2004-2005 Flu Vaccine Shortage:

On October 5, 2004, the Centers for Disease Control and Prevention (CDC) was notified by Chiron Corporation that none of its influenza vaccine (Fluvirin®) would be available for distribution in the United States for the 2004*05 influenza season. Chiron was to make 46-48 million doses of the vaccine for the United States. This action reduced the expected supply of trivalent inactivated vaccine (flu shot) available in the United States for the 2004*05 influenza season by approximately one half.

The remaining supply of influenza vaccine expected to be available in the United States this season is nearly 54 million doses of Fluzone® (inactivated flu shot) manufactured by Aventis Pasteur, Inc. Of these doses, approximately 33 million doses already have been distributed by the manufacturer. In addition, approximately 2 million doses of live attenuated influenza vaccine (LAIV/FluMist®) manufactured by MedImmune will be available this season.

Interim Recommendations:
Because of this urgent situation, the CDC, in coordination with its Advisory Committee for Immunization Practices (ACIP), issued interim recommendations for influenza vaccination during the 2004*05 season. These interim recommendations were formally recommended by ACIP on October 5, 2004, and take precedence over earlier recommendations.

Priority Groups for Influenza Vaccination:
The following priority groups for vaccination with inactivated influenza vaccine this season are considered to be of equal importance and are:
All children aged 6-23 months
Adults aged 65 years and older
Persons aged 2-64 years with underlying chronic medical conditions
All women who will be pregnant during influenza season
Residents of nursing homes and long term care facilities
Children aged 6 months-18 years on chronic aspirin therapy
Health-care workers involved in direct patient care
Out-of-home caregivers and household contacts of children aged younger than 6 months

Other Vaccination Recommendations:
Persons in priority groups identified above should be encouraged to search locally for vaccine if their regular health-care provider does not have vaccine available.

Intranasally administered, live, attenuated influenza vaccine, if available, should be encouraged for health-care workers (except those who care for severely immunocompromised patients in special care units) and persons caring for children aged younger than 6months.

Certain children aged younger than 9 years require 2 doses of vaccine if they have not previously been vaccinated. All children at high risk for complications from influenza, including those aged 6-23 months, who are brought for vaccination, should be vaccinated with a first or second dose, depending on vaccination status. However, doses should not be held in reserve to ensure that 2 doses will be available. Instead, available vaccine should be used to vaccinate persons in priority groups on a first-come, first-serve basis.

Vaccinations of Persons in Non-priority Groups:
Persons who are not included in one of the priority groups described above should be informed about the urgent vaccine supply situation and are asked to forego or defer vaccination.

Nation Allocation Plan: On October 12, CDC and Aventis Pasteur announced the first phase of the plan to allocate influenza vaccine. The plan calls for CDC to work closely with Aventis to distribute in phases 22.4 million doses of unshipped vaccine to identified areas of need throughout the country.

Beginning immediately, about 14 million doses of vaccine will be allocated over the next 6-8 weeks through Aventis Pasteur contracts directly to high-priority vaccine providers, including hospitals, long-term care facilities, nursing homes, and private providers who care for young children.

The CDC will continue to work with Aventis Pasteur and state and local health departments to identify people, by region, on the vaccination priority list. The approximately 8 million doses remaining after the first phase is completed will be shipped to other high-need areas.

Redistribution at the State and Local Levels: Public health departments and healthcare providers and institutions involved in reallocating influenza vaccine this year should be aware of the following information from the FDA.

Anticipated shortages of influenza vaccine this flu season constitute emergency medical reasons, within the meaning of Section 503(c)(3)(B)(iv) of the Food, Drug, and Cosmetic Act (FDC Act), as determined by FDA. It is therefore permissible under the FDC Act for a hospital or health care entity to redistribute influenza vaccine to alleviate shortages this flu season. When redistribution occurs, the hospital or health care entity that is redistributing the influenza vaccine should document and maintain the following information:
· vaccine brand name
· manufacturer and distributor
· lot number
· number of doses transferred
· recipient's name and address

Health departments throughout the United States are trying to make sure that as many high-risk people as possible will eventually be able to go to either their regular vaccine provider or a flu shot clinic to get the vaccine.
More information on the flu vaccine shortage in your state is available through State Health Department immunization programs at http://www.cdc.gov/other.htm#states.

Although vaccination is the best protection against influenza, everyone can take practical steps to help prevent spread of flu, such as avoiding close contact with people who are sick and keeping your distance from others if you're sick; when possible, stay home from work, school, and errands when you are sick; covering your mouth and nose when coughing or sneezing, and cleaning your hands often. Visit the CDC Flu Gallery for printable patient education materials at: http://www.cdc.gov/flu/professionals/patiented.htm

Additional information is available at http://www.cdc.gov/flu or through the CDC ol), orpublic response hotline: 888-246-2675 (English), 888-246-2857 (Espan 866-874-2646 (TTY).

You may also visit the American Academy of Pediatrics Immunizations Initiatives Web site at www.cispimmunize.org for more information.