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Swine Flu (3)
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Swine Flu (3)
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The original documents are located in Box 34, folder "Swine Flu (3)" 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States of America his copyrights in all of his unpublished writings in National Archives collections.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.
Digitized from Box 34 of the James M. Cannon Files at the Gerald R. Ford Presidential Library
MERCK & CO., INC.
RAHWAY, N. J. 07065
April 13, 1976
JOHN J. HORAN
PRESIDENT
Mr. James H. Cavanaugh
Deputy Assistant to the President
for Domestic Affairs
The White House
GERALD FORD LIBRARY
Washington, D. C. 20500
Dear Mr. Cavanaugh:
I want to record with you and others an urgent concern we have about
one aspect of the national vaccination program to protect against a possible
epidemic of swine influenza.
Merck is one of four vaccine manufacturers licensed and able to
produce influenza vaccines this year and thus has a direct interest in the
terms and conditions under which swine influenza vaccine is to be made, pur-
chased by the government, and distributed. We are asked to produce as much
vaccine as we can, as fast as we can, to government specification. This we
will do if our current effort to develop a vaccine is successful.
The government has asked that after the vaccine we produce has
demonstrably met government safety, purity, and potency standards, it be made
available to the government for national distribution. Under such circum-
stances, we would have no further role in its distribution and use.
The cause of our concern is that Congressional and HEW actions to
date indicate that if there is any failure in the government's programs, through
states and municipalities, to use the vaccine properly -- failure to warn
responsible adults of any possible adverse reactions to the vaccine, as well
as any other failure that might become the basis for litigation -- we would
be expected to bear the risk of liability for the government's failures.
HEW proposes to try to help minimize our possible liability by a
national program of communication which would plan for appropriate warnings at
the same time as it encourages citizen participation. This does not deal with
the question of where liability rests if the government fails to inform a
patient who is injured and brings suit. Moreover, whatever degree of protection
even this HEW proposal may afford will be negated if a recent action in
Congress is affirmed.
In Congress, the indemnification question was not dealt with on the
House side. On the Senate side, it was dealt with only in language in the
report associated with the appropriations measure - and that language conveyed
the intent of the Committee that no arm of the government should assume any
liability risk for any part of the swine influenza vaccination program, and
that all such risk should be borne by the vaccine manufacturers!
-2-
The legal risk is very real, even though the vaccine may prove to
be relatively safe. Under similar circumstances involving Sabin polio
vaccine, the courts recently held -- and the Supreme Court refused to review
the case -- that the vaccine manufacturer was liable for patient injury
allegedly related to use of the vaccine on the basis of its failure to pro-
vide adequate warning directly to the participant of the risk of such injury,
even though the vaccine was properly made and the manufacturer's only involve-
ment was to provide vaccine to government specification and sell it to the
state for use in government-sponsored mass immunization programs.
Our own insurance carrier has just told us that it is willing to
insure us only against negligence or fault on our part. Moreover, because
of the massive number of people involved, the carrier considers it not
feasible to place any broader coverage in the existing world insurance
markets at virtually any price. Thus, the carrier is willing to provide us
with protection only against claims arising from our own negligence or failure
to manufacture in accordance with government specifications, i.e., against
those risks which are clearly our responsibility.
I do not want to risk being misunderstood. We do not ask to be relieved
of our responsibility to produce vaccine which meets government safety and
potency standards, or of product liability based on negligence or other fault
on our part in manufacturing the vaccine. We do ask to be relieved of liability
for matters for which we have no responsibility and over which we have no con-
trol. No private company has the resources to assume absolute liability for
the actions of others, including Federal, state, and city governments in an
immunization program designed to reach the total U. S. population.
We want to participate in this program that has been declared to be
in the national interest. But we believe the Administration and the Congress
should find a solution to our current dilemma. I urge your participation
and that of your staff in the search for a solution. We are of course pre-
pared to cooperate to the fullest in this endeavor.
To assure that our concern, and the sense of urgency we accord it, is
known to those who have played active roles in the rapid evolution of this
program to meet a national emergency, I am sending identical letters to those
listed on the attached sheet.
Sincerely,
John J. Horan
FORD 's LIBRARY GENALD
-3-
Mr. James H. Cavanaugh, The White House
Mr. Spencer C. Johnson, The White House
Honorable Theodore Cooper, M. D., HEW
Honorable David Mathews, HEW
Harry M. Meyer, Jr., M. D., HEW
Dr. David J. Sencer, HEW
Honorable Edward W. Brooke, United States Senate
Honorable Clifford P. Case, United States Senate
Honorable Edward M. Kennedy, United States Senate
Honorable Warren G. Magnuson, United States Senate
Honorable Richard S. Schweiker, United States Senate
Honorable Hugh Scott, United States Senate
Honorable Harrison A. Williams, Jr., United States Senate
Honorable Tim Lee Carter, House of Representatives
Honorable Daniel J. Flood, House of Representatives
Honorable Robert H. Michel, House of Representatives
Honorable Paul G. Rogers, House of Representatives
cc: C. Joseph Stetler, PMA
-3-
Mr. James H. Cavanaugh, The White House
Mr. Spencer C. Johnson, The White House
Honorable Theodore Cooper, M. D., HEW
Honorable David Mathews, HEW
Harry M. Meyer, Jr., M. D., HEW
Dr. David J. Sencer, HEW
Honorable Edward W. Brooke, United States Senate
Honorable Clifford P. Case, United States Senate
Honorable Edward M. Kennedy, United States Senate
Honorable Warren G. Magnuson, United States Senate
Honorable Richard S. Schweiker, United States Senate
Honorable Hugh Scott, United States Senate
Honorable Harrison A. Williams, Jr., United States Senate
Honorable Tim Lee Carter, House of Representatives
Honorable Daniel J. Flood, House of Representatives
Honorable Robert H. Michel, House of Representatives
Honorable Paul G. Rogers, House of Representatives
cc: C. Joseph Stetler, PMA
THE WHITE HOUSE
INFORMATION
WASHINGTON
April 14, 1976
MEMORANDUM FOR THE PRESIDENT
FROM:
JIM CANNON
SUBJECT:
Secretary Mathews' First Biweekly Report
on Immunization Campaign
Last week you asked Secretary Mathews for a
biweekly report on the status of implementation of
the national influenza immunization program. Attached
is his first report.
We have sent a copy of the report to our staff and
to Jim Lynn for necessary follow-up and action.
THE WHITE HOUSE
WASHINGTON
4/12/76
TO: JAMES CAVANAUGH
Per our conversation
nDC
Robert D. Linder
WALTH
FDUCA
ATION.
THE SECRETARY OF HEALTH. EDUCATION, AND WELFARE
DIPARTMENT ONV
WASHINGTON. D.C. 20201
U.S.
APR 9 1976
at5:39pm.
Encreased by
APR Î₂ 1976
RECEPTION & SECURITY
WHITE HOUSE MAIL
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.
Darod Walliaws Faithfully yours
Attachment
cc: The Honorable James Lynn
The Honorable James Cavanaugh
Theodore Cooper, M.D., Assistant
Secretary for Health
HEALTH.
DEPARTMENT
OF
THE SECRETARY OF HEALTH, EDUCATION, AND WELFARE
DEPARTMENT OF
WASHINGTON, D.C. 20201
WELFARE
U.S.A.
APR 9 1976
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.
DavidWathap
Secretary
THE WHITE HOUSE
WASHINGTON
April 14, 1976
MEMORANDUM FOR:
JIM CANNON sey
FROM:
SPENCE JOHNSON
SUBJECT:
Presidential Decision Memorandum on
Canadian Vaccine Purchase
Secretary Mathews' memorandum to the President on this
subject was returned to HEW Assistant Secretary Ted
Cooper yesterday to be redrafted to reflect new
information.
A new Presidential decision memorandum will be prepared
as soon as a new memorandum is received from the
Secretary.
THE WHITE HOUSE
ACTION
WASHINGTON
Last Day: April 24
April 15, 1976
MEMORANDUM FOR
THE PRESIDENT
FROM:
JIM CANNON
SUBJECT:
H.J. Res. 890 - Emergency
Supplemental Appropriations, 1976
Attached for your consideration is H.J. Res. 890, sponsored
by Representative Mahon, which provides a total of
$1,942,384 for the following activities:
-- HEW: Nationwide swine influenza immunization program;
-- Labor: Temporary employment assistance; summer youth
employment program and community service employment
for older Americans;
-- Community Services Administration: Summer youth
recreation and sports program.
Additional information is provided in OMB's enrolled bill
report at Tab A.
OMB, Max Friedersdorf, Counsel's Office (Lazarus), Bill
Seidman, CEA (Malkiel) and I recommend approval of the
enrolled resolution and proposed signing statement which
has been cleared by the White House Editorial Office (Smith).
RECOMMENDATION
That you sign H.J. Res. 890 at Tab B.
That you approve the signing statement at Tab C.
Approve
Disapprove
THE WHITE HOUSE
WASHINGTON
SIGNING CEREMONY
EMERGENCY SUPPLEMENTAL APPROPRIATIONS BILL
(H.J. Res. 890)
Thursday, April 15, 1976
1:45 p.m. (10 minutes)
The Oval Office
From: Jim Cannon
I. PURPOSE
To sign into law H.J. Res. 890, Joint Resolution
making emergency supplemental appropriations for
public employment programs, summer youth programs, and
preventive health services (the flu program) for the
fiscal year ending June 30, 1976, and for other purposes.
II.
BACKGROUND, PARTICIPANTS, PRESS PLAN
A. Background: On March 24, 1976, you announced plans
for a National Influenza Immunization Program to
inoculate Americans against a swine-type influenza
virus. You requested the Congress to act on your
supplemental appropriation request of $135 million
for this program before the Easter recess.
This appropriation will be used to manufacture
the necessary vaccine, assist the states in distribution
and inoculation efforts, test the efficacy and
effectiveness of the vaccine, continue ongoing
surveillance of disease trends in outbreaks, and
conduct professional and public awareness programs.
In addition, the measure included the following
program appropriations: $300 million, EPA
construction grants; $528,420,000, summer youth
jobs; $1,200,000,000, public services jobs;
$55,900,000, older americans jobs; $17 million,
summer recreation program; $6 million, summer sports
program.
B. Participants: HEW Secretary David Mathews and
Congressman Paul Rogers (D-Florida), chairman of
the Health and Environment Subcommittee of the House
Interstate and Foreign Commerce Committee. Also
Congressman Dan Flood (D-Penn.), chairman of the
Labor-HEW Appropriations Subcommittee.
2
C. Press Plan: Full press opportunity, photo and
statement.
III.
TALKING POINTS
Talking points to be provided by Bob Orben.
5,
Mr. & Mrs. Harry W. Lewis
10 Oak Street
Spencermont
North Billerica, MA
01862
april 19,1976
Dear mr. President,
Since February fourth, we have been
acutely aware of the news surrounding the
GERALD
swine influenza, since our son David was
the one who deed from it at Fact Dix,
for a time it seemed nothing would be
done, so many were saying one death didn't
Warrant concern. The were very relieved when
you came on TV and showed real concern, and
let us know that indeed something was
being dose. now that the serum is a fact,
werknow the possibility of his illness
causing an epidemic has lessened greatly.
although this concern, andthe actions
taken, can't being us back our son, we have
an assurance it will help protect other sons
and daughters. We thank you so much
for this.
Sincerely,
(Mrs) Harry It. Lewis
THE WHITE HOUSE
WASHINGTON
April 27, 1976
MEMORANDUM FOR: JIM CANNON
sel
FROM:
SPENCE JOHNSON
SUBJECT:
Correspondence for Presidential
Signature
Attached is a draft letter for Presidential
signature in response to an incoming letter
from the parents of the swine-flu victim who
died at Fort Dix in February.
I recommend that you sign the attached memorandum
and forward the package
appropriate action.
Greft LIBRARY à SERVID
THE WHITE HOUSE
WASHINGTON
April 27, 1976
MEMORANDUM FOR:
ROLAND ELLIOTT
FROM:
JIM CANNON
SUBJECT:
Correspondence for Presidential
Signature
Attached is a draft letter for Presidential
signature in response to an incoming letter
from the parents of the swine-flu victim who
died at Fort Dix in February.
I recommend that you prepare the letter for
transmittal over the President's signature.
Dear Mr. and Mrs. Lewis:
Your recent letter in support of my national
influenza immunization effort is very much
appreciated.
I truly regret that your son was fatally stricken
by this swine-type influenza virus. As you
have pointed out, however, this specific incident
has served as a crucial warning so that we can
protect every man, woman and child against this
potential danger.
I also specially commend you for your selfless
outlook in your concern for the well-being of
the entire nation.
Warm personal regards,
Gerald R. Ford
5.
"The giffor God is eternal life through Jesus Christ our Lord."
Mr. & Mrs. Harry W. Lewis
10 Oak Street
Romans 6:23
North Billerica, MA 01862
april 19,1976
President,
Since February fourth, we have been
acutely aware of the news purrounding the
swine influenza, oince our son Llavid was
the one who died from it at doct Day,
for a time et seemed mathing would be
done, so many were saying one death didn't
Warrant concern. I were very relieved when
you came on TV and showed real concern, and
let us know that indeed something was
being done. now that the serum is a fact,
we know the possibility of his illness
causing an epidemic has lessened greatly.
although this concern, and the actions
taken, can't being us back our son, we have
an assuranceit will help protect other Dons
and daughters. We thank you so much
for this
Sincerely,
(Mrs) Harry It. Lewis
E
PLURIBUS UNUM
Mr. & Mrs. Harry W. Lewis
USA13c
10 Oak Street
North Billerica, MA 01862
PM MA 18
19 APR
1976
President Gerald Ford
White House
GERALD LIBRARY R. FORD
Washington, D.C. 2000
Personal
DEPARTMENT or EDUCATION PATIENT
HEALTH.
THE SECRETARY OF HEALTH, EDUCATION, AND WELFARE
WASHINGTON, D.C. 20201
U.S.A.
MAY 5 1976
BERALD FORD LIBRARY
MEMORANDUM FOR THE PRESIDENT
I am submitting here the second in a series of Biweekly Reports on the
National Influenza Immunization Program. It indicates our progress and
problems in achieving essential program goals and timetable targets as
requested in your memorandum on April 6.
Four major goals have been achieved since our last Biweekly Report of
April 12, 1976.
First, on April 15, you signed H.R. Res. 890, Emergency Supplemental
Appropriations for Preventive Services, which contained a $135 million
appropriation for the National Influenza Immunization Program.
Subsequently, during the same week, 24,000 doses of A/New Jersey/76
(the technical and preferred name for swine influenza-type vaccine)
were provided to the Bureau of Biologics of the Food and Drug Administration
for laboratory testing and verification of purity and quality.
On April 21, clinical trials began involving the participation of 3,000
volunteers in an effort to document reactivity, efficacy, and potency
and to determine the dosage of vaccine which is adequate for immunization
against the A/New Jersey/76 virus.
Recently, Immunization Program Guidelines for Grant Applications were
sent to State and Regional Offices and contacts with State and other
health officers have been firmly established by the Center for Disease
Control to insure rapid exchange of technical and administrative in-
formation.
The problems of the moment are confined to three areas.
First, legal concerns consisting of potential tort liability and possible
antitrust violations have not been formally resolved between vaccine
manufacturers and the Department. The General Counsel of DHEW, however,
along with members of the Antitrust Division of the Department of Justice
have met with legal representatives of the four vaccine manufacturers and
have taken steps that promise to resolve these issues effectively.
MEMORANDUM FOR THE PRESIDENT
2.
A major unresolved question still exists. That is, whether the United
States should consider sharing, in view of uncertain and possibly
limited vaccine, our A/New Jersey/76 (swine influenza-type) vaccine
with other countries, and on what basis should we determine our position
vis-a-vis Canada, Mexico, and the rest of the world. We have reached a
preliminary decision as to how to proceed in this matter and it is the
subject of an accompanying memorandum. Presently, the Assistant Secretary
for Health is in regular contact with Dr. Alex Morrison, Deputy Minister
of Health for Canada, regarding our status on the question of vaccine
availability and our ability to assist them in meeting their needs.
A final potential problem relates to the coordination of offers of
assistance by volunteer organizations and the management of plans for
this activity by well-meaning groups. To address this problem, a
series of meetings is planned between members of the Center for Disease
Control, the Office of the Secretary and volunteer groups to determine
how to generate, coordinate, and maximize participation by volunteer
agencies. The first Departmental meeting to formally address this matter
is scheduled for Thursday, May 6, 1976.
/s/David Mathews
Secretary
Enclosure
FORD is LIBRARY GERALD
Cannon FYI
THE WHITE HOUSE
INFORMATION
WASHINGTON
May 6, 1976
MEMORANDUM FOR THE PRESIDENT
FROM:
JIM CANNON
SUBJECT:
Influenza Immunization Program Report
Attached is the second in a series of Biweekly Reports on
the National Influenza Immunization Program by HEW
Secretary David Mathews.
HEALTH EDUCATION
AND
THE SECRETARY OF HEALTH. EDUCATION, AND WELFARE
DEPARTMENT
WASHINGTON, D.C: 20201
DEPART
MAY 5 1976
MEMORANDUM FOR THE PRESIDENT
I am submitting here the second in a series of Biweekly Reports on the
National Influenza Immunization Program. It indicates our progress and
problems in achieving essential program goals and timetable targets as
requested in your memorandum on April 6.
Four major goals have been achieved since our last Biweekly Report of
April 12, 1976.
First, on April 15, you signed H.R. Res. 890, Emergency Supplemental
Appropriations for Preventive Services, which contained a $135 million
appropriation for the National Influenza Immunization Program.
Subsequently, during the same week, 24,000 doses of A/New Jersey/76
(the technical and preferred name for swine influenza-type vaccine)
were provided to the Bureau of Biologics of the Food and Drug Administration
for laboratory testing and verification of purity and quality.
On April 21, clinical trials began involving the participation of 3,000
volunteers in an effort to document reactivity, efficacy, and potency
and to determine the dosage of vaccine which is adequate for immunization
against the A/New Jersey/76 virus.
GERAM FORD LIBRARY
Recently, Immunization Program Guidelines for Grant Applications were
sent to State and Regional Offices and contacts with State and other
health officers have been firmly established by the Center for Disease
Control to insure rapid exchange of technical and administrative in-
formation.
The problems of the moment are confined to three areas.
First, legal concerns consisting of potential tort liability and possible
antitrust violations have not been formally resolved between vaccine
manufacturers and the Department. The General Counsel of DHEW, however,
along with members of the Antitrust Division of the Department of Justice
have met with legal representatives of the four vaccine manufacturers and
have taken steps that promise to resolve these issues effectively.
MEMORANDUM FOR THE PRESIDENT
2.
A major unresolved question still exists. That is, whether the United
States should consider sharing, in view of uncertain and possibly
limited vaccine, our A/New Jersey/76 (swine influenza-type) vaccine
with other countries, and on what basis should we determine. our position
vis-a-vis Canada, Mexico, and the rest of the world. We have reached a
preliminary decision as to how to proceed in this matter and it is the
subject of an accompanying memorandum. Presently, the Assistant Secretary
for Health is in regular contact with Dr. Alex Morrison, Deputy Minister
of Health for Canada, regarding our status on the question of vaccine
availability and our ability to assist them in meeting their needs.
A final potential problem relates to the coordination of offers of
assistance by volunteer organizations and the management of plans for
this activity by well-meaning groups. To address this problem, a
series of meetings is planned between members of the Center for Disease
Control, the Office of the Secretary and volunteer groups to determine
how to generate, coordinate, and maximize participation by volunteer
agencies. The first Departmental meeting to formally address this matter
is scheduled for Thursday, May 6, 1976.
Secretary
Enclosure
THE WHITE HOUSE
WASHINGTON
May 12, 1976
MEMORANDUM FOR
THE SECRETARY OF HEALTH, EDUCATION, AND WELFARE
The purpose of this memorandum is to clarify the
requirements for the President's bi-weekly status
report on the National Influenza Immunization Program.
In order to reduce confusion over the due date of the
report, the report will be due on the 1st and 15th
of every month. In addition, certain format
requirements are necessary in order to coordinate
the informational needs and activities of the
Domestic Council and OMB, as indicated in the
President's original communication.
The report should include a brief outline summary
of accomplishments, as well as identification of
problems and actions taken to resolve problems.
Also, the charts developed that express quantifiable
targets for the Federal effort, State and local
efforts, and industrial efforts, should be included.
Thank you very much.
H. angh
THE WHITE HOUSE
WASHINGTON
May 5, 1976
MEMORANDUM TO:
JIM CAVANAUGH
Sel
FROM:
SPENCER JOHNSON
SUBJECT:
DHEW Secretary Bi-weekly Influenza
Program Status Report.
Attached is a draft memorandum for your signature to the
Secretary defining the contents of the bi-weekly report
to the President.
First, in order to avoid due date confusion and slippage,
I suggest that we require the report on the 1st and 15th
of every month. Also, in order to solve the format dispute
and fulfill the necessary informational requirements I
propose that the report be in three parts:
A.
A summary memorandum by the Secretary to the
President,
B.
An outline of accomplishments, problems and actions,
and;
C.
The inclusion charts that OMB developed for the
program.
Samples are attached.
Tab A Draft memorandum to the Secretary.
Tab B Sample summary of accomplishments, problems
and actions.
Tab C Sample OMB target charts.
A
A
B
MEMORANDUM
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
OFFICE OF THE SECRETARY
DRAFT
TO
: The President
FROM
:
The Secretary
SUBJECT: Biweekly Status Report on the National Influenza Immunization
Program (NIIP), for the Period Ending April 30, 1976
ACCOMPLISHMENTS
1. The President signed H.J. Res. 890, Emergency Supplemental Appropriations
for Preventive Services, which contained the $135 million appropriation
for NIIP, April 15, 1976.
2. 24,000 doses of vaccine were provided to the Bureau of Biologics of FDA
for laboratory testing for purity and quality.
3. Clinical trials were launched on April 21, 1976, involving 3,000
volunteers to document reactivity, efficacy, potency and dosage of vaccine
adequate for immunization against A/New Jersey/76 (swine influenza-type)
virus.
4. Immunization Program Guidelines for grant applications have been sent to
state and regional offices, April 14, 1976.
5. Contacts with state and other health officers were established for
continuing information and technical exchange.
PROBLEMS
1. Legal problems of vaccine manufacturers.
2. International aspects of NIIP.
3. Coordination of offers of assistance and plans of activity by volunteer
organizations.
ACTIONS TAKEN TO RESOLVE PROBLEMS
1. General Counsel of HEW along with members of Anti-trust Division of the
Department of Justice have met with legal representatives of the four
vaccine manufacturers and have taken steps to resolve the issues that
relate to potential tort liability and possible antitrust violations.
2. The Assistant Secretary for Health has been in regular communication
with Dr. Alex Morrison, Deputy Minister of Health of Canada, regarding
vaccine availability.
3. A series of meetings is planned between the Center for Disease Control,
the Office of the Secretary, and volunteer groups to determine how to
generate, coordinate, and maximize participation by volunteer agencies.
FORD
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MEMORANDUM
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
PUBLIC HEALTH SERVICE
CENTER FOR DISEASE CONTROL
:
Special Assistant to
DATE: April 30, 1976
The Assistant Secretary for Health
: Director
Center for Disease Control
SUBJECT: Biweekly Status Report on Nationwide Influenza Immunization Program
Enclosed is the biweekly status report on the National Influenza
Immunization Program and three copies of the Program Guidelines for
influenza immunization project grants.
The biweekly status report provides projected target information for
CDC, Bureau of Biologics (FDA), NIAID, and industry. Dr. George
Galazzo, Chief, Infectious Disease Branch, and Mr. Lawrence Stern,
Executive Officer, will provide the information necessary for comple-
tion of the report from NIAID and BOB, respectively. Dr. Galazzo
has requested the "number of contractual actions" be reduced from-
20 to 16 to reflect what currently appears to be a more accurate
and realistic figure.
Accomplishments noted since our preliminary status report of April 26
are: (1) Initiation of clinical testing of pilot lots at George
Washington University Medical School; (2) verbal approval from OMB
regarding waiver of A-95 review and comment procedures relative to
influenza immunization projects grants (A-95 Clearinghouses will be
notified of grant awards, but pre-award reviews will be waived); and
(3) bids to supply jet injector guns have been received and are
currently being evaluated. We anticipate that contracts will be
awarded next week.
for
William David J. Sencer,
Assistant Surgeon General
Enclosures
NEW on.
5 pages
4/30/76
Please hardcopy to Dr. Merivether
7A
Hardcopy No. -447-5436
FEDERAL EFFORT
FDA
NIH
NO. OF LOTS OF
NO. OF CONTRACTUAL
NO. OF EMPLOYEES
VACCINE CERTIFIED
NO. OF EMPLOYEES
ACTIONS
BIWEEKLY
DATES
ON TARGET
ON TARGET
ON TARGET
ON TARGET
TARGET I
TARGET
TARGET
TARGET
YES
NO
YES:
NO
YESI
NO
YES
NO.
APRIL 30
1
X
MAY 14
3
1
MAY 28
4
1
JUNE 11
5
1
7
JUNE 25
2
2
3
JULY 9
2
32
3
3
JULY 23
2
80
1
AUG. 6
1
80
1
AUG. 20
80
SEPT. 3
80
1
1
SEPT. 17
64
OCT. 1
48
OCT. 15
48
OCT. 29
48
NOV. 12
48
NOV. 26
22
16
TOTAL
20
630
9
RR
CDC 0.754
4.76
FEDERAL EFFORT
CDC
NO. OF DOSES OF
APPROVAL OF STATE
VACCINE CONTRACT
VACCINE PURCHASED
PLANS AND AWARD OF
NO. OF EMPLOYEES
BIWEEKLY
AWARDS
AND DISTRIBUTED
GRANTS TO STATES
DATES
ON TARGET
ON TARGET
ON TARGET
ON TARGET
TARGET
TARGET
TARGET
TARGET
YES
NO
YES
NOI
YES
NO:
YES
NO
APRIL 30
MAY 14
MAY 28
4
32
8
JUNE 11
30
5
JUNE 25
10
JULY 9
8,000,000
16
JULY 23
5
AUG. 6
AUG. 20
SEPT. 3
120,000,000
SEPT. 17
OCT. 1
OCT. 15
OCT. 29
200,000,000
NOV. 12
NOV. 26
TOTAL
4
200,000,000
62
44
CDC 0.754
4-76
STATE AND LOCAL EFFORTS
NO. OF DOSES
NO. OF STATE
NO. OF PEOPLE
OF VACCINE
IMMUNIZED
BIWEEKLY
PLANS SUBMITTED
DISTRIBUTED
DATES
ON TARGET
ON TARGET
ON TARGET
TARGET
TARGET
TARGET
YES,
NO.
YES
NO
YES
NO
APRIL 30
MAY 14
32
MAY 28
30
JUNE 11
JUNE 25
JULY 9
8,000,000
4,000,000
JULY 23
AUG. 6
AUG. 20
SEPT. 2
SEPT. 17
120,000,000
75,000,000
OCT. 1
OCT. 15
OCT. 20
NOV. 12
200,000,000
NOV. 26
200,000,000
TOTAL
62
200,000,000
200,000,000
INDUSTRY REPORT
JET INJECTOR GUNS
VACCINE PRODUCTION
DELIVERED
BIWEEKLY
DATES
ON TARGET
ON TARGET
TARGET
TARGET:
YES
NO
YES
NO
APRIL 30
MAY 14
MAY 28
JUNE 11
600
JUNE 25
JULY 9
8,000,000
600
JULY 23
AUG. 6
800
AUG. 20
SEPT. 3
120,000,000
SEPT. 17
OCT. 1
OCT. 15
OCT. 29
200,000,000
NOV. 12
NOV. 26
TOTAL
200,000,000
2,000
CDC 0.754
4-76
THE WHITE HOUSE
WASHINGTON
May 25, 1976
MEMORANDUM FOR:
JIM CAVANAUGH
Sel
FROM:
SPENCE JOHNSON
SUBJECT:
The National Influenza Immunization
Program update.
The purpose of this memorandum is to outline several issues
that have arisen in the implementation of the President's
National Influenza Immunization Program.
1. Reporting Procedures and Management Practices
A problem still exists with the timeliness and format
of the bi-weekly reports. The May 15th report was not
received until May 20th. In addition, it did not
comply with the format described to the Secretary in
your recent memorandum. Also, in terms of management
practices, there appears to be an undue delay in
programatic decisions to be made by the Secretary.
For example, the delegation of authority to award
state program grants was delayed for one week
pending the Secretary's approval; and a recommendation
from the Secretary to the President on the question
of assistance to Canada and Mexico has been pending
since late March. No serious complications have
arisen yet, however, unless a mechanism is established
to rapidly respond to such decisions, a problem could
arise later in the program when there is shorter turn-
around time.
2. Seed Virus Error
It has been discovered that a lot of vaccine manufactured
by the Parke-Davis Company was at variance with the pro-
duction protocol. A team from CDC and FDA are at the
Parke-Davis facility to determine the extent of the problem.
Apparently the cause of this error is that the wrong
seed virus for the manufacture of the vaccine was
supplied to Parke-Davis. One unconfirmed estimate is
that 15 million doses may be involved. The doses pro-
duced would not represent any danger to those being
inoculated, however, they do not contain the appropriate
antibodies for the A/New Jersey/1976 strain, but rather
- 2 -
a strain isolated in the 1930's identified as
Swine Flu/1976.
3. Liability and Indemnity
Arrangements have been made by the General Counsel
of HEW, with concurrance of the legal representatives
of the four vaccine manufacturers, to relieve the pro-
ducers from liability for those parts of the immunization
program under government control. This was achieved by
inclusion of specific language in the purchase contracts.
Merrill National, the smallest of the producers, has
retained former Secretary of State William Rogers to
reopen this question with HEW. Mr. Rogers has indicated
that Merrill National wishes the government to assume
all risks connected with the manufacture of the vaccine
and further that they deem the assurances in the contract
language as insufficient. Unless their liability is limited
specifically by legislative action by the Congress, they
will withdraw from the program. The HEW General Counsel
and the Assistant Secretary for Health are meeting with
Secretary Mathews today to discuss alternative approaches
to this issue.
4. Liability of Health Professionals
Several questions have been raised by various health
professional organizations about the liability of
practitioners and allied health personnel in delivering
the vaccine. Because of the unusual nature of the program
these organizations feel that health professionals engaging
in the mass delivery of the vaccine should be held harm-
less from any liability. A meeting has been set for
June 3rd with various provider organizations to discuss
this issue. Also on June 4th, there will be meetings to
discuss inter-agency organization and volunteer efforts.
5. International Assistance
We are still waiting for a decision from Secretary Mathews
as to the best possible solution to the question of whether
or not we commit ourselves to share vaccine production with
Canada and Mexico. Our Ambassador in Canada has been con-
tacted several times by the Canadian Health Minister and
the State Department is anxious to formulate a response as
soon as possible, and they have circulated a draft telegram
- 3 -
for White House approval. (Copy attached). . It is my
understanding that this telegram was sent to Secretary
Mathews about two weeks ago for his concurrance and
was rejected.
I believe it is essential to convene a meeting of principals
to reassess our efforts in the program. I would suggest that
the meeting include and be limited to Secretary Mathews,
Assistant Secretary Cooper, and Paul O'Neill.
CC: Jim Cannon
Art Quern
1
THE WHITE HOUSE
WASHINGTON
DATE:
May 18, 1976
TO:
Spencer Johnson
FROM: JIM CAVANAUGH free
SUBJ:
FYI
FORD LIBRARY
ACTION
Julie To MR Covonayh, WH.
HAND DELIVER
LIMITED OFFICIAL USE
EUR/CAN: JHROUSE, DES/APT/BMP:WJHALSH III
22170 5/17/76
DES/APT:CHGANLEY
ARA:HARYAN
NSC:
WHITE HOUSE:
S/S:
0ES:FIRVINGISUBST)
PRIORITY
OTTAWA
OHC
E.O. 11652:
N/A
JHR/
TAGS:
TPHY, TBIO, OSCI, CA
HAR
SUBJECT:
SWINE FLU VACCINE
FOR THE AMBASSADOR
1. IN RESPONSE TO REQUEST OF CANADIAN MINISTER OF HEALTH
C
FOR U.S. ASSISTANCE IN MEETING CANADIAN NEEDS FOR SWINE
FLU VACCINE, YOU SHOULD RESPOND DRAWING FROM FOLLOWING
TALKING POINTS:
--PRESIDENT FORD HAS MADE A PUBLIC COMMITMENT TO
VACCINATE ALL AMERICANS THIS SEASON AGAINST SWINE FLU.
U.S. MUST BE SURE WE HAVE ADEQUATE SUPPLIES TO MEET THAT
COMMITMENT BEFORE UE CAN DETERMINE EXTENT TO WHICH WE WILL
BE ABLE TO ASSIST IN MEETING CANADA'S VACCINE NEEDS AND
REQUESTS FROM OTHER COUNTRIES.
--WE WILL NOT KNOW HOW MANY DOSES VACCINE PRODUCTION WILL
YIELD UNTIL CLINICAL TESTS 70 DETERMINE DOSAGE OF VACCINE
NECESSARY FOR EFFECTIVE IMMUNIZATION ARE COMPLETED.
THESE TESTS ARE NOW UNDERWAY. WIDE POSSIBLE VARIATION
IN STRENGTH OF DOSE NECESSARY FOR IMMUNIZATION MAKES EVEN
ROUGH PREDICTION OF TOTAL NEEDS IMPOSSIBLE AT THIS TIME.
WE EXPECT TEST RESULTS TO BE AVAILABLE AROUND MID-JUNE, AND
AT THAT POINT WE WILL BE ABLE TO DETERMINE AVAILABILITY
QUESTIONS.
LIMITED OFFICIAL USE
FORM DS 3224{0CR}
LIMITED OFFICIAL USE
2
QUESTIONS.
--THE UNITED STATES WILL DO EVERYTHING POSSIBLE WITHIN ITS
MANUFACTURING CAPABILITY TO MAKE THE A/NEW JERSEY/76
STRAIN VACCINE AVAILABLE FOR PURCHASE FOR HIGH RISK
POPULATIONS IN THE NORTH AMERICAN EPIDEMIOLOGIC REGION.
--ONCE SUFFICIENT SUPPLIES ARE ASSURED TO MEET THE U.S.
DEMAND FOR VACCINE, THE HIGH RISK POPULATIONS IN CANADA
AND MEXICO WILL RECEIVE FIRST PRIORITY IN HAVING THE
VACCINE MADE AVAILABLE TO THEM. FYI: MEXICO HAS NOT YET
REQUESTED VACCINE SUPPORT BUT SHOULD IT DO so WE WILL
TREAT SUCH A REQUEST PARALLEL TO THAT OF CANADA- AS THE
MEDICAL CONSIDERATIONS WITHIN THE WHOLE NORTH AMERICAN
EPIDEMIOLOGICAL REGION ARE NOT DISTINGUISHABLE AS TO
RISK OR SEVERITY. END FYI.
--SHOULD U.S. DETERIMINE THAT VACCINE IS AVAILABLE, WE
WILL WORK CLOSELY WITH GOC TO MAKE SUPPLIES AVAILABLE TO
CANADIAN HIGH-RISK POPULATION AS EARLY AS POSSIBLE. WE
WOULD EXPECT TO BE ABLE TO BEGIN TO SUPPLY VACCINE TO
CANADA ONCE U.S. NEEDS ARE ASSURED AND WHILE OUR OWN INOC-
ULATION PROGRAM IS UNDERWAY.
--WE SUGGEST THAT CONCERNED OFFICIALS ON BOTH SIDES GET
TOGETHER SOON TO DISCUSS DETAILS OF CANADIAN AND U.S.
PROGRAMS IN ORDER TO PREPARE AS FULLY AS PSS
PROGRAMS IN ORDER TO PREPARE AS FULLY AS POSSIBLE TO
PUT COOPERATIVE EFFORT INTO PLACE WITHOUT DELAY SHOULD
FAVORABLE SUPPLY DETERMINATION BE MADE. YY
FORD.
&
GERALD
LIBRARY
LIMITED OFFICIAL USE