This is an official
CDC HEALTH UPDATE

Distributed via Health Alert Network
Tuesday, February 2, 2010, 18:45 ET (6:45 PM EST)
CDCHAN-0309-2010-02-02-UPD-N

Sanofi Pasteur Monovalent 2009 (H1N1) Influenza Vaccine in Pre-Filled Syringes — Shortened Shelf Life of Certain Lots

Summary

Sanofi Pasteur has notified CDC and 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 prefilled syringes should be used by February 15, 2010, as indicated in the table below 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 the lots listed below with shortened shelf life do not need to take any action.

Background

As part of its quality assurance program, Sanofi Pasteur performs routine, ongoing stability testing of the vaccine after it has been shipped to providers. Stability testing means measuring the strength of a vaccine over time.

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 below.  However, a related recall (See http://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 described below.

Lot Information

These lots should be used by February 15, 2010, as indicated in the table below 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. 64^{th Street, Milwaukee, WI 53218}

^{Influenza A (H1N1) 2009 Monovalent Vaccine in Pre-Filled Syringes}

^{Expiration Date Change}

^{For More Information:}

• ^{CDC’s toll-free information line, 800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, is available 24 hours a day, every day.}
• ^{For other inquiries, please contact Sanofi Pasteur Customer Services: 1-800-VACCINE (1-800-822-2463) or visit www.vaccineshoppe.com}

Continue to vaccinate for H1N1 influenza and retain current vaccine stocks. January through March is the traditional influenza season. While disease activity is now low, there is a real possibility of a third wave of H1N1 influenza disease, similar to what happened in the 1957-1958 pandemic. As a result, the New York State Department of Health (NYSDOH) is encouraging you to:
• Continue to offer and encourage H1N1 influenza vaccination to your patients;
• Retain your current supply of H1N1 influenza vaccine in your office, unless you do not have sufficient space to store it. Contact your county health department if you have vaccine that you are unable to store;
• Call 1-800-KID-SHOT to place a vaccine order. You may check your order status at: http://www.health.state.ny.us/diseases/communicable/influenza/h1n1/health_care_providers/vaccine/ordering_history.htm;
• Instructions on what to do with unused vaccine will be provided in the future.
Reminder on second vaccine doses for children less than 10. Children less than 10 years old are recommended to get a second dose of H1N1 vaccine at least 28 days after the first dose. The state immunization registry, NYSIIS, can be used to check on which children need a second dose and can generate reminder lists and letters. A short on-line tutorial for using the NYSIIS Reminder-Recall function (Module #10) is located at: https://commerce.health.state.ny.us/hpn/bcdc/immunization/instantdemo/tutorials.html
• Either nasal spray (if appropriate) or injectable vaccine may be used for the second dose regardless of the type of vaccine administered for the first dose.
• Pre-filled 0.25 ml syringes for children under age 3 years are no longer available. Please use Sanofi or CSL multi-dose vials for second doses of injectable vaccine.
• NYSDOH has waived the provisions of state law which usually restricts the use of thimerosal-containing influenza vaccines in pregnant women and children under the age of 3 years. There is no scientific evidence of harm caused by the low doses of thimerosal in vaccines. For more information, see: http://www.nyhealth.gov/diseases/communicable/influenza/h1n1/health_care_providers/frequently_asked_questions/vaccine_containing_thimerosal.htm

Reminder to report vaccine doses administered. The federal provider agreement which you signed to receive H1N1 influenza vaccine commits you to report vaccine usage.
• Vaccine administered to persons less than 19 years of age must be reported by state law to the New York State Immunization Information System (NYSIIS). For more information, see: http://www.health.state.ny.us/prevention/immunization/information_system/
• Doses administered to persons age 19 years and older may be reported to NYSIIS with patient consent, or aggregate doses administered must be reported to the NYSDOH telephone or web-based systems. See the following website for additional information: http://www.nyhealth.gov/diseases/communicable/influenza/h1n1/health_care_providers/vaccine/docs/vaccine_reporting_requirements.pdf.

For more information on your order, second dose administration, or reporting, please call 1-800 KID-SHOT.

Thank you for your continued efforts to vaccinate New Yorkers against influenza.

Dear Chief Executive Officer, Directors of Neonatal Intensive Care Units (NICUs), and Chiefs of Pediatrics and Infection Control:

The purpose of this letter is to advise you of new requirements for offering influenza vaccination to parents and anticipated caregivers of NICU patients and of the reinstatement of requirements for offering influenza vaccination to each admitted person age sixty-five years or older, both effective January 15, 2010. Both requirements are for monovalent H1N1 vaccine.

New requirement in NICUs. On July 31, 2009, Governor Paterson signed into law an amendment to Public Health Law (PHL) section 2805-h that requires all general hospitals with NICUs to offer influenza vaccination annually, between September 1 and April 1, to all persons who are parents or are reasonably anticipated to be caregivers in the households of newborns being treated in NICUs. This law became effective November 25, 2009; however, pursuant to my authority under the statute and because of inadequate supplies of seasonal and 2009 H1N1 influenza vaccines, I modified the requirement by:

• Waiving the requirement for offering the 2009 trivalent seasonal influenza vaccine for the 2009-2010 influenza season, and
• Delaying the effective date of the requirement to offer monovalent 2009 H1N1 influenza vaccine until January 15, 2010.
• 
  

The amendments to PHL section 2805-h support the recommendations of the Advisory Committee on Immunization Practices (ACIP) on influenza. Influenza vaccination is not licensed for children aged less than six months and antiviral medications are not licensed for use in infants less than 12 months of age. Therefore, protection of young infants, who have hospitalization rates similar to those observed among the elderly, depends on vaccination of infants’ close contacts. By providing parents and caregivers of these high-risk infants with the opportunity to receive influenza vaccination while in NICUs, those infants receive some protection against influenza disease. Beginning January 15, 2010, you must offer H1N1 vaccine; I also encourage you to offer seasonal vaccine, when available.

Reinstated requirement for admitted persons age sixty-five years or older. PHL 2805-h also contains a requirement that the administrative officer or other person in charge of each general hospital must offer to each admitted person age 65 years or older vaccination against influenza virus. The requirement, effective since 2006, applies annually between September 1 and April 1.

On November 18, 2009, I waived this provision for seasonal trivalent influenza vaccine and monovalent H1N1 vaccine because of shortages of both vaccines and because monovalent H1N1 vaccine was not recommended for persons over age 65 years or older. However, since that time, H1N1 vaccine has been recommended for persons of all ages greater than six months and sufficient supplies of vaccine have become available. Therefore, I am reinstating this requirement for H1N1 vaccine effective January 15, 2010. You are also encouraged to offer seasonal vaccine, when available.

Hospitals must take steps to adopt and implement both policies as required under law.

Any questions regarding this letter may be directed to the Department’s Bureau of Immunization at (518) 473-4437 or the Office of Health Systems Management at (518) 402-1003.

Sincerely, Richard F. Daines, M.D. Commissioner of Health