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The original documents are located in Box 34, folder "Swine Flu (2)" of the James M.
Cannon Files at the Gerald R. Ford Presidential Library.
Copyright Notice
The copyright law of the United States (Title 17, United States Code) governs the making of
photocopies or other reproductions of copyrighted material. Gerald Ford donated to the United
States of America his copyrights in all of his unpublished writings in National Archives collections.
Works prepared by U.S. Government employees as part of their official duties are in the public
domain. The copyrights to materials written by other individuals or organizations are presumed to
remain with them. If you think any of the information displayed in the PDF is subject to a valid
copyright claim, please contact the Gerald R. Ford Presidential Library.
a
PRESIDENT
Digitized from Box 31 of the James M. Cannon Files
OF DEIG TM UNITED
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF MANAGEMENT AND BUDGET
Congressional Relations
FORD LIBRARY
Jim -
FYI - Dhisis
what we've put out
on Swine 7 ln
today
at the Gerald R. Ford Presidential Ken Library
[Apri I 1976]
CORD LIBRARY :- OF
HR 13012 NATIONAL INFLUENZA IMMUNIZATION PROGRAM
The Administration opposes any additional authorization language on this
issue since existing authority under the Public Health Service Act is all
that is needed. A separate authorization bill risks the possibility of a
disagreement between Congress and the President which could delay this
vital effort.
THE WHITE HOUSE
WASHINGTON
DATE: April 5, 1976
TO: NANCY KENNEDY
FROM: JIM CAVANAUGH
SUBJ:
FYI
ACTION
FORD LIBRARY & GENALD
[April 1976
COLLOQUY CONCERNING INDEMNIFICATION OF DRUG COMPANIES
PRODUCING SWINE FLU VACCINE
FORD & LIBRARY GERALD
Q: I would like to ask a question concerning the liability
of drug companies for possible injuries to those administered
the flu vaccine. The Senate Report recites that "the
various governmental units shall be free from liability in
terms of the vaccine," but that "[t]he drug producers shall
remain responsible for the vaccine, its quality, and any
adverse reactions directly attributable to the vaccine.
I would like to know of the effect, if any, the report
recital will have on the tort liability of the producers
and of the government and what the managers of this bill
perceive that liability to be.
A: The recital in the Senate Report cannot, of course, amend
either State or Federal law concerning tort liability, and
I do not understand the language of the supplemental
appropriation to effect an amendment of the Federal Tort
Claims Act. I, therefore, understand the language of the
Senate Report as merely attempting to insure that the drug
companies retain responsibility for the manufacture of
the vaccine with due care, and that the government not
assume responsibility for indemnifying the industry for
any negligence in the manufacture of that vaccine.
I should add that I think the drug producers have a
legitimate concern regarding whether they might be held
vicariously liable for the claimed adverse effect of an
innoculation where the result is unrelated to their care
in producing the vaccine. This concern, however, can be
adquately dealt with in the arrangements by which the Sec-
retary of HEW procures the vaccine from the producers.
Indeed, I am advised that the Secretary, in requesting contract
proposals for the vaccine, intends to include a commitment
along the following lines:
The Government hereby assumes the responsi-
bility (1) for developing the content of a
notice of the hazards, if any, of innoculation
with the swine influenza vaccine, and (2) of
notifying the public or of taking reasonable
steps to assure that it is notified of such
hazards. Although this responsibility might
or
ordinarily devolve upon the contract as the
manufacturer or seller of the vaccine, the
Government is assuming this responsibility
because the distribution of the vaccine
purchased under this contract will be arranged
by the Government.
I believe that this type of commitment, in whatever form of
words it finally takes, will adequately meet the producers
concerns and will also be consistent with the underlying con-
cern expressed in the Senate Report.
FORD
y
LEBRURY
GERALD
TALKING POINTS ON INFLUENZA IMMUNIZATION PROGRAM
1. On March 24 I announced plans for a national
immunization program to inoculate every American
against a swine-type influenza virus. This flu
strain, discovered during a recent outbreak among
Army recruits at Fort Dix, New Jersey, was the cause
of a pendemic in 1918-19 that killed an estimated
548,000 Americans--200 million people around the
world.
2. I have asked the Congress for a supplemental
appropriation of $135 million for the program. This
effort can be carried out under current health
authorities, and I do not favor separate authorizing
legislation which would impede the swift initiatives
that are required for an endeavor of this magnitude.
3. The Secretary of Health, Education, and Welfare,
David Mathews, is taking the lead in this effort,
with the Public Health Service, under the direction
of HEW Assistant Secretary for Health, Dr. Theodore
Cooper, proceeding with the planning and implementation
efforts to make the vaccine available to the public
at the critical time. State and local health agencies
will be utilized to conduct immunization programs and
as distribution centers for the vaccine. But it will
be essential to have the full cooperation and
participation of private sector health professionals
and facilities, as well as government, to ensure the
immunization of the total population in the brief
time available.
4. Since there are no precedents for such a massive
undertaking, I intend to give this matter my
direct and continuous attention. I have asked for
weekly reports from the Secretary of HEW, SO that
I can gauge our progress toward our goal of ensuring
that the flu vaccine is widely available and that a
maximum of Americans avail themselves of it.
Note for the President: We have asked Dr. Theodore
Cooper, Assistant Secretary for Health at HEW, to
be in attendance at the meeting to take any questions.
THE WHITE HOUSE
WASHINGTON
April 5, 1976
MEMORANDUM FOR:
JIM CAVANAUGH
sel
FROM:
SPENCE JOHNSON
SUBJECT:
Influenza Immunization Program Talking
Points for Bipartisan Briefing,
April 6th.
TALKING POINTS
1. On March 24th, I announced plans for a national
immunization program to inoculate every American
against a swine-type influenza virus. This flu
strain, discovered during a recent outbreak among
Army recuits at Fort Dix, New Jersey, was the cause
of a pandemic in 1918-19 that killed an estimated
548,000 Americans -- 20 million people around the
world.
2. I have asked the Congress for a supplemental appropri-
ation of $135 million for the program. This effort
can be carried out under current health authorities
and I do not favor separate authorizing legislation
which would impede the swift initiatives that are
required for an endeavor of this magnitude.
3. The Secretary of Health, Education, and Welfare,
David Mathews, is taking the lead in this effort,
with the Public Health Service, under the direction
of HEW Assistant Secretary for Health, Dr. Theodore
Cooper, proceeding with the planning and implementation
efforts to make the vaccine available to the public
at the critical time. State and local health agencies
will be utilized to conduct immunization programs
and as distribution centers for the vaccine. But,
it will be essential to have the full cooperation
and participation of private sector health professionals
and facilities, as well as government, to ensure the
immunization of the total population in the brief
time available.
- 2 -
4. Since there are no precendents for such a massive
undertaking, I intend to give this matter my
direct and continuous attention. I have asked for
weekly reports from the Secretary of HEW, so
that I can gauge our progress toward our goal
of ensuring that the flu vaccine is widely available
and that a maximum of Americans avail themselves of
it.
Note for the President: We have asked Dr. Theodore Cooper,
Assistant Secretary for Health at HEW, to be in attendance
at the meeting to take any questions.
COKD
LIBRARY
THE WHITE HOUSE
WASHINGTON
April 6, 1976
FORD LIBRARY
MEMORANDUM FOR:
JIM CAVANAUGH
ART QUERN
FROM:
SPENCE JOHNSON
SUBJECT:
Senate appropriation subcommittee
action on swine flu program.
The Subcommittee on Labor, Health, Education and Welfare
of the Senate Appropriations Committee today attached
a $1.8 billion Second Supplemental Appropriation to the
President's $135 million request for the nationwide
influenza immunization program.
The program breakdown: $1.2 billion for the public service
jobs extension program; $525 million for summer youth
jobs; $56 million for Older Americans; $6 million for
youth sports; and $17 million for summer youth recreation
programs.
THE WHITE HOUSE
WASHINGTON
April 6, 1976
FORD
LIBRARY
MEMORANDUM FOR:
JIM CANNON
FROM:
JIM CAVANAUGH
SUBJECT:
Conversation with David Mathews
this Morning on the NY Times
Editorial on Flu Vaccine.
I noticed you are meeting with Secretary Mathews this
afternoon, and I wanted you to know that I called him
this morning and pointed out the negative New York
Times editorial on the flu vaccine. I suggested that
he respond to it, which he said he would do.
You might want to suggest to him having someone like
Dr. Jonas Salk also respond to the Times.
Junie
In
FORD
THE WHITE HOUSE
WASHINGTON
LIBRARY
April 6, 1976
Jim Cavanaugh
I have not shown the attached to Brent
and would like not to bother him with this.
I believe our guy, Hal Horan, wants to be
helpful in solving such international problems
as may arise in the course of carrying out
the President's concept of immunizing the
US and other populations against the flu. His
reaction (like most good bureaucrats) is to
set up a committee. That may be the answer,
but before getting everyone all exercised, I
wanted to check with you to see if there
weren't a way to informally crank our guy
and State into the HEW operation on this
program? Perhaps something formally
and in writing is necessary, but I hope not.
Please let me know what you think? (and
please protect me on the attachments)
Many thanks
Bud
GERALD FORD LIBRARY
MEMORANDUM
1937
NATIONAL SECURITY COUNCIL
CONFIDENTIAL (GDS)
ACTION
April 1, 1976
MEMORANDUM FOR:
BRENT SCOWCROFT
FROM:
Hal Horan
SUBJECT:
The Federal Program to Immunize all
Americans Against Swine Influenza
Last week you asked me to look into the international implications
of the program the President announced March 24 to begin a crash
program to immunize all Americans against swine influenza. Today
I attended a briefing session in the Department of State given by
HEW officials to explain the program, the reasons behind it, and
the international implications. My impression is that the decision
to immunize Americans was strictly a domestic one and that State
has not made any input. There are a number of issues which I
believe should be examined and resolved in an inter-agency context.
For example, Secretary Mathews has written to the President (Tab A)
suggesting that we provide Canada with enough vaccine to immunize
their population. Once again, I do not believe there was a State
input which I think is essential before the President makes a deci-
sion. Secondly, State has already begun to receive inquiries from
embassies in town seeking information as to how they might procure
vaccines for their own citizens. There is as well the question of
what we do about providing immunization for the millions of official
and private Americans abroad. In this connection I understand DOD
will have its own worldwide immunization program. State, of course,
will be faced with the responsibility for other American citizens
abroad. A final example -- we must prepare public statements and
a public posture with regard to the needs and demands of the rest
of the world should these arise. This is not considered by HEW
as a panic situation since relatively few developing countries ever
engage in flu immunizations anyway. What we seem to have, rather,
is a damage-limiting problem.
CONFIDENTIAL (GDS)
DAR
FORD LIBRARY & CERALD
11/14/83
CONFIDENTIAL (GDS)
-2-
Central to the problems we face is that U.S. capacity to manufacture
vaccine does not, under the best of circumstances, exceed the number
of doses that will be required to carry out the President's program
(approximately 200 million doses) and provide Canada with its need
(approximately fifteen million doses). Another complicating factor
is that under the President's program the Federal Government will
purchase the entire U.S. production, and therefore any third country
requests will be government-to-government
RECOMMENDATION:
In view of the international implications, I believe it is urgent that
an informal interagency group be organized under the chairmanship
of HEW but to include State, Defense and possibly others. Since
Jim Cannon's office has had action on the program within the White
House, I recommend that you seek his agreement that you issue
instructions that such a group be formed and report back to the
White House in writing on the foreign policy implications and pro-
posals for dealing with them.
FORD
LIBRARY
CONFIDENTIAL (GDS)
THE SECRETARY OF HEALTH, EDUCA TON. AND WELFARE
WASHINGTON, D.C.20201
sins
MAR 31 1976
MEMORANDUM FOR THE PRESIDENT
SUBJECT: Cooperation with Canada on Swine Influenza
Attached is a memorandum to me from the Public Health Service
recommending cooperation with the Canadian government on immu-
nizing their population. I believe the recommendation is a
sound one. Both our relationships with the Canadians and the
special circumstances surrounding immunizing of their population
warrant the cooperation without setting any other international
precedents or jeopardizing our ability to meet our own needs.
Unless you feel differently, I would intend to proceed with a
cooperative arrangement with the Canadian authorities.
Darid
Attachment
GERALD R LIBRARY FORD
: The Secretary
DATE: March 31, 1976
Through: U
ES
OM : Assistant Secretary for Health
BJECT: Swine Influenza Vaccine for Canada
As you know, vaccine production in Canada and the U. S. is closely
coordinated at all times. In the case of swine influenza vaccine, the
Canadians are entirely dependent upon the U. S. for a supply. On
March 30, 1976, they announced that they too would undertake a national
immunization effort. Privately, they have indicated that they would
like to purchase approximately 15 million doses this year so that they
may vaccinate that segment of their population which they have
designated as their priority.
At the moment, we estimate U. S. production capability at approximately
200 million doses. The Canadian request is a small fraction - 7% of
this amount. Considering our vaccine manufacturing capabilities and the
ability of the public and private sector of American medicine to deliver
it, I believe that we can accommodate Canada's needs.
From an international policy point of view, it would be unthinkable to
deny the Canadians any vaccine at all. The preferred solution,
assuming all goes as planned, is to provide them with an appropriate
proportion of our production as it becomes available and after sufficient
supplies are assured for our high risk population so that their needs
can be met.
I might note that we have not received formal requests from other
countries on the matter of our providing them with a supply of swine
influenza vaccine. We have discussed the Mexican situation and conclude
that, due to their population density and climate, they are unlikely to
be affected in the way that Canada might be and that the consideration
of swine influenza is not a high priority item with them at this time.
Our positive position as regards providing vaccine to Canada stems from
our humanitarian interest in their situation, their being a contiguous
FORD LIBRARY is GENALD
eighbor who is receptive to launching an immunization effort, their
winter climate, their delivery system capabilities, their socio-cultural
practices and a past history of cooperative relationships with respect
to drug production and health.
Theodore Cooper, M.D.
Prepared by: OASH, JFDickson, 3/31/76, x56811
GERALD FORD LIBRARY
Cooper 2861
THE WHITE HOUSE
WASHINGTON
April 6, 1976
MEMORANDUM FOR:
JIM CAVANAUGH
sel
FROM:
SPENCE JOHNSON
SUBJECT:
Presidential memorandum requesting
flu immunization reports from Secretary
Mathews
Attached is a memorandum for the President's signature
requesting a biweekly status report from Secretary
Mathews. Also, attached is a copy of the agreed-upon
format between Paul O'Neill and Ted Cooper.
MEMORANDUM
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH
TO
:
Director, Office of Management and Budget
DATE:
Assistant Secretary for Health
FROM :
Biweekly Status Report on Nationwide Influenza Immunization Program
SUBJECT:
Accomplishments
1 LIBRARY "4 GERALD
Problems
Actions Taken to Resolve Problems
INFLUENZA TIMETABLE
VACCINE
STATE AND COMMUNITY
NATIONAL
PRODUCTION
PROGRAMS
ACTIONS
March
Vaccine
Policy Decisions
Formulations
on National
Prepared
Program
April
Vaccine
Program Planning
Program
Evaluation
Guidelines
Trials
Initiated
Professional
Education
Appropriations
Enacted
May
Professional
FORD is LIBRARY
Vaccine
Education
Contracts
Awarded
Community
Organization
Award Grants
June
First Lots
of Vaccine
Approved
July
Immunization of
First Distri-
High Risk Groups
bution of
Vaccine
Implementation
of Surveillance
System
August
Public Awareness
Public Awareness
Community
Mobilization
September
Immunization of
General Population
FEDERAL EFFORT
CDC
No. of Doses of
Approval of State
Vaccine Contract
Vaccine Purchased
Plans and Award of
Biweekly
Awards
and Distributed
Grants to States
No. of Employees
Dates
Target
On Target
Target
On Target
Target
On Target
Target
On Target
Yes
No
Yes
No
Yes
No
Yes
No
April 30
May 14
May 28
LIBRARY
June 11
FORD
June 25
07V839
July 9
July 23
Aug. 6
Aug. 20
Sept. 3
Sept. 17
Oct. 1
Oct. 15
Oct. 29
Nov. 12
Nov. 26
Total
4
200,000,000
62
44
FEDERAL EFFORT
FDA
NIH
No. of Lots of
No. of Contractual
Biweekly
No. of Employees
Vaccine Certified
No. of Employees
Actions
Dates
Target
On Target
Target
On Target
Target
On Target
Target
On Target
Yes
No
Yes
No
Yes
No
Yes
No
April 30
May 14
LIBRARY
May 28
FORD
:
June 11
078830
June 25
July 9
July 23
Aug. 6
Aug. 20
Sept. 3
Sept. 17
Oct. 1
Oct. 15
Oct. 29
Nov. 12
Nov. 26
Total
20
630
9
20
INDUSTRY REPORT
Jet Injector Guns
Biweekly
Vaccine Production
Delivered
Dates
Target
On Target
Target
On Target
Yes
No
Yes
No
April 30
May 14
May 28
June 11
June 25
July 9
July 23
Aug. 6
Aug. 20
Sept. 3
Sept. 17
Oct. 1
Oct. 15
Oct. 29
Nov. 12
Nov. 26
Total
200,000,000
2,000
THE WHITE HOUSE
SIGNATURE
WASHINGTON
April 6, 1976
MEMORANDUM FOR THE PRESIDENT
FROM:
JIM CANNON
SUBJECT:
Memorandum to Secretary Mathews
Attached for your signature is a memorandum
requesting Secretary Mathews to submit a biweekly
progress report to you on the influenza immunization
program. We will see that the reports are staffed
to Jim Lynn and that you are kept informed of the
program's progress.
The memorandum has been approved by OMB (O'Neill). .
The text has been approved by Doug Smith.
RECOMMENDATION
I recommend that you sign the attached memorandum.
THE WHITE HOUSE
WASHINGTON
April 6, 1976
MEMORANDUM FOR
THE SECRETARY OF HEALTH, EDUCATION AND WELFARE
Last week, in my memorandum to department and
agency heads, I indicated the steps necessary to
ensure our goal of having the influenza vaccine
available to every American this fall. I directed
that the Department of Health, Education and Welfare,
under your supervision, assume the responsibility
for this effort. Due to the importance that I place
on this effort, I plan to give it my direct and
continuous attention. I expect to be kept informed,
and where necessary, personally involved as the
program proceeds.
Therefore, I am requesting a biweekly report from
you indicating our progress toward the essential
program goals and timetable targets. This is the
single most important public health undertaking
by the Federal Government, and we must assure
completion of the task in a proper and timely manner.
URD
OF HEALTH DECATION
THE SECRETARY OF HEALTH, EDUCATION, AND WELFARE
DEPARTMENTO
AND
WASHINGTON. D.C.20201
DEPART
APR 9 1976
The President
The White House
Washington, D.C. 20500
Dear Mr. President:
I have your memorandum of April 6th concerning the influenza
immunization campaign.
I will most certainly keep you informed as you requested, and
am attaching the first of the reports that you asked for with
this reply.
Faithfully yours,
/s/David Mathews
Secretary
Attachment
CC: The Honorable James Lynn
The Honorable James Cavanaugh
Theodore Cooper, M.D., Assistant
Secretary for Health
HEALTH.
DEPARTION
OF
THE SECRETARY OF HEALTH. EDUCATION, AND WELFARE
DEPARTMENT
WASHINGTON D. C. 20201
APR 9. 976
MEMORANDUM FOR THE PRESIDENT
Since you announced the National Influenza Immunization Program,
hearings have been held before both Houses of Congress. The House
has passed authorization legislation that it felt was necessary to
carry out this program and the House and Senate have passed appro-
priation bills designed to implement it.
I have established an Intradepartmental Task Force, chaired by the
Assistant Secretary for Health, Dr. Theodore Cooper, that will report
directly to me. It will serve as a device for exchanging information
rapidly, expediting needed decisions assuring rapid clearance for
action items, and, in general, facilitating the successful completion
of the program.
In addition, Dr. Cooper has established a management focus in his
office to implement the operational objectives cited by you in your
memorandum of March 31. This management focus will develop policy,
set priorities, and provide guidance for the implementation of the
program. An Operational Planning System Objective with targeted
milestones to monitor the progress of the program has been developed.
The three agencies of the Public Health Service (PHS) that will carry
out these objectives are the Center for Disease Control (CDC), the
Bureau of Biologics (BoB) of the Food and Drug Administration (FDA),
and the National Institute of Allergy and Infectious Diseases (NIAID)
of the National Institutes of Health.
To date (1) initial steps have been taken that will lead to field
testing and subsequent production of the vaccine, (2) an effort is under
way to ensure that the nation's health professionals will be encouraged
to fully support this effort, and that the public will be fully aware
of the necessity to receive the vaccine, (3) a plan is being developed
for the distribution and administration of the vaccine, and (4) steps
are under way to ensure adequate epidemiologic and laboratory surveil-
lance of this effort.
2
On March 25, a workshop was held at the BoB, FDA to discuss develop-
ments relevant to influenza immunization for the 1976-77 influenza
season. This workshop was attended by scientists from BoB, NIAID, and
CDC, representatives from the Department of Defense and Veterans
Administration, university investigators working on influenza research,
members of BoB, NIAID, and CDC advisory committees, pharmaceutical manu-
facturers engaged in producing influenza vaccines, biologics control
authorities from other countries (in this instance Canada), the general
public, and the press. Despite the rapid pace of events, it appears
that the various groups involved in this effort are working together
reasonably well and that a rather remarkable amount of progress has
been made in the short time since the A/swine-like virus was recovered
in early February.
On April 2, CDC, the lead PHS agency for the program, discussed it with
members of the State and Territorial Health Officers Association
representatives from the State medical societies, officials of the major
drug companies, and personnel from other PHS agencies. During the meeting,
the attendees were briefed on the scientific basis for the program and
the general strategy for its implementation. While some health officers
questioned the adequacy of the funds available to the States, and some
health officers and private practitioners questioned the ability to
carry out such a massive immunization effort in such a short period of
time, the overwhelming majority thought it could be done. They indicated
they would make every effort to see to it that the program was success-
fully carried out.
On April 12, a meeting was held by Dr. James H. Cavanaugh, Deputy
Director of the Domestic Council, with some 20 principals concerned in
this effort. Its purpose was to review the current status of the
program vis-a-vis your charge to it and to consider emerging policy,
priority, and implementation problems.
At present:
(1) the lack of an appropriation for the program is the major
impediment to its forward progress;
(2) the question of liability indemnification for the
manufacturers of the vaccine requires further resolution.
Close attention is being given to both of these matters.
FORD
LIBRARY
Secretary
THE WHITE HOUSE
WASHINGTON
April 12, 1976
FORD LIBRARY
MEMORANDUM FOR:
JIM CAVANAUGH
PAUL O'NEILL
FROM:
SPENCER JOHNSON
sel
SUBJECT:
National Influenza Immunization Program
Meeting
Monday, April 12, 1976
11:00 a.m., Roosevelt Room
Today's meeting will provide an opportunity for the
Domestic Council and OMB to be brought up to date
on HEW's implementation of the President's National
Influenza Immunization Program. It will also be an
opportunity to discuss policy and management questions.
Dr. Theodore Cooper, Assistant Secretary for Health, will
be called upon to open the meeting by presenting a status
report. The meeting will be attended by HEW, DOD, State,
VA, CSC, and NSC.
Possible areas of discussion:
1.
The question of any conflict with antitrust laws on
the part of pharmaceutical manufacturers in carrying
out the program. (See Tab C).
2.
The question of relief of liability for manufacturers
for injuries caused by properly manufactured vaccines.
(See Tab D).
3.
When will firm production estimates be available?
This information is required as soon as possible
for distribution, organization and supply planning.
(Also, the Canadian memorandum; see Tab E).
4.
What steps are being taken to determine the method
of delivery and the types of supplies necessary?
(See Tab F).
FURD
- 2 -
LIBRARY
5.
How are the vaccine distribution priorities being
determined? (i.e., by class of people, high risk,
old, young; by states where flu outbreaks are
present; by states whose delivery programs are
developed; by concentration of population; or
through the public system before the private
because of less cost and higher rate of inocula-
tion?)
6.
How were the funding requirements of $26 million
for state project grants determined? What is the
significance of the States' request for an additional
$30 million? Does HEW anticipate the need for
additional appropriations in this area?
7.
What are the cost implications for Medicare, Medicaid,
and other public programs as a result of inoculation
fees?
8.
Will the State and local health departments be per-
mitted to charge nominal fees for inoculation and
administrative costs?
9.
What are the implications for similar programs in
coming years?
This is by no means an exhaustive list of questions, but
rather those that have been asked most since the Presi-
dent's announcement.
One major topic of discussion should be the program
management. At this time no one individual is totally
responsible, nor spending 100 percent of their effort
on the program implementation. There is, however, an
HEW Intra-agency Task Force. The question is one of
management accountability. Since this is a highly visible
Presidential initiative it would seem that there should
be a specific fulltime management team and one individual
accountable 100 percent of the time.
Under the current arrangement, either HEW programs will
suffer in deference to the immunization program, or the
immunization program will suffer in deference to HEW
priorities.
- 3 -
Finally, there may be some time for discussion of
interagency cooperation.
Attachments
Tab A. Participants
Tab B. OPS Plan
Tab C.
Antitrust Letters
Tab D. Liability Memorandum
Tab E. Vaccine Production Memorandum
Tab F. Equipment Questions: HIMA Letter
Tab G. Sample HEW Status Report
A
PARTICIPANTS
Dr. Theodore Cooper
(HEW)
Mr. St. John Barrett
(HEW)
Mr. John Blamphin
(HEW)
Dr. James F. Dickson III
(HEW)
Ms. Vivian Dobson
(HEW)
Dr. Donald S. Fredrickson
(HEW)
Dr. James C. King
(HEW)
Dr. Richard M. Krause
(HEW)
Mr. Michael J. Licata
(HEW)
Dr. Harry M. Meyer, Jr.
(HEW)
Dr. J. Donald Millar
(HEW)
FORD
Mr. Rupert Moure
(HEW)
Dr. Alexander M. Schmidt
(HEW)
Dr. John R. Seal
(HEW)
LIBRARY
Mr. John D. Young
(HEW)
Mr. James C. Wilder
(HEW)
Dr. Paul A. Haber
(VA)
Dr. Oswald Ganley
(Dept. of State)
Mr. Vernon McKenzie
(Dept. of Defense)
Mr. Thomas Campagna
(CSC)
lB
B
HEALTH.
antice
HOMELAND STATE
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
PUBLIC HEALTH SERVICE
USA
ROCKVILLE, MARYLAND 20852
APR 07 1976
NOTE TO DR. COOPER:
re: National Influenza Immunization Plan
Attached are the operating plans of the Center for Disease Control,
Bureau of Biologics, and the National Institutes of Health. We have
discussed these plans with other operating elements of PHS and have
found no disagreement with the approach and scheduling described in
the plans.
It should be noted that the public information activities related to
this campaign should be further developed if other elements of PHS
as well as DHEW are to play a role in this area. Attention will have
to be given to the use of Secretarial and Presidential involvement
vis-a-vis major public appearances and/or national television programming.
The timing of such events anticipated difficulty or success in selling
the campaign to the public, and the availability of key participants
is critical. Accordingly, you should direct the development by CDC
of a public information discussion paper.
Of additional concern is Bureau of Biologics activities related to
evaluation of vaccines used by other agencies in clinical trials.
Although this is treated in the operating plan, the potential difficulty
of coordinating DHEW, VA, and DOD clinical trial activities to ensure
that a fully representative sample is used would justify the development
by BOB of a discussion paper on this matter.
Willesm William R. Berry RBCUZ
Attachment
ORD
ANVERIT
MEMORANDUM
DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE
PUBLIC HEALTH SERVICE
CENTER FOR DISEASE CONTROL
TO
:
The Assistant Secretary for Health
DATE:
MAR 25 1976
Through: ES/PHS
FROM
:
Director
Center for Disease Control
SUBJECT: National Influenza Immunization Plan - INFORMATION
The enclosed documents (TAB A) outline the national influenza immunization
plan we have developed at CDC, using the Operational Planning System (OPS)
approach. The objective and operating plan delineate the key steps which
must be undertaken, and the points in time at which these steps must
be completed. We are continuing to develop plans in greater detail for
managing this program; however, the OPS influenza objective presents all
the essential elements required to implement the program.
U William David J. Sencer,
Assistant Surgeon General
Enclosure
Prepared by: CDC, SENCER, 3/25/76, 283-3291
GERALD R. LIBRARY FORD
FORD
OPERATIONAL PLANNING SYSTEM
LIBRARY
CENTER FOR DISEASE CONTROL
Objective No. 1: NATIONAL INFLUENZA IMMUNIZATION PLAN - Establish an
integrated, comprehensive immunization delivery system utilizing
official health agencies and private medicine, capable of making swine
influenza immunization available to every person in the U.S. for whom
it is not contraindicated.
Resources Required: CDC Direct Operations:
$101,851,000
Project Grants to States: $ 26,000,000
JUSTIFICATION AND APPROACH
Influenza viruses are in a constant state of change with new strains
frequently emerging. Hence, influenza epidemics recur periodically.
The severity of these epidemics depends on a number of factors, but
chief among them is the absence of immunologic familiarity of the pop-
ulation with the emerging strain. Thus, if major changes occur in the
virus producing a strain to which most people are susceptible, vast
epidemics or "pandemics" are expected. Such a situation now exists in
the United States. In February 1976, an outbreak of influenza occurred
among military recruits at Ft. Dix, New Jersey. The virus identified
as the cause of that outbreak is Swine Influenza Virus, known technically
as "A/New Jersey/8/76 (HSW 1 N 1)." This strain has not been prevalent
in the United States for nearly 50 years. The strain shows sharp
antigenic differences from strains which have appeared in the U.S. in
the interim.
Antibody surveys among the U.S. population suggest that only persons
over 50 years of age have had any immunologic experience with a similar
virus. Thus, essentially those under 50 years are presumed to be fully
susceptible to it. Previous experience with other influenza strains
has shown that even among those over 50 who have antibodies to swine
influenza, little residual resistance to the infection can be expected.
In other words, they, too, are vulnerable to infection with swine
influenza virus.
Though typical influenza illness is moderate and self-limited, epidemics
produce large numbers of excess deaths among persons who are aged or
afflicted with chronic diseases. For them, influenza is, as it were,
a final insult pushing them over the brink. The last pandemic, of
Hong Kong influenza in 1968, produced nearly 30,000 deaths and incurred
-2-
costs estimated at $3.9 billion. The Great Pandemic of 1918-1919 which
is thought to have been due to a virus similar to the recently isolated
swine influenza virus, produced over half a million deaths in the
United States alone; costs of that pandemic have not been adequately
estimated.
Because of a short incubation period and a high degree of infectiousness,
influenza spreads with remarkable speed during the season of intense
transmission, September to March. In the past, pandemic strains have
spread around the world in less than a year. Vaccines are about 70 per-
cent effective in preventing influenza but 4 to 6 months is required for
their preparation from newly emergent strains. Thus, frequently in the
past, vaccines have not been available soon enough to significantly
alter the course of pandemics. Immunization which only begins after occur-
rence of an epidemic is too late to effect significant control.
The United States now faces a complex situation. Swine influenza
virus has been isolated and some outbreak activity has occurred near
the end of the current transmission season. The population is extremely
vulnerable to rapid spread of swine influenza because such a large pro-
portion of persons in the population has no previous immunologic experience
with similar viruses. A pandemic is clearly possible. However, intense
transmission is not expected to occur until next fall and winter,
leaving 6 months (if action is immediate) in which to develop a vaccine
and administer it to U.S. citizens.
The solution to the problem facing the United States is universal vac-
cination of U.S. citizens with swine influenza virus vaccine in a period
of about 6 months. There is no precedent for such a program. The
proposed strategy rests on the simultaneous execution of large-scale
vaccination campaigns in each State, under the general direction of the
State Health Officer, covering every significant population aggregate.
Private medicine will be involved by the official health agency to
the extent appropriate to assure universal coverage of all citizens.
Clearly, however, because of the time constraints, l'arge-scale community-
wide mass vaccination programs will be the backbone of the activity.
Major tactical elements in this approach are: (1) operations of mass
vaccination campaigns, (2) assessment to assure adequate coverage of
the population, (3) surveillance of influenza disease (due to swine
influenza virus or other etiologic agents) and of vaccine-associated
reactions.
To accomplish these tactical ends will require specific supporting
activities including (a) production and evaluation of the necessary
vaccines, (b) Federal financial support of official State health
agencies, (c) State planning and community organization, (d) training,
(e) public and professional information and education.
-3-
No reasonable alternative to this course can be justified on epidemi-
ological ground. There is no basis for selective immunization of any
part of the populace. The only other alternative is to ignore the
threat, do nothing, and gamble that a pandemic will not occur. A
decision to take action against the threat is a decision to immunize
all citizens. Based on the most recent pandemic, cost benefit ratios
of widespread immunization will exceed 20 to 1 if a pandemic is averted.
It must be remembered that in addition to swine influenza, influenzas
of other etiology, especially influenza A-Victoria, will be occuring
in the population. As usual, it is recommended that "high-risk" groups
be vaccinated against the prevalent influenza strains. Therefore,
persons in the "high-risk" group will receive a bivalent vaccine,
comprised of influenza A/Victoria antigen and A/swine influenza vaccine,
as part of the national program addressed in this OPS objective.
OPERATIONAL PLANNING SYSTEM
RESOURCES REQUIRED
ORGANIZATION: Center for Disease Control OBJECTIVE AND OPERATING PLAN
CDC Direct Operations: $101,851
FISCAL YEAR 1976-77
Project Grants to States: $ 26,000
7
OBJECTIVE NO. 1 : NATIONAL INFLUENZA IMMUNIZATION PLAN - Establish an integrated,
comprehensive immunization delivery system utilizing official health agencies
OVERALL EVALUATION
and private medicine, capable of making swine influenza immunization available
to every person in the U.S. for whom it is not contraindicated.
STATUS REPORT FOR MONTHS OF
COMPLETION DATE
MILESTONES
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
NOV
DEC
A. PROFESSIONAL EDUCATION
1. Initiate a continuing information program directed at
health professionals, including the established professional
media, direct communications, and a Speakers Bureau for
medical and health related meetings.
B. PRODUCTION AND EVALUATION OF VACCINE
1. Initiate vaccine evaluation field trials with first lots
of Vaccine.
2. Contingent on Bureau of Biologics (FDA) approval of
vaccine formulations, initiate vaccine distribution:
a. Bivalent vaccine for immunization of high-risk
groups (20-25 million doses).
b. Monovalent (swin- only) vaccines for mass campaign
(first 100 million doses).
C. OPERATIONS
1. Design strategy to reach total population and develop
for presentation to State Health Officers.
2. Develop grant guidelines.
3. Provide technical assistance to States in development of
program plans and in organization of community resources,
including volunteers, civic groups, etc.
4. Negotiate and contract with manufacturors for procurement
of total production of influenza vaccine, additional jet guns,
cold chests for field transport of vaccine, and other equip-
ment needed for campaign.
ORGANIZATION: Center for Disease Control
OBJECTIVE NO.:
1
continued
COMPLETION DATE
MILESTONES
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
NOV
DEC
5. Work with other Federal agencies involved to achieve
necessary level of interagency preparedness.
6. Receive and review grant applications, make grant awards
to States, and notify States of proposed vaccine allocations.
7. Implement a comprehensive system for. (a) surveillance of
influenza disease due to swine influenza virus and other
etiologic agents and (b) monitoring vaccine-associated
reactions.
8. Mobilize community resources and initiate campaign among
highest risk (aged and others) population, using initial
(bivalent ) vaccine distribution.
9. Initiate mass campaign to reach total population, using
monovalent vaccine.
10. Develop a plan for dealing with significant focal out-
breaks of influenza.
11. Monitor disease trend and outbreaks in order to direct
additional immunization efforts toward epidemic control.
D. PUBLIC AWARENESS
1. Establish information contacts at State and other
operating levels and begin continuing information exchange
with individuals responsib' for State and local programs.
2. Develop theme, strategy, and informational tools for use
in multi-media campaign to coincide with availability of
vaccine.
3. Work with established media to assure continuing flow of
information to the public through all appropriate mass media
channels.
4. In cooperation with grantees, begin mass media campaign
to stimulate action by the public.
BERALD
RD
LISRARY
ORGANIZATION: Center for Disease Control
OBJECTIVE NO.:
I
continued
COMPLETION DATE
MILESTONES
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
NOV
DEC
E. PROGRAM ASSESSMENT AND EVALUATION
1. Develop methodology to assess program status.
2. Implement assessment mechanism to coincide with initiation
of immunization campaign.
3. Provide feedback of assessment data to State and local
health officers and other interested parties.
4. Evaluate program accomplishments.
F. TRAINING
1. Define tasks State and local employees and volunteers will
undertake in immunization campaign, and potential deficiencies
in the skills and knowledge needed to complete them --
including, but not limited to:
a. Jet gun operation
b. Jet gun maintenance
c. Shipping and storage of vaccine
d. Contraindications
e. Organizing community immunization campaign
2. Select training solutions and develop teaching materials,
checklists, manuals, practice sessions, etc. needed to
achieve a properly trained work force.
3. In cooperation with grantees, identify persons needing
training and provide courses, practice sessions, or other
skill development training as required.
LIBRARY
OPERATIONAL PLANNING SYSTEM
RESOURCES REQUIRED
NIZATION: Bureau of Biologies
OBJECTIVE AND OPERATING PLAN
FISCAL YEAR 197 6-77
DRAFT
CTIVE NO. 1 :
National Influenza Immunization Plan - To establish the requirements
for a vaccine prepared against swine influenza which will be consistent
OVERALL EVALUATIO
with the need to immunize the U.S. population; to establish a smoothly
functioning system which will allow vaccine assessment and
official release of commercial vaccine lots to proceed smoothly STATUS REPORT FOR MONTHS OF
and ranidly
COMPLETION DATE
MILESTONES
JAN
FEB
MAR
APR
MAY
JUNE!
JULY
AUG
SEPT
OCT
NOV
D
Communication
1. Dissemination of information to manufacturers and coordination
of their
vaccine produation schedules with NIAID as it
concerns clinical studies and with the CDC as it concerns mass
immunization programs. This will be accomplished through
frequent meetings between the manufacturers, the involved
governmental agencies, members of the scientific community
and the public.
Production and Evaluation of Vaccine
1. Testing and distribution of virus and seed strains including
original isolates and recombinants.
2. Testing of pilot lots for safety and potency in laboratory
test systems.
3. Clinical testing of pilot tests of swine influenza vaccine
to establish optimum formulation of swine influenza vaccine
in ccllaborative studies with CDC, NIH and military.
4. Development of guidelines for production of swine influenza
vaccine.
5. Control testing of commercial monovalent swine influenza
vaccine lots; this will be done concurrently with the
manufacturers' tests in order to speed release.
6. Clinical testing of pilot lots of polyvalent vaccine.
7. Development of guidelines for production of polyvalent
vaccine.
8. Control test of commercial polyvalent influenza vaccine,
concurrent testing will be performed.
IZATION: Burcau of Biologics
08/SCTIVE 1
continued
COMPLETION DATE
MILESTONES
JAN
FEB
MAR
APR.
MAY
JUNE JULY
AUG
SEPT
OCT
NOV
DEI
9. Apply new potency tests to both polyvalent and monovalent
swine pilot lot vaccines and to a sample of commercial
vaccines.
10. Develop and apply new approaches to the assessment of
clinical reactivity.
11. Evaluation of experimental inactivated influenza virus
vaccines used in clinical trials by other involved agencies.
12. Evaluation of experimental live virus vaccines used in
clinical trials by other involved agencies,
C. Operations
1. Implement system for monitoring flow of completed released
vaccine lots for reliably estimating the timetable on
vaccine availability and for disseminating this information
to the other agencies involved.
2. Develop in coordination with CDC, NIH, and the Armed Services
information systems concerning vaccine reaction monitoring.
3. Schedule and provide additional teams to inspect licensed
vaccine manufacturers.
4. Implement program for post-distribution monitoring of both
monovalent and polyvalent vaccines.
5. Equip facilities for expanded testing workload.
GERALD
n.
FORD
LESRARY
April 2, 1976.
National Institute of Allergy and Infectious Diseases
Fact Sheet
Supplemental Request for Influenza Research
Current Funding
FY 1976 $3,400,000
FY 1977 $4,300,000 estimated
On-going efforts are directed toward development of an improved, live
vaccine which could be administered intranasally. Such a vaccine has the
potentiality of being produced more rapidly and economically than a killed
one. In addition, we are investigating a vaccine made from a component
chemically split off from the whole influenza virus. Grant funded studies
are primarily in epidemiology, virus structure, genetics and virus growth.
an
The NIAID has/influenza research center at Baylor University and 5 vaccine
evaluation centers. Influenza surveillance is also being conducted at these
centers.
Supplemental Request
$4,000,000 and 9 positions
The threat of swine type influenza creates several urgent needs for research.
These are 1) intensive study of the influenza viruses circulating in the pig
population and of changes in these viruses related to increased transmissi-
bility to man, 2) the determinants of pig to man transmission and later
dissemination in man, 3) studies on the antigenicity and reactogenicity of
the vaccines to be commercially produced to provide the data needed for
2
determination of dosage and usage, 4) determination of the efficacy
of amantadine and other drugs in prevention and treatment of swine
type influenza viruses, 5) determination of the efficacy of protec-
tion of influenza vaccines against this type of disease in volunteers
and, if outbreaks occur, in population groups, 6) further research
and development on experimental vaccines including live, attenuated
and subunit vaccines, 7) establishment of special surveillance
facilities to give us early warning of influenza activity 8) additional
highly specific reagents for immunologically dissecting the influenza
virus strains, 9) expanded grant supported activities in epidemiology,
virus structure, genetics and virus growth.
p
C
SSISTANT GENERAL
ANTITHOST DIVISION
Department of Justice
Washington, D.C. 20530
hand
4/6/76
APR 5 1076
Honorable Theodore Cooper, M.D.
Assistant Secretary for Health
Office of the Secretary
Department of Health, Education
and Welfare
GERALD R. LIBRARY FORD
Washington, D. C. 20201
Dear Dr. Cooper:
This is in response to your letter of April 5, 1976,
requesting our opinion as to whether the planned program
for production of sufficient "Swine Flu" vaccine to in-
noculate virtually every American to counter a possibly
serious health threat would create a situation in conflict
with the antitrust laws. According to your letter, poten-
tial manufacturers of vaccine will negotiate separately
with your Department with respect to its purchase of
vaccine, but certain joint action regarding the use of
manufacturing facilities and technology may be necessary
to maximize production in this emergency.
Based upon the description of the program contained
in your letter, the limitation of any joint action found
necessary to the meeting of the exigencies of the current
emergency, and the serious health hazard that the program
is designed to avoid, we do not believe that it would
present a situation in conflict with the antitrust laws.
Sincerely yours,
60:-Im we.
Assista THOMAS Attorney E. KAUPER General
Antitrust Division
ТЕЛСЕКЗ1569
DEPARTMENT FOR ATION Airl, WELLARE
OFFICE lif 1111 TAILI
116, 20/01
APR 5 1976
Mr. Thomas E. Kauper
Assistant Attorney General
Antitrust Division - Room 3109
U.S. Department of Justice
Washington, D. C. 20530
Dear Mr. Kauper:
On March 25 the President, in a special message to the
Congress, announced, "The nation faces a serious potential
public health threat this winter from a strain of virus
known as swine influenza." Accordingly, he asked the
Congress for a special supplemental appropriation of $135
million to ensure the production of sufficient vaccine to
inoculate every man, woman and child in the United States,
and directed Secretary Mathews and me to "develop and implement
plans that will make this vaccine available to all Americans."
In seeking to carry out the President's instructions, we
must call upon the drug industry to manufacture more than
200 million doses of swine influenza vaccine by the fall.
To succeed in this unprecedented industry effort, licensed
vaccine manufacturers may find it necessary to cooperate
with each other in some aspects of the vaccines' manufacture
and distribution. Accordingly, we wish to assure ourselves
that no conflict with the antitrust laws will arise.
In bare outline, the Department will contract with licensed
manufacturers to purchase all of the swine influenza vaccine
that they can produce (subject to certain maximums) during
a specified period, and will arrange to grant those vaccines
to State and local public health authorities under cooperative
arrangements through which those authorities will provide
for the vaccines' administration.
BEBALD R. LIBRARY FORD
Mr. Thomas E. Kauper
2
Specifically, WC are moving now to determine our contract
specifications: the vaccine quantities required, the
packaging, and the delivery dates. When the specifications
are established, we shall deliver them to all licensed
manufacturers and invite their separate bids. Upon receipt
of their bids we would expect to enter into separate negotiations
with each manufacturer to improve the terms of those bids. We
do not intend to negotiate with the manufacturers as a
group, and do not expect them to consult with each other
in formulating their bids.
Upon completion of the negotiation process we would expect
to enter into contracts that, barring an unanticipated
technological breakthrough, would obligate the Department
to purchase the manufacturers' entire output for a certain
period.
During the course of vaccine production there are various
points at which the manufacturers may consult among themselves.
First, in order to maximize production they may find it
necessary to pool certain of their manufacturing facilities
and compare their respective technologies. Second, in
light of the relative efficiency of each manufacturer, it
may be necessary, after their consultation with each other
and the Department, to reallocate production quotas.
Finally, under Department supervision, the companies may be
asked to cooperate with each other in undertaking aspects
of the actual national distribution of the Government-owned
vaccine.
Joint action by these companies will, of course, be limited
to meeting the exigencies arising from the current nationwide
public health emergency.
Please advise us whether, in your opinion, the described
activities will create a situation in conflict with the
antitrust laws.
ORD
Sincerely,
Theodore Cooper, M.D.
Assistant Secretary for Health
I
April 5, 1976
MEMORANDUM
Need for Special Provisions Concerning
Manufacturers' Liability for Swine
Influenza Vaccine Produced and Labeled
in Accordance with Government Specifica-
tions
Legislation to authorize the Department of Health,
Education, and Welfare to initiate a program to inoculate
all Americans against swine influenza is presently pending
before Congress. The necessary vaccine would be purchased
and made available by the federal government for use by
federal, state, and local health authorities and private
physicians. Recent judicial decisions concerning mass im-
munization programs suggest that courts may impose on
manufacturers a duty to warn all persons receiving the
vaccine of any risks that may be associated with its use.
Failure to provide warnings deemed adequate by the courts
may subject manufacturers to liability for any injuries or.
adverse reactions that may result from use of the vaccine.
This liability could be imposed even though the vaccines
supplied to the federal government met the highest standards
of purity, quality, and effectiveness and were labeled and
manufactured in compliance with all Food and Drug Administration
* / E.g., Reyes V. Wyeth Laboratories, 498 F.2d 1264 (5th
Cir. ), cert. denied, 419 U.S. 1096 (1974).
FORD
- 2 -
requirements and HEW contract specifications. Because the
scope of the proposed vaccination program greatly exceeds
that of any prior mass immunization effort, manufacturers
are confronted with incalculable, but potentially over-
whelming, exposure to damage judgments in state or federal
courts.
It has been suggested that HEW could relieve
manufacturers of liability for injuries caused by properly
manufactured vaccines if it agreed, in its contracts with
the manufacturers, to assure that adequate warnings were
provided to all persons receiving the vaccine or to indemnify
manufacturers for any loss they may sustain because of HEW's
failure to assure proper warnings. In the absence of
legislative authorization, neither approach can be counted
on to protect manufacturers from liability for inadequate
warnings.
If a duty to warn is imposed by the courts, it
rests in the first instance on the manufacturer. According
to one court, the manufacturer of a vaccine for use in mass
immunization programs "is required to warn the ultimate
*
/
consumer, or see to it that he is warned. " It is not clear
/ Reyes V. Wyeth Laboratories, supra, at 498 F.2d 1276.
- 3 -
from reported decisions that the manufacturer can discharge
its duty simply by contracting with another party to provide
warnings to recipients. This is especially so if the manu-
facturer knows, or has reason to know, that the contractual
assurances may not be carried out in practice. The proposed
vaccination program for swine influenza will be carried out
at the federal, state, and local levels by government agencies,
private organizations, and physicians. It is at least probable
that HEW will be unable to control the exact manner in which
each of 200 million doses of vaccine is administered. Courts
may impute knowledge of this fact to manufacturers who contract
with the government to supply vaccines.
Even if HEW assures that warnings are given to each
recipient of the vaccine, courts in each state will be free
to second-guess the adequacy of the warning given. They may
assess its content (e.g., whether it fairly informs recipients
of the risks and benefits of vaccination), the clarity of its
language, and the conspicuousness of its presentation. No
one can know in advance whether warnings agreed on by the govern-
ment and the manufacturers will, in later damage suits, be
deemed adequate by the courts. Moreover, different courts may
apply different standards of adequacy. Absent special federal
*/ In Reyes V. Wyeth Laboratories, supra the Court stressed
that Wyeth could be "presumed to know" the manner in which
vaccines were dispensed. 498 F.2d at 1277.
- 4 -
legislation, damage suits against manufacturers are governed
by state law and are for the most part reviewable only by
the highest court in each state.
Thus, even if HEW agrees to "assume" the duty to
warn vaccine recipients, manufacturers will still face the
prospect of damage judgments for injuries resulting from the
vaccination program, even though their products conform fully
with federal specifications. Absent special legislation, it
is extremely unlikely that HEW can contract with manufacturers
to indemnify them for losses sustained under such judgments.
*
The so-called "Anti-Deficiency Act" prohibits government
C
agencies from entering into contracts or obligations for the
payment of money "in advance of appropriations" unless such
an obligation is "authorized by law." In California Pacific
Utilities Co. V. United States, 194 Ct. Cl. 703 (1971), the
Court of Claims held that
"The United States Supreme Court, the
Court of Claims, and the Comptroller
General have consistently held that
absent an express provision in an ap-
propriation for reimbursement adequate
to make such payment, section 665 pro-
scribes indemnification on the grounds
that it would constitute the obligation
of funds not yet appropriated. Chase V.
United States, 155 U.S. 489 (1894) ; Hooe
V. United States, 218 U.S. 322 (1910);
Sutton V. United States, 256 U.S. 575
(1921) ; Leiter V. United States, 271 U.S.
204 (1926) ; Goodyear Co. V. United States,
276 U.S. 287 (1928) ; Shipman V. United
States, 18 Ct. Cl. 138 (1883) ; City of
*/ 31 U.S.C. § 665(a).
- 5 -
Los Angeles V. United States, 107 Ct.
C1. 315, 68 F. Supp. 974 (1946) ; 33
Comp. Gen. 90 (1953); 35 Comp. Gen. 85
(1955) "
For these reasons special provisions must be in-
corporated in the swine influenza vaccine legislation to
protect manufacturers against the risk of essentially un-
limited liability for injuries that may result from the
government's mass immunization program.
E
MEMORANDUM
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
TO
:
Deputy Assistant Secretary for Health
DATE: April 9, 1976
FROM
:
Director, Bureau of Biologics
Food and Drug Administration
SUBJECT: Production Estimations of A/Swine-like Influenza Virus Vaccine.
You asked that we make certain estimates relating to the production of
A/swine-like influenza virus vaccine for the proposed national
immunization program.
The vaccine is a licensed biologic, and the entire domestic supply
is produced by several large pharmaceutical firms located in the
United States. Manufacture of the vaccine requires, in addition
to a license, a reliable supply of fertile eggs, specialized
production facilities and equipment and trained personnel. The
tooling-up process involves a series of manipulations designed to
adapt the new influenza virus to optimum growth in fertile eggs,
As soon as the manufacturer has prepared a supply of egg-adapted
seed virus suspensions, he can institute the vaccine production
cycle. The cycle for production of a particular batch of vaccine
takes about two months. Seed virus is inoculated into large numbers
(thousands) of fertile eggs, and after several days the virus-rich
embryonic fluids are harvested. The virus is purified, concentrated
and inactivated. Finally, the inactivated virus concentrate is
diluted so that the end product will contain a specified amount of
viral antigen per 0.5 ml. of volume human dose. This proper amount
of antigen, for a new type of influenza virus vaccine, is determined
by clinical trials conducted during the tooling-up process. In
these trials one measures the protective antibody response of volunteers FORD
given a range of amounts of viral antigen.
LIBRARY
Two important variables in producing a new type of influenza virus
vaccine are the degree of adaption of the seed virus to growth in
eggs and efficiency of the new virus antigen in evoking a protective
antibody response in recipients. Hard information becomes available
only after one has adapted the virus seed, produced a series of trial
vaccine batches and tested these batches in volunteers. We expect
to have this type of information on the new A/swine-like vaccine by
early June. However, in the absence of hard data, one can make
reasonable estimates by comparing the experience with type A influenza
virus vaccines produced in earlier years with the preliminary information
Page 2 - Memo to the Deputy Assistant Secretary for Health
about the new vaccine. This sort of comparison suggests, at present,
that manufacturers should be able to obtain the equivalent of about
two human doses of vaccine from each fertile egg.
With full commitment, industry has the capacity of processing about
12 to 15 million eggs per month in the preparation of vaccine.
Assuming that full production could be reached by June, one could
then anticipate from that time on the delivery of 24 to 30 million
doses of vaccine each month for as long as full production was
continued.
One needs to recognize that the needs of the delivery system in the
United States (actual reaching the population and inoculating the
vaccine) are also estimates. There will not be 100% coverage - the
inoculation of every person. No immunization program to date has
reached more than 75 to 80% of the target population. Also the
time required to inoculate the public (even if vaccine is available)
is an estimate. Blending these production system and delivery system
estimates, we come out with the impression that it might be possible
to reach those "reachable" Americans by the end of November 1976
but it could require another month or two.
This ties into the question of vaccine for Canada. We will in this
memo only deal with certain logistical considerations. In a normal
year when the U.S. would be using 20 million doses of influenza
vaccine, Canada would be using about 2 million doses. Canada has
only one domestic influenza vaccine manufacturer and this firm
normally supplies less than 100,000 doses; the remaining 95% or
so of their supply comes from U.S. manufacturers. If Canada attempts
large scale vaccination this year, its single domestic firm will
be able to tool-up to produce about 300,000 doses, thus they would
need 10 million or more doses from the U.S. Our production output
is likely to be such that supplying Canada could extend by 10 to 15
days the time required to meet domestic needs in the U.S.
For a number of reasons not dealt with in this memo we feel it would
be wise to consider Canada as an extension of the U.S. program
and see that they are supplied vaccine on the same schedule as the
50 states.
Harry M. Meyer, Jr., M.D.
p
F
Health
Industry
Manufacturers
Association
1030 FIFTEENTH STREET, N.W., WASHINGTON, D.C. 20005
TELEPHONE (202) 452-8240
President
April 8, 1976
Harold O. Buzzell
James F. Dickson, M.D.
Deputy Assistant Secretary for Health
Department of Health, Education
and Welfare
330 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Dr. Dickson:
Thank you for the opportunity to discuss briefly the equipment aspects
of the swine flu vaccination program with you last week. This letter confirms
the willingness of the medical device industry to make the vaccination pro-
gram successful and to bring to your attention the outstanding questions
which must be resolved ---- and resolved quickly -- for the equipment aspects
of the program to be successful.
Two preliminary comments are in order. First, the Association's members
are 160 corporations including more than 235 operating companies making all
varieties of medical device and diagnostic equipment. Among our members
are five - virtually all --- manufacturers of syringes and needles and the
major manufacturer of injection guns. Second, all of our questions assume
that the equipment needs for the swine flu program will be in excess of those
required for supplying the customary needs of hospitals, physicians, and
patients and that no diversion or interruption in supplying these recipients
is contemplated.
The first group of questions relate to the vaccine itself. The answers
here will all have a direct bearing on the nature of the equipment required
by the program and whether it is possible to supply it.
1. How will the dosage be administered, orally or by injection?
2. If injected, will it be by subcutaneous or intramuscular
injection?
3. How large will the dosage be? Will there be a range in
dosage size, for example, for different ages?
4. How many innoculations will there be per dose, i.e., will
one patient dose require two or more innoculations or a
booster shot?
5. If there will be more than one innoculation per dose, what
will the length of time between doses be?
James F. Dickson, M.D.
Page 2
April 8, 1976
The next group of questions relate to the nature of the administration and
distribution system to be employed. (They assume that the vaccine will be ad-
ministered by injection.)
6. What per cent of total vaccinations will be administered by
injector guns? What per cent by syringes/needles? Will the
Federal Government make state-by-state determinations of
equipment needs or gather information about them?
7. In what geographic locations or institutional situations will
each (injector gun/syringes) be used?
8. To the extent syringes are used, will different sized syringes
be permitted for the same dose (e.g., will it be permissible
to use a 3 CC. syringe for a 1 CC. dose)? This may be the
most significant question bearing on syringe supply. The
ability to utilize syringes of different sizes for the same
size dose will be necessary to assure adequate supply.
9. Who will select and procure the equipment and in what quantities?
Will all injector guns be purchased by the Federal Government?
Will all syringes be purchased by State and local officials? If
so, in either case, under what circumstances could this change?
FORD
10. How will equipment be distributed? If Federal procurement is
not involved, are supplies expected to move through normal dis-
LIBRARY
tribution channels, e.g., distributors, dealers or directly,
depending upon an individual manufacturer's practice?
11. Who are the ultimate recipients of injector guns and syringes
expected to be and in what locations? How will these recipients
relate to the Federal or State administrators of the program in
their requirements for equipment? Will private physicians be involved?
12. If normal distribution channels are not used, what provisions for
security against diversion and misuse and, in the case of syringes,
disposal after use are expected?
13. Are non-standard packaging or labelling requirements contemplated?
14. What sort of reporting system will be established? What records
of distribution and ultimate recipients will equipment manufacturers
be expected or required to keep?
15. What other equipment or supply items figure in planning for the
program? To the extent the foregoing questions may be relevant
to them, how will they be treated?
16. Depending on the nature of the procurement arrangements for the
swine flu program, legal antitrust, product liability, and indemnity
issues may arise. We expect to consult the Department's General
Counsel's office on such questions.
James F. Dickson, M.D.
Page 3
April 8, 1976
17. A final question relates to possible international swine flu
vaccination programs and their attendant demands on U.S.-produced
equipment. What is now known about such programs? Would U.S.
demands for equipment be Federally coordinated, if necessary,
with foreign demand and, if so, how?
The foregoing questions must be answered soon. Obtaining new materials
and components prior to production and effecting actual shipping and dis-
tribution after production will take from two to three of the months between
now and September. Actual production time, in other words, is not the sole
consideration in determining whether a given number of injector guns or
syringes can actually reach the hands of users by September and October.
Now, in early April, it is almost too late to be assured that the requisite
equipment to administer a nationwide vaccination program for a large percen-
tage of our citizens can be delivered in a timely fashion.
We urge, therefore, prompt resolution of these issues and the others
which are sure to arise in the course of the program. We know that you and
the Department share our awareness of the necessity for quick action, and
we will do whatever we can to help.
We shall be in touch with appropriate officials at the Center for Disease
Control and the Bureau of Biologics in order to bring our concerns to their
attention and to obtain their guidance. Any information and counsel which
you could provide to us on the matters raised in this letter will be appreciated.
Sincerely,
Harold O. Buzzell
President
HOB/bjo
CC: Theodore Cooper, M.D.
David J. Sencer, M.D.
Harry M. Meyer, Jr., M.D.
6
MEMORANDUM
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH
TO
: Director, Office of Management and Budget
DATE:
Assistant Secretary for Health
FROM :
Biweekly Status Report on Nationwide Influenza Immunization Program
SUBJECT:
Accomplishments
Problems
Actions Taken to Resolve Problems
INFLUENZA TIMETABLE
VACCINE
STATE AND COMMUNITY
NATIONAL
PRODUCTION
PROGRAMS
ACTIONS
March
Vaccine
Policy Decisions
Formulations
on National
Prepared
Program
April
Vaccine
Program Planning
Program
Evaluation
Guidelines
Trials
Initiated
Professional
Education
Appropriations
Enacted
May
Professional
Vaccine
Education
Contracts
Awarded
Community
Organization
Award Grants
June
First Lots
of Vaccine
Approved
July
Immunization of
First Distri-
High Risk Groups
bution of
Vaccine
Implementation
of Surveillance
System
August
Public Awareness
Public Awareness
Community
Mobilization
September
Immunization of
General Population
FEDERAL EFFORT
CDC
No. of Doses of
Approval of State
Vaccine Contract
Vaccine Purchased
Plans and Award of
Biweekly
Awards
and Distributed
Grants to States
No. of Employees
Dates
Target
On Target
Target
On Target
Target
On Target
Target
On Target
Yes
No
Yes
No
Yes
No
Yes
No
April 30
May 14
May 28
June 11
June 25
July 9
July 23
Aug. 6
Aug. 20
Sept. 3
Sept. 17
Oct. 1
Oct. 15
Oct. 29
Nov. 12
Nov. 26
Total
4
200,000,000
62
44
FEDERAL EFFORT
FDA
NIH
No. of Lots of
No. of Contractual
Biweekly
No. of Employees
Vaccine Certified
No. of Employees
Actions
Dates
Target
On Target
Target
On Target
Target
On Target
Target
On Target
Yes
No
Yes
No
Yes
No
Yes
No
April 30
May 14
May 28
June 11
June 25
July 9
July 23
Aug. 6
Aug. 20
Sept. 3
Sept. 17
Oct. 1
Oct. 15
Oct. 29
Nov. 12
Nov. 26
J
Total
20
630
9
20
INDUSTRY REPORT
Jet Injector Guns
Biweekly
Vaccine Production
Delivered
Dates
Target
On Target
Target On Target
Yes
No
Yes
No
April 30
May 14
May 28
June 11
June 25
July 9
July 23
Aug. 6
Aug. 20
Sept. 3
Sept. 17
Oct. 1
Oct. 15
Oct. 29
Nov. 12
Nov. 26
Total
200,000,000
2,000
No. of Doses
No. of State
of Vaccine
No. of People
Biweekly
Plans Submitted
Distributed
Immunized
Dates
Target On Target
Target On Target
Target On Target
Yes
No
Yes
No
Yes
No
April 30
May 14
May 28
June 11
June 25
July 9
July 23
Aug. 6
Aug. 20
Sept. 3
Sept. 17
Oct. 1
Oct. 15
Oct. 29
Nov. 12
Nov. 26
Total
62
200,000,000
200,000,000