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Receiving & Storing Pfizer Vaccine

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Receiving & Storing Pfizer Vaccine Receiving & Storing Pfizer Vaccine California COVID-19 Vaccination Program Never reject vaccine shipments. Upon delivery, sites assume responsibility for ensuring that vaccines are stored in temperature-controlled environments. This job aid compiles guidance from CDC, Pfizer, and Controlant updated for California providers. See Resources for original sources. Key Points • Vaccine ships in a thermal shipping container with dry ice; ancillary kit ships separately • Pfizer 450: Vaccine and pediatric ancillary kit ship in early June 2021; no dry ice kit with this product • Pfizer 1170: Dry ice kit ships within 24 hours of vaccine (unless your site has ULT freezer); kit includes PPE; additional dry ice will not be provided; source dry ice pellets after first re-ice if storing vaccine in thermal shippers for more than 5 days • Store in original packaging, protected from light; vials should always remain upright • See COVID-19 Vaccine Product Guide for details about vaccine, kits and dimensions Vials • 2 mL type-2 glass, preservative-free, multidose vial (MDV); handle with care • 6 doses per vial after dilution; use low dead-volume syringes/needles to maximize doses drawn; don’t draw more than 6 doses/vial Vial Trays • Pfizer 1170: Single tray holds 195 vials; 1 to 5 trays are stacked in the shipper • Pfizer 450: 3 trays of 25 vials each Thermal Shipper California COVID-19 Vaccination Program IMM-1339 (7/30/21) Recommended Storage Conditions Pfizer recommends storing vaccine in ultra-cold freezers between -80°C and -60°C (-112°F and -76°F) until the expiry date printed on the label. Alternatively, vaccine may be stored under conditions below with reduced beyond use dates; beyond use dates must not exceed manufacturer expiration dates. Carefully track cumulative time vials are stored under these alternate conditions. Freezer and refrigerator storage may be easiest. Thermal shippers require significant support, including well-trained staff, dry ice, and consistent protocols. To maximize vaccine shelf life of unpunctured vials: Plan to transfer vial trays to the coldest environment you can support then transfer progressively to the next temperature range as indicated below. (See redistribution guidance at the end of this document.) Original Thermal Shipper Freezer Refrigerator Store between -80⁰C to -60⁰C (-112⁰F Store between -25°C and -15°C (-13°F Store between 2°C to 8°C (35°F to to -76⁰F) for up to 30 days (label with to 5°F) for up to 2 weeks (label with 46°F) for up to 1 month (label a Beyond Use Date of 30 days) then BUD of 14 days) then transfer with BUD of 31 days max) transfer remaining doses to freezer remaining doses to the refrigerator or refrigerator Combined freezer & refrigerator Carefully adjust thermostat to this storage not to exceed 45 days Open container no more than 2 narrow range if storing with routine times/day for up to 3 mins/ opening vaccines Place vaccine vials removed from frozen storage at the same time in Only open to transfer doses you’ll Vials may be returned one time to the a resealable plastic bag or similar need for the day to freezer or recommended storage condition of container refrigerator; plan accordingly -80oC to -60oC (-112oF to -76oF) and used by the expiration date Monitor temperatures twice daily Click link in daily emails to download and report temperature temperature data; save Excel file for Monitor temperatures twice daily and excursions 3 years report temperature excursions After 1 month, report remaining Recharge dry ice every 5 days; reseal doses as waste and discard with packaging tape If proper storage and handling protocols are followed, the following vaccine shelf life can be expected. Plan accordingly. Storage Units Max Shelf Life Thermal shipper to freezer to refrigerator 30 + 14 + 31 = 75 days Freezer to refrigerator 14 + 31 = 45 days Standalone freezer only 14 days Standalone refrigerator only 31 days For punctured vials: Store at 2°C to 25°C (35°F to 77°F) and use within 6 hours from time vaccine was mixed with diluent. California COVID-19 Vaccination Program IMM-1339 (7/30/21) Controlant Monitor Temperatures are monitored using a Controlant monitor embedded in the foam lid. Do not remove. Start Shipment • Do not press. Activated before shipment. Stop Shipment • Press Stop Shipment to accept delivery. • LED indicator will change to a solid color; status report emailed to the order’s Point of Contact • Green: Unpack the vaccine. • No color or red: Wait for the status report. Temperature Monitoring Overview On-Site Monitoring (Controlant) After the box has been delivered, Controlant’s on-site monitoring service will automatically begin. If transferring vaccines to storage units, the order’s Point of Contact must opt out to prevent false temperature excursions and unnecessary emails. Controlant sends emails from delivery until thermal shippers are returned. On-site temperature Initial email links to thermal shipper status webpage, On-Site Monitoring Quick Guide, and monitoring email Controlant customer service Daily temperature Alerts you if daily temperatures are in or out of recommended ranges; for temperature deviation emails excursions, Controlant sends an email and/or text and call if no one responds Final report email Controlant will arrange with UPS or FedEx for thermal shipper to be collected; Controlant Monitor must be inside California COVID-19 Vaccination Program IMM-1339 (7/30/21) Notifications from Pfizer & Controlant The Order’s Point of Contact will receive emails regarding orders and deliveries from various senders. Add these senders to your contact list and work with your IT staff to ensure emails are not blocked by your firewall. For an updated list critical systems and senders, please refer to Critical Systems & Senders. Pfizer Expiration Dates Check the expiration date printed on the vial. Determining when a vaccine or diluent expires is a critical step in proper storage and handling. All vaccines have expiration dates. For COVID-19 vaccines, expiration dates may change as more stability data become available. Email [email protected] to receive auto-generated email updates for COVID-19 Lot Number Expiration Date Reporting. Use CDC’s expiration date tracker to record updated expiration dates. Do not dispose of vaccine without ensuring the expiration date has passed. Resources See EUA Fact Sheet for HCPs and Recipients & Caregivers in multiple languages: FDA website Controlant resources and support: • Controlant On-Site Temperature Monitoring Overview & Videos • 24/7 support hot line: 1-855-442-6687 or 1-701-540-4039, or email [email protected] Pfizer-BioNTech resources on EUA Website: • Videos: Storage & Handling, Vaccine Administration, Returning Shippers • Delivery Checklist • Vaccine Storage and Handling Summary • Vaccine Beyond Use Date/Time Tracking Label (for Refrigerator) • Vaccine Storage and Handling Label • Safe Handling Guidelines about Dry Ice • Thermal Shipping Container Dry Ice Replenishment Instructions Instructions Follow these instructions to receive and store Pfizer COVID-19 vaccine. Step Description 1. Examine the shipping container for signs of physical damage. a) Report shipment incident if shipping container appears damaged and await guidance. California COVID-19 Vaccination Program IMM-1339 (7/30/21) 2. Open the thermal shipper on the floor. a) Use caution when lifting; thermal shipper may weigh up to 80 lbs. b) Review enclosed dry ice safety data sheet before accessing vials in the thermal shipper. c) Open the thermal shipper in a well-ventilated room. 3. Press STOP button on Controlant Monitor for 5 seconds to accept delivery. a) The order’s Point of Contact will receive an email from the manufacturer on the temperature status of the container during transit. b) The LED indicator light on the TMD will change from blinking to a solid light. 4. Proceed based on the color of the LED indicator light. a) Green: Unpack the vaccine. b) No color or red: STOP: Wait for status report (emailed to Point of Contact for the order) to confirm vaccine viability; report shipment incident if a temperature excursion occurred. 5. Unpack the shipping container following the included unpacking instructions. a) Review Dry Ice Safety Job Aid before handling dry ice components. b) Use safety goggles or glasses with side shields. c) Wear waterproof, insulated gloves when handling dry ice. 6. Inspect vaccine vial trays for damage and confirm all ordered vial trays were received. a) Remove dry ice pod and box that holds vial trays. (Vial trays are visible without opening inner box.) b) If you feel resistance, do not pull it out by force; keep the box inside the thermal shipper and remove vial trays separately using clear plastic straps. 7. Transfer vial trays in original packaging and store vials upright, or store temporarily in thermal shipper. If transferring ULT freezer: Store between -80°C and -60°C (-112°F and -76°F) within 5 minutes; do not open tray(s) or touch vials. If transferring to freezer: Store between -25°C and -15°C (-13°F to 5°F) for up to 2 weeks; label with Beyond Use Date (BUD) of 2 weeks. If transferring to refrigerator: Store between 2°C and 8°C (36°F and 46°F) for up to 1 month; label with BUD of 31 days max. If storing doses temporarily in thermal shippers: a) Store between -90°C to -60°C (-130°F to -76°F) for up to 30 days; label with a BUD of 30 days. b) Replenish the container with dry ice pellets (sized 10 mm to 16 mm) within 24 hours of delivery and every 5 days following Pfizer’s Dry Ice Replenishment Instructions. c) Transfer to freezer or refrigerator any doses needed for the day. d) Return box with vial trays to the shipper. e) Fill low edges around the box (that holds vial trays) with dry ice pellets; dry ice should be flush with but not exceed the top edges of the box that holds the vial trays.
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