2009-2010 Influenza Season Update #10
Updated Guidance for the Use of CSL’s 2009 H1N1 Monovalent Vaccine to Include Children Aged 6 Months & Older
To: Vermont Health Care Providers
From: Wendy Davis, MD, Commissioner
Date: November 19, 2009
– Please Distribute Widely –
On November 11, 2009, the Food & Drug Administration (FDA) expanded the approved use of CSL Limited’s seasonal and 2009 H1N1 monovalent influenza vaccines to include children aged 6 months and older. Both vaccines had previously been approved only for use in adults, age 18 years and older. The immediate effect on the national H1N1 flu vaccination program is that CSL’s pre-filled syringe and multi-dose vial formulations can now be used for a much broader range of ages.
Recommendations for Use of CSL 2009 H1N1 Vaccine
Both the CSL H1N1 pre-filled syringe and multi-dose vial vaccine formulations should be reserved for individuals age 3 years and older if alternative products are available for others. Complete dosage and administration information for the CSL 2009 H1N1 vaccine is available from the CSL package insert: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182401.pdf
The Centers for Disease Control & Prevention (CDC) is issuing clarifying guidance on use of CSL H1N1 vaccine that takes into account practical logistical considerations of allocation, ordering, and distribution of vaccine and ancillary supply kits.
- Pre-filled syringes: Since children age 6 to 35 months would only require 0.25ml, or half of the contents of the syringe, only half of the vaccine contained in one syringe could be used, and the rest discarded. While vaccine is in limited supply nationwide, CDC discourages using a half dose of CSL H1N1 pre-filled syringe vaccine for a child age 6 to 35 months.
- Multi-dose vials: Providers will receive ancillary supplies that match the doses provided in the CSL H1N1 multi-dose vial vaccine. If providers choose to administer half doses of the multi-dose vial formulation to children age 6 to 35 months, they will effectively be short half the number of needle/syringe units, alcohol pads, vaccination record cards and sharps containers. Providers must then use their own ancillary supplies to make up the difference, and print additional shot cards from the CDC website: http://www.cdc.gov/flu/freeresources/2009-10/pdf/influenza_record_card2009.pdf
You may receive other vaccines manufactured by Novartis, Sanofi Pasteur, Inc., or MedImmune Vaccines, Inc. These vaccines may include different formulations and age indications. Be careful to review and follow the package inserts for each preparation.