108th Congress

Emergency Flu Response Act of 2004

S. 2968, H.R. 5409

Background

Concerns about the adequacy of annual influenza vaccine supplies are longstanding. In October 2004, however, news that one of two manufacturers of the annual influenza vaccine would not be able to fulfill its production quota due to contamination problems angered Congress and sent public health officials scrambling to find alternative sources of the vaccine. Public health agencies, doctors’ offices, and grocery stores cancelled their planned influenza vaccination clinics, and senior citizens and others waited for hours in long lines to receive the few available vaccinations. As a result, a number of congressional hearings were held, and several bills were introduced that addressed supply shortages, incentives to manufacturers, and related issues.

Two of these bills, S. 2968 and H.R. 5409, the Emergency Flu Response Act of 2004, contained provisions relevant to National Institutes of Health (NIH) research activities. H.R. 5409 would have provided authorization for the declaration of a public health emergency and emergency access to the influenza vaccine from countries that are members of the European Union, the purchase of qualifying vaccine products, grants to States to develop and implement influenza vaccine shortage plans, the monitoring of the Nation’s influenza vaccine supply, and the overall enhancement of existing countermeasures against influenza.

Provisions of the Legislation/Impact on NIH

Section 2148 of the bills would have required the Secretary of Health and Human Services, acting through the Director of NIH, to conduct a clinical trial or trials to determine whether the existing influenza vaccine could be diluted to expand the available supply while maintaining its efficacy in preventing influenza in individuals identified as being at the highest priority to receive the vaccine. Preliminary studies supported by the National Institute of Allergy and Infectious Diseases have indicated that the vaccine’s efficacy may still be maintained if the current influenza vaccine were diluted. Those data and data from future studies may be useful in addressing a future influenza vaccine shortage. The bills would have authorized such sums as may be necessary for fiscal year 2005 to carry out those activities.

Status and Outlook

S. 2968 was introduced by Senator Jack Reed (D-RI) on October 8, 2004, and was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action occurred on this legislation during the 108th Congress.

H.R. 5409 was introduced by Representative Nita M. Lowey (D-NY) on November 17, 2004, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 108th Congress.