccine has been replaced to meet requirements for vaccinations in its program
during the summer and that vaccine will now be available for distribution in
federal-state voluntary allocation program.
July NFIP issues Bulletin
for Physicians on Poliomyelitis Vaccine to all practicing physicians.
August 2 U.S. Congress passes Poliomyelitis
Vaccination Assistance Act (PL 84-377) authorizing appropriation of thirty
million dollars as grants-in-aid to states for purchase of vaccine and for
administration costs to be used prior to February 15, 1956 in carrying out
voluntary federal-state allocation program recommended by National Advisory
Committee.
September 1 Compilation of state health department
reports indicates that between April 6
and the end of August approximately 6,454,000 first inoculations of vaccine
were given under the NFIP program. Approximately 1,730,000 children had
received two inoculations, and about 90,000 booster inoculations had been given
to the 1954 field trial children (Polio Pioneers).
December 13 NFIP begins planning a comprehensive
education campaign for the first six months of 1956 to encourage and stimulate
public acceptance of the polio vaccine.
1956
April 12 Polio Prevention Day with
vaccination clinics in schools throughout the U.S
March 24, 2003 / David Rose / March of Dimes Archives
