On March 10, 1976, the Advisory Committee on Immunization Practices of the United States Public Health Service (ACIP) reviewed the findings. The committee concluded that with a new strain (the H1N1 New Jersey strain) that could be transmitted from person to person, a pandemic was a possibility. Specifically, the following facts were of concern: 1) persons <50 years of age had no antibodies to this new strain; 2) a current interpandemic strain (A/Victoria) of influenza was widely circulating; 3) this early detection of an outbreak caused by A/New Jersey/76/Hsw1N1 (H1N1) provided an opportunity to produce a vaccine since there was sufficient time between the initial isolates and the advent of an expected influenza season to produce vaccine. In the past when a new pandemic strain had been identified, there had not been enough time to manufacture vaccine on any large scale; 4) influenza vaccines had been used for years with demonstrated safety and efficacy when the currently circulating vaccine strain was incorporated; 5) the military vaccine formulation for years had included H1N1, an indication that production was possible, and no documented adverse effects had been described.
ACIP recommended that an immunization program be launched to prevent the effects of a possible pandemic. One ACIP member summarized the consensus by stating "If we believe in prevention, we have no alternative but to offer and urge the immunization of the population." One ACIP member expressed the view that the vaccine should be stockpiled, not given.
Making this decision carried an unusual urgency. The pharmaceutical industry had just finished manufacture of the vaccine to be used in the 1976–1977 influenza season. At that time, influenza vaccine was produced in fertilized hen's eggs from special flocks of hens. Roosters used for fertilizing the hens were still available; if they were slaughtered, as was customary, the industry could not resume production for several months.
On March 13, an action memo was presented to the Secretary of the Department of Health Education and Welfare (DHEW). It outlined the problem and presented 4 alternative courses of action. First was "business as usual," with the marketplace prevailing and the assumption that a pandemic might not occur. The second was a recommendation that the federal government embark on a major program to immunize a highly susceptible population. As a reason to adopt this plan of action, the memo stated that "the Administration can tolerate unnecessary health expenditures better than unnecessary death and illness if a pandemic should occur." The third proposed course of action was a minimal response, in which the federal government would contract for sufficient vaccine to provide for traditional federal beneficiaries—military personnel, Native Americans, and Medicare-eligible persons. The fourth alternative was a program that would represent an exclusively federal response without involvement of the states.
The proposal recommended by the director of CDC was the second course, namely, for the federal government to contract with private pharmaceutical companies to produce sufficient vaccine to permit the entire population to be immunized against H1N1. The federal government would make grants to state health departments to organize and conduct immunization programs. The federal government would provide vaccine to state health departments and private medical practices. Since influenza caused by A/Victoria was active worldwide, industry was asked to incorporate the swine flu into an A/Victoria product to be used for populations at high risk.
Before the discussions with the secretary of DHEW had been completed, a member of his staff sent a memo to a health policy advisor in the White House, raising the specter of the 1918 pandemic, which had been specifically underemphasized in the CDC presentation. CDC's presentation highlighted the pandemic potential, comparing it with the 1968–69 Hong Kong and 1957–58 Asian pandemics. President Gerald Ford's staff recommended that the president convene a large group of well-known and respected scientists (Albert Sabin and Jonas Salk had to be included) and public representatives to hear the government's proposal and make recommendations to the president about it. After the meeting, the president had a press conference, highlighted by the unique simultaneous appearance of Salk and Sabin. President Ford announced that he accepted the recommendations that CDC had originally made to the secretary of DHEW. The National Influenza Immunization Program (NIIP) was initiated.
The proposal was presented to 4 committees of the Congress, House and Senate authorization committees and House and Senate appropriation committees. All 4 committees reported out favorable legislation, and an appropriation bill was passed and signed.
The estimated budgeted cost of the program was $137 million. When Congress passed the appropriation, newspapers mischaracterized the cost as "$1.9 billion" because the $137 million was included as part of a $1.9 billion supplemental appropriation for the Department of Labor. In the minds of the public, this misconception prevailed.
Immediately after the congressional hearing, a meeting of all directors of state health departments and medical societies was held at CDC. The program was presented by CDC, and attendees were asked for comments. A representative from the New Jersey state health department opposed the plan; the Wisconsin state medical society opposed any federal involvement. Otherwise, state and local health departments approved the plan.
Within CDC, a unit charged with implementing the program, which reported to the director, was established. This unit, NIIP, had complete authority to draw upon any resources at CDC needed. NIIP was responsible for relations with state and local health departments (including administration of the grant program for state operations, technical advice to the procurement staff for vaccine, and warehousing and distribution of the vaccine to state health departments) and established a proactive system of surveillance for possible adverse effects of the influenza vaccines, the NIIP Surveillance Assessment Center (NIIP-SAC). (This innovative surveillance system would prove to be NIIP's Trojan horse.) In spite of the obstacles discussed below, NIIP administered a program that immunized 45 million in 10 weeks, which resulted in doubling the level of immunization for persons deemed to be at high risk, rapidly identifying adverse effects, and developing and administering an informed consent form for use in a community-based program.