Covid-19 Vaccine Management Plan

COVID-19 VACCINE MANAGEMENT PLAN New York City Department of Health and Mental Hygiene Bureau of Immunization ● COVID-19 Vaccination Program 347-396-2404 (Phone) ● 347-396-8841 (eFax) ● [email protected]

Directions: • The primary person in charge of the COVID-19 vaccination program must review and complete this document annually. • All staff handling COVID-19 vaccine at this practice must adhere to the protocols described in this document and must review it annually. • This document must be maintained at a location accessible to all staff handling vaccines and close to the vaccine storage unit.

OFFICE / CLINIC NAME:

OFFICE / CLINIC ADDRESS:

PIN #: FACILITY CODE: DATE: ______

THE VACCINE STORAGE PRACTICES LISTED BELOW ARE THE PRIMARY RESPONSIBILITY OF THE FOLLOWING:

VACCINE COORDINATOR:

WORK PHONE: CELL PHONE:

EMAIL:

BACK-UP VACCINE COORDINATOR: WORK PHONE: CELL PHONE: EMAIL:

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1. DESIGNATION OF COVID-19 VACCINE STAFF AND THEIR CONTACTS: . The primary vaccine coordinator is . If the primary person is unavailable, the back-up vaccine coordinator will be . . The responsibilities of the primary vaccine coordinator and the back-up vaccine coordinator include the following vaccine management activities: • Adjusting the temperature of a vaccine storage unit as necessary to keep temperatures in range • Documenting the temperature on the temperature logs for each storage unit daily, preferably at the beginning of the clinic day • Guiding staff who are responsible for administering vaccines, or who may be required to transport vaccine in an emergency, to follow proper procedures for vaccine storage and handling • Reviewing temperature logs weekly to ensure proper temperature recording • Serving as program contacts for the site • Serving as an emergency plan coordinator • Managing routine vaccine storage and handling, including: . Ordering vaccines . Counting vaccine inventory at the time of ordering . Monitoring and documenting vaccine storage units daily . Minimizing vaccine wastage . Receiving and promptly storing vaccines . Packing and transporting vaccines as necessary in an emergency

2. VACCINE STORAGE & HANDLING BASICS A. Vaccine Storage Units Providers must have appropriate vaccine storage units and thermometers that will maintain proper conditions to keep vaccines viable. The minimum requirements for types of storage units are: • Pharmacy or biologic grade storage units specifically designed for vaccine storage OR stand-alone refrigerators and stand-alone freezers

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Dormitory style refrigerators are not acceptable for the storage of vaccines and NEVER permitted. As of April 1, 2013, the use of dorm-style or bar-style refrigerators or freezers are no longer allowed for ANY vaccine storage, even for temporary storage.

(name of practice) has (number of storage units). The type(s) of storage units that our practice has is/are:

Fridge: ______

Freezer: ______

Ultra-cold: ______

These storage units are also compliant with the following requirements: • Large enough to hold your maximum vaccine needs • Large enough to store water bottles in the refrigerator and freezer to stabilize temperatures. This recommendation does not apply to pharmaceutical units if the manufacturer indicates that water bottles negatively impact the functionality of the unit

• Refer to NYC’s Vaccine Storage and Thermometer Guide B. Thermometer Requirements: • Working certified and calibrated continuous digital data logger (DDL) thermometers with a buffered probe in accordance with National Institute of Standards and Technology (NIST) or the American Society for Testing and Materials (ASTM) standards. The certificates for the thermometers are located: (write location of where the certificates are kept)

• Ability maintain required vaccine storage temperatures

• The capacity for continuous temperature monitoring and recording; data can be routinely downloaded into a summary report

• Equipped with a temperature probe, preferably a buffered probe. For accurate ultra-cold temperature monitoring, it is essential to use an air-probe or a probe designed specifically for ultra-cold temperatures with the DDL

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• An active temperature display that can be easily read from the outside of the storage unit • In addition, must keep at least one back up DDL thermometer with a current certificate of calibration on hand not stored in a unit. This back up DDL’s calibration expiration date will not be the same as the primary. Its expiration date will likely be 1-3 months from primary

Additional thermometer recommendations:

• Audible alarm for out-of-range temperatures/excursions. When an alarm is triggered, the device should sound. If there is an alarm delay, determine the number of consecutive readings before it is triggered. Does your DDL have the following?

o Audible alarm? ______(yes/no) o Email Alerts? ______(yes/no). If yes, list each contact’s Email and the order they should be notified ______

o SMS Alerts/Text messages? ______(yes/no). If yes, list each contact’s phone numbers and the order they should be notified ______

o Phone Call? ______(yes/no). If yes, list each contact’s phone numbers and the order they should be notified ______

• Current, minimum, and maximum temperature display • Low battery indicator • Accuracy of +/- 1°F (0.5°C) • Memory storage of at least 4,000 readings • User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes

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• Able to maintain required vaccine storage temperatures • Large enough to hold your maximum vaccine needs • Large enough to store water bottles in the refrigerator and freezer to stabilize temperatures • This recommendation does not apply to pharmaceutical units if the manufacturer indicates that water bottles negatively impact the functionality of the unit • In addition, at least one back up DDL thermometer with a current certificate of calibration must be kept on hand and not stored in a unit (name of practice) has (number of Digital Data Loggers). The type(s) of DDL that our practice has is/are: ______C. Vaccine Handling Practices • Open vaccine shipments as soon as they arrive and store the vaccines immediately • Maintain proper vaccine storage temperatures:

o Refrigerator: 36°F to 46°F (2°C to 8°C) o Freezer: -58°F to 5°F (-50°C to -15°C) [When storing at freezer temperatures, Pfizer should be stored at (-50°C to -15°C)]

o Ultra-Cold Freezer: -76°F to -112°F (-60°C to -80°C) • Place DDL thermometers in the central area of the vaccine storage units • Record temperatures daily on the temperature log, preferably at the beginning of the day, even if you have a DDL thermometer • Retain the temperature logs in your practice for at least 3 years • Store vaccines in the middle of the refrigerator or freezer compartment • Do not store vaccines against storage unit walls (or sides), doors, or vegetable bins, or in the bottom of the refrigerator/freezer unit, or under cold air vents • Ensure stored vaccines have space around them for cold air circulation • Store extra ice packs along the walls and in the door of the freezer • Place water bottles labeled “Do Not Drink” on the top shelf, floor and/or refrigerator door • Check refrigerator/freezer doors to ensure they are closed at the end of each day • Place “Do Not Unplug” signs near the vaccine storage unit’s electrical outlets and circuit breakers Rev.6/2021 Page 5 | 14 COVID-19 VACCINE MANAGEMENT PLAN New York City Department of Health and Mental Hygiene Bureau of Immunization ● COVID-19 Vaccination Program 347-396-2404 (Phone) ● 347-396-8841 (eFax) ● [email protected]

• Store, rotate, and use vaccines with shortest expiration dates first

• Conduct monthly inventory of your vaccines to ensure a minimum 5-week supply of vaccines. This will prevent you from running out of the vaccines. • Do not store food in the vaccine storage units • Never use expired or “potentially spoiled” vaccines. If storage unit temperatures are out of range, immediately place a sign on the vaccines saying, “Do Not Use” maintain the vaccines in the storage unit and call the vaccine manufacturers. If the manufacturers say the vaccines are spoiled, please report them in the CIR Vaccine Inventory Management (VIM) system. If the manufacturers say the vaccines are still viable, use them to vaccinate patients. Please notify the NYC Provider Quality Assurance (PQA) Unit at 347-396-2404 or email [email protected] and document the temperature excursion on the Temperature Excursion Report.

3. VACCINE SHIPPING, RECEIVING AND COLD CHAIN FAILURES A. Staff accepting deliveries must be available on site to receive vaccine at least one day a week, for at least four consecutive hours during the day. Staff accepting deliveries must be aware of the importance of maintaining the cold chain and of the need to notify appropriate staff of the arrival of the vaccine so that it can be handled and stored appropriately and immediately.

B. At this practice, (vaccine coordinator), or (back- up vaccine coordinator) are responsible for the following procedures: • Examining container and contents for physical damage upon receiving a vaccine shipment Please note, COVID-19 vaccine shipments differ depending on the vaccine manufacturer (i.e. COVID-19 Pfizer vaccines have a thermal shipper and GPS-enabled thermal sensors which monitor the location and temperature of each vaccine shipment. Be sure to be review this tracker upon receiving your shipment to ensure temperatures are in range and then turn it off).

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• Looking at the packing list and verify if shipping time is either less than 48 hours or received by the specified date documented by the manufacturer (if the shipping time is greater than 48 hours, this can result in a cold chain failure) • Checking the cold chain temperature monitors to see if temperatures were out of the recommended range • Crosschecking contents and expiration dates with the invoice • Checking that diluents are cold or room temperature, but not frozen • Checking for the correct type and quantity of diluents

C. If there are any discrepancies with the invoice, concerns about the viability of the vaccine, or concern about cold chain failure and exposure of the vaccine to out of range temperatures, notify your clinic’s vaccine coordinator (enter name), mark the vaccine or diluents as “Do Not Use,” store them under proper conditions, and contact the vaccine manufacturer and the NYC Bureau of Immunization Vaccine Management Unit (VMU) at 347- 396-2405 immediately. In addition, if you believe that the vaccine shipment was compromised or there is a problem with the temperature monitors, you must contact VMU at 347-396-2405 on the same day the vaccine arrives.

4. EMERGENCY PLAN (RELOCATION) In the event of refrigerator/freezer malfunctions, power failures, natural disasters, or other emergencies that might compromise appropriate vaccine storage conditions, vaccines may need to be transported to another location. The vaccine coordinator ______(enter name) or the back- up vaccine coordinator (enter name) will be responsible for making decisions about relocating vaccines. In addition, the following staff member ______(enter name) will be available 24/7 as the point person to contact the emergency relocation site so it is prepared for the vaccine. This staff member will also be responsible to pack and relocate the vaccines. The staff member(s) to be contacted to allow access to the site other than business hours is/are_____ (enter name). The telephone number this

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staff member(s) can be reached at outside business hours are:

A. Procedures for Packing Vaccine That Requires Refrigeration: • Use properly insulated containers (e.g. the containers that arrive from McKesson, hard sided plastic insulated containers or Styrofoam coolers with at least 2-inch thick walls). Soft-sided containers specifically engineered for vaccine transport are acceptable. Do not use commercially available soft-sided food or beverage coolers because most are poorly insulated and likely to be affected by room or outdoor temperatures. • Diluents should always travel with their corresponding vaccines • Be sure to place an insulating barrier (e.g., bubble wrap, crumpled brown packing paper, Styrofoam peanuts) between the frozen packs and the vaccines to prevent accidental freezing • Pack vaccines in their original packaging on top of the barrier (do not remove vaccine vials from boxes) • Place a thermometer next to the vaccines to monitor temperature • Pack enough frozen packs to maintain the cold chain • The contents of the container should have:

o frozen packs o barriers (bubble wrap) o vaccines o thermometer • Attach labels to the outside of the container to identify the contents as valuable and fragile vaccines

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Please note that frozen vaccines can only be transported with a portable freezer.

B. Procedures for Transporting Vaccine It is critical that vaccine potency is always protected by maintaining the cold chain during relocation and transport. Always inform the PQA Unit at 347-396-2404 about your intentions to transport vaccines, the location where the vaccines were transferred to, and the amount of vaccines transferred. If it is necessary to move the vaccines to protect their viability outside normal business hours, please proceed transporting vaccines and contact the PQA Unit as soon as possible. The vaccine coordinator (enter name) or back-up vaccine coordinator (enter name) will be responsible for arranging the transportation of vaccines in case of an emergency to ___ (name of site) located at ______(site address). The person in charge of receiving the vaccines at this site will be ______(enter name). D. Guidelines for Transporting Vaccine: During vaccine transportation, the following guidelines must be followed: • Vaccines may be transported using a portable vaccine refrigerator with a temperature monitoring device. If a portable vaccine refrigerator is not available, qualified containers and pack outs can be used with a DDL thermometer or a cold chain monitor.

• If vaccines are maintained in an insulated cooler, the temperatures must be checked and recorded hourly • Always stay with the vaccines during transport and promptly place the vaccines into appropriate storage units upon arrival • When transporting vaccines in vehicles, use the passenger compartment not the trunk. For additional guidelines on Maintaining the Cold Chain, please visit http://www.immunize.org/catg.d/p3049.pdf. • If vaccines are being transported for an offsite vaccination clinic or home vaccination program:

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o The total time for transport alone or transport plus clinic workday should be a maximum of 8 hours (e.g., if transport to an off-site clinic is 1 hour each way, the clinic may run for up to 6 hours).

o Transport only what is needed for the workday, preferably in a portable vaccine Refrigerator or freezer

o It is always safest to have vaccines delivered directly to a facility with a vaccine storage unit ready to receive the shipment.

• If vaccine will be transported or administered in the patient’s home, indicate the process and what will be done to ensure vaccine remain viable between locations:

• Portable vaccine refrigerator/cooler:______(Brand/Model) • DDL/ cold chain monitor being used for transport:______(Brand/Model) 5. VACCINE ORDERING BASICS A. Order vaccine in accordance with actual vaccine need. Avoid stockpiling or build-up of excess vaccine inventory.

B. Depending on volume of patients reported to the Citywide Immunization Registry (CIR) and order

history, practices have been placed on either a monthly, bi-monthly, or quarterly

ordering frequency. COVID-19 Vaccine Ordering is on a weekly basis.

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6. INVENTORY CONTROL GUIDELINES A. The vaccine storage practices listed below are the responsibility of the following staff member:

(this staff member can be the vaccine coordinator, or it can be delegated to another staff member; however, if these practices are delegated to a staff member, the vaccine coordinator should monitor the activity weekly).

• Conduct physical count of vaccines monthly and assess need

• Always place vaccines with shorter expiration dates in front of those with later expiration dates so that they can be used first (“first-in, first-out”). Short-dated vaccines should be checked at least every 4 weeks just in case expiration dates get out of order.

o Vaccines are checked for expiration dates every week(s) o Vaccines are rotated every week(s) • Refer to NYC’s How to Do a Physical Inventory Guide

7. VACCINE EXPIRATION AND SPOILAGE GUIDELINES A. If you experience spoiled or expired vaccine, the vaccine coordinator _ (enter name), or back up person ______(enter name) will be responsible for reporting these vaccines to the health department. This staff member will: • Enter expired/spoiled vaccine information through the CIR Online Registry. Once logged in, click on the VIM icon and on the “VFC Vaccine Returns/Wastage” tab • Review/confirm expired/spoiled VFC vaccine information

• Currently, the CIR Online registry can be used to only report wasted doses. Return labels will not be emailed for COVID-19 vaccines

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B. The items listed below should be reported in the CIR as "Wastage" and must be properly disposed of as medical waste. • Vaccine drawn-up into the syringes but not administered • Multi-dose vials from which some vaccine has already been withdrawn • Broken vials • Used syringes with or without needles

8. WASTAGE PLAN • Include appropriate open vial management • How to avoid wasting dose left in open vials • Partially used vials cannot be transferred between providers OR across state lines.

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9. UPDATE VACCINE-RELATED DOCUMENTS ANNUALLY (OR AS STAFF CHANGES) A. At a minimum, the entire Vaccine Management Plan must be reviewed and updated annually or as necessary or when there is a change in staff who have responsibilities specified in this plan.

Last reviewed on by Date Name Title Signature Last reviewed on by Date Name Title Signature Last reviewed on by Date Name Title Signature Last reviewed on by Date Name Title Signature

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Appendix • Center for Disease Control and Prevention o Center for Disease Control and Prevention Vaccine Storage and Handling Toolkit . Complete the attached Vaccine Storage and Handling Standard Operating Procedures (SOP) Worksheet and keep it in a safe place . Review Labeling Considerations for pre-drawn synringes . Print and complete Beyond Use Date (BUD) Tracking Labels for Pfizer and Moderna . Review Storage and Handling Summary for Pfizer, Moderna & Janssen • New York City Forms and Guides o Bureau of Immunization Vaccine For Children Program Forms, Job Aids and Charts o COVID-19 Temperature Excursion Incident Report

• Immunization Action Coalition Forms and Guides o Temperature Log when Transporting Vaccine at Refrigerated Temperatures o Temperature Log for Refrigerator - Fahrenheit o Temperature Log for Refrigerator - Celsius o Temperature Log for Freezer - Fahrenheit o Temperature Log for Freezer - Celsius

Rev.6/2021 Page 14 | 14 RESOURCES WORKSHEET: Vaccine Storage and Handling SOPs

Complete the following checklist and forms and store this information in an easily accessible area near the vaccine storage unit.

CHECKLIST OF GENERAL INFORMATION

» Up-to-date contact information » Descriptions of the roles and responsibilities of the • Primary vaccine coordinator primary and alternate vaccine coordinators • Alternate vaccine coordinator » Information for each storage unit, including serial • Additional staff to assist in emergencies number, links to equipment websites, installation • Immunization program dates, and routine maintenance and repair • Vaccine manufacturers records • Refrigerator and freezer maintenance and repair companies » Samples of all vaccine-related forms used in your • Temperature monitoring device (TMD) companies facility • Utility/power company » Protocols for staff education and training • Vaccine storage unit alarm company (if applicable) • Generator repair company (if applicable) • Sources for qualified containers and packouts

CHECKLIST FOR ROUTINE STORAGE AND HANDLING » Protocols for: • Ordering and accepting vaccine deliveries • Disposing of vaccines and supplies • Unpacking deliveries • Monitoring storage unit and temperature • Managing inventory • Maintaining storage equipment and TMDs • Storing each vaccine and diluent • Responding to storage and handling problems • Placing vaccines and diluents in storage units • Transporting vaccines to off-site/satellite facilities • Handling vaccines prior to administration

CHECKLIST FOR EMERGENCY VACCINE STORAGE, HANDLING, AND TRANSPORT » All contact information in Checklist for General » Protocols for: Information as well as up-to-date contact information for: • Monitoring vaccines during a power outage • Alternative vaccine storage facility (one or more) • Packing vaccines and diluents for emergency • Transportation of vaccines transport » Vaccine storage unit specifications (type, brand, model • Transporting vaccines to and from an alternative number, serial number) vaccine storage facility • Assessing whether vaccine can be used after an » Diagram of facility showing important elements, including emergency doors, flashlights, packing materials, batteries, circuit • Accessing your building and facility after hours breakers » Keep a copy of emergency SOPs with emergency supplies and at multiple off-site locations such as homes of vaccine coordinator and alternate coordinator and with building manager, security staff, and alternative storage facility.

VACCINE STORAGE AND HANDLING TOOLKIT 1 RESOURCES WORKSHEET: Vaccine Storage and Handling SOPs

Store emergency information with emergency supplies.

STAFF CONTACT LIST Telephone Numbers Name Title home/cell/other E-mail Address Primary Vaccine Coordinator Alternate Vaccine Coordinator

EMERGENCY STAFF CONTACT LIST Telephone Numbers Name Title home/cell/other E-mail Address 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. List contacts in order of preference. Determine whether all or certain persons on the list should be contacted or if the first person reached is sufficient.

2 VACCINE STORAGE AND HANDLING TOOLKIT RESOURCES WORKSHEET: Vaccine Storage and Handling SOPs

GENERAL RESOURCES CONTACT LIST Contact Person Telephone Numbers Resources Name/Title home/cell/other E-mail Address Local Health Department Immunization Program State Health Department Immunization Program Vaccine Manufacturers Refrigerator Repair Company

Freezer Repair Company Utility/Power Company Temperature Monitoring Device Company Vaccine Storage Unit Alarm Company (if applicable) Generator Repair Company (if applicable)

ALTERNATIVE VACCINE STORAGE FACILITIES Alternative Vaccine Storage Contact Person Telephone Numbers Facility Name/Address Name/Title home/cell/other E-mail Address 1. 2. 3. 4.

TRANSPORTATION TO ALTERNATIVE VACCINE STORAGE FACILITIES Emergency Resources Contact Person Telephone Numbers Name/Address Name/Title home/cell/other E-mail Address Refrigeration Company Refrigeration Company (alternative) Private Vehicle Private Vehicle (alternative)

VACCINE STORAGE AND HANDLING TOOLKIT 3 RESOURCES WORKSHEET: Vaccine Storage and Handling SOPs

PACKING MATERIAL SUPPLIERS CONTACT LIST Contact Person Telephone Numbers Emergency Resources Company Name Name/Title home/cell/other E-mail Address Portable vaccine refrigerator/freezer units Qualified containers and packout materials Qualified containers and packout materials (alternative) Packing materials Packing materials (alternative)

VACCINE STORAGE UNIT SPECIFICATIONS Type of Unit (Refrigerator or Freezer) Brand Model Number Serial Number 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

4 VACCINE STORAGE AND HANDLING TOOLKIT COVID-19 Vaccine Handling Toolkit: Operational Considerations for Healthcare Practitioners

Labeling Considerations Pre-drawn syringe labeling components When the COVID-19 Vaccines are not being prepared for immediate administration, appropriate • Name and amount of vaccine labeling considerations should be undertaken. If the • The exact beyond-use date and time: vaccines are sent outside the facility in which they were • Lot number prepared for administration, a designated person must • Initials of preparer(s) ensure that contact information of the preparation facility is conveyed and available at the site where they will be Examples of pre-drawn syringe labels administered. Labels should be adhered to the container(s) (e.g., light protected zip-lock bag in which pre-drawn Pfizer-BioNTech COVID-19 Vaccine (30 mcg / 0.3 mL) IM suspension syringes are stored and transported). Pre-drawn syringes Date & Time to discard (6 hours after dilution): prepared for administration must be labeled with legible Lot no: identifying information to prevent errors during storage, Initials of preparer(s): dispensing, transport and use. Personnel should consider adding the following labeling components to the containers in which the pre-drawn vaccine syringes are Moderna COVID-19 Vaccine (100 mcg / 0.5 mL) IM suspension stored as well as the pre-drawn vaccine syringe. Date & Time to discard (6 hours after puncture): Lot no: Container labeling components: Initials of preparer(s):

• Facility name and phone number Janssen Ad26 COVID-19 Vaccine (5×1010vp / 0.5 mL) IM suspension • Quantity of syringes Date & Time to discard: • Name and amount of vaccine (6 hours after vial puncture at 2°C to 8°C (36° to 46°F) or 2 hours at up to 25°C (77°F)) • The exact beyond-use date and time Lot no: • Lot number Initials of preparer(s): • Initials of preparer(s)

Examples of pre-drawn syringe storage container labels

Pfizer-BioNT ech COVID-19 Vaccine (30 mcg / 0.3 mL) IM suspension References Facility name and phone numbe r : Quantity of syringes: 1 https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical- considerations.html#Interchangeability Date & Ti me to discard (6 hours after dilution ) : Lot no: 2 https://www.janssencovid19vaccine.com/hcp.html

Initials of preparer(s): 3 https://www.modernatx.com/covid19vaccine-eua/providers/ 4 https://www.cvdvaccine-us.com/resources Moderna COVID-19 Vaccine (100 mcg / 0.5 mL) IM suspension 5 https://www.usp.org/covid-19/hand-sanitizer-information Facility name and phone number : 6 https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf Quantity of syringes: 7 https://www.cdc.gov/niosh/npg/npgd0359.html

Date & Time to discard (6 hours after vial is punctured): 8 https://www.cdc.gov/coronavirus/2019-ncov/hcp/hand-hygiene.html Lot no: 9 https://www.ashp.org/-/media/assets/pharmacy-practice/resource- Initials of preparer(s): centers/Coronavirus/docs/FAQ-optimizing-covid-vaccine-prep- safety.ashx Janssen Ad26 COVID-19 Vaccine (5×1010vp / 0.5 mL) IM suspension 10 https://www.cdc.gov/vaccines/hcp/admin/downloads/vaccine- Facility name and phone number: administration-needle-length.pdf Quantity of syringes: 11 https://www.fda.gov/emergency-preparedness-and-response/mcm- legal-regulatory-and-policy-framework/moderna-covid-19-vaccine- Date & Time to discard: frequently-asked-questions (6 hours after vial puncture at 2°C to 8°C (36° to 46°F) or 2 hours at up to 25°C (77°F)) Lot no: Initials of preparer(s): Pfizer-BioNTech COVID-19 Vaccine Beyond-Use Date (BUD) Tracking Labels for Vaccine During Freezer or Refrigerator Storage

Vaccine that has not been mixed has specific beyond-use dates for frozen and refrigerated storage. Use these labels to ensure beyond-use dates are followed.

Storing Vaccine in the Freezer Pfizer-BioNTech COVID-19 Vaccine may be stored in the freezer between -25°C and -15°C (-13°F and 5°F) for up to 2 weeks. Remove the vaccine from ultra-cold temperature storage. Complete the information on the freezer storage label 123456A and attach it to the container or resealable plastic bag 05 18 2021 holding the vaccine vials. 2:30 PM Once labeled, store the vaccine vials in the freezer between -25°C and -15°C (-13°F and 5°F) for up to 2 weeks. 06 01 2021 2:30 PM If the 2-week deadline is met, move any remaining vials to refrigerated storage for an additional 1 month (31 days). Update the beyond-use date labels to reflect the new BUD time frame. Amy Nurse RN Keep vials removed from ultra-cold storage at the same time together.

Storing Vaccine in the Refrigerator Pfizer-BioNTech COVID-19 Vaccine can be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 1 month (31 days.). Remove vaccine vials from ultra-cold or frozen 123456A temperature storage. 06 01 2021 07 01 2021 Complete the information on the refrigerator storage label and attach it to the container or resealable plastic bag holding the vaccine vials. Once labeled, store the vaccine vials in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 1 month 06/07

(31 days). 2 hrs

As the 1 month (31 days) deadline approaches, contact 10 hrs the manufacturer for guidance if you will not be able to use the vaccine. Amy Nurse RN Do NOT refreeze the vaccine.

07/09/2021 CS321570-E 1 Pfizer-BioNTech COVID-19 Vaccine Beyond-Use Date (BUD) Tracking Labels for Vaccine During Freezer or Refrigerator Storage

Transporting Vaccine Between 2°C and 8°C (36°F and 46°F) Pfizer-BioNTech COVID-19 Vaccine may be transported for 12 cumulative hours (e.g., vaccine transported for 2 hours today has 10 hours of transport time remaining). Follow transportation guidance for Pfizer-BioNTech 123456A COVID-19 Vaccine in CDC's Vaccine Storage and 06 01 2021 07 01 2021 Handling Toolkit, COVID-19 Addendum. When you have completed vaccine transport for the day, remove any remaining vials from the transport container. Complete the information on the bottom portion of 06/07

the label indicating the time in transport and hours 2 hrs remaining for transport, if needed. 10 hrs Once you have completed this information, store vaccine upright in the refrigerator between 2°C and 8°C Amy Nurse RN (36°F and 46°F) for up to the indicated BUD. Any time used for transport between 2°C and 8°C (36°F and 46°F) counts against the 1 month (31 days) limit for storage between 2°C and 8°C (36°F and 46°F).

CDC’s Pfizer-BioNTech Storage and Handling Summary www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/storage-summary.pdf CDC’s Refrigerator and Freezer Temperature Logs www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html CDC’s Vaccine Storage and Handling Toolkit www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf

07/09/2021 CS321570-E 2 Pfizer-BioNTech Pfizer-BioNTech COVID-19 Vaccine COVID-19 Vaccine

Store vaccine between 2°C and 8°C (36°F and 46°F) for up to 31 days. Store vaccine in the FREEZER between -25°C and -15°C (-13°F to 5°F) for up to 2 weeks. Lot number(s): Lot number(s): Today’s date: / / USE BY* Date: / / *As the 31 day deadline approaches, contact the manufacturer for guidance if you will not Today’s date: / / Time: be able to use the vaccine. USE BY* Vaccine may be transported for 12 cumulative hours. Date: / / Time: Transport date *If the 2-week deadline is met, move any remaining vials to refrigerated storage for an additional 31 Time in transport: days. Use a refrigerator beyond-use date (BUD) label to reflect the new BUD time frame. Use Time remaining: a refrigerator beyond-use date (BUD) label to reflect the new BUD time frame.

Name: Name:

Pfizer-BioNTech Pfizer-BioNTech COVID-19 Vaccine COVID-19 Vaccine

Name: Name:

Pfizer-BioNTech Pfizer-BioNTech COVID-19 Vaccine COVID-19 Vaccine

Name: Name:

07/09/2021 CS321570-E 3 Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summary

Basics Store vaccine in an ultra-cold freezer, thermal shipping Check and record storage unit temperatures each workday. container, freezer, or refrigerator. See guidance below See guidance below for each type of storage unit. Save for each storage unit. storage records for 3 years, unless your jurisdiction requires Follow the manufacturer’s instructions for returning a longer time period. the thermal shipping container. Deliveries

Vaccine Ancillary Supply Kit An ancillary supply kit will be delivered separately from the 1. The vaccine will arrive in a thermal shipping container at vaccine and includes: ultra-cold temperatures between -90°C and -60°C (-130°F and -76°F) with dry ice. Mixing supplies: Diluent, needles, syringes, and sterile alcohol prep pads 2. Follow the Pfizer-BioNTech COVID-19 Vaccine Delivery Mixing supplies are packaged separately with a green Checklist for detailed steps to ensure the vaccine is identification label. received, stored, and handled appropriately (https:// www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/ Do NOT use mixing supplies to administer vaccine. downloads/delivery-checklist.pdf). Administration supplies: Needles, syringes, sterile alcohol prep pads, vaccination record cards, and some 3. Review practices for working with dry ice in the Dry Ice PPE. Safety for Healthcare Professionals before handling any dry ice (https://www.cdc.gov/vaccines/covid-19/info-by- Ancillary supply kits have been reconfigured to support product/pfizer/downloads/dry-ice-safety-hcp.pdf) the number of doses ordered.

Thermal Shipping Container CDC recommends providers consider using the thermal shipping container for temporary storage only. The container requires significant support to store vaccine at proper temperatures, including trained staff, a regular supply of dry ice, and standard operating procedures for regular maintenance. Use the Controlant temperature monitoring device (TMD) Limit temporary storage in the thermal shipping container to included with the thermal shipping container to monitor 10 days when possible.* the temperature. Arrange for dry ice to maintain the appropriate temperature in Review contact information. the thermal shipping container. Replenish dry ice pellets (10 mm If the contact for your order (inVTrckS) is not valid, you to 16 mm) within 24 hours of delivery and every 5 days thereafter. will NOT be notified in the event of a temperature Follow manufacturer’s guidance for adding dry ice. excursion. Contact your jurisdiction's immunization Dry ice will NOT be provided to replenish the container. program for assistance. Transfer any vaccine remaining in the thermal shipping If your contact is valid and you are not receiving e-mails container after 10 days* to a: or cannot load email hyperlinks, refer to Controlant Freezer for up to 2 weeks, then for troubleshooting (https://in.controlant.com/ onsitemonitoring). Refrigerator for up to 1 month (31 days) Identify up to 4 contacts to receive e-mails and text alerts on Removing vaccine vials/doses for use: the container's temperature status. Determine the number of vials needed before opening the Review DAILY e-mails on the status of the container. thermal shipping container. Click the link in daily e-mails to access and download Open the thermal shipping container no more than 2 times all temperature data. Save the Excel file summarizing all per day for up to 3 minutes each time. Use packaging tape temperature data for at least 3 years. to reseal the outer carton after each entry. Save the return shipping label provided in your shipping Store vaccine vials upright in the tray and protect from light. container at delivery. Use the shipping label to return the thermal shipping container with the Controlant TMD within 10 days.*

08/24/2021 CS321570-I 1 Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summary

Ultra-Cold Freezer Before mixing, the vaccine may be stored in an ultra-cold freezer between -90°C and -60°C (-130°F and -76°F). Store vaccine vials upright in the tray As the expiration date approaches, or box. contact the manufacturer to determine Protect from light. if it has been extended. Do not discard vaccine without ensuring the expiration Vaccine may be stored until the date has passed. expiration date.

Freezer Before mixing, the vaccine may be stored in the freezer between -25°C and -15°C (-13°F to 5°F) for up to 2 weeks. This beyond-use date replaces the manufacturer’s expiration date. The total time vials are stored at these temperatures should be tracked and should not exceed 2 weeks. These temperatures are within the appropriate range for Protect from light. routinely recommended vaccines, BUT the temperature range Do not use dry ice for freezer storage. for this vaccine is tighter. Vials stored in the freezer may be returned one time to ultra- If storing the vaccine in a freezer with routinely recommended cold temperature storage (-90ºC to -60ºC [-130ºF to -76ºF]). vaccines, carefully adjust the freezer temperature to the Once returned to ultra-cold storage, the 2-week time frame correct temperature range for this vaccine. is suspended. Monitor how long the vaccine has been in the freezer Vaccine stored in the freezer can be transferred to refrigerator using CDC’s beyond-use date labels for Pfizer-BioNTech storage where it can be stored for up to 1 month (31 days). COVID-19 vaccine. Store the vaccine in the tray or box.

*It is preferred to return the shipping container within 10 days; however, if maintained properly, the thermal shipping container can be used for up to 30 days.

Refrigerator Before mixing, the vaccine may be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 1 month (31 days). After 31 days, contact the manufacturer for guidance. If directed to discard any remaining vials, follow the manufacturer's and your jurisdiction's guidance for proper disposal. Monitor how long the vaccine has been in the Store the vaccine in the tray or box. refrigerator using CDC’s beyond-use date labels for Protect from light. Pfizer-BioNTech COVID-19 vaccine. Do NOT refreeze thawed vaccine. Temperature Monitoring Ultra-cold freezer, freezer, refrigerator: Storage unit temperatures must be monitored regularly, checked, and recorded at the beginning of the workday to determine if any temperature excursions have occurred since the last temperature check. For accurate temperature monitoring, use a digital data logger (DDL) with a detachable probe that best reflects vaccine temperatures. Ultra-cold temperatures: Use a probe designed specifically to Frozen and refrigerated storage: Use a probe buffered with measure ultra-cold temperatures. glycol, glass beads, sand, or Teflon®. Check and record the temperature daily using CDC’s temperature log. Use one of the options below: Option 1 (preferred): Minimum/Maximum Option 2: Current Temperature (Min/Max) Temperature If the DDL does not display min/max temperatures, check and Most DDLs display min/max temperatures. Check and record record the current temperature at the start and end of the the min/max temperatures at the start of each workday. workday. Review the continuous DDL temperature data daily. Thermal Shipping Container: Use the Controlant temperature monitoring device (TMD) included with the thermal shipping container to monitor the temperature. See thermal shipping container information above.

08/24/2021 CS321570-I 2 Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summary

Diluent 0.9% sodium chloride (normal saline, preservative-free) diluent is included in the ancillary supply kits. Follow the manufacturer’s guidance for storing the diluent. Mixed Vaccine Once mixed, vaccine can be left at room temperature Mixed vaccine should NOT be returned to freezer storage. (2°C to 25°C [35°F to 77°F]) for up to 6 hours. Minimize exposure to room light, and avoid exposure to direct Discard any remaining vaccine after 6 hours. sunlight and ultraviolet light.

Disposal Once vaccine has reached its expiration or beyond-use date, contact the manufacturer for guidance on whether it can still be used. If instructed to dispose of vaccine, dispose of the vial (with any remaining vaccine) and packaging as medical waste according to your local and state regulations. Contact your jurisdiction’s immunization program (https://www.cdc.gov/vaccines/imz-managers/ awardee-imz-websites.html) for guidance. Do NOT return vaccine in the thermal shipping container.

CDC's Pfizer-BioNTech COVID-19 Vaccine materials https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html CDC's Vaccine Storage and Handling Toolkit https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf CDC's Pfizer Beyond-Use Date (BUD) labels https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/bud-tracking-labels.pdf CDC's Delivery Checklist https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/delivery-checklist.pdf CDC's Freezer and Refrigerator Temperature Logs https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html

For additional information, refer to the manufacturer's website at www.cvdvaccine.com

08/24/2021 CS321570-I 3 Moderna COVID-19 Vaccine Beyond-Use Date/Time (BUD) Tracking Label for Vaccine During Refrigerator Storage

Once thawed, Moderna COVID-19 vaccine has specific beyond-use dates/times for refrigerated

storage and transport. Use these labels to ensure beyond-use dates/times are followed.

Storing Vaccine in the Refrigerator U.S. Department of Moderna COVID-19 Health and Human Services Centers for Disease Moderna COVID-19 vaccine may be stored in the refrigerator Vaccine Control and Prevention

between 2°C and 8°C (36°F and 46°F) for up to 30 days. Store vaccine between 2°C and 8°C (36°F and 46°F) for up to 30 days.

123456A Remove the vaccine vials from the freezer. Lot number(s): Today’s date: ____/____/_____4 01 2021 USE BY* Date: ____/____/_____5 01 2021 Complete the information on the top portion of the label and *After this date/time, do NOT use. Contact the manufacturer for guidance. If directed attach it to the box or container holding the vaccine vials. to discard the vaccine, follow the manufacturer's and your jurisdiction's guidance on proper disposal. Once labeled, store vaccine vials upright in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 30 days. Use Vaccine may be transported for 12 cumulative hours.

vaccine vials stored in the refrigerator BEFORE removing Transport date

additional vials from the freezer. Time in transport:

As the 30-day deadline approaches, contact the Time remaining: manufacturer for guidance if you will not be able Name: Amy Nurse RN to use vaccine. If directed to discard vaccine, follow manufacturerand jurisdiction guidance for proper disposal.

Transporting Vaccine Between 2°C and 8°C (36°F and 46°F) U.S. Department of Moderna COVID-19 Health and Human Se Centers for Disease Moderna COVID-19 vaccine may be transported for 12 cumulative Vaccine Control and Prevention hours (e.g., vaccine transported for 2 hours today has 10 hours Store vaccine between 2°C and 8°C (36°F and 46°F) for up to 30 days. of transport time remaining). Follow transportation guidance for Lot number(s): 123456A Moderna COVID-19 vaccine in CDC's Storage and Handling Toolkit, Today’s date: ____/____/_____4 01 2021 USE BY* Date: ____/____/_____5 01 2021 COVID-19 Addendum. *After this date/time, do NOT use. Contact the manufacturer for guidance. If directed to discard the vaccine, follow the manufacturer's and your jurisdiction's guidance When you have completed vaccine transport for the day, on proper disposal. remove any remaining vials from the transport container. Vaccine may be transported for 12 cumulative hours. Complete the information on the bottom portion of the label

indicating the time in transport and hours remaining for Transport date 4/5/21 Time in transport: 2 hrs transport, if needed. Time remaining: 10 hrs Once you have completed this information, store vaccine upright in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to Name: Amy Nurse RN the indicated BUD.

Note: Storage labels on page 2 are formatted to print on 4” x 3-1/3” adhesive labels. We are unable to format for other size labels. If this size label is not available, print on paper and tape to container holding the vaccine.

07/15/2021 CS321571-E 1 Moderna Moderna COVID-19 Vaccine COVID-19 Vaccine

Store vaccine between 2°C and 8°C (36°F and 46°F) for up to 30 days. Store vaccine between 2°C and 8°C (36°F and 46°F) for up to 30 days.

Lot number(s): Lot number(s):

Today’s date: / / USE BY* Date: / / Today’s date: / / USE BY* Date: / / *After this date/time, do NOT use. Contact the manufacturer for guidance. If directed *After this date/time, do NOT use. Contact the manufacturer for guidance. If directed to discard the vaccine, follow the manufacturer's and your jurisdiction's guidance to discard the vaccine, follow the manufacturer's and your jurisdiction's guidance on proper disposal. on proper disposal.

Vaccine may be transported for 12 cumulative hours. Vaccine may be transported for 12 cumulative hours.

Transport date Transport date

Time in transport: Time in transport:

Time remaining: Time remaining:

Name: Name:

Moderna Moderna COVID-19 Vaccine COVID-19 Vaccine

Store vaccine between 2°C and 8°C (36°F and 46°F) for up to 30 days. Store vaccine between 2°C and 8°C (36°F and 46°F) for up to 30 days.

Lot number(s): Lot number(s):

Vaccine may be transported for 12 cumulative hours. Vaccine may be transported for 12 cumulative hours.

Transport date Transport date

Time in transport: Time in transport:

Time remaining: Time remaining:

Name: Name:

Moderna Moderna COVID-19 Vaccine COVID-19 Vaccine

Store vaccine between 2°C and 8°C (36°F and 46°F) for up to 30 days. Store vaccine between 2°C and 8°C (36°F and 46°F) for up to 30 days.

Lot number(s): Lot number(s):

Vaccine may be transported for 12 cumulative hours. Vaccine may be transported for 12 cumulative hours.

Transport date Transport date

Time in transport: Time in transport:

Time remaining: Time remaining:

Name: Name:

07/15/2021 CS321570-E 2 Moderna COVID-19 Vaccine Storage and Handling Label - Intended for print only

Moderna Moderna COVID-19 Vaccine COVID-19 Vaccine

Ages: 18 years of age and older Ages: 18 years of age and older

Use for: Any dose in the 2-dose series. Use for: Any dose in the 2-dose series. COVID-19 vaccines are NOT COVID-19 vaccines are NOT interchangeable. Both doses interchangeable. Both doses should be COVID-19 vaccine (Moderna). should be COVID-19 vaccine (Moderna).

Route: Intramuscular (IM) injection Route: Intramuscular (IM) injection

Beyond Beyond Use Time: Use within 12 hours Use Time: Use within 12 hours after the vial is after the vial is first punctured. first punctured.

Moderna Moderna COVID-19 Vaccine COVID-19 Vaccine

Ages: 18 years of age and older Ages: 18 years of age and older

Route: Intramuscular (IM) injection Route: Intramuscular (IM) injection

Beyond Beyond Use Time: Use within 12 hours Use Time: Use within 12 hours after the vial is after the vial is first punctured. first punctured.

Moderna Moderna COVID-19 Vaccine COVID-19 Vaccine

Ages: 18 years of age and older Ages: 18 years of age and older

Route: Intramuscular (IM) injection Route: Intramuscular (IM) injection

Beyond Beyond Use Time: Use within 12 hours Use Time: Use within 12 hours after the vial is after the vial is first punctured. first punctured.

07/15/2021 CS321571-D 1 Moderna COVID-19 Vaccine Storage and Handling Summary

Basics Store vaccine in a freezer or refrigerator. See guidance below for each storage unit. Use vaccine vials stored in the refrigerator before removing vials from frozen storage. Check and record storage unit temperature each workday. See guidance below for each type of temperature monitoring device. Save storage records for 3 years, unless your jurisdiction requires a longer time period.

Deliveries

Vaccine 1. The vaccine will arrive frozen between -50°C and -15°C (-58°F and 5°F). 2. Examine the shipment for signs of damage. 3. Open the box and remove TagAlert Temperature Monitor from box (placed in the inner box next to vaccine). 4. Check the TagAlert temperature monitoring device by pressing the blue “start and stop” button. Left arrow points to a green checkmark: The vaccine is ready to use. Store the vaccine at proper temperatures immediately. Right arrow points to a red X: The numbers 1 and/or 2 will appear in the display. Store the vaccine at proper temperatures and label DO NOT USE! Call the phone number indicated in the instructions or your jurisdiction's immunization program IMMEDIATELY! 5. The expiration date is NOT printed on the vaccine vial or carton. To determine the expiration date: Scan the QR code located on the outer carton, or Go to www.modernatx.com/covid19vaccine-eua/.

Ancillary Supply Kit An ancillary kit with supplies will be provided for administering the vaccine. Administration supplies include needles, syringes, sterile alcohol prep pads, vaccination record cards (shot cards), and some PPE. The kit is delivered separately from the vaccine. Unpack the kit and check for receipt of the correct administration supplies and quantities.

Freezer Unpunctured vials may be stored in the freezer between -50°C and -15°C (-58°F and 5°F). Store in the original carton. Protect from light. Do not store with dry ice or below -50°C (-58°F).

08/24/2021 CS321571-F 1 Moderna COVID-19 Vaccine Storage and Handling Summary

Refrigerator U.S. Department of Moderna COVID-19 Health and Human Se Centers for Disease Unpunctured vials may be stored in the refrigerator between Vaccine Control and Prevention 2° to 8°C (36° to 46°F) for up to 30 days.* Store vaccine between 2°C and 8°C (36°F and 46°F) for up to 30 days. Do NOT refreeze thawed vaccine.

Lot number(s): 123456A Thawed vaccine can be handled in room light. Today’s date: ____/____/_____4 01 2021 USE BY* Date: ____/____/_____5 01 2021

Monitor how long the vaccine has been in the refrigerator *After this date/time, do NOT use. Contact the manufacturer for guidance. If directed to discard the vaccine, follow the manufacturer's and your jurisdiction's guidance using CDC’s beyond-use date labels. on proper disposal. Remove the box from frozen storage. Vaccine may be transported for 12 cumulative hours. Complete the information on the storage label. Transport date Attach it to the box holding the vaccine vials. 4/5/21 Time in transport: 2 hrs Once labeled, place vaccine in the refrigerator. Time remaining: 10 hrs Punctured vials may be stored between 2°F and 25°C (36°F and 77°F) for up to 12 hours. Name: Amy Nurse RN

Temperature Monitoring Storage unit temperatures must be monitored regularly and checked and recorded at the beginning of each workday to determine if any excursions have occurred since the last temperature check. For accurate temperature monitoring, use a digital data logger (DDL) with a detachable probe that best reflects vaccine temperatures (e.g., probe buffered with glycol, glass beads, sand, or Teflon®). Check and record the temperature daily using a temperature log and one of the options below: Option 1: Minimum/Maximum Temperatures (preferred) Option 2: Current Temperature Most DDLs display minimum and maximum (min/max) If the DDL does not display min/max temperatures, temperatures. Check and record the min/max check and record the current temperature at the temperatures at the start of each workday. start and end of the workday. Review the continuous DDL temperature data daily. For CDC temperatures logs, see https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html. Disposal Once vaccine has reached its expiration or beyond-use date, contact the manufacturer for guidance on whether it can still be used. If instructed to dispose of vaccine, dispose of the vial (with any remaining vaccine) and packaging as medical waste according to your local and state regulations. Contact your jurisdiction’s immunization program for guidance (https://www.cdc.gov/vaccines/imz- managers/awardee-imz-websites.html).

*Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for a total of 24 hours.

For additional information, refer to the manufacturer's product information at https://www.modernatx.com/covid19vaccine-eua/. CDC's Moderna COVID-19 materials https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html CDC's Vaccine Storage and Handling Toolkit https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf CDC's Moderna Beyond-Use Date (BUD) label https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/bud-tracking-labels.pdf Moderna COVID-19 Vaccine Transporting Vaccine for Vaccination Clinics Held at Satellite, Temporary, or Off-Site Locations https://www.cdc.gov/ vaccines/covid-19/info-by-product/moderna/downloads/Moderna-Vaccine-Transport.pdf

08/24/2021 CS321571-F 2 Janssen COVID-19 Vaccine Storage and Handling Label - Intended for print only

Janssen COVID-19 Vaccine Janssen COVID-19 Vaccine (Johnson & Johnson) (Johnson & Johnson)

Ages: 18 years of age and older Ages: 18 years of age and older Use for: Single dose from a multidose Use for: Single dose from a multidose vial. COVID-19 vaccines are vial. COVID-19 vaccines are NOT interchangeable. NOT interchangeable. Route: Intramuscular (IM) injection Route: Intramuscular (IM) injection Beyond- Beyond- Use Time: Use within 6 hours after the vial Use Time: Use within 6 hours after the vial is first punctured if held between is first punctured if held between 2°C and 8°C (36°F and 46°F) 2°C and 8°C (36°F and 46°F) or use within 2 hours after the or use within 2 hours after the vial is first punctured if vial is first punctured if held at room temperature held at room temperature (maximally 25°C or 77°F). (maximally 25°C or 77°F).

Janssen COVID-19 Vaccine Janssen COVID-19 Vaccine (Johnson & Johnson) (Johnson & Johnson)

07/19/2021 CS321571-D 1 Janssen COVID-19 Vaccine (Johnson & Johnson) Storage and Handling Summary

Basics Store vaccine in a refrigerator. See guidance below for further details. Check and record storage unit temperatures each workday. See guidance below for each type of temperature monitoring device. Save storage records for 3 years, unless your jurisdiction requires a longer time period.

Deliveries

Vaccine

1. The vaccine will arrive in a 2° to 8°C (36°F and 46°F) qualified shipping container. 2. Examine the shipment for signs of damage. 3. As a backup to the qualified shipping container, temperature monitors are placed in each shipment. Janssen vaccines may include thawed and frozen/partially frozen vaccines and due to this, only warm monitors will be included in Janssen shipments. 4. Remove the instruction card for the temperature monitor immediately. Follow the guide on the back of the card to read the monitor. 5. The expiration date is NOT printed on the vaccine vial or carton. To determine the expiration date: Scan the QR code on the outer carton, or Call 1-800-565-4008, or Visit www.vaxcheck.jnj. Write the expiration date on the carton.

Ancillary Supply Kit

An ancillary supply kit will be provided and includes enough supplies to administer 100 doses of vaccine. Administration supplies include needles, syringes, sterile alcohol prep pads, vaccination record cards (shot cards), and some PPE. The kit is delivered separately from the vaccine. Unpack the kit and check for receipt of the correct administration supplies and quantities.

1 08/24/2021 CS322139-C Janssen COVID-19 Vaccine (Johnson & Johnson) Storage and Handling Summary

Refrigerator Storage CDC recommends storing vaccine between 2°C and Do not freeze. 8°C (36°F and 46°F): Protect from light. * Unpunctured vials until the expiration date As the expiration date approaches, determine if Punctured vials for up to 6 hours.† Note the date and it has been extended using the same methods time the vial was first punctured. Discard vaccine outlined in the "Deliveries" section. Do not discard not used within this time. vaccine without ensuring the expiration date has passed. Use CDC’s expiration date tracking tool to document expiration date changes.

**Unpunctured vials may also be stored between 9°C and 25°C (47°F and 77°F) for up to 12 hours. †Alternate option: A punctured vial may be stored at room temperature (9°C to 25°C [47°F to 77°F]) for up to 2 hours.

Disposal Once vaccine has reached its expiration or beyond-use date, contact the manufacturer for guidance on whether it can still be used. If instructed to dispose of vaccine, dispose of the vial (with any remaining vaccine) and packaging as medical waste according to your local and state regulations. Contact your jurisdiction’s immunization program for guidance (https://www.cdc.gov/vaccines/imz-managers/awardee-imz-websites.html).

CDC's Janssen COVID-19 vaccine materials https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/index.html CDC's Vaccine Storage and Handling Toolkit https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf CDC's Temperature Logs https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/index.html CDC's Transport Guidance for Janssen COVID-19 Vaccine https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/index.html

For additional information, refer to the manufacturer's product information at https://www.janssencovid19vaccine.com/hcp.html.

2 08/24/2021 CS322139-C TEMPERATURE EXCURSION INCIDENT REPORT NEW YORK CITY DEPARTMENT OF HEALTH & MENTAL HYGIENE BUREAU OF IMMUNZATION ● COVID-19 VACCINATION PROGRAM 347-396-2404 (Phone) ● 347-396-8841 (Fax) ● [email protected]

In the event of a temperature excursion, contact the vaccine manufacturers, complete and submit this form to the New York City Department of Health and Mental Hygiene, Bureau of Immunization, Provider Quality Assurance Unit. This report serves as a record of the incident, the steps taken to determine vaccine viability, and the disposition of the affected vaccines. Keep this report for your records.

Manufacturer Contact Info Vaccine 1-800-565-4008 Sars-COV-2 (Janssen) Janssen www.janssenmd.com/janssen-covid19-vaccine 1-866-663-3762 Moderna Sars-COV-2 (Moderna) www.modernatx.com 1-800-505-4426 Pfizer Sars-COV-2 (Pfizer BioNtech) www.pfizer.com

Pfizer Vaccine Moderna Vaccine Janssen Vaccine Ultra-Cold (-60°C to -80°C)

-up to 6 months in ultra-cold freezer Freezer -25°C to -20°C -up to 15 days in thermal shipper Store in refrigerator. Storage up to 6 months in freezer with dry ice replenishment Do not freeze - Frozen (between -25°C and -15 °C) up to 2 weeks in a standard freezer Refrigerator 2°Cto 8°C (36°F to 46°F) 2°C to 8°C (36°F to 46°F) 2°C to 8°C (36°F to 46°F) Storage for up to 31 days for up to 30 days Until expiration date

Room Unpunctured vials up to 2 hours; Unpunctured Vials up to 12 hours; Punctured vial up to 2 temperature mixed vaccine up to 6 hours Punctured vials up to 6 hours hours Reconstitution required Yes No No

Facility Name: ______PIN #: ______Date Reported: ______

Reported by (first & last name): ______Phone #:______Email: ______

Date of Excursion: ______Time of Excursion: ______Order ID (if applicable): ______

IMMEDIATE ACTION TAKEN 1. Were the Vaccine Coordinator or Back-up Vaccine Coordinator notified of the excursion? □ YES □ NO 2. What was the excursion temperature inside the affected storage unit(s) at the time the problem was discovered? □ Refrigerator Temperature ______°C or ______°F □ Freezer Temperature: ______°C or ______°F □ Ultra-Cold Freezer Temperature: ______°C or ______°F

PROVIDER QUALITY ASSURANCE UNIT │ BUREAU OF IMMUNIZATION │ NEW YORK CITY DEPARTMENT OF HEALTH & MENTAL HYGIENE Revised 4/2021│ Page 1 TEMPERATURE EXCURSION INCIDENT REPORT NEW YORK CITY DEPARTMENT OF HEALTH & MENTAL HYGIENE BUREAU OF IMMUNZATION ● COVID-19 VACCINATION PROGRAM 347-396-2404 (Phone) ● 347-396-8841 (Fax) ● [email protected]

3. How long were the vaccines exposed to inappropriate storage temperatures? Please record the total amount of time or cumulative time outside of range for each unit. □ Refrigerator: _____Days______Hours _____ Minutes □ Freezer: ______Days ______Hours ______Minutes □ Ultra-Cold Freezer: ______Days ______Hours ______Minutes

4. What was the room temperature surrounding the affected unit at the time of the excursion? ______5. Were water bottles in the refrigerator at the time of the event? □YES □NO Were frozen coolant packs in the freezer at the time of the event? □YES □NO 6. Was an inventory of the vaccines within the affected storage unit conducted? □YES □NO 7. Vaccines in the affected storage unit quarantined within the unit and labeled “DO NOT USE” pending manufacturer’s input? □YES □NO *If your vaccine storage unit(s) cannot be reset to maintain the appropriate storage conditions, follow the EMERGENCY PLAN as described within the VFC Vaccine Management Plan. 8. Has the vaccine manufacturer been contacted for further guidance? □YES □NO

CAUSE OF EXCURSION: □ Power Outage Unit(s) not plugged in or not turned on □ Prolonged opening of refrigerator /freezer door □ Temperature Monitoring device moved/misplaced □ Unit’s temperature control knob setting is incorrect □ Poor air circulation inside and outside the unit(s) □ Operational problems with the storage unit(s) □ Other______

Type & Brand Name of Storage Unit Affected by Excursion: □ Small Stand-Alone Refrigerator □ Pharmaceutical Grade (Stand-Alone Refrigerator) □ Small Stand-Alone Chest Freezer □ Pharmaceutical Grade (Combined Refrigerator & Freezer) □ Stand-Alone Freezer □ Small Household Refrigerator & Freezer (Refrigerator Only) □ Regular Stand-Alone Refrigerator □ Regular Household Refrigerator & Freezer (Refrigerator Only) □ Regular Stand-Alone Chest Freezer □ Large Household Refrigerator & Freezer (Refrigerator Only) □ Pharmaceutical Grade (Stand-Alone Freezer) □ Pharmaceutical Grade (Ultra-Cold Freezer)

Storage Unit Brand Name: ______Model/Serial #: ______Thermometer Brand Name: ______Model/Serial #: ______

PROVIDER QUALITY ASSURANCE UNIT │ BUREAU OF IMMUNIZATION │ NEW YORK CITY DEPARTMENT OF HEALTH & MENTAL HYGIENE Revised 4/2021│ Page 2 TEMPERATURE EXCURSION INCIDENT REPORT NEW YORK CITY DEPARTMENT OF HEALTH & MENTAL HYGIENE BUREAU OF IMMUNZATION ● COVID-19 VACCINATION PROGRAM 347-396-2404 (Phone) ● 347-396-8841 (Fax) ● [email protected]

COVID-19 Vaccines, Manufacturer & Lot Number(s) affected due to temperature excursion: Vaccine Vaccine Type Lot Lot Expiration New Expiration Number of (Manufacturer) Number(s) Date Date (if applicable) Doses Place an ‘X’ in box next to spoiled vaccines □ SARS- COV-2® (Pfizer COVID-19 BioNtech) □ SARS-COV-2® COVID-19 (Moderna) □ SARS-COV-2® (Janssen) COVID-19 □ SARS-COV-2® COVID-19 (AstraZeneca)

Describe the incident and corrective actions taken:

BASED ON MANUFACTURER’S REPSONSE: Quality of vaccines has not been compromised and may continue to be used. □YES □NO [CONTINUE TO MANUFACTURER CASE NUMBER(S) SECTION /SIGN FORM ON PAGE 3]

Vaccines were not approved for further use and should be identified as “spoiled”. □YES □NO [CONTINUE TO MANUFACTURER CASE NUMBER(S) SECTION /IDENTIFY ONLY SPOILED DOSES/SIGN FORM]

Manufacturer Case Number(s):

Moderna______Pfizer______

*PLEASE ATTACH COPIES OF ALL DOCUMENTS FROM THE MANUFACUTER STATING THE VIABILITY STATUS OF ALL VACCINES. *DO NOT DISCARD VACCINES UNLESS DIRECTED BY THE MANUFACTURER(S).

NAME: SIGNATURE: DATE REPORTED:

PROVIDER QUALITY ASSURANCE UNIT │ BUREAU OF IMMUNIZATION │ NEW YORK CITY DEPARTMENT OF HEALTH & MENTAL HYGIENE Revised 4/2021│ Page 3 TEMPERATURE EXCURSION INCIDENT REPORT NEW YORK CITY DEPARTMENT OF HEALTH & MENTAL HYGIENE: VACCINES FOR CHILDREN (VFC) PROGRAM 347-396-2404 (Phone) ● 347-396-8841 (Fax) ● [email protected]

VACCINE MANUFACTURER CONTACT INFORMATION MANUFACTURER CONTACT INFO VACCINE CSL 1-888-435-8633 or 1-855-358-8966 • Influenza (Age 9 years and older) (Afluria No Preservative) www.biocsl.com • Influenza (Age 9 years and older) (Afluria)

• DTap (Infanrix) • DTap-IPV (Kinrix) • DTaP-Hep B-IPV (Pediarix) • Hepatitis A Pediatric (Havrix) • Hepatitis A-Hepatitis B 18 only (Twinrix) Hepatitis B Pediatric/Adolescent (Engerix B) 1-877-356-836 HIBMENCY (MENHIBRIX) GlaxoSmithKline https://www.gskusmedicalaffairs.com/st • HPV -Bivalent Human Papillomavirus Types 16 and 18 (Cervarix) ability-calculator.html • Influenza (Age 36 months and older) (Fluarix Quadrivalent Preservative Free) • Influenza (Age 36 months and older) (FluLaval Quadrivalent/ FluLaval Trivalent) [email protected] • MENB – Meningococcal Group B (Bexsero) • Meningococcal Conjugate (Groups A, C, Y and W-135) (Menveo) • Rotavirus, Live, Oral, Oral (Rotarix) • Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Boostrix) 1-800-565-4008 • Sars-COV-2 (COVID-19) Janssen www.janssenmd.com/janssen- covid19-vaccine MedImmune 1-877-633-4411 • Influenza [5] www.medimmune.com • Live, Intranasal (Age 2-49 years) (FluMist® Quadrivalent No Preservative) • Hepatitis A Pediatric (Vaqta) • Hepatitis B Pediatric/Adolescent (Recombivax HB) Hib (PedvaxHIB) • HPV - Quadrivalent Human Papillomavirus Types 6, 11, 16 and 18 Recombinant (Gardasil) 1-877-829-6372 • Measles, Mumps and Rubella (MMR) (M-M-R II) Merck www.merckvaccines.com • MMR/Varicella (ProQuad) • Pneumococcal Polysaccharide (23 Valent) (Pneumovax23) • Rotavirus, Live, Oral, Pentavalent (Rota Teq) • Varicella (Varivax) 1-866-663-3762 • Sars-COV-2 ( ) Moderna COVID-19 www.modernatx.com

|Page 4 TEMPERATURE EXCURSION INCIDENT REPORT NEW YORK CITY DEPARTMENT OF HEALTH & MENTAL HYGIENE: VACCINES FOR CHILDREN (VFC) PROGRAM 347-396-2404 (Phone) ● 347-396-8841 (Fax) ● [email protected]

Pfizer 1-800-505-4426 • Pneumococcal 13-valent (Prevnar 13 TM) www.pfizer.com • MENB – Meningococcal Group B (Trumenba) • Sars-COV-2 (COVID-19) • DTap (Daptacel) • DTaP-IP-HI (Pentacel) • e-IPV (IPOL) • Hib (ActHIB) Sanofi Pasteur 1-800-822-2463 • Influenza (Age 36 months and older) (Fluzone No-Preservative/Quadrivalent NoPreservative) www.sanofipasteur.us • Meningococcal Conjugate (Groups A, C, Y and W-135) (Menactra) • Tetanus & Diphtheria Toxoids (Tenivac) • Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Adacel) • Influenza (Age 6 months and older) (Fluzone/Fluzone Quadrivalent)

|Page 5 Temperature Log when Transporting Vaccine at Refrigerated Temperatures

When transporting refrigerated Temperature monitoring and transport time frames If the temperature is out of range, vaccines, use: Most DDLs display minimum/maximum (min/max) temperatures.* TAKE ACTION! A portable refrigerator or vaccine Record the time and min/max temperatures: storage container qualified to maintain 1. Do NOT discard the vaccine. Ź At the start of transport temperatures between 2°C and 8°C 2. Label the vaccine “Do Not Use.” (36°F and 46°F). Ź Every time the portable storage container is opened 3. Complete the Vaccine Troubleshooting Record. A digital data logger (DDL) with a Ź When transport is completed thermal buffer and external temperature 4. Contact the manufacturer to determine under The total time for transport alone or transport plus clinic workday display (preferred). Place the probe as what conditions (refrigerated) to store the should be a maximum of 8 hours.± close as possible to the vaccine. vaccine as quickly as possible. Beyond-use date/time (BUD), if applicable, are included in transport This temperature log to document time. For example, if the vaccine may be stored at refrigerated temperatures and how long the vaccine temperature for 120 hours, transport is included in this time frame. is in the portable storage container.

Today's date: Transport start time: Transport end time: Provider name: Facility name: PIN number: Temperatures measured in (circle one): Celsius Fahrenheit

Time

Staff initials

Min/max temperatures

Temperatures lower than 2°C (36°F) and higher than 8°C (46°F) are out of range.± Complete a Vaccine Troubleshooting Record. Contact the manufacturer and your immunization program.

After packing the vaccine, open the portable storage container only when necessary. Save this record for 3 years, unless your state/local jurisdiction requires a longer time If using a company or personal vehicle, transport vaccines inside the passenger period. See CDC’s Vaccine Storage and Handling Toolkit for additional guidance. compartment (not in the trunk or bed of a truck, which may be too hot or too cold). Refer to CDC’s Vaccine Storage and Handling Toolkit for additional guidance when Avoid leaving the portable storage container in direct sunlight or unattended. transporting vaccines. If needed, transport diluents with their corresponding vaccines to ensure there * are equal amounts of vaccines and diluents. Follow the manufacturer’s guidance If the DDL does not measure min/max temperatures, check and record temperatures hourly. for specific temperature requirements for diluents. ± Follow the manufacturer’s guidance if it differs from this time frame.

03/04/2021 CS322033-C For information on storage and handling of COVID-19 vaccines, see the COVID-19 Vaccine Addendum in CDC’s Temperature Log for Refrigerator – Fahrenheit updated Vaccine Storage and Handling Toolkit at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html. F° DAYS 1–15 / Monitor temperatures closely! Month Year VFC PIN or other ID # Page 1 of 3 1. Write your initials below in “Staff Initials,” and note the time in “Exact Time.” Facility Name 2. If using temperature monitoring device (TMD; digital data logger recommended) that records min/max temps (i.e., the highest and lowest temps recorded in a spe- Take action if temp is out of range – too warm (above 46ºF) or too cold (below 36ºF). cific time period), document current and min/max once each workday, preferably in 1. Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible. the morning. If using TMD that does not record min/max temps, document current Do not discard vaccines unless directed to by your state/local health department and/or the temps twice, at beginning and end of each workday. manufacturer(s). 3. Put an “X” in the row that corresponds to the refrigerator’s temperature. 2. Record the out-of-range temps and the room temp in the “Action” area on the bottom of the log. 4. If any out-of-range temp observed, see instructions to the right. 3. Notify your vaccine coordinator, or call the immunization program at your state or local health 5. After each month has ended, save each month’s log for 3 years, unless state/local department for guidance. jurisdictions require a longer period. 4. Document the action taken on the “Vaccine Storage Troubleshooting Record” on page 3. Day of Month 1 2 3 4 5 6 7 8 910 11 12 13 14 15

Staﬀ Initials am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm Exact Time

Min/Max Temp in Unit (since previous reading)

Danger! Temperatures above 46ºF are too warm! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately! 46˚F 45˚F 44˚F 43˚F 42˚F Aim for 41º 41˚F 40˚F 39˚F 38˚F 37 F acceptable temperatures ˚ 36˚F Danger! Temperatures below 36ºF are too cold! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately! Write any out-of-range temps (above 46ºF or below 36ºF) here:

ctio n Room Temperature a

If you have a vaccine storage issue, also complete “Vaccine Storage Troubleshooting Record” found on page 3. Adapted with appreciation from California Department of Public Health

Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.org www.immunize.org/catg.d/p3037F.pdf • Item #P3037F (3/21) Temperature Log for Refrigerator – Fahrenheit For information on storage and handling of COVID-19 vaccines, see the COVID-19 Vaccine Addendum in CDC’s ° updated Vaccine Storage and Handling Toolkit at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html. F DAYS 16–31 Monitor temperatures closely! Month/Year VFC PIN or other ID # Page 2 of 3 1. Write your initials below in “Staff Initials,” and note the time in “Exact Time.” 2. If using temperature monitoring device (TMD; digital data logger recommended) Facility Name that records min/max temps (i.e., the highest and lowest temps recorded in a spe- Take action if temp is out of range – too warm (above 46ºF) or too cold (below 36ºF). cific time period), document current and min/max once each workday, preferably in 1. Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible. the morning. If using TMD that does not record min/max temps, document current Do not discard vaccines unless directed to by your state/local health department and/or the temps twice, at beginning and end of each workday. manufacturer(s). 3. Put an “X” in the row that corresponds to the refrigerator’s temperature. 2. Record the out-of-range temps and the room temp in the “Action” area on the bottom of the log. 4. If any out-of-range temp observed, see instructions to the right. 3. Notify your vaccine coordinator, or call the immunization program at your state or local health 5. After each month has ended, save each month’s log for 3 years, unless state/local department for guidance. jurisdictions require a longer period. 4. Document the action taken on the “Vaccine Storage Troubleshooting Record” on page 3. Day of Month 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Staﬀ Initials am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm Exact Time

Min/Max Temp in Unit (since previous reading) Danger! Temperatures above 46ºF are too warm! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately! 46˚F 45˚F 44˚F 43˚F 42 F temperatures ˚ Aim for 41º 41˚F 40˚F 39˚F 38˚F 37˚F

acceptable 36˚F Danger! Temperatures below 36ºF are too cold! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately! Write any out-of-range temps (above 46ºF or below 36ºF) here:

ctio n Room Temperature a

If you have a vaccine storage issue, also complete “Vaccine Storage Troubleshooting Record” found on page 3.

Adapted with appreciation from California Department of Public Health

Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.org www.immunize.org/catg.d/p3037F.pdf • Item #P3037F (3/21) Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.org For information on storage and handling of COVID-19 vaccines, see the COVID-19 Vaccine Addendum in CDC’s C° Temperature Log for Refrigerator – Celsius updated Vaccine Storage and Handling Toolkit at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html. DAYS 1–15 Month/Year VFC PIN or other ID # Page 1 of 3 Monitor temperatures closely! 1. Write your initials below in “Staff Initials,” and note the time in “Exact Time.” Facility Name 2. If using temperature monitoring device (TMD; digital data logger recommended) that records min/max temps (i.e., the highest and lowest temps recorded in a spe- Take action if temp is out of range – too warm (above 8ºC) or too cold (below 2ºC). cific time period), document current and min/max once each workday, preferably in 1. Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible. the morning. If using TMD that does not record min/max temps, document current Do not discard vaccines unless directed to by your state/local health department and/or the temps twice, at beginning and end of each workday. manufacturer(s). 3. Put an “X” in the row that corresponds to the refrigerator’s temperature. 2. Record the out-of-range temps and the room temp in the “Action” area on the bottom of the log. 4. If any out-of-range temp observed, see instructions to the right. 3. Notify your vaccine coordinator, or call the immunization program at your state or local health 5. After each month has ended, save each month’s log for 3 years, unless state/local department for guidance. jurisdictions require a longer period. 4. Document the action taken on the “Vaccine Storage Troubleshooting Record” on page 3.

Day of Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Staff Initials am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm Exact Time

Min/Max Temp in Unit (since previous reading)

Danger! Temperatures above 8ºC are too warm! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately! 8˚C 7˚C 6 C

temperatures ˚ Aim for 5º 5˚C

4˚C 3˚C acceptable 2˚C Danger! Temperatures below 2ºC are too cold! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately! Write any out-of-range temps (above 8ºC or below 2ºC) here:

Room Temperature action

If you have a vaccine storage issue, also complete “Vaccine Storage Troubleshooting Record” found on page 3.

distributed by the Adapted with appreciation from California Department of Public Health Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.org www.immunize.org/catg.d/p3037C.pdf • Item #P3037C (3/21) Temperature Log for Refrigerator – Celsius For information on storage and handling of COVID-19 vaccines, see the COVID-19 Vaccine Addendum in CDC’s ° updated Vaccine Storage and Handling Toolkit at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html. C DAYS 16–31 / Page 2 of 3 Monitor temperatures closely! Month Year VFC PIN or other ID # 1. Write your initials below in “Staff Initials,” and note the time in “Exact Time.” Facility Name 2. If using temperature monitoring device (TMD; digital data logger recommended) that records min/max temps (i.e., the highest and lowest temps recorded in a spe- Take action if temp is out of range – too warm (above 8ºC) or too cold (below 2ºC). cific time period), document current and min/max once each workday, preferably in 1. Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible. the morning. If using TMD that does not record min/max temps, document current Do not discard vaccines unless directed to by your state/local health department and/or the temps twice, at beginning and end of each workday. manufacturer(s). 3. Put an “X” in the row that corresponds to the refrigerator’s temperature. 2. Record the out-of-range temps and the room temp in the “Action” area on the bottom of the log. 4. If any out-of-range temp observed, see instructions to the right. 3. Notify your vaccine coordinator, or call the immunization program at your state or local health 5. After each month has ended, save each month’s log for 3 years, unless state/local department for guidance. jurisdictions require a longer period. 4. Document the action taken on the “Vaccine Storage Troubleshooting Record” on page 3.

Day of Month 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Staﬀ Initials am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm Exact Time

Min/Max Temp in Unit (since previous reading) Danger! Temperatures above 8ºC are too warm! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately! 8˚C 7˚C 6 C

temperatures ˚

Aim for 5º 5˚C

Room Temperature actio n

If you have a vaccine storage issue, also complete “Vaccine Storage Troubleshooting Record” found on page 3.

distributed by the Adapted with appreciation from California Department of Public Health Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.org www.immunize.org/catg.d/p3037C.pdf • Item #P3037C (3/21) Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.org For information on storage and handling of COVID-19 vaccines, see the COVID-19 Vaccine Addendum in CDC’s ° Temperature Log for Freezer – Fahrenheit updated Vaccine Storage and Handling Toolkit at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html. F DAYS 1–15 Monitor temperatures closely! Month/Year VFC PIN or other ID # Page 1 of 3 1. Write your initials below in “Staff Initials,” and note the time in “Exact Time.” Facility Name 2. If using a temperature monitoring device (TMD; digital data logger recommended) that records min/max temps (i.e., the highest and lowest temps recorded in a spe- Take action if temp is out of range—too warm (above 5ºF) or too cold (below -58ºF). cific time period), document current and min/max once each workday, preferably in 1. Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible. the morning. If using TMD that does not record min/max temps, document current Do not discard vaccines unless directed to by your state/local health department and/or the temps twice, at beginning and end of each workday. manufacturer(s). 3. Put an “X” in the row that corresponds to the freezer’s temperature. 2. Record the out-of-range temps and the room temp in the “Action” area on the bottom of the log. 4. If any out-of-range temp observed, see instructions to the right. 3. Notify your vaccine coordinator, or call the immunization program at your state or local health 5. After each month has ended, save each month’s log for 3 years, unless state/local department for guidance. jurisdictions require a longer period. 4. Document the action taken on the “Vaccine Storage Troubleshooting Record” on page 3. Day of Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Staff Initials am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm Exact Time

Min/Max Temp in Unit (since previous reading)

Danger! Temperatures above 5ºF are too warm! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately! 5°F 4°F 3°F 2°F 1°F 0°F -1°F -2°F -3°F -4°F

acceptable temperatures -58°F to -5°F Write any out-of-range temps (above 5ºF or below -58ºF) here.

Room Temperature action

If you have a vaccine storage issue, also complete “Vaccine Storage Troubleshooting Record” found on page 3.

distributed by the Adapted with appreciation from California Department of Public Health • • • Immunization Action Coalition Saint Paul, Minnesota 651-647-9009 www.immunize.org www.vaccineinformation.org www.immunize.org/catg.d/p3038F.pdf • Item #P3038F (3/21) For information on storage and handling of COVID-19 vaccines, see the COVID-19 Vaccine Addendum in CDC’s ° Temperature Log for Freezer – Fahrenheit updated Vaccine Storage and Handling Toolkit at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html. F DAYS 16–31 Month/Year VFC PIN or other ID # Page 2 of 3 Monitor temperatures closely! 1. Write your initials below in “Staff Initials,” and note the time in “Exact Time.” Facility Name 2. If using a temperature monitoring device (TMD; digital data logger recommended) that records min/max temps (i.e., the highest and lowest temps recorded in a spe- Take action if temp is out of range – too warm (above 5ºF) or too cold (below -58ºF). cific time period), document current and min/max once each workday, preferably in 1. Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible. the morning. If using TMD that does not record min/max temps, document current Do not discard vaccines unless directed to by your state/local health department and/or the temps twice, at beginning and end of each workday. manufacturer(s). 3. Put an “X” in the row that corresponds to the freezer’s temperature. 2. Record the out-of-range temps and the room temp in the “Action” area on the bottom of the log. 4. If any out-of-range temp observed, see instructions to the right. 3. Notify your vaccine coordinator, or call the immunization program at your state or local health 5. After each month has ended, save each month’s log for 3 years, unless state/local department for guidance. jurisdictions require a longer period. 4. Document the action taken on the “Vaccine Storage Troubleshooting Record” on page 3.

Day of Month 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Staff Initials am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm Exact Time

Min/Max Temp in Unit (since previous reading)

Danger! Temperatures above 5°F are too warm! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately! 5°F 4°F 3°F 2°F 1°F 0°F -1°F -2°F -3°F -4°F

acceptable temperatures acceptable -58°F to -5°F Write any out-of-range temps (above 5ºF or below -58°F) here.

Room Temperature action

If you have a vaccine storage issue, also complete “Vaccine Storage Troubleshooting Record” found on page 3.

distributed by the Adapted with appreciation from California Department of Public Health • • • Immunization Action Coalition Saint Paul, Minnesota 651-647-9009 www.immunize.org www.vaccineinformation.org www.immunize.org/catg.d/p3038F.pdf • Item #P3038F (3/21) For information on storage and handling of COVID-19 vaccines, see the COVID-19 Vaccine Addendum in CDC’s ° Temperature Log for Freezer – Celsius updated Vaccine Storage and Handling Toolkit at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html. C DAYS 1–15 Monitor temperatures closely! Month/Year VFC PIN or other ID # Page 1 of 3 1. Write your initials below in “Staff Initials,” and note the time in “Exact Time.” 2. If using temperature monitoring device (TMD; digital data logger recommended) Facility Name that records min/max temps (i.e., the highest and lowest temps recorded in a spe- Take action if temp is out of range—too warm (above -15ºC) or too cold (below -50ºC). cific time period), document current and min/max once each workday, preferably in 1. Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible. the morning. If using TMD that does not record min/max temps, document current Do not discard vaccines unless directed to by your state/local health department and/or the temps twice, at beginning and end of each workday. manufacturer(s). 3. Put an “X” in the row that corresponds to the freezer’s temperature. 2. Record the out-of-range temps and the room temp in the “Action” area on the bottom of the log. 4. If any out-of-range temp observed, see instructions to the right. 3. Notify your vaccine coordinator, or call the immunization program at your state or local health 5. After each month has ended, save each month’s log for 3 years, unless state/local department for guidance. jurisdictions require a longer period. 4. Document the action taken on the “Vaccine Storage Troubleshooting Record” on page 3.

Day of Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Staff Initials am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm Exact Time

Min/Max Temp in Unit (since previous reading)

Danger! Temperatures above -15ºC are too warm! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately! -15˚C -16˚C -17˚C -18˚C - temperatures 19˚C

-20˚C -21˚C -22˚C

acceptable -50˚C to -23˚C Write any out-of-range temps (above -15ºC or below -50ºC) here.

Room Temperature action

If you have a vaccine storage issue, also complete “Vaccine Storage Troubleshooting Record” found on page 3.

distributed by the Adapted with appreciation from California Department of Public Health Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.org www.immunize.org/catg.d/p3038C.pdf • Item #P3038C (3/21) For information on storage and handling of COVID-19 vaccines, see the COVID-19 Vaccine Addendum in CDC’s ° Temperature Log for Freezer – Celsius updated Vaccine Storage and Handling Toolkit at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html. C DAYS 16–31 Month/Year VFC PIN or other ID # Page 2 of 3 Monitor temperatures closely! 1. Write your initials below in “Staff Initials,” and note the time in “Exact Time.” Facility Name 2. If using temperature monitoring device (TMD; digital data logger recommended) Take action if temp is out of range – too warm (above -15ºC) or too cold (below -50ºC). that records min/max temps (i.e., the highest and lowest temps recorded in a spe- 1. Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible. cific time period), document current and min/max once each workday, preferably in Do not discard vaccines unless directed to by your state/local health department and/or the the morning. If using TMD that does not record min/max temps, document current manufacturer(s). temps twice, at beginning and end of each workday. 2. Record the out-of-range temps and the room temp in the “Action” area on the bottom of the log. 3. Put an “X” in the row that corresponds to the freezer’s temperature. 3. Notify your vaccine coordinator, or call the immunization program at your state or local health 4. If any out-of-range temp observed, see instructions to the right. department for guidance. 5. After each month has ended, save each month’s log for 3 years, unless state/local 4. Document the action taken on the “Vaccine Storage Troubleshooting Record” on page 3. jurisdictions require a longer period.

Day of Month 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Staff Initials am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm Exact Time

Min/Max Temp in Unit (since previous reading)

Danger! Temperatures above -15ºC are too warm! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately! -15ºC -16ºC -17ºC -18ºC

temperatures -19ºC

-20ºC -21ºC -22ºC

acceptable -50ºC to -23ºC Write any out-of-range temps (above -15ºC or below -50°C) here.

Room Temperature action

If you have a vaccine storage issue, also complete “Vaccine Storage Troubleshooting Record” found on page 3.