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Planning guidance for immunization clinics for COVID-19 vaccines: Managing vaccine administration errors or deviations

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Preamble

This website is for health care providers. It offers an approach to preventing and managing COVID-19 vaccines that are administered in a manner that differs from the recommendations of the manufacturer as authorized by Health Canada and the National Advisory Committee on Immunization (NACI). These are referred to as vaccine administration errors or deviations.

The Canadian Immunization Committee provided input into the development of this document.

For complete NACI advice, please see the following:

Note that this document should be used only to manage errors or deviations that have already occurred, and should not be used to justify practices that are different than what are recommended based on provincial or territorial guidance, the product monographs and recommendations from NACI statements and publications when administering COVID-19 vaccines.

Strategies to prevent COVID-19 vaccine errors or deviations

Due to the multiple products, doses, and schedules for COVID-19 vaccines, there is the potential for errors when storing, handling and administering these vaccines. The purpose of this document is to assist with error prevention for COVID-19 vaccines. If you require advice or assistance, contact your local public health department.

These strategies support error prevention in all settings:

Error prevention is also supported by:

Encourage staff to ask questions, contribute suggestions and double check their practices to create a culture of error prevention.

Staff members should be aware of the importance of recognizing and reporting errors, and encouraged to do so to:

The process for reporting errors should be made clear to staff members. Any reported errors or near misses should be analyzed to inform adjustments in policies, procedures and training.

Learn more about:

Community health care providers
Table 1: Strategies to prevent errors or deviations with regard to COVID-19 immunizations
Stage in the vaccination process Potential vaccine errors or deviations Strategies for preventing errors or deviations

Client screening and verification of vaccine eligibility
  • Wrong vaccine product or dose
  • Dose given too early (interval too short)

Ensure client is eligible by verifying their information when they book a vaccination appointment on the phone or through an online electronic system.

  • Use jurisdictional vaccination portals, clinic databases or information provided by the client to determine the client's eligibility for the requested vaccination.
  • Eligibility may be assessed based on:
    • client age
    • dates of previous doses of COVID-19 vaccines
    • date of previous SARS-CoV-2 infection and underlying medical conditions, if available and as applicable

Ensure client is eligible by verifying their information on arrival at the office.

  • Confirm the identity of the client by asking the client or caregiver to provide full name and date of birth.
  • Verify the client's eligibility for the vaccine:
    • If available, verify the client's eligibility for the requested vaccine in the central jurisdictional or locally available COVID-19 vaccine database that contains their past vaccination information. These systems may be able to flag potential eligibility with regard to upcoming vaccinations.
    • If access to jurisdictional or local databases is not available, obtain the client's past vaccination history from the client's personal immunization record, if available.
    • Refer to Table 2 of the COVID-19 chapter of the Canadian Immunization Guide for a summary of the recommended doses based on previous vaccination history, however jurisdictional recommendations may differ.
  • Verify the date of SARS-CoV-2 infection (if possible and as applicable) and any applicable underlying medical conditions as needed to determine eligibility.

Storage and handling
  • Interruption of the cold chain, potentially affecting potency or safety
  • Poor organization of storage areas, leading to selection of the wrong product
  • Selection of outdated product (expired or past "use by" date)

Prevent temperature excursions.

  • Check the accuracy of thermometers.
  • Check and record the minimum and maximum refrigerator temperatures (and freezer temperatures if applicable) as well as the room temperature, for a minimum of twice daily on all business days or as required by your jurisdiction.
  • If any temperature deviations are noted, follow the jurisdiction's processes on who to contact before administering any affected vaccines. Ensure vaccines under investigation for possible temperature deviations are quarantined and properly stored under cold chain conditions in a manner that prevents them from being used until:
    • determined to be appropriate based on consultation with the jurisdictional authority who provides recommendations
    • or they need to be appropriately discarded

Ensure good organization of stored vaccines.

  • When receiving vaccines into the office, carefully inspect all vials, as well as temperature-monitoring devices that accompany the product.
  • Store each product in a separate, clearly labelled container in a dedicated vaccine refrigerator.
    • Use unique colours for the labels on the storage containers of different vaccine products and for vaccine vial log sheets for each vaccine type. Never store different vaccines in the same container.
    • Ensure that look-alike products are stored in different areas of the refrigerator or freezer.
    • Ensure the container label indicates if a diluent is required for the product and where it is stored.
  • Use bar-coding technology for product identification and inventory management, if available.
  • Only stock 1 vaccine product for each indication or minimize the number of products available in the office, if possible.

Ensure vaccines are not expired.

  • Regularly review the expiry date of refrigerated or frozen vaccines and remove any expired product. Health Canada will occasionally extend the vaccine shelf life. Refer to the manufacturer's website or the Canadian Vaccine Catalogue for expiration dates by lot numbers.
  • Put shortest expiry dated product at the front of the labelled container so it is used first.
  • Always check the expiry date as a product is removed from the refrigerator or freezer and then again before preparing it or administering it to the client.

Ensure punctured vials are used within the recommended time after first puncture of the vial ("use by" date and time).

  • At the time of first puncture, mark the vaccine vial with the date and time of first puncture and the "use by" date and time (based on the manufacturer's time interval for use after first puncture of the vial [refer to job aids]).
  • Store previously punctured vials in an appropriately labelled container in a designated part of the refrigerator. Do not put previously punctured and unpunctured vials together in the same storage container in the refrigerator.
  • Ensure that the previously punctured vials are used by the "use by" date and time after first puncture of the vial or are discarded.

Office setup
  • Product or dose mix-ups
  • Incorrect vaccine preparation

Ensure appropriate office setup for preparing and administering vaccines.

  • Have a designated vaccination refrigerator (and freezer if required).
  • Provide a quiet area for vaccine preparation, if possible.
  • Provide quick reference materials in the vaccine preparation area to support selecting the correct product and dose for the client (refer to Table 2 of the COVID-19 chapter of the Canadian Immunization Guide for a summary of the recommended doses based on previous vaccination history, or jurisdictional or local resources).
  • Ensure appropriate sharps containers are available in all areas where vaccines are prepared and administered.

Prepare the office for emergencies.

  • Ensure the office has at least 1 anaphylaxis kit and that staff are aware of its location, as well as any other emergency management equipment.
  • Ensure that the anaphylaxis kit is appropriately stocked and that the products are not expired (see the Canadian Immunization Guide for items to be in the anaphylaxis kit).
  • Ensure staff are trained in anaphylaxis and fainting management. Ensure appropriate resource materials, instructions and medical directives are available, if applicable.

Preparation of the vaccine
  • Improper dilution or no dilution of vaccines that require dilution
  • Use of product past its "use by" date and time
  • Selection of incorrect product due to similarities in cap colours or labels

Ensure proper vaccine preparation.

  • Plan ahead for the number and types of vaccines that will be required that day, and check that they are already thawed, if possible.
  • Develop and follow a standard process, supported by a quick reference sheet for dose preparation of each vaccine product. Refer to job aids.
  • Verify that the correct product has been selected based on the client's request and eligibility, and that its expiry date or "use by" date and time (for previously punctured vials) have not passed.
  • If dilution is required, ensure that the appropriate diluent is used with the proper volume (only required for some Pfizer-BioNTech COVID-19 vaccines).
  • If drawing up several vaccines for the client to be used right away, ensure each is properly labelled with the product name and dose volume. Record the lot number and expiry date on the label or ensure the vial is available to provide that information for the vaccination record.

Use product before its "use by" date and time.

  • Label all prefilled syringes immediately after preparation with the:
    • product name
    • dose volume
    • lot number
    • expiry date
    • "use by" date and time (based on the manufacturer's time interval for use after first puncture of the vial [refer to job aids])
  • For examples of labels, refer to page 6 of the USP COVID-19 Vaccine Handling Toolkit (PDF).
  • Mark all punctured vaccine vials with the "use by" date and time based on first puncture of the vial.

Ensure correct product selection and dose.

  • Incorporate independent double checks with other regulated clinicians at key points in the preparation and drawing up process, if possible.

Administration
  • Providing a vaccine when contraindicated
  • Full dose not administered
  • Wrong site or route used
  • Wrong vaccine product or dose
  • Vaccine administered with a used needle and syringe
  • Needle stick injuries

Pre-vaccination counseling.

  • Ensure that the client or caregiver has:
    • read about or been advised about the vaccine being offered and its benefits and risks
    • had the opportunity to ask questions
  • Ensure that the client has no contraindications to vaccination using a prepared list of contraindications.

Ensure administration of correct vaccine with correct dosage at correct time interval.

  • Immediately before vaccination, ask the client or caregiver to provide their name and date of birth.
  • Verify the date of the last vaccine dose and the date of the last SARS-CoV-2 infection, if applicable.
  • Verify that the correct product and dose is in the syringe and verify the expiry date or "use by" date, if applicable.
  • If possible, ask the client or caregiver to read out loud the vial label or syringe label and expiry date and "use by" date, if applicable.

Develop a standard protocol if administering more than 1 vaccine to the client.

  • If administering more than 1 vaccine, develop a standard order (such as COVID-19 vaccine first, influenza vaccine second) and preferred site (such as left deltoid for the COVID-19 vaccine, right deltoid for the influenza vaccine), unless the client has a specific preference.
  • Develop a mechanism to keep track of which vaccine is given in which site so that it can be accurately recorded in the immunization record.

Ensure appropriate administration technique.

  • Use appropriate landmarking in the deltoid or anterolateral thigh.
  • All current COVID-19 vaccines are administered intramuscularly (IM).
  • Ensure children are appropriately supported so that the complete dose can be administered. Use resources such as the CARD system to help children with fear of vaccination.

Preventing needlestick injuries.

  • Immediately activate the safety mechanism after administering the vaccine.
  • Immediately dispose of the used needle and syringe in the sharps container. Never put the used needle and syringe down on the worktable.

Documentation
  • Inaccurate or lack of documentation

Provide accurate and complete documentation in appropriate formats.

  • Document the vaccination in the health care record and provide clients with documentation of vaccination.
  • Records and documentation should include:
    • client name
    • date of birth
    • product name
    • dose volume
    • site of administration
    • lot number
    • expiry date
    • date of vaccination
    • name and professional designation of the vaccinator
  • Refer to the Canadian Immunization Guide for additional details.
  • Provide documentation to the client in an electronic format, and documentation on paper during the visit if requested.
  • Review and confirm with the client that the information on the vaccination record is accurate.

As appropriate, book the next vaccination appointments. Send appointment reminders by phone, text or email.

Evaluation and continuous quality improvement

no data

Use continuous improvement processes.

  • Stay informed of changes to vaccination recommendations, schedules and products through:
  • Ensure training and resources are updated as needed.
  • Analyze the causes of any vaccination errors or near misses so that changes can be made to prevent future errors.
  • Incorporate frequent audits of the workflow to identify and modify problematic processes that can lead to errors.

Plan for the response to possible errors.

  • Ensure staff members are aware of the importance of reporting any errors that are detected and the mechanism for reporting errors.
  • Develop plans to support the client and family members and members of the health care team in the event of a vaccine error, including who to consult for advice (such as a local public health department or manufacturer).

Job aids

References

This document was prepared by the Ontario Ministry of Health, the Public Health Agency of Canada and the Institute for Safe Medication Practices Canada with input from the Canadian Immunization Committee.

Community pharmacies
Table 2: Strategies to prevent errors or deviations with regard to COVID-19 immunizations
Stage in the vaccination process Potential vaccine errors or deviations Strategies for preventing errors or deviations

Client screening and verification of vaccine eligibility
  • Wrong vaccine product or dose
  • Dose given too early (interval too short)

Ensure client is eligible by verifying their information when they book a vaccination appointment on the phone or through an online electronic system.

  • Determine the client's eligibility for the requested vaccination with the use of:
    • clinic databases
    • jurisdictional vaccination portals
    • information provided by the client
  • Eligibility may be assessed based on:
    • client age
    • dates of previous doses of COVID-19 vaccines
    • date of previous SARS-CoV-2 infection and underlying medical conditions, if available and as applicable

Ensure client is eligible by verifying their information on arrival at the pharmacy.

  • Confirm the identity of the client by asking the client or caregiver to provide full name and date of birth.
  • Verify the client's eligibility for the vaccine:
    • If available, verify the client's eligibility for the requested vaccine in the central jurisdictional or locally available COVID-19 vaccine database that contains their past vaccination information. These systems may have the capability to flag potential eligibility with regard to upcoming vaccinations.
    • If access to jurisdictional or local databases is not available, obtain the client's past vaccination history from the client's personal immunization record, if available.
    • Checklists and resource documents can be used to verify eligibility. Refer to Table 2 of the COVID-19 chapter of the Canadian Immunization Guide for a summary of the recommended doses based on previous vaccination history, however jurisdictional recommendations may differ.
  • Verify the date of SARS-CoV-2 infection (if possible and as applicable) and any applicable underlying medical conditions as needed to determine eligibility.

Ensure the client gets the right product if multiple vaccines are being offered at the pharmacy.

  • Colour code the various vaccines being offered and give the client a paper or wristband with the colour corresponding to the vaccine they are to receive.
  • If the pharmacy has different spaces or offices for different vaccines, direct the client to the appropriate area where the vaccine is being offered.

Storage and handling
  • Interruption of the cold chain, potentially affecting potency or safety
  • Poor organization of storage areas, leading to selection of the wrong product
  • Selection of outdated product (expired or past "use by" date)

Prevent temperature excursions.

  • Check the accuracy of thermometers.
  • Check and record the minimum and maximum refrigerator temperatures (and freezer temperatures if applicable) as well as the room temperature, for a minimum of twice daily on all business days or as required by your jurisdiction.
  • If any temperature deviations are noted, follow the jurisdiction's processes on who to contact before administering any affected vaccines. Ensure vaccines under investigation for possible temperature deviations are quarantined and properly stored under cold chain conditions in a manner that prevents them from being used until:
    • determined to be appropriate based on consultation with the jurisdictional authority who provides recommendations
    • or they need to be appropriately discarded

Ensure good organization of stored vaccine.

  • When receiving vaccines at the pharmacy, carefully inspect all vials, as well as temperature-monitoring devices that accompany the product.
  • Store each product in a separate, clearly labelled container in a dedicated vaccine refrigerator.
    • Use unique colours for the labels on the storage containers of different vaccine products and for vaccine vial log sheets for each vaccine type. Never store different vaccines in the same container.
    • Ensure that look-alike products are stored in different areas of the refrigerator or freezer.
    • Ensure the container label indicates if a diluent is required for the product and where it is stored.
  • Use bar-coding technology for product identification and inventory management, if available.
  • Only stock 1 vaccine product for each indication or minimize the number of products available in the pharmacy, if possible.

Ensure vaccines are not expired.

  • Regularly review the expiry date of refrigerated or frozen vaccines and remove any expired product. Health Canada will occasionally extend the vaccine shelf life. Refer to the manufacturer's website or the Canadian Vaccine Catalogue for expiration dates by lot numbers.
  • Put shortest expiry dated product at the front of the labelled container so it is used first.
  • Always check the expiry date:
    • as a product is removed from the refrigerator or freezer
    • before preparing the product or administering it to the client

Ensure punctured vials are used within recommended time after first puncture of the vial ("use by" date and time).

  • At the time of first puncture, mark the vaccine vial with the date and time of first puncture and the "use by" date and time (based on the manufacturer's time interval for use after first puncture of the vial [refer to job aids]).
  • Store previously punctured vials in an appropriately labelled container in a designated part of the refrigerator. Do not put previously punctured and unpunctured vials together in the same storage container in the refrigerator.
  • Ensure that the previously punctured vials are used by the "use by" date and time after first puncture of the vial or are discarded.

Pharmacy setup
  • Product or dose mix-ups
  • Incorrect vaccine preparation

Ensure appropriate pharmacy setup for preparing and administering vaccines.

  • Have a designated vaccination refrigerator (and freezer if required).
  • Provide a quiet area for vaccine preparation, if possible.
  • Provide quick reference materials in the vaccine preparation area to support selecting the correct product and dose for the client (refer to Table 2 of the COVID-19 chapter of the Canadian Immunization Guide for a summary of the recommended doses based on previous vaccination history, or jurisdictional or local resources).
  • Ensure appropriate sharps containers are available in all areas where vaccines are prepared and administered.

Prepare the pharmacy for emergencies.

  • Ensure the pharmacy has at least 1 anaphylaxis kit and that staff are aware of its location, as well as the location of other emergency management equipment.
  • Ensure that the anaphylaxis kit is appropriately stocked and that the products are not expired (refer to the Canadian Immunization Guide for items to be in the anaphylaxis kit).
  • Ensure staff are trained in anaphylaxis and fainting management, and appropriate resource materials, instructions and medical directives are available, if applicable.

Preparation of the vaccine
  • Improper dilution or no dilution of vaccines that require dilution
  • Use of product past its "use by" date and time
  • Selection of incorrect product due to similarities in cap colours or labels

Ensure proper vaccine preparation.

  • Plan ahead for the number and types of vaccines that will be required that day, and check that they are already thawed, if possible.
  • Develop and follow a standard process, supported by a quick reference sheet for dose preparation of each vaccine product (refer to job aids).
  • Verify that:
    • the correct product has been selected based on the client's request and eligibility
    • the product's expiry date or "use by" date and time (for previously punctured vials) have not passed
  • If dilution is required, ensure that the appropriate diluent is used with the proper volume (only required for some Pfizer-BioNTech COVID-19 vaccines).
  • If drawing up several vaccines for the client to be used right away, ensure each is properly labelled with the product name and dose volume. Record the lot number and expiry date on the label or ensure the vial is available to provide that information for the vaccination record.

Use product before its "use by" date and time.

  • Label all prefilled syringes immediately after preparation with the:
    • product name
    • dose volume
    • lot number
    • expiry date
    • "use by" date and time (based on the manufacturer's time interval for use after first puncture of the vial [refer to job aids])
  • For examples of labels, refer to page 6 of the USP COVID-19 Vaccine Handling Toolkit (PDF).
  • Mark all punctured vaccine vials with the "use by" date and time based on first puncture of the vial.

Ensure correct product selection and dose.

  • Incorporate independent double checks with other pharmacy staff members at key points in the preparation and drawing up process, if possible.

Administration
  • Providing a vaccine when contraindicated
  • Full dose not administered
  • Wrong site or route used
  • Wrong vaccine product or dose
  • Vaccine administered with a used needle and syringe
  • Needle stick injuries

Pre-vaccination counseling.

  • Ensure that the client or caregiver has:
    • read about or been advised about the vaccine being offered and its benefits and risks
    • had the opportunity to ask questions
  • Ensure that the client has no contraindications to vaccination using a prepared list of contraindications.

Ensure administration of correct vaccine with correct dosage at correct time interval.

  • Immediately before vaccination, ask the client or caregiver to provide their name and date of birth.
  • Verify the date of the last vaccine dose and the date of the last SARS-CoV-2 infection (if applicable).
  • Verify:
    • that the correct product and dose is in the syringe
    • the expiry date or "use by" date (if applicable)
  • If possible, ask the client or caregiver to read out loud the vial label or syringe label and expiry date and "use by" date (if applicable).

Develop a standard protocol if administering more than 1 vaccine to the client.

  • If administering more than 1 vaccine, develop a standard order (such as COVID-19 vaccine first, influenza vaccine second) and preferred site (such as left deltoid for the COVID-19 vaccine, right deltoid for the influenza vaccine), unless the client has a specific preference.
  • Develop a mechanism to keep track of which vaccine is given in which site so that it can be accurately recorded in the immunization record.

Ensure appropriate administration technique.

  • Use appropriate landmarking in the deltoid or anterolateral thigh.
  • All current COVID-19 vaccines are administered intramuscularly (IM).
  • Ensure children are appropriately supported so that the complete dose can be administered. Use resources such as the CARD system to help children with fear of vaccination.

Preventing needlestick injuries.

  • Immediately activate the safety mechanism after administering the vaccine.
  • Immediately dispose of the used needle and syringe in the sharps container. Never put the used needle and syringe down on the worktable.

Documentation
  • Inaccurate or lack of documentation

Provide accurate and complete documentation in appropriate formats.

  • Document the vaccination in the pharmacy record and provide clients with documentation of vaccination.
  • Records and documentation should include:
    • client name
    • date of birth
    • product name
    • dose volume
    • site of administration
    • lot number
    • expiry date
    • date of vaccination
    • name and professional designation of the vaccinator
  • Refer to the Canadian Immunization Guide for additional details.
  • Provide documentation to the client in an electronic format, and on paper during the visit if requested by the client.
  • Review and confirm with the client that the information on the vaccination record is accurate.

As appropriate, book the next vaccination appointments. Send appointment reminders by phone, text or email.

Evaluation and continuous quality improvement

no data

Use continuous improvement processes.

  • Stay informed of changes to vaccination recommendations, schedules and products through:
  • Ensure training and resources are updated as needed.
  • Analyze the causes of any vaccination errors or near misses so that changes can be made to prevent future errors.
  • Incorporate frequent audits of the workflow to identify and modify problematic processes that can lead to errors.

Plan for the response to possible errors.

  • Ensure staff members are aware of the importance of reporting any errors that are detected and the mechanism for reporting errors.
  • Develop plans to support the client and family members, and all members of the pharmacy team in the event of a vaccine error, including who to consult for advice (e.g., local public health department, manufacturer).

Job aids

References

This document was prepared by the Ontario Ministry of Health, the Public Health Agency of Canada and the Institute for Safe Medication Practices Canada with input from the Canadian Immunization Committee.

Large scale immunization clinics
Table 3: Strategies to prevent errors or deviations with regard to COVID-19 immunizations
Stage in the vaccination process Potential vaccine errors or deviations Strategies for preventing errors or deviations

Client screening and verification of vaccine eligibility
  • Wrong vaccine product or dose
  • Dose given too early (interval too short)

Ensure client is eligible by verifying their information when they book a vaccination appointment on the phone or through an online electronic system.

  • Determine the client's eligibility for the requested vaccination with the use of:
    • clinic databases
    • jurisdictional vaccination portals
    • information provided by the client
  • Eligibility may be assessed based on:
    • client age
    • dates of previous doses of COVID-19 vaccines
    • date of previous SARS-CoV-2 infection and underlying medical conditions, if available and as applicable

Ensure client is eligible by verifying their information on arrival at the immunization clinic.

  • Confirm the identity of the client by asking the client or caregiver to provide full name and date of birth.
  • Verify the client's eligibility for the vaccine:
    • If available, verify the client's eligibility for the requested vaccine in the central jurisdictional or locally available COVID-19 vaccine database that contains their past vaccination information. These systems may be able to flag potential eligibility with regard to upcoming vaccinations.
    • If access to jurisdictional or local databases is not available, obtain the client's past vaccination history from the client's personal immunization record, if available.
    • Checklists and resource documents can be used to verify eligibility. Refer to Table 2 of the COVID-19 chapter of the Canadian Immunization Guide for a summary of the recommended doses based on previous vaccination history, but jurisdictional recommendations may differ.
  • Verify the date of SARS-CoV-2 infection and any applicable underlying medical conditions as needed to determine eligibility, if possible and as applicable.

Ensure the client gets to the right place if multiple vaccines are being offered at the immunization clinic.

  • Colour code the various vaccines being offered and the locations they are being offered. Give the client a paper or wristband with the colour corresponding to the vaccine they are to receive.
  • Direct the client to the appropriate area of the clinic where the vaccine is being offered.

Storage and handling
  • Interruption of the cold chain, potentially affecting potency or safety
  • Poor organization of storage areas, leading to selection of the wrong product
  • Selection of outdated product (expired or past "use by" date)

Prevent temperature excursions.

  • Check the accuracy of thermometers.
  • Check and record the minimum and maximum refrigerator temperatures (and freezer temperatures if applicable) as well as the room temperature, for a minimum of twice daily on all business days or as required by your jurisdiction.
  • Frequently monitor and record temperatures in containers used to:
    • transport vaccines to the clinic
    • store vaccines on-site at the clinic
  • If any temperature deviations are noted, follow the jurisdiction's processes on who to contact before administering any affected vaccines. Ensure vaccines under investigation for possible temperature deviations are quarantined and properly stored under cold chain conditions in a manner that prevents them from being used until:
    • determined to be appropriate based on consultation with the jurisdictional authority who provides recommendations
    • or they need to be appropriately discarded

Ensure good organization of stored vaccines (if vaccines are stored at the clinic).

  • When vaccines arrive at the clinic, carefully inspect all vials, as well as temperature-monitoring devices that accompany the product.
  • Store each product in a separate, clearly labelled container in a dedicated vaccine refrigerator.
    • Use unique colours for the labels on the storage containers of different vaccine products and for vaccine vial log sheets for each vaccine type. Never store different vaccines in the same container.
    • Ensure that look-alike products are stored in different areas of the refrigerator or freezer.
    • Ensure the container label indicates if a diluent is required for the product and where it is stored.
  • Use bar-coding technology for product identification and inventory management, if available.
  • Only stock 1 vaccine product for each indication, or minimize the number of products available in the clinic, if possible.

Ensure vaccines are not expired.

  • Regularly review the expiry date of refrigerated or frozen vaccines and remove any expired product. Health Canada will occasionally extend the vaccine shelf life. Refer to the manufacturer's website or the Canadian Vaccine Catalogue for expiration dates by lot numbers.
  • Put shortest expiry dated product at the front of the labelled container so it is used first.
  • Always check the expiry date as a product is removed from the refrigerator or freezer and then again before preparing it.
  • Try to ensure that only 1 lot (with only 1 expiry date) is used at each clinic for each product.

Ensure punctured vials are used within the recommended time after first puncture of the vial ("use by" date and time).

  • If the vaccines are not being drawn up from the vial all at one time, at the time of first puncture, mark the vaccine vial with the:
    • date and time of first puncture
    • "use by" date and time (based on the manufacturer's time interval for use after first puncture of the vial [refer to job aids])
  • Store previously punctured vials in an appropriately labelled container, and if stored in the refrigerator, have a designated location for previously punctured vials. Do not put previously punctured and unpunctured vials together in the same container.
  • Ensure that the previously punctured vials are used by the "use by" date and time after first puncture of the vial or are discarded.

Clinic setup
  • Product or dose mix-ups
  • Incorrect vaccine preparation

Ensure appropriate clinic setup.

  • Ensure that the clinic location is large enough for separate areas for:
    • vaccine preparation
    • vaccine administration
    • pre-vaccination and post-vaccination waiting
  • Conduct vaccine preparation in a separate, quiet area with:
    • good lighting
    • sufficient workspace
    • minimal traffic and disruptions
  • Ensure ample room in the vaccine administration area to avoid crowding of clients, and ensure the location has good lighting and sufficient workspace for each vaccinator.
  • Ensure appropriate sharps containers are in easy reach of those preparing vaccines and of each vaccinator.

Avoid vaccine mix-ups and errors in dilution.

  • Designate people to specific tasks such that only 1 task is done per person, such as:
    • dilution (if needed)
    • drawing-up vaccine
    • administering vaccine
  • For sites that are administering more than 1 vaccine product:
    • Set up separate preparation areas and if possible, separate pre-vaccination waiting areas and vaccine administration areas for each product.
    • Clearly post signage to identify the product being prepared or administered in each area.
    • Colour code all items associated with each vaccine being administered, including:
      • trays
      • the line-up area
      • labels for vaccines
      • consent forms

Prepare the clinic for emergencies.

  • Ensure each clinic has at least 2 anaphylaxis kits (more may be required in larger clinics) and all staff are aware of the location of:
    • the anaphylaxis kits
    • other emergency management equipment
  • Ensure that the anaphylaxis kits are appropriately stocked and that the products are not expired (refer to the Canadian Immunization Guide for items to be in the anaphylaxis kit).
  • Ensure:
    • staff are trained in anaphylaxis and fainting management
    • appropriate resource materials, instructions and medical directives are available, if applicable

Preparation of the vaccine
  • Improper dilution or no dilution of vaccines that require dilution
  • Use of product past its "use by" date and time
  • Selection of incorrect product due to similarities in cap colours or labels

Ensure proper vaccine preparation.

  • If possible, based on registered clients, plan ahead for the number and types of vaccines that will be required that day, and check that they are already thawed.
  • Develop and follow a standard process, supported by a quick reference sheet for dose preparation of each vaccine product. Refer to job aids.
  • Assign staff members to only 1 task (such as dilution or drawing up vaccine).
  • If dilution is required, ensure that the appropriate diluent is used with the proper volume (only required for some Pfizer-BioNTech COVID-19 vaccines).
  • If dilution is required, put the same number of vaccine vials and diluent in the workspace. Ensure that the number of vaccine vials and diluent continue to be equal during and at the end of the clinic.
  • If providing more than 1 vaccine or more than 1 dose volume at each clinic, ensure that there is no way for the vaccinators to confuse the products. For example, by using:
    • colour coding
    • labels on the syringe
    • labelled containers for storing or transporting the vaccine within the clinic
  • Ensure that the vaccinators have access to the expiry date and lot number of each product they are using, such as by using:
    • labels
    • bar-coding
    • pre-printed information at their workstation
    • information entered into the electronic system

Use product before its "use by" date and time.

  • If drawn up product is not being used rapidly at the clinic, label all prefilled syringes immediately after preparation with the product:
    • name
    • dose volume
    • "use by" date and time (based on the manufacturer's time interval for use after first puncture of the vial [refer to job aids])
    • other appropriate information as per the clinic process (such as lot and expiry date)
  • For examples of labels, refer to page 6 of the USP COVID-19 Vaccine Handling Toolkit (PDF).
  • If all doses are not being drawn-up from the vial all at once, mark all puncture vaccine vials with the:
    • date and time of the first puncture
    • "use by" date and time based on first puncture of the vial

Ensure correct product selection and dose.

  • If possible, incorporate independent double checks with other clinic staff members at key points in the preparation and drawing up process.

Administration
  • Providing a vaccine when contraindicated
  • Full dose not administered
  • Wrong site or route used
  • Wrong vaccine product or dose
  • Vaccine administered with a used needle and syringe
  • Needle stick injuries

Pre-vaccination counseling.

  • Ensure that the client or caregiver has:
    • read about or been advised about the vaccine being offered and its benefits and risks
    • had the opportunity to ask questions
  • Ensure that the client has no contraindications to vaccination using a prepared list of contraindications.

Ensure administration of correct vaccine with correct dosage at correct time interval.

  • Immediately before vaccination, ask the client or caregiver to provide their name and date of birth.
  • Verify the date of the last vaccine dose, and the date of the last SARS-CoV-2 infection, if applicable.
  • Verify the correct dose, and if possible, based on clinic processes, verify:
    • that the correct product is in the syringe
    • the expiry date or "use by" date (if applicable)
  • If possible, ask the client or caregiver to read out loud the vial label or syringe label, expiry date and "use by" date (if applicable).

Develop a standard protocol if administering more than 1 vaccine to the client.

  • If administering more than 1 vaccine, develop a standard order (such as COVID-19 vaccine first, influenza vaccine second) and preferred site (such as left deltoid for the COVID-19 vaccine, right deltoid for the influenza vaccine), unless the client has a specific preference.
  • Develop a mechanism to keep track of which vaccine is given in which site so that it can be accurately recorded in the immunization record.

Ensure appropriate administration technique.

  • Use appropriate landmarking in the deltoid or anterolateral thigh.
  • All current COVID-19 vaccines are administered intramuscularly (IM).
  • Ensure children are appropriately supported so that the complete dose can be administered. Use resources such as the CARD system to help children with fear of vaccination.

Preventing needlestick injuries.

  • Immediately activate the safety mechanism after administering the vaccine.
  • Immediately dispose of the used needle and syringe in the sharps container. Never put the used needle and syringe down on the worktable.

Documentation
  • Inaccurate or lack of documentation

Provide accurate and complete documentation in appropriate formats.

  • Document the vaccination in the clinic's record (online system or paper record) and provide clients with documentation of vaccination.
  • Records and client documentation should include:
    • client name
    • date of birth
    • product name
    • dose volume
    • site of administration
    • lot number
    • expiry date
    • date of vaccination
    • name and professional designation of the vaccinator
  • Refer to the Canadian Immunization Guide for additional details.
  • Provide documentation to the client in an electronic format, and on paper during the visit if requested.
  • Review and confirm with the client that the information on the vaccination record is accurate.

As appropriate, advise the client to book their next vaccination appointments.

Evaluation and continuous quality improvement

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Training, supervision and debriefing.

  • Ensure all clinic procedures and roles and responsibilities are appropriately documented and disseminated to staff.
  • Before staff members begin their first shift at the clinic, provide:
    • online or in-person training
    • written training materials and medical directives (as appropriate)
  • Buddy new staff members with experienced staff members for the first few shifts.
  • Provide brief updates and information sessions before the start of each clinic.
  • Ensure adequate on-site supervision to respond to questions and issues and to monitor practice.
  • Conduct a debrief session after clinics to identify areas for improvement.

Use continuous improvement processes.

  • Stay informed of changes to vaccination recommendations, schedules and products through:
  • Ensure training, resources, policies and procedures and medical directives (as appropriate) are updated as needed.
  • Analyze the causes of any vaccination errors or near misses so that changes can be made to prevent future errors.
  • Incorporate frequent audits of the workflow to identify and modify problematic processes that can lead to errors.

Plan for the response to possible errors.

  • Ensure staff members are aware of the importance of reporting any errors that are detected and the mechanism for reporting errors.
  • Develop plans to support the client, family members and involved staff members in the event of a vaccine error, including who to consult for advice (such as a local public health department or manufacturer).

Job aids

References

This document was prepared by the Ontario Ministry of Health, the Public Health Agency of Canada and the Institute for Safe Medication Practices Canada with input from the Canadian Immunization Committee.

What to do after an error or deviation is detected

If an inadvertent vaccine administration error or deviation is found, health care providers should:

The purpose of the remaining sections of this document are to assist in the management of specific errors and deviations that may arise.

Important context regarding guidance

There is limited evidence to guide the management of errors or deviations. The manufacturer may have information that can assist with making decisions regarding error and deviation management, and public health officials are available to assist with management advice regarding vaccine errors or deviations.

This document provides guidance only. Note that provincial and territorial protocols may differ from this guidance document. Clinical judgement is necessary for making appropriate decisions regarding vaccine administration errors and deviations and may result in management decisions that differ from those outlined in this guidance.

The term "valid" in this document refers to a dose that is considered acceptable for the purposes of managing an error or deviation and not for the proof of vaccination requirements. The term "invalid" in this document refers to a dose that may not result in the desired effects and is recommended to be repeated. However, as noted above, clinical judgement is required to determine whether a dose is invalid and should be repeated. Factors that can be considered in making clinical judgements about whether to consider a dose invalid and whether to repeat the dose include:

Once a decision is made that a dose is "invalid" and needs to be repeated, guidance on how to repeat the dose is provided in the following sections on Recommendations for repeating a dose in the primary series, Recommendations for repeating a subsequent dose, and Recommendations for repeating an invalid dose.

Recommendations for repeating a dose in the primary series

The following guidance relates to recommendations for repeating a dose in the primary series that is considered invalid due to the potential for an inadequate response because of too small a dose, over-dilution, or storage or handling deviations that could impact potency.

Recommendations for repeating a subsequent dose

The following guidance relates to recommendations for repeating a subsequent dose in those who have previously completed a primary series when the dose is considered invalid due to the potential for an inadequate response because of too small a dose, over-dilution, or storage or handling deviations that could impact potency.

Recommendations for repeating an invalid dose

The following guidance relates to recommendations for repeating an invalid dose if the dose is considered invalid because the interval is too short between vaccine doses.

Serologic testing

Serologic testing to assess vaccine-induced immunity following COVID-19 vaccine errors or deviations is generally not recommended. Health care providers are encouraged to contact their local public health department or their provincial or territorial public health laboratory for advice if considering using serology to investigate an error or deviation.

For other resources on vaccine administration practices, please consult the Canadian Immunization Guide.

Type of administration errors or deviations: Guiding principles and recommended actions

Site or route errors

Recommended site and route

COVID-19 vaccines should be administered intramuscularly. The anterolateral thigh (vastus lateralis) is the preferred site for children less than 1 year of age. The anterolateral thigh or the deltoid muscle can be used for toddlers and older children. The deltoid is usually selected as the injection site in toddlers and older children as temporary muscle pain post-vaccination in the anterolateral thigh muscle may affect ambulation. The deltoid muscle of the arm is the preferred injection site in adolescents and adults (unless the muscle mass is not adequate, in which case the anterolateral thigh can be used). See Route, site and technique for vaccine administration: Canadian Immunization Guide for additional information.

Guiding principles for site or route errors

If a site other than the deltoid muscle or anterolateral thigh is used:

  • consider the dose valid
  • inform the client (and parent or guardian) of the error or deviation and the potential for local and systemic adverse events and that the dose is acceptable

If an incorrect route (for example, subcutaneous) is used:

  • consider the dose valid
  • inform the client (and parent or guardian) of the error or deviation and the potential for local and systemic adverse events and that the dose is acceptable

Too high a dose

Recommended dosages by age

See the Recommendations for use in the Canadian Immunization Guide: COVID-19 vaccines chapter.

Guiding principle for too high a dose

Too high a dose can result from:

  • using the wrong dosage according to the client's age
  • not adding diluent or not adding enough diluent to a product that requires dilution
    • note that only the Pfizer-BioNTech Comirnaty XBB.1.5 3 mcg maroon-coloured product for children 6 months to less than 5 years requires dilution using 2.2 mL of 0.9% sodium chloride provided by the manufacturer

Doses that are higher than the authorized amount are considered valid. The client should be advised of the potential for local and systemic adverse events.

Dose, product or schedule error based on age

Select the age group of your client:

Children 6 months to under 5 years of age

Recommendations for children 6 months to less than 5 years of age who are previously unvaccinated or started but did not complete a primary series

Children 6 months to less than 5 years of age who are previously unvaccinated against COVID-19 and who are at high risk of severe illness due to COVID-19 should be vaccinated with a primary series of an XBB.1.5 vaccine and other children in this age group may be vaccinated.

Children at increased risk for severe outcomes may include children who are medically fragile or have medical complexities, children with more than 1 comorbidity, children with neurological disorders, children with chronic lung disease, and children with Down syndrome (Trisomy 21) and other immunocompromising conditions.

The recommended schedule for those who are not immunocompromised is:

  • 2 doses of Moderna Spikevax XBB.1.5-containing vaccine (25 mcg), 8 weeks apart
  • 3 doses of Pfizer-BioNTech Comirnaty XBB.1.5-containing vaccine (3 mcg), 8 weeks apart

For those who are moderately to severely immunocompromised the schedule is:

  • 3 doses of Moderna Spikevax XBB.1.5 vaccine (25 mcg) [this is the preferred product], with a 4 to 8 week interval between doses
  • if the Moderna Spikevax XBB.1.5 (25 mcg) vaccine is not available, 4 doses of Pfizer-BioNTech Comirnaty XBB.1.5 vaccine (3 mcg) may be offered, with a 4 to 8 week interval between doses

Note that when starting a series in those 6 months to less than 5 years of age who are moderately to severely immunocompromised, NACI prefers Moderna Spikevax XBB.1.5 vaccine as it is easier to implement as it only requires 3 doses, instead of 4 doses for Pfizer-BioNTech Comirnaty XBB.1.5 vaccine (see recommendations of the Updated guidance on the use of COVID-19 vaccines in individuals who have not previously been vaccinated against COVID-19).

mRNA XBB.1.5-containing vaccines are recommended for children 6 months to less than 5 years of age who previously started but did not complete the primary series of COVID-19 vaccines. Refer to Table 2 of the COVID-19 chapter of the Canadian Immunization Guide for a summary of the recommended doses based on previous vaccination history.

If products from Pfizer-BioNTech Comirnaty and Moderna Spikevax are used in the same primary series (i.e., a mixed schedule), the number of doses should follow the Pfizer-BioNTech Comirnaty schedule.

If a child transitions from 4 to 5 years of age during the primary series, see Table 2 of the COVID-19 chapter of the Canadian Immunization Guide and follow the recommendations for those who are 5 years of age and over, including the relevant footnotes.

Recommendations for children 6 months to less than 5 years of age who previously completed a primary series

For children 6 months to under 5 years of age who have previously been vaccinated with a complete primary series that did not include an XBB.1.5 vaccine, a single dose of XBB.1.5 vaccine is recommended 6 months following the previous COVID-19 vaccination or SARS-CoV-2 infection (whichever is later). Shorter intervals (i.e., 3 months to less than 6 months) following previous vaccination or infection have also not been shown to pose a safety risk.

Guiding principles for managing too low of a dosage given to children 6 months to under 5 years of age

Too low a dose could result from the following:

  • using the wrong dosage according to the client's age
  • a product requiring dilution was over diluted
  • a product not requiring dilution was diluted
  • only diluent was administered
  • leakage of vaccine during administration
  • equipment failure
  • the client pulled away while the dose was being injected

Note that only the Pfizer-BioNTech Comirnaty XBB.1.5 3 mcg maroon-coloured product for children 6 months to less than 5 years requires dilution using 2.2 mL of 0.9% sodium chloride provided by the manufacturer. Any amount in excess of 2.2 mL will result in over-dilution based on a 0.2 mL dose.

Any dose that is known or suspected to be below the age-appropriate dosage (for both Pfizer-BioNTech Comirnaty and Moderna Spikevax) should be considered invalid and repeated as per the section for the primary series and the section for subsequent doses in those who have previously completed a primary series.

See the section on important context regarding guidance when considering a dose invalid.

Guiding principle for non-XBB.1.5 COVID-19 vaccines administered instead of XBB.1.5 vaccines

If a non-XBB.1.5 COVID-19 vaccine was given in error instead of an XBB.1.5 vaccine, consider the dose valid and administer the next dose(s) as per Table 2 of the COVID-19 chapter of the Canadian Immunization Guide.

Individuals 5 years of age and older

Recommendations for individuals 5 years of age and older who are previously unvaccinated or started but did not complete a primary series

NACI recommends that individuals 5 years of age and older who are previously unvaccinated against COVID-19 should be vaccinated. One dose of an XBB.1.5-containing vaccine is recommended as per the authorized schedule in the product monograph. An additional dose is recommended for individuals who are moderately to severely immunocompromised with a 4 to 8 week interval between the 2 doses.

mRNA XBB.1.5 vaccines are recommended for individuals 5 years of age and older who previously started but did not complete the primary series of COVID-19 vaccines. Refer to Table 2 of the COVID-19 chapter of the Canadian Immunization Guide for a summary of the recommended doses based on previous vaccination history.

If a child transitions from 4 to 5 years of age during the primary series, see Table 2 of the COVID-19 chapter of the Canadian Immunization Guide recommendations for those who are 5 years of age and over, including the relevant footnotes.

The Novavax Nuvaxovid XBB.1.5 vaccine has been recently authorized for use by Health Canada. NACI has not yet deliberated on its use. This guidance will be forthcoming. For information on the use of this vaccine, refer to the product monograph in Health Canada's COVID-19 vaccines and treatments portal.

Recommendations for individuals 5 years of age and older who previously completed a primary series

For individuals 5 years of age and older who have previously been vaccinated with a complete primary series that did not include an XBB.1.5 vaccine, a dose of XBB.1.5 is recommended 6 months following the previous COVID-19 vaccination or SARS-CoV-2 infection (whichever is later). Shorter intervals (i.e., 3 months to less than 6 months) following previous vaccination or infection have also not been shown to pose a safety risk.

The Novavax Nuvaxovid XBB.1.5 vaccine has been recently authorized for use by Health Canada. NACI has not yet deliberated on its use. This guidance will be forthcoming. For information on the use of this vaccine, refer to the product monograph in Health Canada's COVID-19 vaccines and treatments portal.

Guiding principles for managing too low of a dosage given to individuals 5 years of age and over

Too low a dose could result from the following:

  • using the wrong dosage according to the client's age
  • a product not requiring dilution was diluted
  • only diluent was administered
  • leakage of vaccine during administration
  • equipment failure
  • the client pulled away while the dose was being injected

The dosages of COVID-19 vaccine vary by product and age. See the COVID-19 chapter of the Canadian Immunization Guide.

Any dose that is known or suspected to be below the age-appropriate dosage (for Pfizer-BioNTech Comirnaty, Moderna Spikevax and Novavax Nuvaxovid) should be considered invalid and repeated as per the section for the primary series and the section for subsequent doses in those who have previously completed a primary series.

See the section on important context regarding guidance when considering a dose invalid.

Guiding principle for non-XBB.1.5 COVID-19 vaccines administered instead of XBB.1.5 vaccines

If a non-XBB.1.5 COVID-19 vaccine was given in error instead of an XBB.1.5 vaccine, consider the dose valid and administer the next dose(s) as per Table 2 of the COVID-19 chapter of the Canadian Immunization Guide.

Concurrent administration

Recommendations for concurrent administration

NACI recommends that for individuals 6 months of age and older, COVID-19 vaccines may be given concurrently with (i.e., same day), or at any time before or after non-COVID-19 vaccines (including live and non-live vaccines).

With regard to Imvamune (for the prevention of mpox), NACI has issued some precautionary suggestions regarding the timing of this vaccine relative to COVID-19 vaccines.

Mixing more than 1 vaccine in the same syringe

Recommendations

COVID-19 vaccines should never be mixed in the same syringe as other vaccines, as it is possible that the components of 1 vaccine may have a detrimental effect on the other(s).

Guiding principle for different vaccines combined in 1 syringe for single administration

The manufacturer should be consulted to determine if they have any particular information on the mixing of vaccines (including the particular vaccines that were mixed), recognizing that this information may not be available. In general, if 2 or more vaccines were administered in the same syringe, consider all vaccine doses as invalid and all vaccines mixed together should be repeated.

For an invalid COVID-19 vaccine dose, the vaccine should be repeated as per the section for the primary series and the section for subsequent doses in those who have previously completed a primary series. The repeat COVID-19 vaccine dose can be given concurrently at the same visit with the other vaccine(s) that require repeating (i.e., the other vaccines that were erroneously mixed in the same syringe). The repeat vaccines should be administered using separate injection sites and separate injection equipment (i.e., separate needles and syringes).

See the section on important context regarding guidance when considering a dose invalid.

Interval errors

Recommended intervals between COVID-19 vaccine doses or SARS-CoV-2 infection and COVID-19 vaccine doses

Recommended intervals between COVID-19 vaccine doses or between SARS-CoV-2 infection and COVID-19 vaccination for those who are not immunocompromised and those who are moderately to severely immunocompromised are provided in:

Guiding principle for COVID-19 vaccine doses given longer than the recommended interval

Recommended intervals are attempting to balance achieving a good immune response and the period at risk between COVID-19 vaccine doses. All doses given beyond the recommended interval are considered valid, whether for the primary series that requires more than 1 dose or for the subsequent doses, including for moderately to severely immunocompromised people.

Guiding principle for COVID-19 vaccine doses given earlier than the recommended interval

Doses given too close together may not result in an optimal immune response because of:

  • less than recommended time to allow for the immune response to mature between doses
  • antibodies produced to the early dose may interfere with the antibody response to the later dose

Primary series: When the primary series consist of more than 1 dose, COVID-19 vaccine doses given less than 21 days apart (for both Pfizer-BioNTech Comirnaty or Moderna Spikevax) are considered invalid and should be repeated as per the section on repeating an invalid dose.

See the section on important context regarding guidance when considering a dose invalid.

Subsequent doses in those who previously completed a primary series: COVID-19 vaccine doses given less than 8 weeks apart are considered invalid and should be repeated as per the section on repeating an invalid dose.

See the section on important context regarding guidance when considering a dose invalid.

Vaccine doses given at any interval after infection are considered valid and do not need to be repeated.

Storage and handling errors

Recommendations regarding storage and handling

Storage and handling recommendations can be found in the product monographs for Pfizer-BioNTech Comirnaty and Moderna Spikevax.

Guiding principles for storage and handling errors

Storage and handling errors or deviations can include:

  • Excursions beyond the recommended time or temperature based on the product monograph.
  • Incorrect diluent type (e.g., sterile water instead of 0.9% sodium chloride for Pfizer-BioNTech Comirnaty XBB.1.5 [3 mcg] for children 6 months to less than 5 years).

Management of storage and handling errors requires individual consideration based on the particular circumstances, in consultation with the manufacturer and based on clinical judgment. Local public health officials can also be contacted for assistance and should be notified of any temperature excursions.

In consulting with the manufacturer, inquire if they have any specific information related to the particular storage and handling error or deviation involving the specific product or lot number or more general information that may help to inform decisions regarding the error or deviation. In addition to information from the manufacturer, and as noted in the section on important context regarding guidance, other factors to consider in deciding whether a dose requires repeating and when it should be repeated include:

  • How substantial was the deviation (e.g., how long was the product exposed to an inappropriate temperature and what was the temperature deviation)?
  • How many other doses has the client received, and when are they scheduled to receive their next dose if the dose is not repeated?
  • Were there any other errors or deviations in the client's previous doses?
  • What are the client's underlying COVID-19 related risk factors for serious COVID-19 disease or a less than an optimal response to the vaccine (e.g., age, underlying medical conditions, including immunocompromising conditions)?
  • Has the client had any significant adverse events after previous doses?

If a dose is deemed to be invalid, it should be repeated as per the section for the primary series and the section for subsequent doses in those who have previously completed a primary series. For the second, third or fourth doses in the primary series (if applicable), the section for the primary series suggests an interval of 4 to 8 weeks to repeat the invalid dose:

  • the longer interval of up to 8 weeks to repeat the invalid dose can be considered if there was only a relatively small deviation in time or temperature above cold chain requirements
  • the shorter interval of down to 4 weeks can be considered to repeat the invalid dose if there was a relatively large deviation in time or temperature above cold chain requirements

More or less than authorized number of doses obtained from vial
  • Depending on the type of supplies used (e.g., low dead volume syringe), the number of doses obtained from vials may vary.
  • As long as the correct volume was drawn up per dose (and the correct amount of diluent was used if the product required dilution), the doses are considered valid.

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