|The Department of Health and Human Services Food and Drug
Administration and CDC are working closely with vaccine manufacturers to
facilitate the availability of safe and effective influenza vaccine for
the upcoming flu season. Influenza vaccine manufacturers have told FDA
and CDC to expect delays in flu vaccine shipments and that it is
possible there will be reductions of available influenza virus vaccine
for the 2000-01 season.
The FDA and CDC today briefed the Advisory
Committee on Immunization Practices (ACIP) about the current situation
regarding influenza vaccine supply. The FDA and CDC stressed to the ACIP
that the situation is very fluid and that health care providers should
expect periodic updates from them through the summer and fall.
ACIP, in a consensus recommendation, urged health care providers to
begin thinking now about delaying adult mass influenza vaccination
campaigns to November (usually recommended for October through
mid-November) based on supply availability, and to consider ways to
ensure their high risk patients receive vaccination if a severe vaccine
shortfall were to occur.
The total amount of vaccine available for the influenza season is
uncertain at this time; however, both FDA and CDC are actively working
with manufacturers to determine how much and when vaccine will be
available. The amount of available flu vaccine will become more clear
within the next two months.
Many potential flu vaccine providers, including health care offices,
hospitals, health care organizations, nursing homes and other
organizations, who are currently in the midst of preparing for their
fall and winter influenza vaccination efforts, need this information at
this time to adequately prepare for the upcoming season. Persons who
normally receive influenza vaccine should not be concerned and should
delay inquiries about flu vaccination until the fall.
- It is important to stress that FDA, CDC and vaccine manufacturers
are confident that vaccine will be available to vaccinate those at
highest risk of complications from influenza, including those over 65,
those who are immunosuppressed and others.
- The amount of vaccine available is complicated by two important
factors: 1) the yield for this years influenza vaccine A(H3N2)
component appears to be lower than expected which limits the supply
that can be developed in time for this flu season and, 2) other
manufacturing issues. Manufacturers are working closely with the FDA
to address these issues.
- If a substantial shortfall of vaccine were to occur, the ACIP and
CDC would provide modified recommendations for the 2000-2001 influenza
season that emphasize vaccinating persons at highest risk of death
from influenza (and the health care workers who take care of them) and
then vaccinating, as the vaccine supply allows, the other groups for
whom vaccine is traditionally recommended.
- Currently, four antiviral drugs are approved by FDA to treat
acute, uncomplicated influenza. These drugs are not a substitute for
influenza vaccine and should not be used as such. The annual use of
influenza vaccine is the primary means for minimizing adverse outcomes
from influenza virus infections.
- Over the course of the summer and the influenza season new
information is expected to become available, and CDC and FDA will
issue information updates. If a shortfall does occur, ACIP and CDC
request that persons and organizations administering influenza vaccine
join in voluntary efforts to ensure that influenza vaccine is
administered first to the persons most likely to develop serious and
life threatening complications from influenza.