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Notice to Readers: Supplemental Recommendations About the Timing
of Influenza Vaccination, 2004--05 Season
In early August 2004, discussion with the Food and Drug Administration (FDA) and influenza vaccine
manufacturers indicated that production of vaccine for the 2004--05 influenza season was proceeding satisfactorily. However, on August 26, Chiron Corporation announced that, in conducting final internal release procedures for its inactivated influenza
vaccine, Fluvirin®, the company's quality-assurance systems had identified a small number of lots that did not meet product sterility specifications; these lots will not be distributed. In recent discussions with CDC, the company stated that laboratory
testing determined the problem was localized. After the company completes its quality-assurance testing, all remaining lots that have met sterility specifications will be available for distribution. Chiron expects to distribute 46--48 million doses during this influenza season, with 42--44 million doses distributed in October and the remaining doses distributed in early
November. Total influenza-vaccine production from all manufacturers who will supply the U.S. market during the 2004--05 influenza season is estimated at 100 million doses, which is approximately 13 million more doses than was produced for the 2003--04 influenza season.
CDC is recommending that influenza vaccination proceed for all recommended persons as soon as vaccine is
available, recognizing that availability might be limited in early October. Some delay might occur for customers
receiving influenza-vaccine doses purchased from Chiron, which might result in a need to reschedule planned clinics and other vaccination campaigns. The optimal time to vaccinate against influenza is October and November, and the Advisory Committee
on Immunization Practices (ACIP) recommends that persons planning substantial organized vaccination campaigns
consider scheduling those events after mid-October because availability of vaccine in any one location cannot be ensured consistently
in early fall. Aventis Pasteur, Inc. expects to distribute approximately 52 million doses of inactivated influenza vaccine (Fluzone®) this season. MedImmune Vaccines, Inc., expects to distribute approximately 1.5 million doses of live attenuated influenza vaccine (FluMist). No delays in the timing of distribution of vaccine from these two manufacturers of influenza vaccine are expected.
The annual preseason assessment of each year's projected vaccine supply was requested by ACIP to help address
vaccine shortages first experienced in 2000. The committee recommended that mass vaccination campaigns for the 2000--01 season be delayed until the availability of supply was ensured
(1,2). ACIP issued similar recommendations for the
2001--02 influenza season (3) and incorporated into its annual influenza recommendations the possible use of prioritized timing of
vaccine administration when necessary because of vaccine shortages or delays
(4). No delays occurred in vaccination campaigns
during either the 2002--03 or the 2003--04
(5) seasons.
CDC also will purchase 4.5 million doses of inactivated influenza vaccine, which will be held in a stockpile to
ensure sufficient supply in the event of increased demand like that experienced last winter. CDC has legislative authority through
the Vaccines for Children program to purchase influenza vaccine for a national stockpile program for children aged
<18 years. Additional information about influenza and influenza vaccination is available from CDC at
http://www.cdc.gov.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of
Health and Human Services.References to non-CDC sites on the Internet are
provided as a service to MMWR readers and do not constitute or imply
endorsement of these organizations or their programs by CDC or the U.S.
Department of Health and Human Services. CDC is not responsible for the content
of pages found at these sites. URL addresses listed in MMWR were current as of
the date of publication.
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