Please see the FDA news release HERE. The issuance of the EUA allows for the shipment of pediatric vaccine to providers to be initiated. Although vaccine allocated from Waves 1-3 of the initial pediatric vaccine roll-out will start to be on shelves, providers are restricted from administering the vaccine until ACIP and CDC recommendations are made. 

The Advisory Committee for Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) will be meeting on November 2 and November 3 to discuss and determine recommendations for the use of Pfizer’s pediatric COVID-19 vaccine for kids ages 5-11.  

The ACIP’s recommendation must then be followed by a recommendation from the CDC Director before administration of the vaccine may begin. Vaccinating outside of CDC recommendations could result in the following:  

1. Loss of PREP Act liability coverage 

2. Loss of compensation through CICP for individuals injured following vaccination  

3. Lack of reimbursement from payers 

4. Violation of your COVID-19 vaccine provider agreement with the CDC 

Please reference the  revised EUA fact sheets: 

• 5-11 Pfizer Fact Sheet for Healthcare Providers

• 5-11 Pfizer Fact Sheet for Recipients and Caregivers 

Additional Pfizer Pediatric Vaccine Information 

As we prepare for the potential administration of Pfizer pediatric vaccines, it is important to keep the following topics below in mind. 

Shipping 

NCDHHS has completed allocation of vaccine from Waves 1-3 of the initial pediatric vaccine roll-out. These doses will begin shipping now that the EUA has been granted. Please see below for an estimated delivery timeline by wave. 

• Wave 1 deliveries are anticipated to arrive between one (1) and five (5) business days after EUA issuance     

• Wave 2 deliveries will commence immediately after Wave 1 deliveries are complete. It is possible that some early Wave 2 deliveries may be made on the same day as final Wave 1 deliveries.  Wave 2 deliveries are anticipated to arrive three (3) to seven (7) days after EUA issuance.    

• Wave 3 deliveries will commence immediately after Wave 2 deliveries are complete. It is possible that some early Wave 3 deliveries may be made on the same day as final Wave 2 deliveries. Wave 3 deliveries will arrive five (5) to nine (9) days after EUA issuance 

Shipping boxes will contain a Controlant temperature monitor. Upon delivery, your shipper should be unpacked and the temperature monitor should be checked for any excursion warnings. Following this, turn off the monitor and safely return it in the provided packaging. Please see the images below of the Controlant temperature monitor and its packaging. 

The Pfizer pediatric vaccines will be shipped on dry ice in smaller disposable shippers that cannot be used for temporary storage. Upon arrival, the contents MUST be removed and placed either in a refrigerator at 2°C to 8°C or an ultra-cold freezer -90⁰C to -60⁰C.  Do not store Pfizer pediatric vaccines in a standard freezer. The disposable shippers can be seen below. 

Storage and Handling  

Please note that storing the vaccine for 10 weeks in the refrigerator is not in addition to storing it for 6 months in the ULT freezer. All conditions for storage must be completed within the overall timeframe and once expired, the vaccine should be discarded regardless of storage conditions. Refer to the table below to view the length of time the pediatric vials can be stored at each temperature. 

Pediatric Vials 

The pediatric vials will come packaged in cartons of 10 vials each with each vial filled to 1.3mL before dilution. These vials are distinct with an orange cap and orange stripping on the label and carton. The pediatric formula will continue to require an additional 1.3mL of diluent (1:1 ratio) and contain 10 doses per vial. Please remember that the current adult formulation cannot be administered to children under the age of 12 as the injection volume of 0.1mL from the 10mcg adult dose is considered too small for IM injections and has not been studied. An image of the pediatric vials along with the cartons these vials are packaged in can be found below. 

Dilution 

All Pfizer pediatric vaccine orders will include ancillary kits that contain 10mL diluent vials. Even though these vials appear to contain sufficient diluent for multiple vials, they must only be used once. Some best practices when dealing with these vials include: 

• Discarding diluent vials with the remaining content after each use. 

• Extracting 1.3mL of diluent from a single-use vial to reconstitute 1.3mL of vaccine for each vile. 

• Refraining from temptation to puncture diluent vials more than once.