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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Influenza Virus Vaccine for the 2000-2001 Season

2000/2001 Season Lot Release Status (as of December 27, 2000)
Flu vaccine lots that have been released by FDA and are available for distribution by the manufacturers.

For information on flu vaccine distribution schedules, please contact the manufacturers directly.

Manufacturer Total Number of Lots Released by FDA
Fluzone
Aventis-Pasteur Inc.
(Connaught Laboratories, Inc.)
Discovery Drive
Swiftwater, PA 18370-0187
(800) 720-8972
fax: 888-889-7129
61
Fluvirin
Medeva Pharma Ltd.
Gaskill Road
Speke, Liverpool
United Kingdom L24 95D
(888) 963-3382
fax: (716) 272-3935 in the U.K.
011-44-49-46-6111
22
Flushield
Wyeth Laboratories, Inc.
Wasp and Biddle Streets
P.O. Box 354
Marietta, PA 17547-0354
(800) Flushield
(800) 358-7443
65

Delayed Distribution of Influenza Vaccine

Based on information received from manufacturers, the FDA currently estimates that the total number of doses of vaccine available for administration will ultimately be approximately 75 million doses in 2000-2001. This compares with approximately 74 million doses distributed in 1999-2000. While a major vaccine shortage has not occurred, and supplies of vaccine should ultimately be sufficient to allow vaccination of high-risk individuals, there will be delays in the distribution of the vaccine. In most years, the majority of flu vaccine is available by October. However, due to a variety of factors (see below), in 2000-2001, the majority of flu vaccine will likely become available considerably later, e.g., in November-December. As a result, temporary shortages could occur, depending on supply and demand.

Why the Delay

The delayed availability of influenza vaccine is due to lower than expected production yields of the new influenza A H3N2 strain for some of the vaccine manufacturers and manufacturing problems that occurred at two companies. The current estimated supply is based on the most recent information that FDA has received from the vaccine manufacturers and is potentially subject to change.

CDC Recommendations

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended that, as influenza vaccine becomes available, vaccination efforts should be focused on persons in the following groups at high risk of complications from influenza as well as their close contacts and health care workers:

  • Persons aged 65 years and older.
  • Residents of nursing homes and other chronic-care facilities with residents of any age who have chronic medical conditions.
  • Adults and children aged 6 months and older who have chronic pulmonary or cardiovascular disease, including asthma.
  • Adults and children aged 6 months and older who have required regular medical follow-up or hospitalization during the past year because of chronic metabolic diseases (including diabetes mellitus), kidney dysfunction, blood disorders (hemoglobinopathies), or immune system problems (immunocompromised, e.g., HIV infection, immunosuppressed by medication, chemotherapy or radiation therapy).
  • Children and teenagers (aged 6 months to 18 years) who are receiving long-term aspirin therapy and therefore might be at risk for developing Reye Syndrome after influenza infection.
  • Women who will be in the second or third trimester of pregnancy during the influenza season.

ACIP has also recommended that, to optimize the availability of vaccine to these high risk individuals, health care providers and other organizations delay the implementation of organized vaccination programs for non-high risk groups until November 2000 or later.

ACIP further recommends that vaccine providers continue to administer the vaccine after mid-November as additional supplies become available, and for as long as the influenza season continues, because the vaccine can still provide substantial protective benefits to high risk individuals and others.

Next Steps

The availability of influenza vaccine is a high priority for FDA. FDA will continue to work with the U.S. Department of Health and Human Services, CDC and ACIP, National Institutes of Health, other government agencies, vaccine manufacturers and private organizations to expedite vaccine availability wherever possible, to respond to the delays, and to communicate important information to the public.

 

For information on availability of influenza vaccine:

Food and Drug Administration
Center for Biologics Evaluation and Research (CBER)
Office of Communication, Training & Manufacturers Assistance
800-835-4709 or 301-827-1800
fax: 301-827-3843
octma@cber.fda.gov

For information on drugs used to treat influenza:

Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Drug Information Line
888-infoFDA or 301-827-4573
fax: 301-827-4577
druginfo@cder.fda.gov

For information on influenza prevention and control:

Centers for Disease Control and Prevention (CDC)
Public Inquiries Office
800-311-3435 or 404-639-3311
fax: 770-488-4995
inquiry@cdc.gov