Influenza Vaccine Supply and Production
2004-2005 Influenza Vaccine Production
Vaccine production is on schedule, and no delays are anticipated, according to the Food and Drug Administration (FDA) and vaccine manufacturers. However, it is still early in the manufacturing process, and issues can arise. The Influenza Bulletin provides regular updates on the status of vaccine production. The three manufacturers of influenza vaccine anticipate total influenza vaccine production of between 90 and 100 million doses. Between six and eight million of those doses will include reduced amounts of thimerosal.
Place Orders for Influenza Vaccine!
In order to ensure the availability of influenza vaccine for administration in the fall of 2004, healthcare providers should order supplies of influenza vaccine now if orders have not been placed. Last year, cases of influenza began to appear in October with widespread activity in November and December. Because increased demand for vaccine is anticipated, healthcare providers who care for Medicare beneficiaries and others at high risk for complications from influenza must prepare for the upcoming influenza season immediately.
Additional information on sources of vaccine can be found at www.hidanetwork.com/govtrelations/flulinks.asp, a service provided by the Health Industry Distributors Association.
Influenza Vaccine Contracts
- For 2004, CDC contracts have a maximum quantity of 6.75 million doses, up from 4.8 million in 2003. These figures represent vaccine purchased with VFC, 317, or state funds for persons of all ages.
VFC Influenza Vaccine Stockpile
Demand for influenza vaccine during the 2003-2004 influenza season significantly exceeded supply. Unfortunately, the current manufacturing process does not allow for additional vaccine to be produced in a timely manner after supplies are low. These factors highlight the need for a plan to ensure availability of an adequate supply of influenza vaccine in the U.S.
In FY 2004 and FY 2005, CDC will purchase influenza vaccine for a national stockpile. This purchase was authorized by the Omnibus Reconciliation Act (OBRA) of 1993 which allows CDC to use Vaccines for Children (VFC) program funds for stockpile purchases. This stockpile, because it is funded through the VFC program, can only be used to provide vaccine to VFC eligible children 18 years of age and younger. Approximately 54 percent of U.S. children would be eligible.
- In FY 2004, $40 million in VFC program funds has been provided for the influenza stockpile. Based on discussions with vaccine manufacturers, CDC estimates purchasing approximately 4 to 4.5 million doses of influenza vaccine for the stockpile.
In FY 2005, $40 million in VFC program funds was included in the President's Budget request. The exact number of doses to be purchased in 2005 will ultimately depend on manufacturers' production and timing capacity and will not be known until they respond to the FY 2005 contract solicitation in May, 2005.
- In the event that influenza vaccine demand exceeds supply, the VFC-eligible children for whom the vaccine is recommended will have priority access to the stockpile. As determined by CDC, VFC stockpile vaccine may be made available to state and local health departments and manufacturers for distribution. If no influenza vaccine supply shortage occurs, CDC will attempt to distribute the stockpiled vaccine in consultation with the manufacturers.
Influenza Vaccine Distribution and Administration
2004 Influenza Vaccination Recommendations of the Advisory Committee on Immunization Practices (ACIP)
Recommendations have been broadened to protect more people from influenza.
- The Centers for Disease Control and Prevention (CDC) has adopted the following recommendations.
- Children 6 months to 23 months of age should be vaccinated annually against influenza.
- Household contacts and out-of-home caregivers of children 0 to 23 months of age should be vaccinated annually to prevent these contacts from infecting young children with influenza.
Other changes from last year's recommendations include the composition of the influenza vaccine for the 2004-2005 season and clarification about the use of live, attenuated influenza vaccine in healthcare workers and close contacts of severely immunosuppressed persons.
Review the ACIP Recommendations at www.cdc.gov/mmwr/pdf/rr/rr53e430.pdf.
Update on Medicare Payment for Influenza Vaccine Purchase and Administration
- The basis for Medicare payment of influenza vaccine will continue to be 95% of the average wholesale price, as stated by the Centers for Medicare and Medicaid Services (CMS) at www.cms.hhs.gov/medlearn/refimmu.asp.
MedImmune Reacquires Rights to FluMist from Wyeth
On April 26, 2004, MedImmune, Inc. and Wyeth announced the dissolution of their collaboration for the nasal influenza vaccine, FluMist (Influenza Virus Vaccine Live, Intranasal) and an investigational second-generation liquid formulation, Cold Adapted Influenza Vaccine-Trivalent (CAIV-T). As a result of the dissolution, subject to obtaining necessary government approval, MedImmune will have worldwide rights to these products and will assume full responsibility for the manufacturing, marketing, and selling of FluMist.
As part of the dissolution process, MedImmune will acquire Wyeth's distribution facility in Louisville, Kentucky. Wyeth is providing bulk manufacturing materials and will transfer clinical trial data, as well as provide manufacturing services, during a transition that the companies expect to complete in large part by fourth quarter 2004.
Influenza Vaccine Communications & Resources
38th National Immunization Conference
The objective of the conference, held on May 11-14, 2004 in Nashville, Tennessee, was to bring together a wide variety of local, state, federal, and private-sector immunization partners to explore science, policy, education, and planning issues related to immunization in general and vaccine-preventable disease. The conference featured plenary sessions on influenza and adult immunization, as well as a total of 14 workshops dedicated to the two topics. Over 1300 persons were pre-registered for the conference. For additional information, please visit www.cdc.gov/nip/NIC/default.htm.
2004 National Influenza Vaccine Summit
The National Influenza Summit is acknowledged as an informal partnership of stakeholders who advise on and respond to issues of influenza vaccination all year round. This year, the Summit moved away from the workgroup-oriented approach of the previous summits and towards a topical/ thematic approach. This topical approach allowed relevant and current background material to be presented at the plenary session for each theme. The plenary sessions were then followed by moderated breakout sessions on a variety of topics pertinent to that theme allowing all Summit participants an opportunity to contribute to all themes.
To view individual presentations and additional information from the Summit, visit www.ama-assn.org/ama/pub/article/1826-8377.html.
- "Influenza Immunization Among Health Care Workers". A call for action, published by The National Foundation for Infectious Diseases, suggests that a comprehensive approach is essential to improve influenza vaccination rates among health care workers. Since influenza vaccine coverage for health care professionals is estimated nationally at 38 percent, additional efforts are needed to reach a greater percentage of this important subpopulation.
You may download the entire Call to Action at www.nfid.org/publications/calltoaction.pdf
- An article in Volume 26, Number 4 of the 2004 American Journal of Preventive Medicine, "Operational Conditions Affecting the Vaccination of Older Adults", by John Fontanesi and colleagues, suggests that adequate description has not been provided on the content and context of the process for vaccinating older adults against influenza in outpatient settings. While patient and provider beliefs and characteristics may affect the likelihood that a provider recommends influenza immunization, other factors may present as much or even greater influence.
- Review recently published Morbidity and Mortality Weekly Reports (MMWRs) related to influenza by clicking on the following links:
"Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP)" MMWR April 30, 2004; 53 (Early Release)
"Update: Influenza ActivityUnited States, 2003-04 Season" MMWR April 9, 2004; 53(13):284-287
"Preliminary Assessment of the Effectiveness of the 2003-04 Inactivated Influenza Vaccine --- Colorado, December 2003" MMWR January 16, 2004; 53(1):8-11
"Recommended Childhood and Adolescent Immunization ScheduleUnited States, January-June 2004" MMWR January 16, 2004; 53(1):Q1-4
"Update: Influenza-Associated Deaths Reported Among Children Aged <18 YearsUnited States, 2003-04 Season" MMWR January 9, 2004; 52(53):1286-1288
- Reference previous bulletins at www.cdc.gov/flu/professionals/flubulletin.htm