| Flu
Season 2004-05
Influenza Vaccine Bulletin
#2
Flu Season 2004-2005
May 20, 2004
Topics
Influenza Vaccine Supply and Production
Vaccine
Distribution and Administration
Vaccine Communications and Resources
Miscellaneous
Information
version
of this bulletin
The
National Immunization Program (NIP) of the Centers for Disease Control
and Prevention (CDC) publishes and distributes periodic
bulletins to update partners about recent developments related to
the production, distribution, and administration of influenza
vaccine. All recipients of this bulletin are encouraged to distribute
each issue widely to colleagues, members and constituents.
| 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
Resource
Materials
• “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.
“Update:
Influenza Activity—United States, 2003-04 Season”
MMWR April 9, 2004; 53(13):284-287 , www.cdc.gov/mmwr/PDF/wk/mm5313.pdf
“Preliminary
Assessment of the Effectiveness of the 2003-04 Inactivated Influenza
Vaccine - Colorado, December 2003” MMWR January
16, 2004; 53(1):8-11, www.cdc.gov/mmwr/pdf/wk/mm5301.pdf
“Recommended
Childhood and Adolescent Immunization Schedule—United States,
January-June 2004” MMWR January 16, 2004; 53(1):Q1-4
www.cdc.gov/mmwr/pdf/wk/mm5301-Immunization.pdf
“Update:
Influenza-Associated Deaths Reported Among Children Aged <18
Years—United States, 2003-04 Season” MMWR
January 9, 2004; 52(53):1286-1288 www.cdc.gov/mmwr/PDF/wk/mm5253.pdf
•
Refer to previous bulletins at www.cdc.gov/flu/professionals/flubulletin.htm
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