Wednesday, December 23, 2009, 09:20 EST (9:20 AM EST)
CDCHAN-00304-2009-12-23-UPD-N
MedImmune Monovalent
2009 (H1N1) Influenza Nasal Spray Vaccine - Shortened Shelf Life of Certain Lots
MedImmune announces
limited, voluntary, non-safety-related recall of remaining unused product
Summary
On December
18 and 21, MedImmune notified CDC and FDA that the potency of 13 lots of monovalent 2009 (H1N1) nasal spray vaccine had
decreased below a pre-specified limit or were at risk of falling below that
limit in the next week. This slight decrease in vaccine potency is not expected
to have an impact on the protective response to vaccination. There are no
safety concerns with these lots of 2009 H1N1 vaccine. All lots successfully
passed pre-release testing for purity, potency and safety. However, because
their potency is now or might soon be below the specified lower limit,
MedImmune will send providers directions for returning any unused vaccine from
these lots.
The potency of
these lots is now or might soon be slightly below the specified range for the
product. CDC and FDA are in agreement that the slight decrease in vaccine potency is not expected to
have an impact on the protective response to vaccination. For this reason, there is no need to revaccinate
persons who have received vaccine from these lots.
People who
received vaccine from the recalled lots do not need to take any action.
Children and adults aged 10 years and older who received the vaccine do not
need any further doses of vaccine. As is
recommended for all 2009 H1N1 vaccines, all children younger than 10 years old
should get the recommended two doses of 2009 H1N1 vaccine approximately a month
apart. Therefore, children younger than 10 years old who have only received one
dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.
It is best to use the same type of vaccine for the first and second doses.
Background
As part of
its quality assurance program, the manufacturer of the nasal spray 2009 H1N1 influenza
vaccine, MedImmune, performs routine, ongoing stability testing of the vaccine
after it has been shipped to providers. Stability testing means measuring the
strength of a vaccine over time.
The 13 lots
subject to the recall include approximately 4.7 million doses. These doses were shipped to CDC's contract
distributor in October and early November.
Most of the doses are believed to
have already been administered while fully potent and within
specifications. However, there are
almost certainly some doses that have not yet been used.
The potency
issue described here is specific to the 13 lots of nasal spray 2009 H1N1 influenza
vaccine listed below. Subsequent lots of
the vaccine were produced with a slightly higher initial potency to decrease
the chance that the potency would fall - below specification - before their
expiration dates. Following its routine
practice, the manufacturer will continue to monitor the stability of these subsequent
lots.
This recall
does not affect 2009 H1N1 vaccine produced by other manufacturers. However, a similar recall was conducted
recently, which involved lots from Sanofi Pasteur's pediatric 2009 H1N1 vaccine
in 0.25 mL pre-filled syringes. (See http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00303)
Before they
were shipped, the lots currently being recalled passed all quality controls and
met all specifications for safety, purity, and potency.
MedImmune
will send a notification to providers who received doses from any of the 13 lots
of vaccine so that they can return any unused vaccine.
Providers are being
asked to return any vaccine in the following lots that remains unused to the
manufacturer:
500754P
500751P
500756P
500757P
500758P
500759P
500760P
500761P
500762P
500763P
500764P
500765P
500776P
For More Information:
For information about the recalled vaccine, see http://www.cdc.gov/h1n1flu/vaccination/sprayrecall_qa.htm.
HAN Message Types
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- Health Advisory: Provides important information for a specific incident or situation; may not require immediate action. Example: HAN00316
- Health Update: Provides updated information regarding an incident or situation; unlikely to require immediate action. Example: HAN00309
- Info Service: Provides general information that is not necessarily considered to be of an emergent nature. Example: HAN00319
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