Updates on
Influenza Vaccine Distribution/Use
Oct
20, 2005
Projected vaccine production includes the
following amounts by each company:
sanofi pasteur 60 million doses
GlaxoSmithKline 7.5 million doses
MedImmune 3 million doses
Chiron The company now expects that the
total number of Fluvirin® vaccine doses it will
produce for the 2005-2006
influenza season will be below its previously stated
range [18 million to 26
million doses] due to production delays related to
remediation as well as
lower production output associated with adaptation to new
processes and procedures
implemented in remediation. For more details, go to
www.chiron.com
Through September, approximately 28 million doses of influenza
vaccine have been distributed. Through October, it is projected
that approximately 57 million doses will have been distributed
nationally, and a total of 80+ million doses are projected to be
distributed by the end of November. Up to 90 million doses could
potentially be distributed this season if demand warrants late
season distribution, including utilization of the influenza
vaccine stockpile.
As
of October 12, 2005, all four manufacturers had vaccine lots
released for distribution by the Food and Drug Administration.
Typically, once a lot is released by the FDA, the manufacturer
completes its internal lot release protocol and begins shipping
vaccine from that lot to distributors or end users in one to two
weeks. For the latest information on influenza vaccine lot
releases, please see
http://www.fda.gov/cber/flu/flu2005.htm.
-
Influenza vaccine cannot be produced so that the entire
supply is available at once;
rather, while vaccine begins to become available in late
summer, production and distribution often continue into
December and even January.
-
All four of the U.S.-licensed influenza vaccine
manufacturers are producing and distributing their influenza
vaccine on different timetables.
o
Sanofi pasteur is
trying to provide all those who placed orders with their company
some vaccine - - that is, providing their customers with partial
orders (e.g., 20% of the order) and filling the rest of each
order in the coming weeks. CDC has endorsed sanofi pasteur’s
approach to the distribution of vaccine in partial shipments and
has encouraged other vaccine distributors to adopt it. This
process allows almost all their customers to begin their
vaccination efforts as early as possible. Following is a
statement from sanofi pasteur dated October 13, 2005.
“Sanofi pasteur, the vaccines business of the sanofi-aventis
Group, is ahead of its influenza vaccine shipping schedule to
provide 60 million doses for the 2005-2006 immunization season.
The company began shipping influenza vaccine to customers during
the first week of August. Approximately 45 million doses will be
shipped by the end of October. To date, approximately 95 percent
of sanofi pasteur customers have received at least a partial
delivery of their orders, which allows them to begin immunizing
their high-risk patients.
The company will continue to ship vaccine as quickly as possible
on a continuous basis into November, with shipping expected to
be completed by the middle of November, six weeks ahead of its
initial forecast. This split-delivery distribution process was
initiated by sanofi pasteur several years ago in support of the
U.S. Centers for Disease Control and Prevention’s (CDC)
recommendation for immunization prioritization.”
o
If an influenza
vaccine provider did not place an order with sanofi pasteur, and
ordered from a distributor, they may have received some vaccine
(either the GlaxoSmithKline or sanofi pasteur brand) or should
be receiving vaccine soon (i.e., in the coming weeks).
o
Those placing
orders with a distributor for Chiron’s vaccine will experience
the greatest delays since Chiron’s product is just becoming
available for distribution.
o
Those ordering the
nasal-spray vaccine, FluMist®, appear to be receiving
their orders in a timely way.
·
Many different types of health care settings provide influenza
vaccine annually.
The following data are derived from CDC’s Behavioral
Risk Factor Surveillance System, and they compare venues
where influenza vaccine was administered in 2001, the most
recent non-shortage year for which complete data are
available, and 2004 when an influenza vaccine
shortage occurred.
|
Vaccination Venue |
2001 |
2004 |
|
Doctor’s Office or HMO |
43.81% |
40.38% |
|
Health Department |
5.11% |
10.34% |
|
Clinic or Health Center |
11.26% |
12.10% |
|
Community Center |
3.05% |
4.12% |
|
Store |
6.07% |
6.19% |
|
Hospital or Emergency Room |
5.23% |
7.61% |
|
Workplace |
19.71% |
11.71% |
|
Other |
5.77% |
7.54% |
|
Total |
100.00% |
100.00% |
The 2004 influenza vaccine shortage resulted in a
substantial reduction in workplace vaccination and a 3.4
percentage point decline in doses administered by private
physicians. Public health departments doubled their
rate to 10 percent and hospital/emergency room vaccination
increased slightly. Given current circumstances, including a
delay in distribution of part of this year’s vaccine
supply, we would expect that in 2005, vaccine administration by
venue would resemble what occurred in 2001.
-
CDC values the contributions of all healthcare organizations
and providers to influenza vaccination, and prefers that all
have similar access to influenza vaccine.
Health care providers and health departments which have not
received enough influenza vaccine for their priority
patients are concerned that their patients may not be
vaccinated, particularly if they are caring for underserved
persons with limited options for health care (who may not be
able to receive vaccine at a community vaccination clinic).
We are hopeful that they will have vaccine soon.
Influenza Vaccination Recommendations
-
CDC and HHS attempt to influence influenza vaccine
distribution and use through recommendations, guidelines,
and extensive collaborations.
The Centers for Disease
Control and Prevention (CDC) does not usually buy or
distribute influenza vaccine - - the vast majority of doses
are purchased and provided by state and local health
departments and private healthcare providers. However, CDC
encourages wide adoption of its influenza vaccination
recommendations, and works with state and local health
departments, professional medical organizations, vaccine
manufacturers, and other influenza vaccine providers to
achieve the highest rates of cooperation possible.
- While
encouraging available influenza vaccine be directed to
people in priority groups, CDC recommends using strategies
that minimize the amount of time people spend waiting in
lines, including scheduling appointments.
We
do not yet know if CDC’s recommendation to direct the currently
available doses of influenza vaccine to people in priority
groups is successful.
CDC, state and local health departments and other stakeholder
organizations have received some reports that certain influenza
vaccine providers are not following the recommendation, but upon
further investigation, many of these reports prove to be
unfounded. Compliance with CDC’s recommendation is voluntary
except in states that have chosen to invoke a rule, regulation,
statute or legal order to mandate it. Nevertheless, most health
care providers, including community or “mass” vaccinators, are
following and promoting the recommendation. Last year,
this strategy effectively directed most of the available vaccine
to people in the priority groups.
