The decision to vaccinate the United States against swine influenza was taken on paper before it was taken anywhere else, and the paper survives: nine typed pages, headed “Swine Influenza–ACTION,” addressed from the Assistant Secretary for Health to the Secretary of Health, Education, and Welfare, with the line “Prepared by: CDC, SENCER, 3/13/76” at the foot. It went up through the Office of Management and Budget to the President as Attachment B to his briefing for the meeting of 22 March, and the Gerald R. Ford Presidential Library has scanned that copy from the White House central files. Neustadt and Fineberg, who printed it in their 1978 report, said it was “worth reading in full.” This piece follows it in its own order, with the Budget Office’s one-page list of doubts, Attachment A, at the end.

Issue

The memorandum begins with a single question: “How should the Federal Government respond to the influenza problem caused by a new virus?” The word “problem” is doing work. The question is not whether to respond.

Facts

Seven numbered facts follow.

The first names the virus: “In February 1976 a new strain of influenza virus, designated as influenza A/New Jersey/76 (Hsw1N1), was isolated from an outbreak of disease among recruits in training at Fort Dix, New Jersey.”

The second supplies 1918: “The virus is antigenically related to the influenza virus which has been implicated as the cause of the 1918-1919 pandemic which killed 450,000 people–more than 400 of every 100,000 Americans.” Neustadt and Fineberg observed that officials at the CDC later complained of the “overemphasis on 1918” at the Secretary’s level and the White House, and that “here is where it began.” The figure, 450,000, is lower than the 548,000 the President would use eleven days later and the 543,000 of the White House fact sheet; Ford’s own briefing paper used 500,000.

The third: “The entire U.S. population under the age of 50 is probably susceptible to this new strain.” The fourth explains why: before 1930 the strain “was the predominate cause of human influenza in the U.S.,” and since then it had been confined to pigs “with only occasional transmission from swine to man–with no secondary person-to-person transmission.”

The fifth and sixth give the cost of ordinary and extraordinary years. In an average year influenza “causes about 17,000 deaths (9 per 100,000 population) and costs the nation approximately $500 million.” “Severe epidemics, or pandemics, of influenza occur at approximately 10 year intervals. In 1968-69, influenza struck 20 percent of our population, causing more than 33,000 deaths (14 per 100,000) and cost an estimated $3.2 billion.”

The seventh is the hinge: “A vaccine to protect against swine influenza can be developed before the next flu season; however, the production of large quantities would require extraordinary efforts by drug manufacturers.”

Assumptions

Eight assumptions come next, and the first converts the facts into a forecast. “Although there has been only one outbreak of A/swine influenza, person-to-person spread has been proven and additional outbreaks cannot be ruled out. Present evidence and past experience indicate a strong possibility that this country will experience widespread A/swine influenza in 1976-77. Swine flu represents a major antigenic shift from recent viruses and the population under 50 is almost universally susceptible. These are the ingredients for a pandemic.”

The second rules out the usual answer: vaccinating the elderly and the chronically ill “would not forestall a flu pandemic. Routine actions would have to be supplemented.”

The third sets the clock. “The situation is one of ‘go or no go’. If extraordinary measures are to be undertaken there is barely enough time to assure adequate vaccine production and to mobilize the nation’s health care delivery system. Any extensive immunization program would have to be in full scale operation by the beginning of September and should not last beyond the end of November 1976. A decision must be made now.”

The fourth sets the target, and it is the sentence from which every later promise descended. “There is no medical epidemiologic basis for excluding any part of the population–swine flu vaccine will be recommended for the total population except in individual cases. Similarly there is no public health or epidemiologic rationale for narrowing down the targeted population. Further, it is assumed that it would be socially and politically unacceptable to plan for less than 100 percent coverage. Therefore, it is assumed that any recommendations for action must be directed toward the goal of immunizing 213 million people in three months (September through November 1976). The nation has never attempted an immunization program of such scope and intensity.” Neustadt and Fineberg note that Sencer afterwards “still is seething about Ford and Cooper who were soon to make exaggerated pledges of vaccine for everybody. But the drafters of their statements were following his lead.”

The fifth: nothing of this size “can succeed without Federal leadership, sponsorship, and some level of financial support.” The sixth prices the vaccine at “around 50 cents per dose,” in excess of $100 million for the nation, with delivery, surveillance and monitoring on top, and concedes that “it will be extremely difficult to estimate the amount of additional costs that will result from a crash influenza immunization program.” The seventh promises that the Advisory Committee on Immunization Practices “will recommend formally and publicly, the immunization of the total U.S. population.” The eighth lists what any course other than no action must assure: enough vaccine for everyone, vaccine at the points of delivery, public awareness, a population that reaches or is reached by the health system, surveillance “for complications of vaccination, for influenza morbidity and mortality, and for vaccine effectiveness and efficacy,” research, and evaluation.

Four alternatives

The memorandum then offers four courses, each with its pros and cons. Neustadt and Fineberg called this “a common sort in government, three framed to be rejected by the reader, with the fourth the one desired by the writer.”

No Action. The market would prevail, the pandemic “might not occur and the Department would have avoided unnecessary health expenditures,” and “any real action would require direct Federal intervention which is contrary to current administration philosophy.” Against: “Congress, the media, and the American people will expect some action.” “The Administration can tolerate unnecessary health expenditures better than unnecessary death and illness, particularly if a flu pandemic should occur.” “In all likelihood, Congress will act on its own initiative.”

Minimum Response. The government would advise industry to make vaccine for everyone and promise to buy it for the 58 million federal beneficiaries; a public awareness campaign; community programmes; CDC surveillance; NIH research. Cost “would not exceed $40 million.” Against: “There is little assurance that vaccine manufacturers will undertake the massive production effort”; “the poor, the near poor, and the aging usually get left out. Even under routine flu recommendations in which the elderly are a primary target, only about half the high risk population gets immunized against flu.” And: “Probably only about half the population would get immunized.”

Government Program. Federal purchase of up to 200 million doses, distribution only through state health departments, “intensive, high volume immunization techniques and procedures–particularly the use of jet-injector guns,” and “temporary employment of unemployed workers, high school and college students, housewives, and retired people as outreach workers.” Cost: $190 million. Against: “A totally ‘public’ program is contrary to the spirit and custom of health care delivery in this country.”

Combined Approach. The federal government for “technical leadership and coordination, and its purchase power”; the states “as logical distribution centers”; the private sector “for its medical and other resources which must be mobilized.” The Public Health Service would contract for 200 million doses “at no cost through State health agencies”; the states would plan; mass immunization “where appropriate” and every existing delivery point otherwise. Among the pros, the last: “Undertaking the program in this manner provides a practical, contemporary example of government, industry, and private citizens cooperating to serve a common cause–an ideal way to celebrate the nation’s 200th birthday.” Among the cons: “A supplemental request of approximately $134 million would be needed,” and “the greatest possibility of some people being needlessly reimmunized.”

Discussion and recommendation

The discussion is where the memorandum argues with its own department. “We have not undertaken a health program of this scope and intensity before in our history. There are no precedents, nor mechanisms in place that are suited to an endeavor of this magnitude. Given this situation, can we afford the administrative and programmatic inflexibility that would result from normal considerations about duplicative costs, third party reimbursements, and Federal-State or public-private relationships and responsibilities? The magnitude of the challenge suggests that the Department must either be willing to take extraordinary steps or be willing to accept an approach to the problem that cannot succeed.”

The recommendation is alternative four, “the most likely to succeed–more people would be protected.” The request: “approximately $134 million made up as follows: Immunization Programs (vaccines, supplies, temporary personnel, awareness) $126 million; Surveillance and Research 8 million.” On authority, the memorandum thought Section 311(a) of the Public Health Service Act would do, and if not, “point of order” language in the appropriation.

Attachment A

The Office of Management and Budget put one page of its own in front of the memorandum for the President: “Uncertainties Surrounding a Federal Mass Swine Influenza Immunization Program.” Neustadt and Fineberg thought it “not a very arresting list,” and that Cooper “made short work of it” in the meeting. Read now, it asks most of the questions the year would answer.

On the evidence: “Person-to-person transmission of the swine virus has been proven in only one location, Fort Dix in New Jersey. Further scientific evidence on the probability of an occurrence of swine flu virus next year may or may not become available before the current flu season is over. HEW epidemiologists have stated that the probability is ‘unknown.’” On the vaccine: it “will have no effect whatever on preventing these more conventional flus,” and “there remains a possibility that mutated swine virus may occur–against which the vaccine to be developed would not be effective.” On severity: the toll “may not be analogous to the 1919 experience of 500,000 deaths because of the absence in 1919 of antibiotics.” On precedent: “Will it be necessary to mount another massive Federal effort in each succeeding year (1) if the swine influenza epidemic does not occur in the winter of 1976/1977 or (2) in order to protect every American against mutating versions of swine virus?” And on dissent: “HEW is now in the process of trying to obtain consensus from all important members of the virology scientific community on the advisability of a nationwide immunization drive against the swine flu virus. Nevertheless, what is the contrary virology argument against the massive immunizations?”

The briefing’s talking points for the President asked Mathews three things: what swine influenza is and how it differs from other flu in severity; “What is the probability of an occurrence of an epidemic in the winter of 1976-1977, given the 10-year cycle of epidemics”; and why the very same virus found in New Jersey, rather than a mutant or another virus, would cause a nationwide epidemic. There is no record that the second was answered with a number.

Sources

• “Swine Influenza–ACTION,” memorandum from the Assistant Secretary for Health to the Secretary, prepared by David Sencer, 13 March 1976; James Lynn’s briefing paper for the “Swine Influenza Program Meeting” of Monday 22 March 1976, 11:00 to 11:30 a.m., the Cabinet Room, with Attachment A, “Uncertainties Surrounding a Federal Mass Swine Influenza Immunization Program,” and Attachment B, the memorandum. White House Central Files, Subject File HE 1, Gerald R. Ford Presidential Library. fordlibrarymuseum.gov
• Richard E. Neustadt and Harvey V. Fineberg, The Swine Flu Affair: Decision-Making on a Slippery Disease, U.S. Department of Health, Education, and Welfare, 1978, chapter 2, “Sencer Decides,” and chapter 4, “Ford Announces,” for the memorandum’s reception and the OMB attachment. archive.org
• White House fact sheet, “Swine Influenza Immunization Program,” 24 March 1976, for the 543,000, and Gerald R. Ford, “Remarks Announcing the National Swine Flu Immunization Program,” 24 March 1976, for the 548,000. fact sheet, remarks