Nirsevimab is a passive immunization product that is available through the Vaccines For Children program (VFC) program. It is administered shortly before or during  the RSV season (October – March in most of the continental US).   

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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 

Adequate supply is anticipated for the 24-25 season.  

Nirsevimab purchase cost 

The private-sector cost for nirsevimab is: 

  • $519.75 per dose for 50mg and 100mg doses 
  • $1039.50 per dose for a 200mg dose (Two 100mg doses)

Product-need forecasting

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, 2024? 
    • 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 likely as updated COVID-19 vaccines become available.)
  • How much cash is available to purchase this product? What financing options are available to purchase this product?  
  • How many local OB/GYN practices are administering Abrysvo?
  • How many local birthing hospitals are administering nirsevimab/enrolled in VFC?

Ordering nirsevimab 

VFC product will be ordered directly from the state immunization program. No supply challenges are anticipated, and distribution will occur using an allocation system similar to the 23-24 RSV season.  

For commercial product, the Beyfortus Reservation Program allows users to forecast product needs and offers several benefits such as prioritized shipping, reserved doses, an additional 2% discounts for orders placed on VaccineShop.com, and 90-day payment terms. Participation in the program required completion of a forecasting tool in the Spring; ordering occurs before August 31, 2024 and shipments beginning in September 2024. Those who order outside of the Beyfortus Reservation Program will be able to order product beginning in September 2024.  

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. 
  • Participation in the reservation program affords practices longer payment terms (90 days), than ordering outside of the program.  
  • 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. 

Additional Information

Last Updated

07/11/2024

Source

American Academy of Pediatrics