COVID-19 VACCINE MANAGEMENT PLAN

P a g e 1 | 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]

Rev.12/2021

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:

mailto:[email protected]

P a g e 2 | 14



Rev.12/2021

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 inrange

• 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 storageOR stand-alone refrigerators and stand-alone freezers


P a g e 3 | 14



Rev.12/2021

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 routinelydownloaded into a summary report

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


https://www1.nyc.gov/assets/doh/downloads/pdf/imm/vac-storage-therm-guide.pdf

P a g e 4 | 14



Rev.12/2021

• An active temperature display that can be easily read from the outside of thestorage 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, thedevice should sound. If there is an alarm delay, determine the number of consecutivereadings 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


P a g e 5 | 14



Rev.12/2021

• 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. Refer to CDC’s Product Info by U.S. Vaccine Webpage for the latest information on COVID Vaccine storage and temperature requirements.

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: -130°F to -76°F (-90°C to -60°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


https://www.cdc.gov/vaccines/covid-19/info-by-product/index.html

P a g e 6 | 14



Rev.12/2021

• Place "Do not Unplug" sign near the vaccine sorage unit's electrical outets and circuit breakers

• 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).


https://www1.nyc.gov/assets/doh/downloads/pdf/cir/covid-19-2021-temperature-excursion-form.pdf

P a g e 7 | 14



Rev.12/2021

• 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


P a g e 8 | 14



Rev.12/2021

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 packso barriers (bubble wrap)o vaccineso thermometer

• Attach labels to the outside of the container to identify the contents as valuable and

fragile vaccines


P a g e 9 | 14



Rev.12/2021

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

B. Procedures for Transporting VaccineIt 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:


http://www.immunize.org/catg.d/p3049.pdf

http://www.immunize.org/catg.d/p3049.pdf

P a g e 10 | 14



Rev.12/2021

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.

• 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.

• If vaccines will be transported or transferred (in-network or out-of-network) to another location,

it must be documented in the CIR Online Registry.

• If vaccines will be transported or administered at another location (i.e. mobile clinic, patient’s

home, etc..) indicate the process and what will be done to ensure that vaccines remain viable

between locations:


P a g e 11 | 14



Rev.12/2021

6. INVENTORY CONTROL GUIDELINES

A. The vaccine storage practices listed below are the responsibility of the following staffmember:

(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


https://www1.nyc.gov/assets/doh/downloads/pdf/imm/physical-inventory-aid.pdf

P a g e 12 | 14



Rev.12/2021

B. The items listed below should be reported in the CIR as "Wastage" and must beproperly 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 and how to avoid wasting doses left in open vials

• Document wastage in CIR

• Partially used vials cannot be transferred between providers OR across state lines


P a g e 13 | 14



Rev.12/2021

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 oras necessary or when there is a change in staff who have responsibilities specified in this plan.

Last reviewed on byDate Name Title Signature

Last reviewed on by

Date Name Title Signature

Last reviewed on by


Last reviewed on by



P a g e 14 | 14



Rev.12/2021

Appendix

• Center for Disease Control and Preventiono 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 Guideso Bureau of Immunization Vaccine For Children Program Forms, Job Aids and Chartso COVID-19 Temperature Excursion Incident Report

• Immunization Action Coalition Forms and Guideso Temperature Log when Transporting Vaccine at Refrigerated Temperatureso Temperature Log for Refrigerator - Fahrenheito Temperature Log for Refrigerator - Celsiuso Temperature Log for Freezer - Fahrenheito Temperature Log for Freezer - Celsius


https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf

https://www1.nyc.gov/site/doh/providers/nyc-med-cir/vaccines-for-children-forms.page

https://www1.nyc.gov/assets/doh/downloads/pdf/imm/vac-storage-therm-guide.pdf

https://www1.nyc.gov/assets/doh/downloads/pdf/cir/covid-19-2021-temperature-excursion-form.pdf

https://www1.nyc.gov/site/doh/providers/nyc-med-cir/vaccines-for-children-forms.page

https://www.immunize.org/catg.d/p3037c.pdf

https://www.immunize.org/catg.d/p3037f.pdf

https://www.immunize.org/catg.d/p3038c.pdf

https://www.immunize.org/catg.d/p3038f.pdf

https://www.immunize.org/handouts/vaccine-storage-handling.asp

1VACCINE STORAGE AND HANDLING TOOLKIT

WORKSHEET: Vaccine Storage and Handling SOPsR E S O U R C E S

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• Primary vaccine coordinator• Alternate vaccine coordinator• Additional staff to assist in emergencies• Immunization program• Vaccine manufacturers• Refrigerator and freezer maintenance and repair

companies• Temperature monitoring device (TMD) companies• Utility/power company• Vaccine storage unit alarm company (if applicable)• Generator repair company (if applicable)• Sources for qualified containers and packouts

» Descriptions of the roles and responsibilities of theprimary and alternate vaccine coordinators

» Information for each storage unit, including serialnumber, links to equipment websites, installationdates, and routine maintenance and repairrecords

» Samples of all vaccine-related forms used in yourfacility

» Protocols for staff education and training

CHECKLIST FOR ROUTINE STORAGE AND HANDLING

» Protocols for:• Ordering and accepting vaccine deliveries• Unpacking deliveries• Managing inventory• Storing each vaccine and diluent• Placing vaccines and diluents in storage units• Handling vaccines prior to administration

• Disposing of vaccines and supplies• Monitoring storage unit and temperature• Maintaining storage equipment and TMDs• Responding to storage and handling problems• Transporting vaccines to off-site/satellite facilities

CHECKLIST FOR EMERGENCY VACCINE STORAGE, HANDLING, AND TRANSPORT

» All contact information in Checklist for GeneralInformation as well as up-to-date contact information for:

• Alternative vaccine storage facility (one or more)• Transportation of vaccines

» Vaccine storage unit specifications (type, brand, modelnumber, serial number)

» Diagram of facility showing important elements, includingdoors, flashlights, packing materials, batteries, circuitbreakers

» Keep a copy of emergency SOPs with emergencysupplies and at multiple off-site locations such as homesof vaccine coordinator and alternate coordinator andwith building manager, security staff, and alternativestorage facility.

» Protocols for:• Monitoring vaccines during a power outage• Packing vaccines and diluents for emergency

transport• Transporting vaccines to and from an alternative

vaccine storage facility• Assessing whether vaccine can be used after an

emergency• Accessing your building and facility after hours

VACCINE STORAGE AND HANDLING TOOLKIT


Store emergency information with emergency supplies.

STAFF CONTACT LIST

Name TitleTelephone Numbers home/cell/other E-mail Address

Primary Vaccine CoordinatorAlternate Vaccine Coordinator

EMERGENCY STAFF CONTACT LIST

Name TitleTelephone Numbers 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

3VACCINE STORAGE AND HANDLING TOOLKIT


GENERAL RESOURCES CONTACT LIST

ResourcesContact Person Name/Title

Telephone Numbers home/cell/other E-mail Address

Local Health Department Immunization ProgramState Health Department Immunization ProgramVaccine Manufacturers

Refrigerator Repair Company

Freezer Repair Company

Utility/Power CompanyTemperature Monitoring Device CompanyVaccine Storage Unit Alarm Company (if applicable)Generator Repair Company (if applicable)

ALTERNATIVE VACCINE STORAGE FACILITIESAlternative Vaccine Storage Facility Name/Address

Contact Person Name/Title


1.

2.

3.

4.

TRANSPORTATION TO ALTERNATIVE VACCINE STORAGE FACILITIESEmergency Resources Name/Address

Contact Person Name/Title


Refrigeration Company

Refrigeration Company (alternative)Private Vehicle

Private Vehicle (alternative)

4 VACCINE STORAGE AND HANDLING TOOLKIT


PACKING MATERIAL SUPPLIERS CONTACT LIST

Emergency Resources Company NameContact Person Name/Title


Portable vaccine refrigerator/freezer unitsQualified containers and packout materialsQualified containers and packout materials (alternative)Packing materials

Packing materials (alternative)

VACCINE STORAGE UNIT SPECIFICATIONSType of Unit (Refrigerator or Freezer) Brand Model Number Serial Number

1.2.3.4.5.6.7.8.9.10.

COVID-19 Vaccine Handling Toolkit: Operational Considerations for Healthcare Practitioners

Pre-drawn syringe labeling components

• Name and amount of vaccine

• The exact beyond-use date and time:

• Lot number

• Initials of preparer(s)

Examples of pre-drawn syringe labels

• Facility name and phone number

• Quantity of syringes

• Name and amount of vaccine

• The exact beyond-use date and time

• Lot number

• Initials of preparer(s)

References1 https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-

considerations.html#Interchangeability

2 https://www.janssencovid19vaccine.com/hcp.html

3 https://www.modernatx.com/covid19vaccine-eua/providers/

4 https://www.cvdvaccine-us.com/resources

5 https://www.usp.org/covid-19/hand-sanitizer-information

6 https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf

7 https://www.cdc.gov/niosh/npg/npgd0359.html

8 https://www.cdc.gov/coronavirus/2019-ncov/hcp/hand-hygiene.html

9 https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/Coronavirus/docs/FAQ-optimizing-covid-vaccine-prep-safety.ashx

Pfizer-BioNTech COVID-19 Vaccine (30 mcg / 0.3 mL) IM suspensionDate & Time to discard (6 hours after dilution):

Lot no:

Initials of preparer(s):

Moderna COVID-19 Vaccine (100 mcg / 0.5 mL) IM suspensionDate & Time to discard (6 hours after puncture):

Lot no:


Janssen Ad26 COVID-19 Vaccine (5×1010vp / 0.5 mL) IM suspensionDate & Time to discard:

(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:


Labeling ConsiderationsWhen the COVID-19 Vaccines are not being

prepared for immediate administration, appropriate labeling considerations should be undertaken. If the vaccines are sent outside the facility in which they were prepared for administration, a designated person must ensure that contact information of the preparation facility is conveyed and available at the site where they will be administered. Labels should be adhered to the container(s) (e.g., light protected zip-lock bag in which pre-drawn syringes are stored and transported). Pre-drawn syringes prepared for administration must be labeled with legible identifying information to prevent errors during storage, dispensing, transport and use. Personnel should consider adding the following labeling components to the containers in which the pre-drawn vaccine syringes are stored as well as the pre-drawn vaccine syringe.

Container labeling components:

Examples of pre-drawn syringe storage container labels

Moderna COVID-19 Vaccine (100 mcg / 0.5 mL) IM suspension Facility name and phone number:

Quantity of syringes:

Date & Time to discard (6 hours after vial is punctured):

Lot no:


Pfizer-BioNT

ech COVID-19

Va

ccine (30 mcg / 0.3 mL) IM suspension

Facility name and phone number : Quantity of syringes:

Date & Ti me to discard (6 hours after dilution) :

Lot no: Initials of preparer(s):

10 https://www.cdc.gov/vaccines/hcp/admin/downloads/vaccine-administration-needle-length.pdf

11 https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/moderna-covid-19-vaccine-frequently-asked-questions

Janssen Ad26 COVID-19 Vaccine (5×1010vp / 0.5 mL) IM suspension Facility name and phone number:

Quantity of syringes:

Date & Time to discard:

(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:


https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Interchangeability

https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Interchangeability

https://www.janssencovid19vaccine.com/hcp.html

https://www.modernatx.com/covid19vaccine-eua/providers/

https://www.cvdvaccine-us.com/resources

https://www.usp.org/covid-19/hand-sanitizer-information

https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf

https://www.cdc.gov/niosh/npg/npgd0359.html

https://www.cdc.gov/coronavirus/2019-ncov/hcp/hand-hygiene.html

https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/Coronavirus/docs/FAQ-optimizing-covid-vaccine-prep-safety.ashx



https://www.cdc.gov/vaccines/hcp/admin/downloads/vaccine-administration-needle-length.pdf

https://www.cdc.gov/vaccines/hcp/admin/downloads/vaccine-administration-needle-length.pdf

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/moderna-covid-19-vaccine-frequently-asked-questions



1CS321570-AC

12 Years of Age and Older (Gray Cap)

Pfizer-BioNTech COVID-19 Vaccine Beyond-Use Date (BUD) Tracking Labels for Vaccine During Freezer or Refrigerator Storage

Vaccine that has not been punctured has a specific beyond-use date for refrigerated storage. Do NOT use vaccine after the beyond-use date. Use these labels to ensure beyond-use dates are followed.

Storing Vaccine in the Refrigerator Pfizer-BioNTech COVID-19 Vaccine: 12 years of age and older formulation (gray cap) can be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 10 weeks.

� Remove vaccine vials from ultra-cold temperature storage.

� 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 10 weeks.

� As the 10 weeks deadline approaches, contact the manufacturer for guidance if you will not be able to use the vaccine.

� Do NOT refreeze the vaccine.

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

123456A

06 01 2021

08 10 2021

2:30 PM

2:30 PM

Amy Nurse RN

12/13/2021

http://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/storage-summary.pdf

http://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html

http://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf

12/13/2021 2CS321570-V


Pfizer-BioNTech COVID-19 Vaccine











Store vaccine between 2°C and 8°C (36°F and 46°F) for up to 10 weeks.






Lot number(s):

Today’s date: / / Time:

Lot number(s):


Lot number(s):


Lot number(s):


Lot number(s):


Lot number(s):


USE BY*

USE BY*

USE BY*

USE BY*

USE BY*

USE BY*

Date: / / Time:

Date: / / Time:

Date: / / Time:

Date: / / Time:

Date: / / Time:

Date: / / Time:

*As the 10 week deadline approaches, contact the manufacturer for guidance if you will not be able to use the vaccine.

Name:


Name:


Name:


Name:


Name:


Name:

1CS321570-AE


Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summary

Basics � Store vaccine in an ultra-cold freezer or refrigerator. See guidance below for each storage unit. � Do NOT store in:

� The thermal shipping container* � A freezer

� Check and record storage unit temperatures each workday.See guidance below for each type of storage unit. Save storage records for 3 years, unless your jurisdiction requires a longer time period.

Deliveries

Vaccine

1. The vaccine will arrive in a thermal shipping container at ultra-cold temperatures between -90°C and -60°C (-130°F and -76°F) with dry ice or between -25°C and -15°C (-13°F and 5°F). The vial for people 12 years of age and older that does NOT require diluent has a gray cap and gray border on the label.

2. Follow the manufacturer's guidance for unpacking the vaccine. (www.cvdvaccine-us.com/product-storage-and-dry-ice).

3. Remove the temperature monitoring device from the shipping container and return using the included pre-labeled foldable return box.

4. Dispose of the single-use thermal shipping container. Do NOT use the thermal shipping container for storage.*

Ancillary Supply Kit

An ancillary supply kit will be delivered separately from the vaccine and includes:

� Administration supplies: Needles, syringes, sterile alcohol prep pads, vaccination record cards, and some PPE. � Ancillary supply kits have been reconfigured to support

the number of doses ordered.

*Thermal shipping containers delivered to Alaska, Hawaii, and the US-affiliated Pacific Islands may be used as temporary storage. Refer to the manufacturer for more detailed guidance on using the thermal shipping container for storage: https://www.cvdvaccine-us.com/product-storage-and-dry-ice

Ultra-Cold FreezerBefore 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 or box. � Protect from light. � Vaccine may be stored until the expiration date. Vaccine expires 6 months after the manufacture date. � The manufacture date is printed on the vial (gray cap) � Count out 6 months, using the month printed on the vial as

month 1.

� The vaccine expires on the last day of the 6th month � Expired vaccine should NEVER be administered. To prevent this,

use CDC’s COVID-19 Vaccine Expiration Date Tracking Tool � As the expiration date approaches, contact the manufacturer

to determine if it has been extended. Do not discard vaccine without ensuring the expiration date has passed.

Month 1: August 2021

(Printed on vial)

Month 2: September 2021

Month 3: October 2021

Month 4: November 2021

Month 5: December 2021

Month 6: January 2022

Expires January 31, 2022

12/13/2021

https://www.cvdvaccine-us.com/product-storage-and-dry-ice



212/13/2021 CS321570-AE


Pfizer-BioNTech COVID-19 VaccineStorage and Handling Summary

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 10 weeks. After 10 weeks, 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 refrigerator using CDC’s beyond-use date labels for Pfizer-BioNTech COVID-19 Vaccine.

� Store the vaccine in the tray or box. � Protect from light. � Do NOT refreeze thawed vaccine.

Temperature Monitoring Ultra-cold freezer or 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 measure ultra-cold temperatures.

� Refrigerated storage: Use a probe buffered with 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 (Min/Max) Temperature Most DDLs display min/max temperatures. Check and record the min/max temperatures at the start of each workday.

� Option 2: Current Temperature If the DDL does not display min/max temperatures, check and record the current temperature at the start and end of the workday. Review the continuous DDL temperature data daily.

Punctured Vials � Once punctured, vials can be stored between 2°C to 25°C (36°F to 77°F) for up to 12 hours. � Discard any remaining vaccine after 12 hours.

� Punctured vials should NOT be returned to ultra-cold freezer storage.

DisposalOnce 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.

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 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

https://www.cdc.gov/vaccines/imz-managers/awardee-imz-websites.html


https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html


https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/bud-tracking-labels.pdf


https://www.cvdvaccine.com

1CS321570-E

12 Years of Age and Older (Purple Cap)


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 and attach it to the container or resealable plastic bag holding the vaccine vials.

� 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.

� 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.

� 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 temperature storage.


� 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 (31 days).

� As the 1 month (31 days) deadline approaches, contact the manufacturer for guidance if you will not be able to use the vaccine.


123456A

05 18 2021

06 01 2021

Amy Nurse RN

2:30 PM

2:30 PM

123456A

06 01 2021

06/07

07 01 2021

Amy Nurse RN

2 hrs

10 hrs

12/13/2021

2



12/13/2021 CS321570-E

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 COVID-19 Vaccine in CDC's Vaccine Storage and 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 the label indicating the time in transport and hours remaining for transport, if needed.

� 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 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).




123456A

06 01 2021

06/07

07 01 2021

Amy Nurse RN

2 hrs

10 hrs




12/13/2021 3CS321570-E

12 Years of Age and Older (Purple Cap) Pfizer-BioNTech COVID-19 Vaccine



Store vaccine between 2°C and 8°C (36°F and 46°F) for up to 31 days.



Lot number(s):

Today’s date: / / USE BY* Date: / /*As the 31 day deadline approaches, contact the manufacturer for guidance if you will not be able to use the vaccine.

Lot number(s):


Lot number(s):


Vaccine may be transported for 12 cumulative hours.



Transport date

Time in transport:

Time remaining:

Name:

Transport date

Time in transport:

Time remaining:

Name:

Transport date

Time in transport:

Time remaining:

Name:




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):


Lot number(s):


USE BY*

USE BY*

USE BY*

Date: / / Time: *If the 2-week deadline is met, move any remaining vials to refrigerated storage for an additional 31 days. Use a refrigerator beyond-use date (BUD) label to reflect the new BUD time frame. Use a refrigerator beyond-use date (BUD) label to reflect the new BUD time frame.

Name:


Name:


Name:

1CS321570-I



Basics � Store vaccine in an ultra-cold freezer, thermal shipping container, freezer, or refrigerator. See guidance below for each storage unit. � Follow the manufacturer’s instructions for returning the thermal shipping container.

� Check and record storage unit temperatures each workday.See guidance below for each type of storage unit. Save storage records for 3 years, unless your jurisdiction requires a longer time period.

Deliveries

Vaccine

1. The vaccine will arrive in a thermal shipping container at ultra-cold temperatures between -90°C and -60°C (-130°F and -76°F) with dry ice. The vial for people 12 years of age and older has a purple cap and purple border on the label.

2. Follow the manufacturer's guidance for unpacking the vaccine. (https://www.cvdvaccine-us.com/product-storage-and-dry-ice).

3. Review practices for working with dry ice in the Dry Ice Safety for Healthcare Professionals before handling any dry ice (https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/dry-ice-safety-hcp.pdf )


An ancillary supply kit will be delivered separately from the vaccine and includes:

�Mixing supplies: Diluent, needles, syringes, and sterile alcohol prep pads � Mixing supplies are packaged separately with a green

identification label. � Do NOT use mixing supplies to administer vaccine.

� Administration supplies: Needles, syringes, sterile alcohol prep pads, vaccination record cards, and some PPE. � Ancillary supply kits have been reconfigured to support


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) included with the thermal shipping container to monitor the temperature.

� Review contact information. � If the contact for your order (inVTrckS) is not valid, you

will NOT be notified in the event of a temperature excursion. Contact your jurisdiction's immunization program for assistance.

� If your contact is valid and you are not receiving e-mails or cannot load email hyperlinks, refer to Controlant for troubleshooting (https://in.controlant.com/onsitemonitoring).

� Identify up to 4 contacts to receive e-mails and text alerts on the container's temperature status.

� Review DAILY e-mails on the status of the container. � Click the link in daily e-mails to access and download all temperature data. Save the Excel file summarizing all temperature data for at least 3 years.

� Save the return shipping label provided in your shipping container at delivery. Use the shipping label to return the thermal shipping container with the Controlant TMD within 10 days.*

� Limit temporary storage in the thermal shipping container to 10 days when possible.*

� Arrange for dry ice to maintain the appropriate temperature in the thermal shipping container. Replenish dry ice pellets (10 mm to 16 mm) within 24 hours of delivery and every 5 days thereafter. Follow manufacturer’s guidance for adding dry ice. � Dry ice will NOT be provided to replenish the container. � Transfer any vaccine remaining in the thermal shipping container after 10 days* to a: � Freezer for up to 2 weeks, then � Refrigerator for up to 1 month (31 days)

Removing vaccine vials/doses for use: � Determine the number of vials needed before opening the thermal shipping container. � Open the thermal shipping container no more than 2 times per day for up to 3 minutes each time. Use packaging tape to reseal the outer carton after each entry. � Store vaccine vials upright in the tray and protect from light.

*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.

12/13/2021



https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/dry-ice-safety-hcp.pdf

https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/dry-ice-safety-hcp.pdf

https://in.controlant.com/onsitemonitoring

https://in.controlant.com/onsitemonitoring

212/13/2021 CS321570-I




� Store vaccine vials upright in the tray or box. � Protect from light. � Vaccine may be stored until the expiration date.

� As the expiration date approaches, contact the manufacturer to determine if it has been extended. Do not discard vaccine without ensuring the expiration date has passed.

FreezerBefore 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 routinely recommended vaccines, BUT the temperature range for this vaccine is tighter. � If storing the vaccine in a freezer with routinely recommended vaccines, carefully adjust the freezer temperature to the correct temperature range for this vaccine. �Monitor how long the vaccine has been in the freezer using CDC’s beyond-use date labels for Pfizer-BioNTech COVID-19 vaccine. � Store the vaccine in the tray or box.

� Protect from light. � Do not use dry ice for freezer storage. � Vials stored in the freezer may be returned one time to ultra-cold temperature storage (-90ºC to -60ºC [-130ºF to -76ºF]). � Once returned to ultra-cold storage, the 2-week time frame

is suspended. � Vaccine stored in the freezer can be transferred to refrigerator storage where it can be stored for up to 1 month (31 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 refrigerator using CDC’s beyond-use date labels for Pfizer-BioNTech COVID-19 vaccine.

� Store the vaccine in the tray or box. � Protect from light. � 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 measure ultra-cold temperatures.

� Frozen and refrigerated storage: Use a probe buffered with glycol, glass beads, sand, or Teflon®.


� Option 1 (preferred): Minimum/Maximum (Min/Max) Temperature Most DDLs display min/max temperatures. Check and record the min/max temperatures at the start of each workday.


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.

312/13/2021 CS321570-I



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 (2°C to 25°C [35°F to 77°F]) for up to 6 hours. � Discard any remaining vaccine after 6 hours.

�Mixed vaccine should NOT be returned to freezer storage. �Minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.


� Do NOT return vaccine in the thermal shipping container.













1CS321570-V

FORMULATION: 5 Through 11 Years of Age


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

Storing Vaccine in the Refrigerator Pfizer-BioNTech COVID-19 Vaccine: 5 through 11 years of age formulation (orange cap) can be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 10 weeks.

� Remove vaccine vials from ultra-cold temperature storage.


� Once labeled, store the vaccine vials in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 10 weeks.

� As the 10 weeks deadline approaches, contact the manufacturer for guidance if you will not be able to use the vaccine.





123456A

06 01 2021

08 10 2021

2:30 PM

2:30 PM

Amy Nurse RN

11/05/2021




11/05/2021 2CS321570-V



















Lot number(s):

Today’s date: Time: / /

Lot number(s):


Lot number(s):


Lot number(s):


Lot number(s):


Lot number(s):


USE BY*

USE BY*

USE BY*

USE BY*

USE BY*

USE BY*

Date: / / Time:

Date: / / Time:

Date: / / Time:

Date: / / Time:

Date: / / Time:

Date: / / Time:


Name:


Name:


Name:


Name:


Name:


Name:

1CS321570-X



Basics� Store vaccine in an ultra-cold freezer or refrigerator. See

guidance below for each storage unit.� Do NOT store in:

� The thermal shipping container* � A freezer

� Check and record storage unit temperatures each workday.See guidance below for each type of storage unit. Savestorage records for 3 years, unless your jurisdiction requiresa longer time period.

Deliveries

Vaccine

1. The vaccine will arrive in a thermal shipping container atultra-cold temperatures between -90°C and -60°C (-130°Fand -76°F) with dry ice or between -25°C and -15°C (-13°Fand 5°F). The vial for children 5 through 11 years of agehas an orange cap and orange border on the label.

2. Follow the manufacturer's guidance for unpackingthe vaccine. (www.cvdvaccine-us.com/product-storage-and-dry-ice).

3. Remove the temperature monitoring device from theshipping container and return using the included pre-labeled foldable return box.

4. Dispose of the single-use thermal shipping container.Do NOT use the thermal shipping container for storage.*


An ancillary supply kit will be delivered separately from the vaccine and includes: �Mixing supplies: Diluent, needles, syringes, and sterile

alcohol prep pads � Mixing supplies are packaged separately with a green

identification label. � Do NOT use mixing supplies to administer vaccine.

� Administration supplies: Needles, syringes, sterilealcohol prep pads, vaccination record cards, and somePPE. � Ancillary supply kits have been reconfigured to support


*Thermal shipping containers delivered to Alaska, Hawaii, and the US-affiliated Pacific Islands may be used as temporary storage. Refer to the manufacturer for more detailed guidance on using the thermal shipping container for storage: https://www.cvdvaccine-us.com/product-storage-and-dry-ice


� Store vaccine vials upright in the tray or box.� Protect from light.� Vaccine may be stored until the expiration date. Vaccine

expires 6 months after the manufacture date. � The manufacture date is printed on the vial (orange cap) � Count out 6 months, using the month printed on the vial as

month 1.

� The vaccine expires on the last day of the 6th month � Expired vaccine should NEVER be administered. To prevent this,

use CDC’s COVID-19 Vaccine Expiration Date Tracking Tool � As the expiration date approaches, contact the manufacturer

to determine if it has been extended. Do not discard vaccine without ensuring the expiration date has passed.

Month 1: August 2021

(Printed on vial)

Month 2: September 2021

Month 3: October 2021

Month 4: November 2021

Month 5: December 2021

Month 6: January 2022

Expires January 31, 2022

11/04/2021




211/04/2021 CS321570-X



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 10 weeks. After 10 weeks, 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 therefrigerator using CDC’s beyond-use date labels forPfizer-BioNTech COVID-19 Vaccine.

� Store the vaccine in the tray or box.� Protect from light.� Do NOT refreeze thawed vaccine.

Temperature Monitoring Ultra-cold freezer or 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 tomeasure ultra-cold temperatures.

� Refrigerated storage: Use a probe buffered with glycol, glassbeads, sand, or Teflon®.


� Option 1 (preferred): Minimum/Maximum(Min/Max) Temperature Most DDLs display min/max temperatures. Check and recordthe min/max temperatures at the start of each workday.

� Option 2: Current TemperatureIf the DDL does not display min/max temperatures, check andrecord the current temperature at the start and end of theworkday. Review the continuous DDL temperature data daily.

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, vials can be stored between 2°C to 25°C (35°F to

77°F) for up to 12 hours.� Discard any remaining vaccine after 12 hours.

�Mixed vaccine should NOT be returned to ultra-cold freezerstorage.














1CS321571-E

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 Moderna COVID-19 vaccine may be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 30 days.

� Remove the vaccine vials from the freezer.

� Complete the information on the top portion of the label and attach it to the box or container holding the vaccine vials.

� 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 vials stored in the refrigerator BEFORE removing additional vials from the freezer.

� As the 30-day deadline approaches, contact the manufacturer for guidance if you will not be able to use vaccine. If directed to discard vaccine, follow manufacturerand jurisdiction guidance for proper disposal.

U.S. Department of Health and Human Services Centers for Disease Control and Prevention

123456A4 501 012021 2021

Moderna COVID-19 Vaccine

Amy Nurse RN

Lot number(s):

Today’s date: ____/____/_____ Date: ____/____/_____ *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 on proper disposal.

Name:

USE BY*



Transport date

Time in transport:

Time remaining:

Transporting Vaccine Between 2°C and 8°C (36°F and 46°F)Moderna 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 Moderna COVID-19 vaccine in CDC's Storage and 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 the label indicating the time in transport and hours remaining for transport, if needed.

� 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 the indicated BUD.

U.S. Department of Health and Human SeCenters for Disease Control and Prevention

123456A

2 hrs

10 hrs

4 501 012021 2021


Amy Nurse RN

Lot number(s):


Name:

USE BY*



Transport date

Time in transport:

Time remaining:

4/5/21

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

07/15/2021 2CS321570-E

ModernaCOVID-19 Vaccine







Lot number(s):

Today’s date: / / USE BY* Date: / /*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 on proper disposal.


Transport date

Time in transport:

Time remaining:

Name:






Lot number(s):


Lot number(s):


Lot number(s):


Lot number(s):


Lot number(s):







Transport date

Time in transport:

Time remaining:

Name:

Transport date

Time in transport:

Time remaining:

Name:

Transport date

Time in transport:

Time remaining:

Name:

Transport date

Time in transport:

Time remaining:

Name:

Transport date

Time in transport:

Time remaining:

Name:

1CS321571-F

Moderna COVID-19 Vaccine Storage and Handling Summary

Basics � Store vaccine in a freezer or refrigerator. See guidance below for each storage unit. � Each box contains 10 multidose vials.

� Each multidose vial contains up to 15 doses. � Each box is approximately 2 inches by 2 inches by 5.4 inches

� 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

Vaccine1. 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/.


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.

FreezerUnpunctured 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).

10/26/2021

https://www.modernatx.com/covid19vaccine-eua/

210/26/2021 CS321571-F

Moderna COVID-19 VaccineStorage and Handling Summary

Refrigerator Unpunctured vials may be stored in the refrigerator between 2° to 8°C (36° to 46°F) for up to 30 days.*

� Do NOT refreeze thawed vaccine.

� Thawed vaccine can be handled in room light.

�Monitor how long the vaccine has been in the refrigerator using CDC’s beyond-use date labels.

� Remove the box from frozen storage.

� Complete the information on the storage label.

� Attach it to the box holding the vaccine vials.

� Once labeled, place vaccine in the refrigerator.

Punctured vials may be stored between 2°F and 25°C (36°F and 77°F) for up to 12 hours. After a vial is punctured 20 times it should be discarded even if the 12 hour time limit has not been met.

U.S. Department of Health and Human SeCenters for Disease Control and Prevention

123456A

2 hrs

10 hrs

4 501 012021 2021


Amy Nurse RN

Lot number(s):


Name:

USE BY*



Transport date

Time in transport:

Time remaining:

4/5/21

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) Most DDLs display minimum and maximum (min/max) temperatures. Check and record the min/max temperatures at the start of each workday.


For CDC temperatures logs, see https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html.

Transporting Vaccine Moderna COVID-19 vaccine may be transported at frozen and refrigerated temperatures using a portable unit or container qualified to maintain appropriate temperatures. Detailed guidance can be found in CDC's Storage and Handling Toolkit COVID-19 addendum and Transporting Vaccine for Vaccination Clinics Held at Satellite, Temporary, or Off-Site Locations

DisposalOnce vaccine has reached its expiration or beyond-use date, contact the manufacturer for guidance on whether it can still be used. Vials that have been punctured 20 times should always be discarded. 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 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

https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html


https://www.modernatx.com/covid19vaccine-eua/

https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html


https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/bud-tracking-labels.pdf

https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/Moderna-Vaccine-Transport.pdf

https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/Moderna-Vaccine-Transport.pdf

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

Use for: Single dose from a multidose vial.

Route: Intramuscular (IM) injection

Beyond-Use Time: Use within 6 hours after the vial

is frst punctured if held between 2°C and 8°C (36°F and 46°F) or use within 2 hours after the vial is frst punctured if held at room temperature (maximally 25°C or 77°F).

Janssen COVID-19 Vaccine (Johnson & Johnson)





























10/27/2021 CS321571-D 1

108/24/2021 CS322139-C

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.


� 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.

https://www.vaxcheck.jnj

208/24/2021 CS322139-C

Janssen COVID-19 Vaccine (Johnson & Johnson)Storage and Handling Summary

Refrigerator Storage � CDC recommends storing vaccine between 2°C and 8°C (36°F and 46°F):

� Unpunctured vials until the expiration date*

� Punctured vials for up to 6 hours.† Note the date and time the vial was first punctured. Discard vaccine not used within this time.

� Do not freeze.

� Protect from light.

� As the expiration date approaches, determine if it has been extended using the same methods outlined in the "Deliveries" section. Do not discard vaccine without ensuring the expiration date has passed. Use CDC’s expiration date tracking tool to document expiration date changes.

Temperature MonitoringStorage 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 (preferred): Minimum/Maximum Temperatures Most DDLs display minimum and maximum (min/max) temperatures. Check and record the min/max temperatures at the start of each workday.

�Option 2: Current Temperature If the DDL does not display min/max temperatures, check and record the current temperature at the start and end of the workday. Review the continuous DDL temperature data daily.

**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.pdfCDC's Temperature Logs https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/index.htmlCDC'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.


https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/index.html




https://www.janssencovid19vaccine.com/hcp.html

PROVIDER QUALITY ASSURANCE UNIT │ BUREAU OF IMMUNIZATION │ NEW YORK CITY DEPARTMENT OF HEALTH & MENTAL HYGIENE Revised 12/2021│ 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]

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 via email or fax. 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.

Refer to CDC’s Product Info by U.S. Vaccine webpage for the latest information on COVID Vaccine storage and temperature requirements.

Manufacturer Contact Info Vaccine

Janssen 1-800-526-7736/1-800-565-4008

www.janssenmd.com/janssen-covid19-vaccine Sars-COV-2 (Janssen)

Moderna 1-866-663-3762

Sars-COV-2 (Moderna) www.modernatx.com [email protected]

Pfizer 1-800-505-4426 Sars-COV-2 (Pfizer BioNtech) www.pfizer.com

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

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


https://www.cdc.gov/vaccines/covid-19/info-by-product/index.html

http://www.janssenmd.com/janssen-covid19-vaccine

http://www.modernatx.com/


http://www.pfizer.com/




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 #: _____________________________

COVID-19 Vaccines, Manufacturer & Lot Number(s) affected due to temperature excursion: Vaccine

(Manufacturer) Place an ‘X’ in box next to

spoiled vaccines

Vaccine Type Lot Number(s)

Lot Expiration Date

New Expiration Date (if applicable)

Number of Doses

□ SARS- COV-2® (Pfizer BioNtech)

COVID-19

□ SARS-COV-2® (Moderna)

COVID-19

□ SARS-COV-2® (Janssen) COVID-19

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__________________________

Janssen___________________________

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:


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]

|Page 4

FULL VACCINE MANUFACTURER CONTACT INFORMATION SHEET MANUFACTURER CONTACT INFO VACCINE

CSL 1-888-435-8633 or 1-855-358-8966www.biocsl.com

• Influenza (Age 9 years and older) (Afluria No Preservative)• Influenza (Age 9 years and older) (Afluria)

GlaxoSmithKline 1-877-356-836

https://www.gskusmedicalaffairs.com/stability-calculator.html

[email protected]

• 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)

HIBMENCY (MENHIBRIX)• HPV -Bivalent Human Papillomavirus Types 16 and 18 (Cervarix)• Influenza (Age 36 months and older) (Fluarix Quadrivalent Preservative Free)• Influenza (Age 36 months and older) (FluLaval Quadrivalent/ FluLaval Trivalent)• 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)

Janssen 1-800-565-4008

www.janssenmd.com/janssen-covid19-vaccine

• Sars-COV-2 (COVID-19)

MedImmune 1-877-633-4411www.medimmune.com

• Influenza [5]• Live, Intranasal (Age 2-49 years) (FluMist® Quadrivalent No Preservative)

Merck 1-877-829-6372

www.merckvaccines.com

• Hepatitis A Pediatric (Vaqta)• Hepatitis B Pediatric/Adolescent (Recombivax HB) Hib (PedvaxHIB)• HPV - Quadrivalent Human Papillomavirus Types 6, 11, 16 and 18 Recombinant (Gardasil)• Measles, Mumps and Rubella (MMR) (M-M-R II)• MMR/Varicella (ProQuad)• Pneumococcal Polysaccharide (23 Valent) (Pneumovax23)• Rotavirus, Live, Oral, Pentavalent (Rota Teq)• Varicella (Varivax)

Moderna 1-866-663-3762www.modernatx.com

• Sars-COV-2 (COVID-19)

http://www.biocsl.com/






http://www.medimmune.com/

https://www.merckvaccines.com/

http://www.modernatx.com/

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]

|Page 5

Pfizer 1-800-505-4426www.pfizer.com

• Pneumococcal 13-valent (Prevnar 13 TM)• MENB – Meningococcal Group B (Trumenba)• Sars-COV-2 (COVID-19)

Sanofi Pasteur 1-800-822-2463www.sanofipasteur.us

• DTap (Daptacel)• DTaP-IP-HI (Pentacel)• e-IPV (IPOL)• Hib (ActHIB)• Influenza (Age 36 months and older) (Fluzone No-Preservative/Quadrivalent NoPreservative)• 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)

https://www.pfizer.com/

http://www.sanofipasteur.us/

VACCINE STORAGE AND HANDLING TOOLKIT

Handling a Temperature Excursion in Your Vaccine Storage UnitAny temperature reading outside ranges recommended in the manufacturers’ package inserts is considered a temperature excursion. Identify temperature excursions quickly and take immediate action to correct them. This can prevent vaccine waste and the potential need to revaccinate patients.

» Notify the primaryor alternatevaccine coordinatorimmediately or reportthe problem to asupervisor.

» Notify staff by labelingexposed vaccines, “DONOT USE,” and placingthem in a separatecontainer apart fromother vaccines in thestorage unit. Do notdiscard these vaccines.

Notify

» Document details of thetemperature excursion:• Date and time• Storage unit

temperature (includingminimum/maximumtemperatures duringthe time of the event, ifavailable)

• Room temperature, ifavailable

• Name of the personcompleting the report

• General descriptionof the event (i.e., whathappened)

• If using a digital datalogger (DDL), determinethe length of timevaccine may have beenaffected

• Inventory of affectedvaccines

• List of items in the unitother than vaccines(including water bottles)

• Any problems with thestorage unit and/oraffected vaccines beforethe event

• Other relevantinformation

Document

» Contact yourimmunization programand/or vaccinemanufacturer(s) forguidance per yourstandard operatingprocedures (SOPs).

» Be prepared to providethe immunization programor manufacturer withdocumentation and DDLdata so they can offer youthe best guidance.

Contact

» If the temperaturealarm goes offrepeatedly, do notdisconnect thealarm until you havedetermined andaddressed the cause.

» Check the basics,including:• Power supply• Unit door(s)• Thermostat settings

» If the excursionwas the result of atemperature fluctuation,refer to the section,“Vaccine Storage andTemperature MonitoringEquipment,” in CDC’sVaccine Storage andHandling Toolkit fordetailed guidance onadjusting storage unittemperature to theappropriate range.

» If you believe thestorage unit hasfailed, implement youremergency vaccinestorage and handlingSOPs. Never allowvaccines to remain ina nonfunctioning unitfollowing a temperatureexcursion.

Correct

03/04/2021 CS322033-C

Temperature Log when Transporting Vaccine at Refrigerated Temperatures

When transporting refrigerated vaccines, use:

� A portable refrigerator or vaccinestorage container qualified to maintaintemperatures between 2°C and 8°C(36°F and 46°F).

� A digital data logger (DDL) with athermal buffer and external temperaturedisplay (preferred). Place the probe asclose as possible to the vaccine.

� This temperature log to documenttemperatures and how long the vaccineis in the portable storage container.

Temperature monitoring and transport time frames

� Most DDLs display minimum/maximum (min/max) temperatures.*

� Record the time and min/max temperatures:

Ź At the start of transport

Ź Every time the portable storage container is opened

Ź When transport is completed

� The total time for transport alone or transport plus clinic workdayshould be a maximum of 8 hours.±

� Beyond-use date/time (BUD), if applicable, are included in transporttime. For example, if the vaccine may be stored at refrigeratedtemperature for 120 hours, transport is included in this time frame.

If the temperature is out of range, TAKE ACTION!

1. Do NOT discard the vaccine.

2. Label the vaccine “Do Not Use.”

3. Complete the Vaccine Troubleshooting Record.

4. Contact the manufacturer to determine under what conditions (refrigerated) to store the vaccine as quickly as possible.

Today's date:

Provider name:

Temperatures measured in (circle one): Celsius Fahrenheit

Transport start time:

Facility name:

Transport end time:

PIN number:

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.

� If using a company or personal vehicle, transport vaccines inside the passengercompartment (not in the trunk or bed of a truck, which may be too hot or too cold).

� Avoid leaving the portable storage container in direct sunlight or unattended.

� If needed, transport diluents with their corresponding vaccines to ensure thereare equal amounts of vaccines and diluents. Follow the manufacturer’s guidancefor specific temperature requirements for diluents.

� Save this record for 3 years, unless your state/local jurisdiction requires a longer time period. See CDC’s Vaccine Storage and Handling Toolkit for additional guidance.

� Refer to CDC’s Vaccine Storage and Handling Toolkit for additional guidance whentransporting vaccines.

* If the DDL does not measure min/max temperatures, check and record temperatures hourly. ± Follow the manufacturer’s guidance if it differs from this time frame.

Day of Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Staff Initials

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!

46̊ F

45̊ F

44̊ F

43̊ F

42̊ F

41̊ F

40̊ F

39̊ F

38̊ F

37̊ F

36̊ 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:

Room Temperature

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

acce

ptab

le

tem

pera

ture

sac

tio

n

Aim for 41º

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

Temperature Log for Refrigerator – Fahrenheit

Page 1 of 3DAYS 1–15

Monitor temperatures closely!1. Writeyourinitialsbelowin“StaffInitials,”andnotethetimein“ExactTime.”2. Ifusingtemperaturemonitoringdevice(TMD;digitaldataloggerrecommended)

thatrecordsmin/maxtemps(i.e.,thehighestandlowesttempsrecordedinaspe-cifictimeperiod),documentcurrentandmin/maxonceeachworkday,preferablyinthemorning.IfusingTMDthatdoesnotrecordmin/maxtemps,documentcurrenttemps twice,atbeginningandendofeachworkday.

3. Putan“X”intherowthatcorrespondstotherefrigerator’stemperature.4. Ifanyout-of-rangetempobserved,seeinstructionstotheright.5. Aftereachmonthhasended,saveeachmonth’slogfor3years,unlessstate/local

jurisdictionsrequirealongerperiod.

Take action if temp is out of range – too warm (above 46ºF) or too cold (below 36ºF).1. Labelexposedvaccine“donotuse,”andstoreitunderproperconditionsasquicklyaspossible.

Donotdiscardvaccinesunlessdirectedtobyyourstate/localhealthdepartmentand/orthemanufacturer(s).

2. Recordtheout-of-rangetempsandtheroomtempinthe“Action”areaonthebottomofthelog.3. Notifyyourvaccinecoordinator,orcalltheimmunizationprogramatyourstateorlocalhealth

departmentforguidance.4. Documenttheactiontakenonthe“VaccineStorageTroubleshootingRecord”onpage3.

Month/Year VFC PIN or other ID #

Facility Name

F°

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)

ForinformationonstorageandhandlingofCOVID-19vaccines,seetheCOVID-19 Vaccine AddenduminCDC’supdatedVaccine Storage and Handling Toolkitatwww.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html.

http://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html

Temperature Log for Refrigerator – Fahrenheit


Take action if temp is out of range – too warm (above 46ºF) or too cold (below 36ºF).1. Labelexposedvaccine“donotuse,”andstoreitunderproperconditionsasquicklyaspossible.





Facility Name

F°

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)


Day of Month

Staff Initials

Exact Time


46̊ F

45̊ F

44̊ F

43̊ F

42̊ F

41̊ F

40̊ F

39̊ F

38̊ F

37̊ F

36̊ F

Write any out-of-range temps (above 46ºF or below 36ºF) here:

Room Temperature

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 pmam pm

ac

cep

tabl

e

tem

pera

ture

sa

cti

on

Aim for 41º

16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31


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!

Monitor temperatures closely!1. Writeyourinitialsbelowin“StaffInitials,”andnotethetimein“ExactTime.”2. Ifusingtemperaturemonitoringdevice(TMD;digitaldataloggerrecommended)


3. Putan“X”intherowthatcorrespondstotherefrigerator’stemperature.4. Ifanyout-of-rangetempobserved,seeinstructionstotheright.5. Aftereachmonthhasended,saveeachmonth’slogfor3years,unlessstate/local



Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.org

http://www.immunize.org

http://www.vaccineinformation.org

http://www.immunize.org/catg.d/p3037F.pdf

Temperature Log for Refrigerator – CelsiusPage 1 of 3

DAYS 1–15

Take action if temp is out of range – too warm (above 8ºC) or too cold (below 2ºC).1. Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible.

Do not discard vaccines unless directed to by your state/local health department and/or themanufacturer(s).

2. Record the out-of-range temps and the room temp in the “Action” area on the bottom of the log.3. Notify your vaccine coordinator, or call the immunization program at your state or local health

department for guidance.4. Document the action taken on the “Vaccine Storage Troubleshooting Record” on page 3.


Facility Name

C°


Day of Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Staff Initials

Exact Time


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!

8̊ C

7̊ C

6̊ C

5̊ C

4̊ C

3̊ C

2̊ 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


acce

ptab

le

tem

pera

ture

sac

tio

n

Aim for 5º

Adapted with appreciation from California Department of Public Healthdistributed by the

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)

Monitor temperatures closely!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)

that records min/max temps (i.e., the highest and lowest temps recorded in a spe-cific time period), document current and min/max once each workday, preferably inthe morning. If using TMD that does not record min/max temps, document currenttemps twice, at beginning and end of each workday.

3. Put an “X” in the row that corresponds to the refrigerator’s temperature.4. If any out-of-range temp observed, see instructions to the right.5. After each month has ended, save each month’s log for 3 years, unless state/local

jurisdictions require a longer period.

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.



http://www.immunize.org/catg.d/p3037C.pdf

Temperature Log for Refrigerator – Celsius

Page 2 of 3

DAYS 16–31


that records min/max temps (i.e., the highest and lowest temps recorded in a spe-cific time period), document current and min/max once each workday, preferably inthe morning. If using TMD that does not record min/max temps, document currenttemps twice, at beginning and end of each workday.

3. Put an “X” in the row that corresponds to the refrigerator’s temperature.4. If any out-of-range temp observed, see instructions to the right.5. After each month has ended, save each month’s log for 3 years, unless state/local


Take action if temp is out of range – too warm (above 8ºC) or too cold (below 2ºC).1. Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible.





Facility Name

C°

Day of Month 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Staff Initials

Exact Time


Danger! Temperatures above 8º C 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!

8̊ C

7̊ C

6̊ C

5̊ C

4̊ C

3̊ C

2̊ C

Danger! Temperatures below 2º C 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 orbelow 2ºC) here:

Room Temperature

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

acce

ptab

le

tem

pera

ture

sac

tio

n

Aim for 5º





Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.org




Temperature Log for Freezer – Fahrenheit


Monitor temperatures closely!1. Writeyourinitialsbelowin“StaffInitials,”andnotethetimein“ExactTime.”2. Ifusingatemperaturemonitoringdevice(TMD;digitaldataloggerrecommended)


3. Putan“X”intherowthatcorrespondstothefreezer’stemperature.4. Ifanyout-of-rangetempobserved,seeinstructionstotheright.5. Aftereachmonthhasended,saveeachmonth’slogfor3years,unlessstate/local


F°


DayofMonth 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

StaffInitials

ExactTime

Min/Max TempinUnit(sincepreviousreading)


5°F

4°F

3°F

2°F

1°F

0°F

-1°F

-2°F

-3°F

-4°F

-58°F to -5°F

Write any out-of-range temps(above5ºF or below -58ºF)here.

Room Temperatureacti

on

Take action if temp is out of range—too warm (above 5ºF) or too cold (below -58ºF).1. Labelexposedvaccine“donotuse,”andstoreitunderproperconditionsasquicklyaspossible.





Facility Name


ac

ce

pt

ab

le

te

mp

er

at

ur

es


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)



Temperature Log for Freezer – FahrenheitDAYS 16–31

F°Page 2 of 3Month/Year VFC PIN or other ID #

Facility Name

Take action if temp is out of range – too warm (above 5ºF) or too cold (below -58ºF).1. Labelexposedvaccine“donotuse,”andstoreitunderproperconditionsasquicklyaspossible.





DayofMonth 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

StaffInitials

ExactTimeam 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

Min/Max TempinUnit (sincepreviousreading)

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

-58°F to -5°F

acti

on Write any out-of-range

temps(above5ºForbelow-58°F)here.

RoomTemperature

ac

cep

table

tem

per

atu

res


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)


Monitor temperatures closely!1. Writeyourinitialsbelowin“StaffInitials,”andnotethetimein“ExactTime.”2. Ifusingatemperaturemonitoringdevice(TMD;digitaldataloggerrecommended)


3. Putan“X”intherowthatcorrespondstothefreezer’stemperature.4. Ifanyout-of-rangetempobserved,seeinstructionstotheright.5. Aftereachmonthhasended,saveeachmonth’slogfor3years,unlessstate/local





Day of Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Staff Initials

Exact Time


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!

-15̊ C

-16̊ C

-17̊ C

-18̊ C

-19̊ C

-20̊ C

-21̊ C

-22̊ C

-50̊ C to -23̊ C

Write any out-of-range temps (above -15ºC or below -50ºC) here.

Room Temperatureacti

on


acce

ptab

le t

empe

ratu

res

Temperature Log for Freezer – CelsiusDAYS 1–15


that records min/max temps (i.e., the highest and lowest temps recorded in a specific time period), document current and min/max once each workday, preferably in

the morning. If using TMD that does not record min/max temps, document current temps twice, at beginning and end of each workday.

3. Put an “X” in the row that corresponds to the freezer’s temperature.4. If any out-of-range temp observed, see instructions to the right.5. After each month has ended, save each month’s log for 3 years, unless state/local


C°


Page 1 of 3

Take action if temp is out of range—too warm (above -15ºC) or too cold (below -50ºC).1. Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible.





Facility Name






Day of Month 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Staff Initials

Exact Timeam 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

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

-19ºC

-20ºC

-21ºC

-22ºC

-50ºC to -23ºC

acti

on Write any out-of-range

temps (above -15ºC or below -50°C) here.

Room Temperature

Temperature Log for Freezer – CelsiusPage 2 of 3

DAYS 16–31

Take action if temp is out of range – too warm (above -15ºC) or too cold (below -50ºC).1. Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible.

Do not discard vaccines unless directed to by your state/local health department and/or the manufacturer(s).




Facility Name

C°


acce

ptab

le t

empe

ratu

res




that records min/max temps (i.e., the highest and lowest temps recorded in a specific time period), document current and min/max once each workday, preferably in

the morning. If using TMD that does not record min/max temps, document current temps twice, at beginning and end of each workday.

3. Put an “X” in the row that corresponds to the freezer’s temperature.4. If any out-of-range temp observed, see instructions to the right.5. After each month has ended, save each month’s log for 3 years, unless state/local





Documents

COVID-19 VACCINE MANAGEMENT PLAN