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