Press Release

Flu Season 2000-01

FLU VACCINE SUPPLY

The Department of Health and Human Services' Food and Drug Administration and CDC are working closely with vaccine manufacturers to facilitate the availability of safe and effective influenza vaccine for the upcoming flu season. Influenza vaccine manufacturers have told FDA and CDC to expect delays in flu vaccine shipments and that it is possible there will be reductions of available influenza virus vaccine for the 2000-01 season.

The FDA and CDC today briefed the Advisory Committee on Immunization Practices (ACIP) about the current situation regarding influenza vaccine supply. The FDA and CDC stressed to the ACIP that the situation is very fluid and that health care providers should expect periodic updates from them through the summer and fall.

ACIP, in a consensus recommendation, urged health care providers to begin thinking now about delaying adult mass influenza vaccination campaigns to November (usually recommended for October through mid-November) based on supply availability, and to consider ways to ensure their high risk patients receive vaccination if a severe vaccine shortfall were to occur.

The total amount of vaccine available for the influenza season is uncertain at this time; however, both FDA and CDC are actively working with manufacturers to determine how much and when vaccine will be available. The amount of available flu vaccine will become more clear within the next two months.

Many potential flu vaccine providers, including health care offices, hospitals, health care organizations, nursing homes and other organizations, who are currently in the midst of preparing for their fall and winter influenza vaccination efforts, need this information at this time to adequately prepare for the upcoming season. Persons who normally receive influenza vaccine should not be concerned and should delay inquiries about flu vaccination until the fall.

• It is important to stress that FDA, CDC and vaccine manufacturers are confident that vaccine will be available to vaccinate those at highest risk of complications from influenza, including those over 65, those who are immunosuppressed and others.

• The amount of vaccine available is complicated by two important factors: 1) the yield for this year's influenza vaccine A(H3N2) component appears to be lower than expected which limits the supply that can be developed in time for this flu season and, 2) other manufacturing issues. Manufacturers are working closely with the FDA to address these issues.

• If a substantial shortfall of vaccine were to occur, the ACIP and CDC would provide modified recommendations for the 2000-2001 influenza season that emphasize vaccinating persons at highest risk of death from influenza (and the health care workers who take care of them) and then vaccinating, as the vaccine supply allows, the other groups for whom vaccine is traditionally recommended.

• Currently, four antiviral drugs are approved by FDA to treat acute, uncomplicated influenza. These drugs are not a substitute for influenza vaccine and should not be used as such. The annual use of influenza vaccine is the primary means for minimizing adverse outcomes from influenza virus infections.

• Over the course of the summer and the influenza season new information is expected to become available, and CDC and FDA will issue information updates. If a shortfall does occur, ACIP and CDC request that persons and organizations administering influenza vaccine join in voluntary efforts to ensure that influenza vaccine is administered first to the persons most likely to develop serious and life threatening complications from influenza.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES