Flu Vaccine Information
Flu Question & Answer Flumist vs. Flu Shot H1N1 Novel Influenza Information
Non-Safety Voluntary Recall of H1N1 Vaccine for Children 6-35 months of age and H1N1 Mist. We will continue to monitor this situation closely and provide our patients with any changes in this situation. For more information please visit http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm and http://www.cdc.gov/h1n1flu/vaccination/sprayrecall_qa.htm
Attention all providers pre-registered with MDH to receive 2009 H1N1 vaccine.
CDC: Non-Safety-Related Voluntary Recall of Unused Doses from Certain Lots of Sanofi Pasteur H1N1 Vaccine in pre-Filled Syringes
MDH Summary points:
- No safety concerns for those who have received this vaccine from these lots.
- Vaccine is unlikely to result in a clinically significant reduction in immune response.
- No need to re-administer a dose to those who received vaccine from these lots (see lot numbers below).
- Providers are asked to stop using any vaccine from these specific lots and return it to the manufacturer.
- In Minnesota, 56 providers received approximately 20,200 doses of vaccine from these lots. MDH will be contacting these providers.
- If you redistributed vaccine to other providers, please make certain that they receive this information. Additionally, an email describing this situation will go out to all pre-registered H1N1 vaccine providers later today.
- Sanofi Pasteur will send directions for returning unused vaccine from these lots to providers
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.
Providers will be asked to return any unused vaccine from the affected lots to the manufacturer. 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.
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.
For more information or to order additional H1N1 vaccine, please email health.flu@state.mn.us
H1N1 Vaccine Now Available 2-2-2010
We are currently scheduling H1N1 vaccination for any established patient 6 months through 24 years of age. Please call to schedule an appointment or use our Request an Appointment On-line form.
Request an Appointment On-line
Booster doses are now available. Please make your appointment 1 week before booster is due.
Seasonal Flu Vaccine Available 2-2-2010
We are currently scheduling for all children aged 6 months through 4 years of age, and adolescents aged 5-23 years. Please call to schedule an appointment or use our Request an Appointment On-line form.
Supply of vaccine: Shipments of flu vaccine are staggered, so our supply is constantly changing. For up to the minute information, sign-up for e-news and check our website frequently.
Preventing the spread of infection: Our disinfecting efforts in all patient contact areas of the clinic have been increased. Patients with flu like symptoms, as well as those accompanying them will be asked to wear a mask. Hand sanitizer is available at the front desk, and we also have touch-free waste baskets. Signage is also posted throughout the clinic encouraging hand washing and the proper way to cover a cough.
