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Influenza Vaccine Prebooking and Distribution Strategies for the 2005--06 Influenza Season

For the 2004--05 influenza season, CDC, in coordination with the Advisory Committee on Immunization Practices (ACIP), issued interim influenza vaccine use recommendations after Chiron Corporation announced that none of its inactivated influenza vaccine (Fluvirin®) would be available in the United States (1). To plan for the upcoming 2005--06 influenza season, CDC has met with influenza vaccine manufacturers, including those intending to apply for approval to sell in the United States, to develop supply projections and distribution strategies, including prebooking (i.e., advance ordering of vaccine) and partial shipment of orders to those customers who prebook. As of March 25, 2005, the supply of inactivated influenza vaccine projected for the 2005--06 season appeared adequate to meet the historical demand from persons in the priority groups established by ACIP during the 2004--05 season. If more vaccine becomes available, additional groups can also be targeted for vaccination.

Projected Vaccine Supply for the 2005--06 Influenza Season

During 2004--2005, Aventis Pasteur (now Sanofi Pasteur, after the merger of Aventis Pasteur and Sanofi) and MedImmune produced approximately 61 million doses of influenza vaccine for distribution in the United States. These two manufacturers anticipate producing approximately the same amount or slightly more doses for the upcoming season. How much, if any, influenza vaccine will be supplied by Chiron to the U.S. market is not known. On March 2, 2005, the British Medicines and Healthcare products Regulatory Agency (MHRA) lifted its October 5, 2004, suspension of Chiron's license to manufacture influenza vaccine (announcement available at http://www.fda.gov/bbs/topics/news/2005/new01160.html). The Food and Drug Administration (FDA) must also give its approval before this vaccine can be distributed in the United States. In addition, other manufacturers are discussing with FDA the possible licensure of influenza vaccine for the 2005--06 influenza season and beyond.

Prebooking and Distribution of Inactivated Influenza Vaccine

The primary method for reducing infections and complications from influenza is immunoprophylaxis with vaccine. The 2010 national health target for influenza vaccine coverage in noninstitutionalized adults aged >65 years is 90% (objective 14-29a); for noninstitutionalized adults at high risk aged 18--64 years, the coverage target is 60% (objective 14-29c) (2). Neither objective has been achieved. Based on data from the Behavioral Risk Factor Surveillance System (BRFSS) survey for the 2004--05 influenza season, influenza vaccination coverage was estimated at 62.7% for persons aged >65 years. For persons aged 18--64 with high-risk conditions, coverage was estimated at 25.5%, and for health-care workers with patient contact coverage was estimated at 35.7%. For children aged 6--23 months, coverage was estimated at 48.4% and for children aged 2--17 years with high-risk conditions, coverage was estimated at 34.8% (3). When combined with population estimates for these priority groups, the coverage estimates correspond to a total of approximately 40 million doses of influenza vaccine. To achieve 90% coverage in adults aged >65 years and 60% coverage for all other priority groups, approximately 70 million doses of vaccine would be needed (CDC, unpublished data, 2005). The supply of influenza vaccine projected from Sanofi Pasteur and MedImmune for the 2005--06 influenza season appears sufficient to meet the historical demand for vaccine by persons in all the priority groups established by ACIP during the 2004--05 influenza season. If additional vaccine becomes available above these levels (e.g., as a result of licensure of one or more additional manufacturers), additional groups can also be targeted for vaccination during the 2005--06 season.

Given the uncertainty about the number of doses of inactivated influenza vaccine that might be available for the 2005--06 season, CDC encourages implementation of a two-tiered prebooking strategy by manufacturers, distributors, and customers of inactivated vaccine. This prebooking strategy requires customers of inactivated vaccine to provide two requests for supplies, using 1) the number of doses needed based on anticipated demand among persons in the priority groups, in the event vaccine supply is limited, and 2) the number of doses needed based on priority group use, plus other groups, if supplies prove sufficient to meet demand from other persons seeking vaccination.

Whenever feasible, CDC also encourages a distribution strategy in which partial shipments are first shipped to all prebooked customers, early in the vaccination season, followed by additional shipments later in the season. This strategy will enable all providers to administer vaccine initially to those persons at high risk, even when supplies are limited.

Priority Groups for Prebooking of Inactivated Influenza Vaccine

The following priority groups should be used as a guide for prebooking orders for inactivated influenza vaccine:

  • Persons aged >65 years.
  • Persons aged 2--64 years with underlying chronic medical conditions.
  • All women who will be pregnant during the influenza season.
  • All children aged 6--23 months.
  • Health-care workers involved in direct patient care.
  • Out-of-home caregivers and household contacts of children aged <6 months.
  • Residents of nursing homes and long-term--care facilities.
  • Children aged 6 months--18 years on chronic aspirin therapy.

These strategies for prebooking and distribution do not apply to live, attenuated influenza vaccine (LAIV), manufactured by MedImmune, which can be ordered in the usual manner for those persons for whom LAIV is indicated. LAIV can be administered to healthy persons aged 5--49 years who are not pregnant, including health-care workers who are not caring for severely immunocompromised patients in special care units. Further details regarding CDC influenza vaccination recommendations will be published in April 2005 in the annual Prevention and Control of Influenza MMWR Recommendations and Reports. In addition, updated information on inactivated influenza vaccine supply for the 2005--06 influenza season will be provided as it becomes available.

References

  1. CDC. Interim influenza vaccination recommendations, 2004--05 influenza season. MMWR 2004;53:923--4.
  2. US Department of Health and Human Services. Healthy People 2010, 2nd ed. With understanding and improving health and objectives for improving health (2 vols.). Washington, DC: US Department of Health and Human Services; November 2000.
  3. CDC. Estimated influenza vaccination coverage among adults and children---United States, September 1, 2004--February 27, 2005. MMWR 2005;54:304-7.

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.


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