Tuesday, December 15, 2009, 10:05 EST (10:05 AM EST)
CDCHAN-00303-2009-12-15-UPD-N
Non-Safety Related
Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine in Pre-Filled Syringes
Summary: As part of its quality assurance program, Sanofi
Pasteur, Inc., performs additional routine, ongoing testing of influenza
vaccines after the vaccine has been distributed to health care providers to
ensure that vaccines continue to meet required specifications. In recent testing of the amount of
antigen in its influenza A (H1N1) monovalent vaccine,
Sanofi Pasteur found four distributed lots of single-dose,
pre-filled syringe pediatric (0.25 mL.) vaccine with
antigen content lower than required potency levels. The manufacturer is conducting a non-safety
related voluntary recall of these affected lots of vaccine.
Background
After
performing these tests, Sanofi Pasteur notified the
Centers for Disease Control and Prevention (CDC) and the Food and Drug
Administration (FDA) that the antigen content in one lot of pediatric syringes
that had been distributed to providers was later found to have dropped below a
pre-specified limit. As a result of this finding, Sanofi Pasteur tested
additional lots and found that three other lots that had been distributed also
had an antigen content that had fallen below pre-specified limits. This means that doses from these four vaccine
lots no longer meet the specifications for antigen content.
Recommendations
While the antigen content of
these lots is now below the specification limit 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 are being asked to
return any vaccine to the manufacturer in the following lots that remains
unused to the manufacturer:
- 0.25 mL
pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as
49281-0650-25):
UT023DA
UT028DA
UT028CB
- 0.25 mL
pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as
49281-0650-70):
UT030CA
These lots
were shipped in November and are intended for children 6 months through 35
months of age. Sanofi Pasteur
will send directions for returning unused vaccine from these lots to providers.
All vaccines are thoroughly tested prior to release and shipping to
determine that they meet all manufacturer and FDA standards for purity, potency
and safety. The affected vaccine met all
specifications at the time of release. CDC and FDA have determined that there are no safety concerns for children who
have received this vaccine. Sanofi Pasteur has discontinued
distribution of the 0.25 mL syringes of H1N1
pediatric vaccines.
The drop in antigen content below the required specification that is described here is specific to Sanofi Pasteur's pediatric H1N1 monovalent vaccine in 0.25 mL pre-filled syringes. The same vaccine packaged in other forms, such as 0.5 mL pre-filled syringes for older children and adults and multi-dose vials, continue to meet specifications.
The antigen content in the affected lots
of vaccine is only slightly below the specification limit. The slightly reduced
concentration of vaccine antigen found in retesting these lots is 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. However, 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. One difference between vaccine in pre-filled
syringes and the multidose vials is that the multidose vials contain a
preservative (thimerosal) to prevent potential
contamination after the vial is opened. 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.
For More Information:
- For
Questions and
Answers related to the withdrawn vaccine see http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm
- 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.
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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