Preventive Health Services Public Health Service Act, Sections 301, 311, 317, and 318 1/ The purpose of the Influenza Vaccination program is to assist States and localities in carrying out immunization programs against influenza. This program is designed to reduce morbidity and mortality among persons who are particularly vulnerable to the serious complications of influenza because of advancing age or the presence of chronic illnesses. The proposal is based on the recommendations of the Conference on Influenza A/USSR/77 (H1N1), held on January 30, 1978, and was prepared after consultation with State and Territorial health officials and a variety of technical advisors. 1978 Budget Policy The 1978 supplemental is designed to increase influenza immunization levels of the high risk target group. Major aspects of the program are: 1. A project grant program administered by the Center for 1/ Sections 301 and 311 of the Public Health Service Act provide indefinite authority for the $4.1 million direct Federal program; section 318 permits funds appropriated to be used by the Secretary for grants to support programs authorized by section 317. 2. 3. 4. Vaccine will be made available in the same manner as under the childhood immunization program; Increased immunization coverage among high risk persons Establishment of an influenza immunization capability Target groups for vaccination continue to be comprised of those persons at greatest risk of dying from influenza. While prevention of disease per se is worthwhile and possibly cost beneficial, it is considered that the influenza vaccine production and distribution system cannot respond to such a program, nor would the general public find it valuable at this time. The high risk target groups which will receive first attention are: 1. 2. 3. Persons age 6 months through 24 years who have under- Persons age 25 through 64 years who have underlying Persons age 65 and over with or without known chronic Actions taken this year are planned as part of a long-range strategy for increasing the number of persons vaccinated annually. The decision in favor of a phased program reflects the particular circumstances of the reappearance of H1N1 influenza viruses. While the severity of influenza A/USSR/77 cannot be predicted with certainty, the reappearance of this type of influenza virus after an absence of only 20 years is a cause for considerable concern. Reasonable goals for vaccination coverage of high risk groups must take into account a variety of factors, including that, with few exceptions, there are few public influenza programs in place at the present time. Prior to 1976, an average of only about 20 percent of high risk persons received influenza vaccine in any given year, virtually all through the private medical sector. Public programs supported by this supplemental can reasonably match this effort in 1978. It is unlikely that this goal can be exceeded during the first year of federallyassisted State efforts without establishing crash programs and without sacrificing other essential activities, notably childhood immunizations. It is assumed that enough vaccine to raise vaccination coverage of high risk groups to at least 40 percent can be produced, and that a decision by the Federal Government to assist States in establishing programs in 1978 will create adequate market forces to prompt this level of production by the pharmaceutical industry. In the future, when annual immunization programs are well established, the proportion of high risk persons who receive annual immunization can be increased to 60-70 percent. Grant assistance to States and communities will be directed toward the following target groups: 1/ Assumes Federal share of two-thirds of program costs. Grants will provide assistance to States and communities for the organization and conduct of public influenza immunization programs. These grant funds will be used for the purchase of vaccine, to assure accessibility of immunization services to the target population, for increased epidemiologic and laboratory surveillance of influenza disease and vaccine reactions, and for informational and educational efforts. The Center will provide national leadership and technical assistance and consultation to between 60 and 65 State and local health agencies in planning, establishing, and conducting influenza immunization programs directed toward the high risk population. Informational and educational activities aimed toward the target, the medically high risk population, and health providers in both the public and private sectors will be required. Trained volunteers to assist in influenza immunization programs will be provided. The Center will be responsible for the national surveillance of influenza and the assessemnt of immunization delivery services. Additional reporting sites will be established to provide more accurate and timely disease surveillance data about influenza morbidity. More intensive outbreak investigation activities will be required to assure that the medically high risk population is being properly protected. Concurrent assessment of influenza immunization delivery services and childhood disease immunization delivery will be required to assure noninterference with the Administration's childhood immunization initiative. Studies will be initiated to measure morbidity and mortality and transmission patterns in large populations of children and/or adults who are partially immunized and the impact of influenza infection on the unimmunized segment of the population. Significant questions remain regarding the possible increased morbidity and mortality from influenza in pregnant women as well as adverse fetal outcomes as a result of influenza infection during gestation. The effects, if any, of influenza or immunization during gestation will be monitored in a suitably large population of pregnant females. Amantadine Rimantadine Prophylaxis for Influenza. These drugs have been demonstrated to be effective in prophylaxis of influenza disease although rimantadine is not yet licensed for use in this country. The relative effectiveness of these two compounds as well as their relative toxicities should be studied during outbreaks of influenza. Of particular importance would be the ability of these drugs to prevent hospital-acquired or nursing home resident spread of influenza illness. The threat of A/USSR/77 (H1N1) influenza creates an urgent need for the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health to conduct the clinical testing of vaccines. The clinical tests are needed to provide the information necessary for recommendations on dose size and schedules in clinical use of the vaccines. The trials will be aimed at developing maximally efficient dosages for each age/risk group and to determine antibody response levels in individuals previously experienced with this type of influenza virus or inexperienced because of being born since the H1N1 virus last circulated in 1956. The data are needed as soon as possible for manufacturers to be able to package and label the vaccines under Food and Drug Administration (Bureau of Biologics) direction. It will be necessary to fieldtest the vaccines in four different age/risk groups. This requires 2,700 volunteers who must be followed for 3 months for adverse reactions and 2 years for occurrence of influenza. The testing will be accomplished by providing supplemental funds to a network of institutions that already exist under contract to NIAID. It will take approximately 20 contracts to provide the necessary mix and number of volunteers to conduct the vaccine evaluation trials. The Food and Drug Administration (FDA) has responsibility for licensing vaccines. To meet the demands of the program it will be necessary to: 1. Increase the number of lots of vaccine tested and released. 2. Conduct clinical investigations to ascertain the appropriate 3. Support laboratory efforts required by vaccine clinical This supplemental includes 20 positions and $10,900,000 for influenza grants to States and 46 positions and $4,100,000 for in-house activities including 9 positions and $1,350,000 for NIAID and 7 positions and $450,000 for FDA. |