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FLUZONE CODING INFORMATION
Delaware Health Alert Network #218 Sanofi Pasteur Monovalent 2009 (H1N1) Influenza Vaccine in Pre-Filled Syringes

Delaware Health Alert Network #218
February 4, 2010

Sanofi Pasteur Monovalent 2009 (H1N1) Influenza Vaccine in Pre-Filled Syringes

Sanofi Pasteur Monovalent 2009 (H1N1) Influenza Vaccine in Pre-Filled Syringes Shortened Shelf Life of Certain Lots. The Delaware Division of Public Health (DPH) is forwarding this health alert from the Centers for Disease Control and Prevention. For more information from the Division of Public Health, contact the immunization program at 1-800-282-8672.

Summary: Sanofi Pasteur has notified CDC and FDA that some lots of monovalent 2009 (H1N1) influenza vaccine in prefilled syringes will have a shorter expiration period than indicated on the label. The lots of Sanofi Pasteur monovalent 2009 H1N1 influenza vaccine in prefilled syringes should be used by February 15, 2010, as indicated in the table below regardless of the expiration imprinted on the package.  This is to ensure that the vaccine is used while it remains within its potency specification.  There are no safety concerns with these lots of 2009 H1N1 vaccine. People who received vaccine from the lots listed below with shortened shelf life do not need to take any action.

Background

As part of its quality assurance program, Sanofi Pasteur 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 50 lots subject to this change in expiration date include approximately 12 million doses.  These lots were shipped to providers between November 2009 and January 2010. Although these lots remain potent, they are losing their potency more rapidly than expected, and therefore the shelf life is being shortened.  While most of the doses from these lots are believed to have already been administered, there are almost certainly some doses that have not yet been used.

 

The change in expiration date described here is specific to the 50 lots of Sanofi Pasteur 2009 H1N1 influenza vaccine in pre-filled syringes listed below.  However, a related recall (See http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00306) was conducted recently, which involved lots from Sanofi Pasteurs 2009 H1N1 vaccine in 0.25 mL and 0.5 mL pre-filled syringes. These actions do not affect Sanofi Pasteurs 2009 H1N1 vaccine in multi-dose vials. 

Sanofi Pasteur will send a notification to providers who received doses from any of the 50 lots of vaccine described below.

 

Lot Information

These lots should be used by February 15, 2010, as indicated in the table below regardless of the expiration date imprinted on the package.

All pre-filled syringes that have not been used by February 15, 2010 should be discarded in an appropriate manner, or you may return the product for destruction to Sanofi Pasteur Inc., c/o Capital Returns at 6101 N. 64th Street, Milwaukee, WI 53218.

DPH has determined that of the affected vaccine, the lot numbers listed below were delivered to providers in Delaware. DPH will send notifications to those providers that did not receive the vaccine directly from the CDC distributor McKesson. As indicated above, Sanofi will send notifications to those providers that received the vaccine directly from McKesson.

Table 1: Influenza A (H1N1) 2009 Monovalent Vaccine in Pre-Filled Syringes. Expiration Date Change. Lot #s received in Delaware

LOT #                         # of doses

UP035BA                 3000

UP037CA                 1500

UP040CA                 200

UP048CA                 1600

UP048DA                 1160

UP059DA                 1700

UP060CA                 440

UT033CA                 2673

UT041AA                 2500

UT045BA                 100

UT047BA                 1000

UT048BA                 100

UT058BA                 100

UT036DA                 900

UT047AA                 1500

UT029BA                 2170

UT029EA                 3990

 

Table 2: Influenza A (H1N1) 2009 Monovalent Vaccine in Pre-Filled Syringes. Expiration Date Change

 

Product Code (NDC)           Description   Lot Number  Labeled Exp Date   Re-Assigned  Exp Date

49281-650-25           0.25mL syringes in             10-packs       

 

                        UT014AA     March 4, 2011          February 15, 2010

                        UT014BA     March 4, 2011          February 15, 2010

                        UT014CA     March 4, 2011          February 15, 2010

                        UT014DA     March 4, 2011          February 15, 2010

                        UT014FA      March 27, 2011        February 15, 2010

                        UT014EA     March 25, 2011        February 15, 2010

                        UT029DA     April 7, 2011            February 15, 2010

                        UT029BA     April 6, 2011            February 15, 2010

                        UT029CA     April 6, 2011            February 15, 2010

                        UT029EA     April 8, 2011            February 15, 2010

 

Product Code (NDC)           Labeled ExpDate   Re-Assigned  ExpDate

                        UT030EA     April 10, 2011          February 15, 2010

                        UT030FA      April 11, 2011          February 15, 2010

                        UT033CA     April 12, 2011          February 15, 2010

                        UT033DA     April 12, 2011          February 15, 2010

 

49281-650-50           0.5mL syringes in    10-packs       

                         UP033CA     April 16, 2011         February 15, 2010

                        UP036CA     April 19, 2011          February 15, 2010

                        UP034BB     April 22, 2011          February 15, 2010

                        UP036EA     May 3, 2011              February 15, 2010

                        UP037CA     April 30, 2011          February 15, 2010

                        UP037DA     May 2, 2011              February 15, 2010

                        UP048CA     May 6, 2011              February 15, 2010

                        UP040CA     May 4, 2011              February 15, 2010

                        UP048DA     May 9, 2011              February 15, 2010

                        UP049FA      May 16, 2011           February 15, 2010

                        UP049CA     May 11, 2011            February 15, 2010

                        UP049DA     May 13, 2011            February 15, 2010

                        UP035BA     April 15, 2011           February 15, 2010

                        UP059DA     May 16, 2011           February 15, 2010

                        UP060CA     May 17, 2011           February 15, 2010

                        UP060DA     May 19, 2011           February 15, 2010

                        UT047BA     May 11, 2011           February 15, 2010

                        UP033AB     April 9, 2011            February 15, 2010

                        UP041BA     April 30, 2011          February 15, 2010

                        UT041AA     April 29, 2011          February 15, 2010

                        UT034AA     April 19, 2011          February 15, 2010

                        UT045BA     May 5, 2011              February 15, 2010

                        UP061DA     May 21, 2011           February 15, 2010

                        UP061FA      May 23, 2011           February 15, 2010

                        UP035AA     April 12, 2011          February 15, 2010

                        UT048BA     May 12, 2011           February 15, 2010

                        UT058BA     May 16, 2011           February 15, 2010

                        UT059AA     May 18, 2011           February 15, 2010

                        UT058AA     May 14, 2011           February 15, 2010

                        UT061GA     May 24, 2011           February 15, 2010

                        UP045EA     June 9, 2011 February 15, 2010

 

49281-650-90           0.5mL syringes in   25-packs       

                         UT036DA     April 26, 2011          February 15, 2010

                        UT040BA     April 28, 2011          February 15, 2010

                        UT047AA     May 9, 2011             February 15, 2010

                        UT046BA     May 9, 2011             February 15, 2010

                        UT046AA     May 4, 2011             February 15, 2010

For More Information:

Call CDCs toll-free information line, 800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, is available 24 hours a day, every day.

For other inquiries, please contact Sanofi Pasteur Customer Services: 1-800-VACCINE (1-800-822-2463) or visit www.vaccineshoppe.com

 

 
Delaware Health Alert Network #217

 

  Message: Delaware Health Advisory

Non-Safety-Related Voluntary Recall of Unused Doses from Certain Lots of Sanofi Pasteur H1N1 Vaccine in Pre-Filled Syringes The Delaware Division of Public Health (DPH) is forwarding this health alert from the Centers for Disease Control and Prevention. For more information from the Division of Public Health, contact the immunization program at 1-800-282-8672.

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.

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 (NDC # 49281-650-25, which also may be recorded as # 49281-0650-25), 0.25 mL syringes in 10-packs

 

UT037AA

(NDC # 49281-650-90, which also may be recorded as # 49281-0650-90), 0.5 mL syringes in 25-packs 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.

DPH has determined that the three lot numbers and vaccine quantities listed below were the only ones from the affected lots received in Delaware. As indicated above, Sanofi will contact these providers directly with directions for returning unused vaccine:

UT023AA;         100 doses

UT023CA; 3,600 doses

UT037AA; 2,700 doses

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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Categories of Health Alert Messages:

Health Alert: Conveys the highest level of importance; warrants immediate action or attention.

Health Advisory: Provides important information for a specific incident or situation; may not require immediate action.

Health Update: Provides updated information regarding an incident or situation, unlikely to require immediate action.

Health Information: Provides general health information, which is not considered to be of an emergent nature.

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FDA Licenses New Influenza

Fluzone® High-Dose (Influenza Virus Vaccine) strengthens immune response in the 65+ population, an age group that suffers disproportionately from influenza and its complications –

The U.S. Food and Drug Administration (FDA) recently approved Sanofi Pasteur’s supplemental biologics license application (sBLA) for licensure of Fluzone® High-Dose (Influenza Virus Vaccine). The new vaccine, for adults 65 years of age and older, will be available to health-care providers for immunizations administered this fall in preparation for the upcoming 2010-2011 influenza season.
Fluzone High-Dose vaccine was specifically designed to generate a more robust immune response in people 65 years of age and older. This age group typically does not respond as well to the standard dose of influenza virus vaccines as younger individuals because they have weakened immune systems.
Fluzone High-Dose vaccine contains 60 mcg of hemagglutinin per strain of influenza virus in the vaccine as compared to 15 mcg of influenza virus hemagglutinin per strain of influenza virus in standard-dose Fluzone vaccine.

In a clinical study of 3,876 adults 65 years of age and older, the key finding was that the new high-dose vaccine induced statistically significant increases in immune responses compared to standard-dose Fluzone vaccine in the study population. Fluzone High-Dose vaccine was also shown to have a clinically comparable safety profile to Fluzone vaccine.

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