Distributed via Health Alert Network
Friday, January 29, 2010, 19:15 EST (7:15 PM EST)
CDCHAN-00306-2010-01-29-UPD-N
Non-Safety-Related
Voluntary Recall of Unused Doses from Certain Lots of Sanofi Pasteur H1N1 Vaccine
in Pre-Filled Syringes
Summary: As part of its quality
assurance program, Sanofi Pasteur, Inc., performs routine, ongoing testing of
influenza vaccines after the vaccine has been distributed to health care
providers to ensure that the vaccine continues to meet required specifications. In recent testing of its influenza A (H1N1) monovalent vaccine, Sanofi Pasteur
found five distributed lots of single-dose, pre-filled syringe pediatric (0.25 mL) vaccine and one distributed lot of single-dose pre-filled
syringe for older children and adults (0.5 mL) vaccine had potency below
pre-specified limits. The manufacturer
is conducting a non-safety related voluntary recall of any unused doses of these
affected lots of vaccine. Information
will be sent by Sanofi Pasteur to providers who received vaccine from the
affected lots.
Background
After
performing routine tests, Sanofi Pasteur
notified the Centers for Disease Control and Prevention (CDC) and the Food and
Drug Administration (FDA) that the potency in five lots of pediatric pre-filled
syringes and one lot of adult pre-filled syringes that had been distributed to
providers was later found to have dropped below a pre-specified limit.
Recommendations
While the potency of these lots
is now below the manufacturer's specification for the product, CDC and FDA are
in agreement that the small decrease in antigen content is
unlikely to result in a clinically significant reduction in immune
response among persons who have received the vaccine. For this reason, there is no
need to revaccinate persons who have received vaccine from these lots.
Providers will be
asked to return any unused vaccine from the affected lots to the manufacturer. The only vaccine affected by this recall is supplied in pre-filled
syringes and is identified by the following lot numbers:
UT023AA,
UT023BA, UT023CA, UT023EA, UT023FA
(
UT037AA
(
These lots were shipped to providers between November 2009 and
January 2010. Sanofi Pasteur will send directions for returning unused vaccine
from these lots to providers.
All
vaccines are thoroughly tested prior to release and shipping for safety,
purity, and potency. The affected lots met
all required specifications at the time of release. CDC and FDA have determined that there are no safety
concerns for people who have received these vaccines.
The potency of the affected lots of vaccine
is only slightly below the specification limit. Vaccine doses from these lots are
still expected to be effective in stimulating a protective response. There is
no need to re-administer a dose to those who received vaccine from these
lots.
As is recommended for all 2009 H1N1 vaccines,
all children less than 10 years old should get the recommended two doses of
H1N1 vaccine approximately a month apart for the optimal immune response. So, children less than 10 years old who have
only received one dose of vaccine thus far should still receive a second dose
of 2009 H1N1 vaccine.
For
children 6 months of age and older, vaccine is available in multidose
vials. The vaccine in multidose vials is
safe and effective vaccine for children. The standard dose for this preparation
for administration to infants 6-35 months old is the same as for the pre-filled
syringes, 0.25 mL. For healthy children at
least 2 years of age, the nasal spray (live, attenuated influenza vaccine) is
also an option. The nasal spray vaccine
is produced in single units that do not contain thimerosal.
Sanofi Pasteur has informed the CDC that it will be submitting a
field correction to the FDA to request a change for the expiration date of
the company's remaining pediatric and adult pre-filled syringes. CDC will share
additional information as soon as it is available.
For More Information:
Call
CDC's toll-free information line, 800-CDC-INFO (800-232-4636) TTY: (888)
232-6348, which is available 24 hours a day, every day.
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- Page last reviewed: April 6, 2012 5:00 PM ET
- Page last updated: April 6, 2012 5:00 PM ET
- Content source: CDC Emergency Risk Communication Branch (ERCB), Division of Emergency Operations (DEO), Office of Public Health Preparedness and Response (OPHPR)
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