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Distributed via Health Alert
Network
December 23, 2009, 9:20 EST (9:20 AM
EST)
CDCHAN-00304-09-12-23-ADV-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.
Recommendations
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.
Lot
Information
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:
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