NVX-CoV2373 EUC Delivery Information Sheet

Communications:

– Novavax will communicate the monthly quantity and date of delivery. Communication will come from customerorders@novavax.com.
– Any requested changes to the quantity/date should be communicated to Novavax within 3 days of receipt. Change requests should be sent to customerorders@novavax.com.
– Such requests will be considered, and a response will be sent with the determination within 5 business days of receipt.

Product Shipment:

Product could be packaged at one or more facilities over time. Initially, all deliveries will be packaged with the following dimensions:

SERUM

 

 

 

 

*As additional packaging sites are planned, updated information will be communicated.  

– Product delivered is vaccine vials only, no additional vaccine administration materials will be included.

– Product will be shipped at 2-8°C while in transit. The following thermal shipping systems and security seals will be used:

– For small orders, less than a pallet: product will be packed in single use thermal shipper sealed with tamper evident tape. After delivery, the thermal shippers may be discarded.
– For large orders, pallet(s): product will be loaded in:

– Ground Shipments: Temperature-controlled vehicle set to maintain 2-8°C. Vehicles will have a GPS/Satellite tracking capability and secured with a uniquely numbered high-security bolt seal.
– Air Shipments: An active RKN ULD container set to maintain 2-8°C. Vehicles will be secured with uniquely numbered cable seal. Upon receipt, product must be unloaded, and the container returned to the driver.

– The receiving site should take care to ensure the appropriate level of cold storage is available to accommodate multiple pallets as needed. A high-security bolt seal will require a bolt cutter to remove from the vehicle doors.
– Additional security features and protocols including but not limited to, security escorts, customer tracking GPS devices or driver protocol may be accommodated upon review.

– Shipment information such as ASN (Advanced Shipping Notification) and shipment details can be arranged with the customer upon request. Shipment and logistics inquiries can be sent to NVXGlobalLogs@novavax.com.

– A temperature monitoring device, TempTale Ultra will be included with the shipment to monitor the temperature. Upon receipt, ideally in a 2-8°C storage, press the “stop” button. Remove the cap and insert into a computer USB port to download and review temperature data. The device is a single use device and after download the device can be recycled or disposed. Detailed instructions will be provided upon shipment.

–  Vaccine Reminder Cards & Lot Stickers:

– For those Member States who have selected to receive VRCs, they will be provided as 1 card per dose and shipped separately to the Member State warehouse location.
– Lot specific stickers will be placed within the shipper. Full shippers will contain a total of 6,000 stickers, one for the patient record, one for the reminder card.

– Patient Information Leaflet: each 10-vial box contains 1 Patient Information Leaflet (PIL)

– Initial shipments contain a “blank” PIL with QR code that would direct a patient or health care professional to a website for the SmPC and PIL information.
– Subsequent shipments will contain a single English PIL in the carton with the exception of Belgium, Croatia, Czech Republic and Greece; language specific PILs will be sent to these countries.
– Downloadable translations of PIL and SMPC will be posted for all countries on novavaxcovidvaccine.com

 Product Delivery:

– At delivery, TempTale device should be removed, and data transmitted to tempdata@novavax.com
– Within 3 business days, Product should be visibly inspected to confirm 1) correct quantity and 2) delivery constitutes Conforming Product

– If needed, request for additional 48 hours can be submitted to customerorders@novavax.com for Novavax to consider
– Customer to notify Novavax of Product acceptance via email to customerorders@novavax.com
– Product is deemed accepted after the Inspection Period unless Novavax receives notification of temperature excursion or non-Conforming Product.

– Contacts for delivery questions or reporting are as follows:

 

Inquiries/Reporting Items:	Contact:
Temp Tale Reporting	tempdata@novavax.com
Missing in Transit, Damage Upon Receipt, Concealed Damage or Shortage	distribution@novavax.com
Import Paperwork Inquiry	NVXGlobalLogs@novavax.com
Product Quality Complaint Reporting	PQC@novavax.com

You may also dial 240-268-2000 to reach a member of our Customer Experience team