Nirsevimab is part of the Vaccines For Children program and will be available for the 23-24 RSV season. While administration will start in early October, practices should start planning now for implementation of this new product.
Formulations
Nirsevimab is packaged in pre-filled syringes of either:
- 50mg (0.5mL) with purple plunger rod (for infants weighing <5 kg)
- 100 mg (1mL) with light blue plunger rod (weighing ≥5kg)
Supply and Ordering
Nirsevimab Supply
Demand for nirsevimab is outpacing expectations by the manufacturer, Sanofi, who has released a statement noting their attempt to work with the Centers for Disease Control and Prevention on equitable distribution of the product.
Ordering the 50 mg formulation of nirsevimab through the Vaccines for Children (VFC) program is limited (contact your state immunization program for more details), and the 100-milligram formulation remains unavailable through VFC and from Sanofi – although deliveries are expected to continue. For more information view the AAP News article (login required).
Nirsevimab purchase cost
The private-sector cost for nirsevimab is:
- $495 per dose for 50mg and 100mg doses
- $990 per dose for a 200mg dose (Two 100mg doses)
Ordering nirsevimab
As with other vaccines, your practice will need to determine how to order and stock the right amount of product. Demand from families, cost to purchase and storage space are factors that drive how much your practice should/is able to order.
When placing your order, consider the following in determining your order size:
- How many patients were born after March 1, 2023?
- What is the monthly average of new patients who are newborns?
- What % of these patients are likely to be under 5kg?
- How many patients who will be 8-19 months of age during the RSV season are at high risk and meet the eligibility criteria for nirsevimab during their 2nd RSV season?
- What percentage of your patients are insured privately?
- How much enthusiasm for this product is there in your practice? What % of families do you believe will agree to nirsevimab?
- How much storage space is in your vaccine refrigerators? (Remember that this product will be administered during influenza season, and as new COVID-19 vaccines become available.)
- How much cash is available to purchase this product? What financing options are available to purchase this product?
Additional considerations:
- The formulation of nirsevimab will not change from year to year.
- Nirsevimab has a shelf life of about 18 months.
- Nirsevimab can be returned after it expires, similar to other Sanofi vaccine products.
- Sanofi allows payment up until 150 days from the product shipment date if ordered directly from them.
- Nirsevimab can be ordered as often as desired and in any quantity (there is no minimum order). The product will come in the following pack sizes:
- Five 50 mg/0.5 mL single-dose pre-filled syringes in a carton
- Five 100 mg/mL single-dose pre-filled syringes in a carton
For additional guidance on ordering vaccines, please see the AAP Ordering Vaccines page.
Storage and Handling
You will store nirsevimab the way many vaccines are stored.
Routine Storage: In a refrigerator at 2˚C– 8˚C ; DO NOT FREEZE
Short-term Storage: Room temperature (20˚C – 25˚C), for 8 hours, if protected from light. After removal from the refrigerator, nirsevimab must be used within 8 hours or discarded.
Activated Syringe: Manufacturer-Filled Syringes (MFSs) are prepared and sealed under sterile conditions by the manufacturer. Activate an MFS (ie, remove the syringe cap or attach the needle) only when ready to use. An MFS does not contain a preservative to help prevent the growth of microorganisms. Once the sterile seal has been broken, the vaccine should be used or discarded by the end of the workday.
Last Updated
10/11/2023
Source
American Academy of Pediatrics