Health

Alert

NON-SAFETY RELATED VOLUNTARY RECALL OF CERTAIN LOTS OF SANOFI PASTEUR H1N1 PEDIATRIC VACCINE IN PRE-FILLED SYRINGES

The Delaware Division of Public Health is forwarding this health alert from a Centers for Disease Control

and Prevention advisory. For more information from the Division of Public Health, contact the Division

or Public Health Immunization Program at 1-800-282-8672.

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:

• 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 has sent directions for returning unused vaccine from these lots to providers that received

the vaccine.

Eight providers in Delaware received 1,840 doses of vaccine from the affected lots. These providers

will be contacted by DPH and by the vaccine manufacturer Sanofi on the process to return any unused vaccine.

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 multi-dose vials. The vaccine in multi-dose

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.
• Sanofi Pasteur will provide you with additional communication materials upon request.Please call 1-888-241-9288 for these items. For other inquiries, please contact Sanofi Pasteur Customer

  Services at 1-800-VACCINE (1-800-822-2463).

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