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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