Novel H1N1 Influenza Vaccine
National Vaccine Recovery Program for H1N1 Influenza Vaccines Ends December 1, 2010
November 3, 2010 -- The Bureau of Immunization is reminding all novel H1N1 influenza and Vaccines for Children (VFC) Program providers who participated in the mass vaccination campaign for novel H1N1 influenza that all novel H1N1 influenza vaccines should be returned through the National Vaccine Recovery Program. The National Vaccine Recovery Program ends December 1, 2010.
Please note the following information:
- The Health and Human Services (HHS) Supply Service Center will accept all packages posted by December 1, 2010, and will honor pick-up arrangements that are scheduled by December 1, 2010.
- The HHS Supply Service Center will not accept packages mailed after December 1, 2010, or honor pick up requests placed after December 1, 2010.
Providers should contact the HHS Supply Service Center with questions. The HHS Supply Service Center can be reached at 1-800-642-0263 between 7:00 AM to 7:00 PM EST, Monday through Friday or vial email at H1N1Recovery@hhs.gov.
REMINDER: National Vaccine Recovery Program for H1N1 Influenza Vaccines
September 21, 2010 -- The Bureau of Immunization is reminding all novel H1N1 influenza and Vaccines for Children (VFC) Program providers who participated in the mass vaccination campaign for novel H1N1 influenza that all novel H1N1 influenza vaccines should be returned through the National Vaccine Recovery Program. Novel H1N1 influenza vaccine should NOT be returned to McKesson Specialties.
The Centers for Disease Control and Prevention (CDC) continues to remind all H1N1 immunization providers of the process to return 2009 H1N1 vaccines. Only unused and unopened 2009 H1N1 influenza vaccines are included in the National Vaccine Recovery Program. Ancillary supplies such as needles, syringes, and sharps containers supplied by the federal government are NOT included and should not be returned through this program.
- Providers contacting Health and Human Services (HHS) Supply Service Center: The service center is being overwhelmed with providers calling to inform that they have nothing to return. It is not necessary to call with this information. Only providers requiring assistance with returning their novel H1N1 vaccine should call the service center. They may be contacted at 1-800-642-0263 between 7:00 AM to 7:00 PM EST, Monday through Friday.
- Packing Slips: Some providers are not including a packing slip when vaccines are being picked up or shipped back via UPS. It is imperative that a complete packing list be included with all vaccine returns to track formulations and doses being returned. Please remember to include a completed packing slip with your novel H1N1 vaccine returns. The Central 2009 H1N1 Influenza Vaccine Recovery Program Packing Slip is linked below.
Reference documents pertaining to the Central H1N1 Vaccine Recovery Program can be found at: sscweb.psc.gov/h1n1/. They are also linked below for your reference to provide additional information regarding the National Vaccine Recovery Program for H1N1 influenza vaccine.
Update: Phase 2: National Vaccine Recovery Program for H1N1 Influenza Vaccines
September 2 , 2010 -- The Bureau of Immunization is pleased to provide this updated information on the National Vaccine Recovery Program for 2009 H1N1 influenza vaccines.
The Centers for Disease Control and Prevention (CDC) provides the following information for providers regarding Phase 2 of the National Vaccine Recovery Program:
- Healthcare providers who received 2009 novel H1N1 influenza vaccines and have signed a Provider Agreement now have a final opportunity to return all unused vaccines.
- Labels will be shipped to providers on or shortly after September 1, 2010.
- Providers who hold an Environmental Protection Agency (EPA) ID number as well as providers who have to return more than 20 lbs of unused novel H1N1 influenza vaccine should not use the label received, but instead should contact the Department of Health and Human Services (HHS) Supply Service Center to arrange pick-up of vaccine.
- Providers who have a pending pick-up already scheduled should include their remaining 2009 novel H1N1 influenza vaccines with this shipment.
- The 2009 H1N1 National Vaccine Recovery Program ends December 1, 2010. The HHS will accept all packages posted by December 1, 2010, and will honor pick-up arrangements that are scheduled by December 1, 2010. The HHS will not accept packages mailed after December 1, or honor pick up requests placed after December 1.
- Providers should contact the HHS Supply Service Center with questions. The HHS Supply Service Center can be reached at 1-800-642-0263 between 7:00AM to 7:00PM EST, Monday through Friday
or via email at H1N1Recovery@hhs.gov.
Update: National Vaccine Recovery Program for 2009 H1N1 Influenza Vaccines
August 27, 2010 -- The Bureau of Immunization wishes to remind all novel H1N1 influenza immunization providers participating in the National Vaccine Recovery Program of the following information.
The Centers for Disease Control and Prevention (CDC) continues to remind all H1N1 immunization providers of the process to return 2009 novel H1N1 influenza vaccines. Recently, some providers returned signed 2009 vaccine consent forms with their novel H1N1 influenza vaccine returns to the Vaccine Recovery Program contractor. This is in violation of the Vaccine Recovery Program and really jeopardizes central recovery operation. These consent forms should be maintained by the healthcare provider and NOT returned to the Vaccine Recovery Program contractor.
Reference documents pertaining to the Central H1N1 Vaccine Recovery Program can be found at: sscweb.psc.gov/h1n1/. They are also linked below for your reference to provide additional information regarding the National Vaccine Recovery Program for H1N1 influenza vaccine.
Reminder of Procedure
National Vaccine Recovery Program for 2009 H1N1 Influenza Vaccines
August 18, 2010 -- The Bureau of Immunization wishes to remind all novel H1N1 influenza immunization providers participating in the National Vaccine Recovery Program of the following information.
The Centers for Disease Control and Prevention (CDC) continues to remind all novel H1N1 influenza immunization providers of the process to return last season's novel H1N1 influenza vaccines since many providers continue to return novel H1N1 influenza vaccines to McKesson as part of their Vaccines for Children (VFC) Program vaccine returns.
It is not acceptable to include novel H1N1 influenza vaccine returns as part of their VFC Program returns or to send them to the McKesson VFC Program depots. McKesson has been instructed to refuse to accept these, resulting in unnecessary cost. This is problematic as the VFC Program distribution program is not set up to handle novel H1N1 influenza vaccine returns or recovery.
Reference documents pertaining to the Central H1N1 Influenza Vaccine Recovery Program can be found at sscweb.psc.gov/h1n1/. The documents linked below provide additional information regarding the National Vaccine Recovery Program for novel H1N1 influenza vaccine.
Here is a brief recapitulation of the information the bureau sent on June 24 of this year.
On or after Monday, June 28, 2010, providers will receive two prepaid UPS shipping labels to return up to 20 lbs of unused novel H1N1 influenza vaccine per label through UPS. Providers should check each shipping label for their unique provider identification number (PIN). The PIN cannot be shared and should be kept in a safe location. It will be used by the Department of Health and Human Services (HHS) Supply Service Center (SSC) for validation purposes.
However, the following providers cannot use the pre-paid shipping labels to return vaccine and should contact HHS SSC at 1-800-642-0263 between 7:00 am to 7:00 pm EST, Monday through Friday to make separate arrangements within two weeks of receiving the prepaid shipping labels:
- Providers who are required by law to hold an Environmental Protection Agency (EPA) identification number
- Providers who wish to return more than 20 lbs of unused novel H1N1 influenza vaccine per label
All providers will be responsible for packing and returning their unused 2009 novel H1N1 influenza vaccines. Vaccines being returned to the Vaccine Recovery Program do not have to maintain the cold chain. Only vaccines that will expire by the end of June 2010 should be returned at this time. Vaccines with expiration dates in 2011 (Sanofi Pasteur multi-dose vials) should continue to be refrigerated in case novel H1N1 influenza disease incidence results in an increased demand for vaccination before seasonal vaccine becomes available in sufficient quantity. During Fall 2010, providers will receive a third UPS prepaid label and have the opportunity to return the remaining 2009 novel H1N1 influenza vaccine (Sanofi Pasteur vaccine).
All immunization partners should be aware of the following:
- Do not return seasonal influenza vaccine – or – any other non-H1N1 influenza vaccines
- Do not return any ancillary kit items (needles, syringes, vaccination records, alcohol prep pads, etc.)
- Do not return any antiviral drugs – or – any other medication
- Do not return syringes with needles attached
- Do not return broken, partially used, or empty vials/pre-filled syringes/nasal sprayers
- Do include the attached Central Recovery Packing Slip (linked above) with the unused 2009 novel H1N1 influenza vaccines
Sanofi Pasteur Influenza A (H1N1) 2009 Monovalent Vaccine in
Multi-dose Vials—Shortened Shelf Life
August 12, 2010 -- The Bureau of Immunization is pleased to share the information in the Centers for Disease Control and Prevention (CDC) Health Alert Network (HAN) service message concerning the shortening of shelf life for Sanofi Pasteur Influenza A (H1N1) 2009 Monovalent Vaccine in multi-dose vials. This alert,
HANINFO-00317-2010-08-05-N, conveys the highest level of importance and warrants immediate action or attention, and was released via the Health Alert Network on August 5, 2010, at 5:00 PM. EDT. We request that our partners read the attached portable document file carefully and completely. Excerpts are presented below.
Sanofi Pasteur has notified the CDC and Food and Drug Administration (FDA) that their influenza A (H1N1) 2009 monovalent vaccine manufactured in 2009 in multi-dose vials will have a shorter expiration period than indicated on the label, and they will provide more specific notification of which lots will be affected and the new expiration date in the very near future. 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 were immunized with Sanofi Pasteur influenza A (H1N1) 2009 monovalent vaccine from multi-dose vials do not need to take any action.
The multi-dose vials subject to this change in expiration date include approximately 16 million doses of vaccine manufactured in 2009 that has not yet been administered, but that has been shipped to providers. Although the vaccine remains potent, it is losing potency more rapidly than expected, and therefore the shelf life will be shortened.
Sanofi Pasteur will send a notifications to providers who received this product regarding the specific lot numbers and the new expiration date, which we will continually share with our immunization partners.
For more information, please visit www.cdc.gov/flu/about/qa/infohealthcare.htm, contact Sanofi Pasteur Customer Services: 1-800-VACCINE (1-800-822-2463) or visit: http://www.vaccineshoppe.com.
Update: National Vaccine Recovery Program for H1N1 Influenza Vaccines
July 26, 2010 -- The Bureau of Immunization is pleased to provide this updated information on the National Vaccine Recovery Program for novel H1N1 influenza vaccines.
The Centers for Disease Control and Prevention has developed a webpage with questions and answers about the Central Vaccine Recovery Program for providers who signed a Provider Agreement to administer 2009 novel H1N1 influenza vaccine regarding the recovery of unused and expired 2009 novel H1N1 influenza vaccine. This information is available at http://www.cdc.gov/h1n1flu/vaccination/QA_Central_Vacc_Rcvry_Prog.htm.
The Health and Human Services Service Supply Center experienced a phone outage during the early part of last week. Management from the call center assures this issue has since been resolved. Please continue to call to schedule pick-ups and request additional labels. Their contact information is 1-800-642-0263 between 7:00 am to 7:00 pm EST, Monday through Friday.
Deadline for 2009 H1N1 Influenza Vaccine Orders
July 20, 2010 -- The Bureau of Immunization, in collaboration with the Centers for Disease Control and Prevention (CDC), is announcing the deadline for the final ordering and distribution of 2009 novel H1N1 influenza vaccines. Providers interested in receiving additional doses of novel H1N1 influenza vaccine should place their order through Florida SHOTS NO LATER THAN FRIDAY, JULY 30, 2010. This is the final day for ordering 2009 novel H1N1 influenza vaccine. Orders received after this date will not be processed.
Healthcare providers are encouraged to continue refrigerating all viable 2009 novel H1N1 influenza vaccine with expiration dates in 2011 (Sanofi Pasteur multi-dose vials). This vaccine may be needed if novel H1N1 influenza incidence results in an increased demand for vaccination before seasonal influenza vaccine becomes readily available in sufficient quantity.
Also, as a reminder, the Central H1N1 Vaccine Recovery Program is only accepting unused and unopened 2009 novel H1N1 influenza vaccines. Do not send used or opened vaccines back to McKesson.
Update: National Vaccine Recovery Program for H1N1 Influenza Vaccines
June 24, 2010 -- The Bureau of Immunization is pleased to provide this updated information on the National Vaccine Recovery Program for H1N1 influenza vaccines. The U.S. Government has organized a Central Vaccine Recovery Program to assist states in recovering unused doses of 2009 H1N1 influenza vaccines. Only unused and unopened 2009 H1N1 influenza vaccines are included in this program. Ancillary supplies such as needles, syringes, and sharps containers supplied by the federal government are NOT included and should not be returned through this program.
This week, all healthcare providers who signed a Provider Agreement for participation in the H1N1 mass vaccination campaign will receive a letter from the Bureau of Immunization outlining this vaccine recovery program. On or after Monday, June 28, 2010, providers will receive two prepaid UPS shipping labels to return up to 20 lbs of unused H1N1 influenza vaccine per label through UPS. Providers should check each shipping label for their unique provider identification number (PIN). The PIN cannot be shared and should be kept in a safe location. It will be used by the Department of Health and Human Services (HHS) Supply Service Center (SSC) for validation purposes.
However, the following providers cannot use the pre-paid shipping labels to return vaccine and should contact HHS SSC at 1-800-642-0263 between 7:00 am to 7:00 pm EST, Monday through Friday to make separate arrangements within two weeks of receiving the prepaid shipping labels:
- Providers who are required by law to hold an Environmental Protection Agency (EPA) identification number.
- Providers who wish to return more than 20 lbs of unused H1N1 vaccine per label.
All providers will be responsible for packing and returning their unused 2009 H1N1 influenza vaccines. Vaccines being returned to the Vaccine Recovery Program do not have to maintain the cold chain. Only vaccines that will expire by the end of June 2010 should be returned at this time. Vaccines with expiration dates in 2011 (Sanofi Pasteur multi-dose vials) should continue to be refrigerated in case H1N1 disease incidence results in an increased demand for vaccination before seasonal vaccine becomes available in sufficient quantity. During Fall 2010, providers will receive a third UPS prepaid label and have the opportunity to return the remaining 2009 H1N1 influenza vaccine (Sanofi Pasteur vaccine).
All immunization partners should be aware of the following:
- Do not return seasonal influenza vaccine – or – any other non-H1N1 influenza vaccines.
- Do not return any ancillary kit items (needles, syringes, vaccination records, alcohol prep pads, etc.).
- Do not return any antiviral drugs – or – any other medication.
- Do not return syringes with needles attached.
- Do not return broken, partially used, or empty vials/pre-filled syringes/nasal sprayers.
- Do include the attached Central Recovery Packing Slip (attached below) with the unused 2009 H1N1 vaccines.
These documents provide additional information regarding the National Vaccine Recovery Program for H1N1 influenza vaccine:
Where to Get the Latest Updates
The Bureau of Immunization provides links to information regarding the novel H1N1 influenza vaccine and recommendations for vaccination. Novel H1N1 influenza information specific to Florida is available at the Department of Health’s novel H1N1 influenza website www.MyFluSafety.com. Locations of Florida public health-sponsored novel
H1N1 influenza vaccine clinics are available at www.myflusafety.com/myfluclinic.htm.
The Centers for Disease Control and Prevention (CDC) has established novel H1N1 influenza web resources for healthcare professionals and the public. Some websites that are particularly helpful include:
In addition, the Immunization Action Coalition (IAC) has developed a novel H1N1 influenza information webpage at www.immunize.org/h1n1. The IAC selects from CDC website content, journal articles, partner resources, and news articles to present novel H1N1 influenza information that may have special relevance.
ATTENTION: Sanofi Pasteur Shortens Shelf Life on 50 lots of H1N1 Vaccine
February 8, 2010 -- The Bureau of Immunization, as part of our commitment to our partners, brings to your attention the following Centers for Disease Control and Prevention (CDC) information distributed via the Health Alert Network Tuesday, February 2, 2010, concerning the adjustment of the shelf life of specific lot numbers of Sanofi Pasteur monovalent 2009 (H1N1) influenza vaccine in pre-filled syringes.
Sanofi Pasteur has notified the CDC and the Food and Drug Administration (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 pre-filled syringes should be used by February 15, 2010, 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 these lots do not need to take any action.
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 in the Health Alert Network document available at www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00309. However, a related recall (See www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00306) was conducted recently, which involved lots from Sanofi Pasteur’s 2009 H1N1 vaccine in 0.25 mL and 0.5 mL pre-filled syringes. These actions do not affect Sanofi Pasteur’s 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 listed in the attached document. County health department directors received the list of providers who received recalled and shortened shelf life H1N1 vaccines in an email dated February 4, 2010.
These lots should be used by February 15, 2010, 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.
Please account for any wasted H1N1 influenza vaccine using the NOVEL H1N1 INFLUENZA VACCINE WASTE FORM. Upon completion, fax a copy of the Novel H1N1 Influenza Vaccine Waste Form to the Florida State Health Online Tracking System (Florida SHOTS™) staff at (850) 412-5801.
Letter from Thomas R. Frieden, MD, MPH,
Director of the Centers for Disease Control and Prevention
February 3, 2010 -- In conjunction with Thomas R. Frieden, MD, MPH, Director of the Centers for Disease Control and Prevention, the Bureau of Immunization adds our support to Dr. Frieden's encouragement to all healthcare providers to make efforts to ensure all children are fully protected against novel H1N1 influenza through administration of both doses of vaccine recommended for children from 6 months through 9 years of age.
Public and private healthcare providers in our state are to be commended for their efforts to protect our most precious investment, the children in our care. We encourage our immunization partners to complete the coverage begun with the first H1N1 vaccination.
IMPORTANT: Non-Safety-Related Voluntary Recall of Sanofi Pasteur Lot Numbers for H1N1 Vaccine in Pre-Filled Syringes
February 2, 2010 -- The Bureau of Immunization is forwarding this Health Alert Network Update titled Non-Safety-Related Voluntary Recall of Unused Doses from Certain Lots of Sanofi Pasteur H1N1 Vaccine in Pre-Filled Syringes.
Please read the official release carefully. Excerpts are included below:
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 healthcare providers to ensure the vaccine continues to meet required specifications. In recent testing of its influenza A (H1N1) 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.
Recommendations: While the potency of these lots is now below the manufacturer’s specification for the product, the Centers for Disease Control and Prevention and the Food and Drug Administration are in agreement 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.
Ordering of all other Sanofi Pasteur pre-filled syringes (0.25 and 0.5 ml) is temporarily blocked, as well.
ATTENTION: MedImmune Shortens Shelf Life on 12 lots of H1N1 Intranasal Vaccine
January 11, 2010 -- The Bureau of immunization, as part of our commitment to our partners and our customers, brings to your attention the following Centers for Disease Control and Prevention (CDC) information concerning the adjustment of the shelf life of specific lot numbers of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal.
Please be aware that based on ongoing stability testing, MedImmune has shortened the shelf life of 12 lots of H1N1 vaccine from 18 weeks to 16 weeks.
These 12 lots were originally labeled with expiration dates from January 29 through February 22, 2010. For simplicity, the manufacturer has changed the expiration date on all 12 lots to January 15, 2010.
The lot numbers for these 12 lots are between 500778P and 500799P (for specific lot numbers, please reference the MedImmune Letter to Distributors and Health Care Providers). Approximately 2.9 million doses of H1N1 vaccine from these lots have been shipped out.
Any provider that received these lots directly from McKesson should have received a notice on Friday, January 8, 2010 explaining the change in expiration date and providing instructions on what to do with unused H1N1 vaccine doses in these lots after January 15, 2010.
At this point, it is not anticipated that the expiration dates on other lots (i.e., 2009 H1N1 influenza vaccine lots 500800P and higher) will need to be changed.
On Monday, January 11, 2010, the CDC will distribute lists of providers in each jurisdiction who received H1N1 vaccine from these lots.
Please account for any wasted novel H1N1 vaccine using the Novel H1N1 Influenza Vaccine Waste Form.
IMPORTANT: Non-Safety Related Voluntary Recall of Specific Lots of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
December 23, 2009 -- The Bureau of Immunization is forwarding this important vaccine recall information to our immunization partners. Please read the following information and guidance carefully.
MedImmune's top priority is the health and safety of the patients who receive their products. As such, through consultation with public health authorities, on December 22, 2009 MedImmune announced that it is voluntarily recalling unused doses of 13 specific lots of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal due to a slight decrease in potency. There is no safety concern with the lots that are being recalled and therefore no need to revaccinate anyone who had been immunized with vaccines from these specific lot numbers.
- 500754P
- 500751P
- 500756P
- 500757P
- 500758P
- 500759P
- 500760P
- 500761P
- 500762P
- 500763P
- 500764P
- 500765P
- 500776P
MedImmune is sending a notification to providers who received doses directly from McKesson of the 13 lots of vaccine so they can return any unused vaccine. Please quarantine any affected lots in your inventory until you can act on the directions you receive from the manufacturer. Until such time as the manufacturer distributes vaccine return information, there is no need to contact the Florida Vaccines For Children (VFC) Program, the Florida SHOTS (Florida State Health Online Tracking System) team, or McKesson Specialty. You will be notified as more information becomes available. All returns should be sent to: Stericycle®, Attention: Event 2073, 2670 Executive Drive, Suite A, Indianapolis, IN 46241. Stericycle® is handling the return of affected vaccines for MedImmune, they can be reached at 866-209-9273.
There were approximately 4.7 million doses in these lots that were distributed to providers. Most of the doses were shipped to vaccine providers in the first few weeks of the vaccination campaign, during a time when the vaccine potency was still at or above the recommended level. MedImmune is recalling any doses from these lots that may still be unused.
The slight decrease in vaccine potency is expected to have little, if any, impact on the response to vaccination. Revaccination is not recommended because the vaccine in the affected lots is still expected to be effective in stimulating a protective immune response. These doses were well within potency specifications at the time they were distributed, and in fact, some of the doses being recalled are actually still within required potency limits. In exercising the most conservative approach, MedImmune is recommending that all lots marked with an expiration date between January 19 and January 26, 2010 not be used.
Parents of children who received vaccine from the recalled lots do not need to take any special actions. As is recommended for all 2009 H1N1 vaccines, all children 9 years of age and younger should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. Therefore, children less than 10 years old who have only received one dose of the nasal spray vaccine thus far should still receive a second dose of 2009 H1N1 nasal spray vaccine.
Updated: H1N1 Vaccine - Return Communication
December 22, 2009 -- The Bureau of Immunization is pleased to bring the following updated guidance document to the attention of our partners.
The attached H1N1 Vaccine Return document REPLACES the previous version distributed by the CDC on November 19, 2009.
Change in the 6th paragraph of the document includes the following: "Grantees should plan for disposal of their H1N1 vaccine according to the rules and policies of their state/local jurisdiction. Outside of the setting [of] a vaccine recall, neither McKesson nor the manufacturers will accept returned H1N1 vaccine". Therefore, all wasted and expired H1N1 vaccine should be disposed of according to usual medical biosafety procedures. All wasted and expired H1N1 vaccines should be documented on the Novel H1N1 Influenza Vaccine Waste Form and then faxing the completed form to Florida SHOTS at 850-412-5801. This form is attached for your use.
This does not alter our current return policy for the return of H1N1 vaccine. McKesson does not have a means to accept returned H1N1 vaccines. The only vaccines that should be returned to McKesson are those that arrive in a nonviable condition or appear to have been damaged during transit. Providers who have concerns about vaccine viability in transit should contact McKesson Customer Service IMMEDIATELY UPON RECEIPT OF THE PACKAGE.
This guidance only applies to the H1N1 influenza vaccine. Vaccine return policy and procedure for all other McKesson deliveries, including Vaccines for Children Program vaccines, remain unchanged.
IMPORTANT: Voluntary Recall of Sanofi Pasteur H1N1 Vaccine Lot Numbers
December 16, 2009 -- Sanofi Pasteur, Inc., has notified the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) that routine testing of its pediatric H1N1 2009 monovalent vaccine in 0.25 ml syringes in four identified lots have been identified with lower antigen content than the specification limit.
The FDA and the CDC have determined there are no safety concerns with these lots of H1N1 vaccine. The vaccine in these lots is still expected to be effective in providing protection. Therefore, 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 one month apart for optimal protection.
The lot numbers affected by this recall are:
- 0.25 ml pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25):
- 0.25 ml pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70):
Providers should not use these affected lots. Follow instructions from Sanofi-Pasteur for returning the affected H1N1 vaccine using the postage-paid shipping label. Providers who have received H1N1 vaccine from the lots in question directly from McKesson will also receive a packet with instructions from Sanofi Pasteur. Sanofi Pasteur will ship their packets on Wednesday, December 16, 2009 for arrival on Thursday, December 17, 2009. All returns should be sent to: Capital Returns, 6101 North 64th Street, Milwaukee, WI 53218. Capital Returns is handling the return of affected vaccines for Sanofi Pasteur, they can be reached at 888-241-9288.
Centers for Disease Control and Prevention
Sanofi Pasteur
National Influenza Vaccination Week
January 10-16, 2010
The Centers for Disease Control and Prevention (CDC) has announced the week of January 10-16, 2010, as National Influenza Vaccination Week (NIVW). This event highlights the importance of continuing influenza vaccination, as well as fosters greater use of flu vaccine after the holiday season into January and beyond. This year's NIVW (originally scheduled for December 6-10, 2009) is now rescheduled for January 10-16, 2010. (NIVW)
Update on Expanded Use of CSL H1N1 Vaccine
December 11, 2009 -- This is updated information on the expanded use of CSL's H1N1 vaccine to persons 6 months of age and older.
Due to the limited availability of certain age-appropriate H1N1 vaccine presentations, the flyer language has been revised to reflect more permissive use of the CSL vaccine in order to reduce missed opportunities for vaccination in younger age groups. The revised ‘CSL Provider Package Flyer’ replaces the original flyer previously distributed and will be included in H1N1 vaccine shipments after December 22, 2009.
Beware: Fraudulent Email – Not Sent by the Centers for Disease Control and Prevention
December 1, 2009 -- The Bureau of Immunization wishes to bring to your attention the following important information forwarded to us by the Centers for Disease Control and Prevention (CDC). Some providers have reported receiving a potentially fraudulent email (text only). The email appears to come from the CDC, but instead, points users to a fake website that may be phishing for personal information. Immunization partners are advised to avoid clicking on embedded links to sites not familiar to them. Immunization partners should also consider advising providers of novel H1N1 influenza vaccine that fraudulent emails may be circulating.
If you receive such an email or have questions about the authenticity of emails received from CDC, please avoid clicking on any embedded links. You may verify the authenticity of any suspect emails with an IT specialist in your agency or you may contact the CDC to verify the sender is a CDC employee.
Transfer of Novel H1N1 Influenza Vaccines
December 1, 2009 -- We have received multiple inquiries about transferring novel H1N1 influenza vaccines between various H1N1 registered providers. After reviewing this matter with Medical Quality Assurance (MQA), we are providing the following guidance. At this point, this guidance applies only to the distribution, redistribution, and transfer of novel H1N1 influenza vaccines.
County health departments (CHDs) are responsible for approving, documenting, and accounting for all novel H1N1 influenza vaccine transfers between the following H1N1 registered providers.
- Vaccine transfers from one CHD to another CHD.
- Vaccine transfers between the CHD and a local H1N1 registered provider(s).
- Vaccine transfers between a local H1N1 registered provider and another local H1N1 registered provider. These transfers must be approved and written documentation maintained (i.e., vaccine transfer log) by the CHD.
It is important to stress that proper storage and handling of the vaccine must be maintained during all vaccine transfers. It is also essential that CHDs ensure appropriate documentation of vaccine adjustments and transfers in the Florida State Health Online Tracking System (Florida SHOTS™) for novel H1N1 influenza inventory accountability. Please call the Florida SHOTS™ Help Desk at (888) 877-7468 if you have questions regarding inventory adjustments, and Laura Rutledge at 850- 245-4342 for questions regarding the vaccine transfer process.
Updated Guidance on CSL's Novel H1N1 Influenza Vaccine and Differentiating Between Seasonal and Novel H1N1 Influenza Live Attenuated Vaccine
November 23, 2009 -- This important update from the Centers for Disease Control and Prevention (CDC) provides information regarding the expanded Food and Drug Administration (FDA) approval for the use of CSL’s novel H1N1 influenza vaccine to include children 6 months of age and older. Both vaccines had previously been approved only for use in adults 18 years of age and older.
Please pay special attention to these CDC recommendations.
- Both the CSL novel H1N1 influenza 0.5 mL pre-filled syringe and multi-dose vial vaccine formulations should be reserved for use in individuals 3 years of age and older if alternative products are available to administer to children 6 through 35 months of age.
- Using the CSL novel H1N1 influenza 0.5 mL pre-filled syringe to vaccinate children 6 through 35 months of age would result in wastage of one 0.25 mL dose per syringe.
Also, the CDC issued guidance to assist providers in differentiating between live attenuated seasonal vaccine and novel H1N1 influenza vaccine. Healthcare providers who plan to vaccinate patients with a dose of the injectable seasonal influenza vaccine, as well as a dose of the new novel H1N1 influenza intranasal vaccine (or vice versa), should be careful to differentiate between the two to avoid administration errors.
Effective Immediately: Updated Guidance on CSL's Novel H1N1 Influenza Vaccine
November 17, 2009 -- Updated Guidance for the Use of CSL’s 2009 H1N1 Monovalent Vaccine from the Centers for Disease Control and Prevention (CDC) provides information regarding the expanded Food and Drug Administration's (FDA) approval for the use of CSL’s seasonal and novel H1N1 influenza vaccines to include children 6 months of age and older. Both vaccines had previously been approved only for use in adults 18 years of age and older.
Please pay special attention to the CDC's recommendation and rationale to reserve both the CSL novel H1N1 influenza pre-filled syringe and multi-dose vial vaccine formulations for individuals 3 years of age and older if alternative products are available. Additionally, the CDC discourages using a half-dose of the CSL novel H1N1 influenza pre-filled syringe vaccine on a child 6 through 35 months of age and discarding the remaining half-dose.
This expanded age provides an additional FDA-approved product for children 3 to 4 years of age. There is no recommendation or age extension from the FDA, or a CDC recommendation to use products off-label at this time for other flu products. For example, the Novartis product is licensed and approved for children 4 years of age and above and should not be administered to children younger than 4 years of age.
Novel H1N1 Influenza Pandemic Update:
Pneumococcal Vaccination Recommended to Help Prevent Secondary Infections
November 17, 2009 -- The Bureau of Immunization is pleased to bring to your attention the Centers for Disease Control and Prevention's (CDC) Health Advisory, which reminds us that pneumococcal vaccines can prevent some very serious secondary bacterial infections following infection with influenza viruses.
Streptococcus pneumoniae (pneumococcus) remains a leading cause of vaccine-preventable illness and death in the U.S. Influenza predisposes individuals to developing bacterial community-acquired pneumonia. During each of the influenza pandemics of the 20th century, secondary bacterial pneumonia was a frequent cause of illness and death and S. pneumoniae was reported as the most common etiology. These findings also apply to seasonal influenza. Recently, pneumococcal infections have been identified as an important complication in severe and fatal cases of novel H1N1 influenza virus infection (www.cdc.gov/mmwr/preview/mmwrhtml/mm5838a4.htm). A key difference between this pandemic and those of the past is that now we have two pneumococcal vaccines that may help to prevent these infections. However, approximately 70 million persons with existing pneumococcal polysaccharide vaccine (PPSV) indications are unvaccinated (National Health Interview Survey, 2007).
The CDC's Advisory Committee on Immunization Practices (ACIP) recommends a single dose of PPSV for all people 65 years of age and older and for persons 2 through 64 years of age with certain high-risk conditions. Among those with high-risk conditions for pneumococcal disease, most are also at high risk for severe complications from influenza. Special emphasis should be placed on vaccinating adults under 65 years of age who have established high-risk conditions for pneumococcal disease; PPSV coverage among this group is low and this group may be more likely to develop secondary bacterial pneumonia after an influenza infection. All children younger than 5 years of age should continue to receive pneumococcal conjugate vaccine (PCV7) according to existing recommendations.
For additional information regarding S. pneumoniae and influenza, visit:
Additional information can be found in the links at the end of the advisory document.
The bureau has educational materials concerning pneumococcal vaccines on our website at www.immunizeflorida.org/publications/brochures.htm#adult.
VIS News - 2009 H1N1 Influenza Vaccine Information Statements - Spanish Translation
October 12, 2009 -- The Bureau of Immunization wishes to announce the availability of the 2009 H1N1 Influenza Vaccine Information Statements (VIS) - Spanish translation. These files replace the 'temporary' VISs in Spanish that were distributed previously. The VIS may be accessed on the Centers for Disease Control and Prevention's (CDC) website at www.cdc.gov/vaccines/pubs/vis/default.htm#h1n1live.
VISs are information sheets produced by the CDC that explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Federal law requires that a VIS be handed out before each dose of certain vaccines.
Healthcare providers should periodically access the VIS electronically and print out a supply for routine distribution. If necessary, bureau staff can FAX copies to providers without internet access.
Vaccine Information Statements - 2009 H1N1 Influenza Vaccine Information Statements
October 6, 2009 -- The Bureau of Immunization wishes to announce the availability of the 2009 H1N1 Influenza Vaccine Information Statements (VIS).
VISs are information sheets produced by the Centers for Disease Control and Prevention (CDC) that explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Federal law requires that a VIS be handed out before each dose when certain vaccinations are given.
Print-ready files can be found on the CDC website at www.cdc.gov/vaccines/pubs/vis/default.htm#h1n1live.
These new VISs have been integrated into the Florida State Health Online Tracking System (Florida SHOTS™), so registry users can access them electronically.
Healthcare providers should periodically access the VIS electronically and print out a supply for routine distribution. If you do not have web access, please contact the bureau at 850-245-4342 and staff can FAX copies to you.
Follow-up to Vaccine Information Statements - 2009 H1N1 Influenza Vaccine Information Statements
Following the release of the Vaccine Information Statements - 2009 H1N1 Influenza Vaccine Information Statements announcement, our office would like to respond to two questions that county health departments (CHDs) have asked our office.
- When/where will the foreign language translations of the 2009 H1N1 Influenza VIS be available?
The CDC is working to translate the H1N1 Live Attenuated Influenza Vaccine (LAIV) VIS and H1N1 Trivalent Inactivated Influenza Vaccine (TIV) VIS into the following languages: Arabic, Armenian, Bengali, Cambodian, Chinese, Farsi, Haitian Creole, Hmong, Karen, Korean, Russian, Somali, Spanish, Tagalog, Thai, Urdu, and Vietnamese.
The CDC would like to have the translated VISs available on the CDC's and Immunization Action Coalition's (IAC) websites soon. As soon as the CDC tells us the translations are available, we will notify all providers.
- Will the Bureau of Immunization print and stock any VISs in the State Distribution Center?
No. The bureau will not be printing or storing VISs at the State Distribution Center. Providers are responsible for their own printing needs.
Interested in Administering Novel H1N1 Influenza Vaccine?
- Current Florida SHOTS users, please log onto Florida SHOTS and follow the directions for H1N1 registration.
- New applicants, to be an H1N1 vaccine provider, please click here to start the process.
- Providers who have pre-registered can contact the Florida SHOTS enrollment desk at 1 (877) 888-7468 to request the status of your application.
Use of Influenza A (H1N1) 2009 Monovalent Vaccine, Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009
August 28, 2009 -- This report, released in Mortality and Morbidity Weekly Report (MMWR), Recommendation and Reports, August 28, 2009/58(RR10);1-8, provides recommendations by Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) regarding the use of vaccine against infection with novel H1N1 influenza virus. Licensed vaccine is expected to be available by mid-October 2009.
The guiding principle of these recommendations is to vaccinate as many persons as possible as quickly as possible. Vaccination efforts should begin as soon as vaccine is available. State and local health officials and vaccination providers should make decisions about vaccine administration and distribution in accordance with state and local conditions.
Highlights of these recommendations include:
- Identification of five general population target groups for initial focus of vaccination efforts:
- Pregnant women.
- Persons who live with or provide care for infants less than 6 months of age.
- Healthcare and emergency medical services personnel.
- Children and young adults 6 months through 24 years of age.
- Persons 25 through 64 years of age who have medical conditions that put them at higher risk for influenza-related complications.
- Establishment of a priority for a subset of persons within the initial target groups in the event that initial vaccine availability is unable to meet demand.
- Guidance on use of vaccine in other adult population groups as vaccine availability increases.
CDC Influenza Plain Language Materials
Available from: Seasonal Flu: Free Resources
Trifold Brochures
Flyers
Posters
Other Materials
