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9/24/2001

October Supply of Flu Vaccine to Be Less Than Originally Expected, CDC Warns

Cheryl A. Thompson

The National Immunization Program (NIP) of the Centers for Disease Control and Prevention (CDC) last week adjusted its projection on the distribution of the influenza vaccine for the 2001–02 season, lowering the amount that will likely be delivered by the end of October. In response to this information, the Food and Drug Administration (FDA) will allow health care providers to redistribute doses of the vaccine to other providers in the state (but not in another state) as long as the vials are properly handled, stored, and shipped.

NIP, on Sept. 17, issued the bulletin below.

INFLUENZA VACCINE SUPPLY AND PRODUCTION

An updated projection of influenza vaccine supply reflects a slight change in monthly distribution.

Projected distribution of influenza vaccine for 2001, based on aggregate manufacturers' estimates as of September 10, remains at 79.1 million doses. However, monthly estimates of distribution have changed slightly. Approximately 56 percent of the total supply should be distributed by the end of October. An additional 31 percent of the total influenza vaccine supply will be delivered in November and the final 13 percent is expected in early December. Officials at FDA and CDC stress that these projections from manufacturers could change as the season progresses. Information on influenza vaccine lots that are released by FDA and available for distribution by manufacturers can be found at www.fda.gov/cber/flu/flu.htm

INFLUENZA VACCINE DISTRIBUTION AND ADMINISTRATION

FDA is again allowing health care providers to sell, buy or transfer influenza vaccine this year.

FDA has determined that, due to delays in influenza vaccine delivery this year, health care providers are authorized to redistribute influenza vaccine to other providers in their state under the emergency medical reasons exemption of the Prescription Drug Marketing Act (PDMA) at 21 CFR 205.3(f)(5) and 210.2(b). Further, as per the PDMA, influenza vaccine handled between providers must adhere to good manufacturing practices relating to storage and shipping conditions. More information on proper handling, storage and shipping can be found on the CDC influenza website at www.cdc.gov/nip/flu

Medicare has given guidance to carriers about updating payment rates for influenza vaccine.

Medicare recently released Program Memorandum B-01-49 giving additional information regarding "Medicare Payment Allowance for Flu Vaccine" to its carriers, reminding them that new flu vaccines have been approved and to update their payment rates accordingly. To check with your specific Medicare Part B carrier about the specific payment rate in a your state, you can identify the appropriate carrier and contact information at www.hcfa.gov/medicare/incardir. Two carriers which have listed payment rates for influenza vaccine are 1) Trailblazers Health Enterprises LLC, providing service for providers in Colorado, New Mexico, District of Columbia metropolitan area, Delaware, Maryland, Texas and Virginia (see www.THE-Medicare.com/new.asp under Provider Notices, under Part B, 8/20/2001, Flu Vaccine Reimbursement) and 2) Noridian Mutual Insurance company, serving Alabama, Arizona, Colorado, Hawaii, Iowa, Nevada, North Dakota, Oregon, South Dakota, Washington and Wyoming (see www.noridian.com/medweb/notices/oct_qtr_inj_updt.pdf [PDF]). If you have questions about the payment rate, contact the appropriate CMS Regional Office. Program Memorandum B-01-49 can be found at www.hcfa.gov/pubforms/transmit/B0149.pdf (PDF)

State health departments are encouraged to organize coalitions of all providers of influenza vaccine services in their state to support the ACIP supplemental influenza recommendations for 2001-2002.

To assist in this effort, CDC is making state contingency plans available on the influenza website (www.cdc.gov/nip/flu) as they are received by CDC.

The Minnesota State Health Department, for example, is undertaking the following activities to encourage support for this year's influenza recommendations: 1) letters to the top 100 businesses asking them to schedule worksite programs on or after November 5, 2) letters to local health agencies to encourage them to form coalitions, and 3) assuring that local public health agencies (LPHA) will monitor influenza vaccine supply in their area, and if any clinic or facility has not had sufficient vaccine to meet the demand, LPHA will attempt to locate additional resources in the community (e.g., vaccine, clinic services, etc.).

The American Lung Association of Virginia, in cooperation with the Virginia State Department of Health, developed an item on their website that permits users to learn about influenza vaccine services by region, clinic type and location. The address is www.flushotsvirginia.org. To view how this website works, access the homepage, click on the "select a region" drop down box on the home page, and select "Central Virginia". Then click on the "select a provider" drop down box and select "physicians". Information regarding an influenza clinic to be held throughout January appears. For additional information, contact Jim Farrell, Immunization Division Manager at (804) 786-6246 or 6247 (email address is jfarrell@vdh.state.va.us).

INFLUENZA VACCINE COMMUNICATION

CDC is continuing communication activities to increase awareness and adoption of the ACIP recommendations for addressing this season's influenza vaccine delays.

Public service announcements and video news releases on influenza are in development this month. Print materials are in production and will be distributed by the end of the month.