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Shortened Shelf Life of Some 2009 Sanofi Pasteur Monovalent Vaccine in Pre-Filled Syringes

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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  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.

Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza

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The California Department of Public Health (CDPH) has reviewed and concurs with the Centers for Disease Control and Prevention’s (CDC) Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season released on December 7, 2009. These recommendations focus on the use of antiviral medications for the treatment and chemoprophylaxis of influenza.

CDPH Recommends Free H1N1 Vaccination to Healthcare Facility Employees (11-17-09)

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The California Department of Public Health (CDPH) recommends facilities offer H1N1 vaccines to all of their employees free of charge in this letter from Dr. Mark Horton:

H1N1 Vaccine and the California Mercury Free Vaccine Act 10-16-09

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An exemption has been granted from California Health and Safety Code Section 124172 subdivision (a) for influenza A (H1N1) 2009 monovalent influenza vaccine administered to children younger than 3 years old and pregnant women for the period of October 12, 2009 – November 30, 2009.

CDC Vaccination Information Statements (VIS)

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Vaccination Information Statements for H1N1 vaccines (live, intranasal 2009 H1N1 influenza vaccine and inactivated, 2009 H1N1 influenza vaccine) have been posted and are available at http://www.cdc.gov/vaccines/pubs/vis/default.htm. “Any person being vaccinated for H1N1 must be given a copy of the CDC’s Vaccine Information Statement prior to being vaccinated. If an employee is being vaccinated, the additional elements required by the Cal-OSHA Aerosol Transmissible Disease standard must also be disclosed to the employee prior to vaccination.”

New H1N1 CPT Codes Announced

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The American Medical Association (AMA) has announced two new Current Procedural Terminology (CPT) codes, effective immediately, for reporting the H1N1 vaccine and administration. The codes are as follows: 90470 H1N1 immunization administration, including counseling when performed, 90663 Influenza virus vaccine, pandemic formulation, and H1N1.  The Centers for Medicare & Medicaid (CMS) also created two HCPCS codes: G9141 Influenza A (H1N1) immunization administration (includes the physician counseling the patient/family), G9142 Influenza A (H1N1) vaccine, any route of administration.

CMS typically adopts published CPT codes, known as Medicare HCPCS Level I codes. In this case, CMS released their own set of H1N1 codes prior to the published AMA CPT codes. The California Hospital Association has brought to the attention of CMS that there are now two sets of H1N1 codes which could create billing confusion for providers. At this time, CMS has advised providers use the CMS HCPCS codes (G9141 and G9142) for Medicare billing until further notice.

The following links include the AMA and CMS fact sheets for H1N1 billing:

Novartis Ships H1N1 & Seasonal Vaccines to US

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Vaccine manufacturer Novartis said yesterday it has completed shipments of its seasonal flu vaccine, Fluvirin, to the United States after delivering 27 million doses. The Swiss company originally had said it planned to supply about 30 million doses to the US market. Yesterday the firm also said it started shipping swine flu vaccine on Sept. 27, 2 weeks after the formulation received approval from the US Food and Drug Administration. 

      

CDPH H1N1 Vaccine Website – Home Page and H1N1

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Beginning September 1, 2009 CDPH's Pandemic H1N1 Vaccine website will go live. The website will allow you to pre-register for vaccine, order vaccine, receive vaccine information and updates, and report your H1N1 vaccine usage.
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