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
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:
Categories of Health Alert messages:
##This Message was distributed to State and Local Health Officers, Public Information Officers, Epidemiologists and HAN Coordinators as well as Clinician organizations##
You have received this message based upon the information contained within our emergency notification data base. If you have a different or additional e-mail or fax address that you would like us to use please contact your State-based Health Alert Network program at your State or local health department.
The CDC and HHS logos are the exclusive property of the Department of Health and Human Services and may not be used for any purpose without prior express written permission. Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.
Links to non-Federal organizations are provided solely as a service to our users. Links do not constitute an endorsement of any organization by CDC or the Federal Government, and none should be inferred. The CDC is not responsible for the content of the individual organizations.
Please send us your feedback or comments: http://www.cdc.gov/flu/coca/feedback.htm.
Our Clinician Communication Team is committed to excellence in reporting our weekly updates. Please e-mail firstname.lastname@example.org should you note any written errors or discrepancies.