New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers - Department of Health Public Health New Brunswick July 23, 2021
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New Brunswick
COVID-19 Vaccine Clinic
Guide for Immunizers
Department of Health
Public Health New Brunswick
July 23, 2021
Public Health New Brunswick New Brunswick Department of Health PO Box 5100 Fredericton, New Brunswick, E3B 5G8 Canada This report is available online: www.gnb.ca/publichealth Ce document est aussi disponible en français sur le titre «Guide sur la vaccination contre la COVID-19 pour les Vaccinateurs du Nouveau-Brunswick ».
TABLE OF CONTENTS
NEW BRUNSWICK COVID-19 CLINIC GUIDE FOR IMMUNIZERS ..........................................................1
1.0. PURPOSE .......................................................................................................................................1
2.0. VACCINE SOP ON TRANSPORTATION AND RECEIPT .............................................................1
Vaccines – storage and handling and maintaining cold chain to prevent temperature
excursions (portable freezers and refrigeration) ...........................................................2
3.0. SCHEDULES, DOSES AND ADMINISTRATION OF COVID-19 VACCINES ...............................3
US Labelling of COVID-19 Vaccine .................................................................................3
4.0. REDUCING UNNECESSARY VACCINE WASTAGE ....................................................................4
Extra doses ........................................................................................................................4
Mixing and pooling of vials ..............................................................................................4
Reporting Wastage ...........................................................................................................5
5.0. HEALTH CANADA APPROVED AND NON-APPROVED VACCINES FOR COVID-19 ...............5
6.0. PFIZER-BIONTECH (COMIRNATY, TOZINAMERAN, BNT162B2) ..............................................5
7.0. VACCINE INTERCHANGEABILITY ...............................................................................................6
8.0. NB RECOMMENDED INTERVAL FOR COVID-19 VACCINES APPROVED BY HEALTH
CANADA .........................................................................................................................................6
9.0. CONTRAINDICATIONS AND PRECAUTIONS ..............................................................................7
10.0. ANAPHYLAXIS MANAGEMENT ....................................................................................................7
Anaphylaxis Contraindication .........................................................................................8
Anaphylaxis Planning Principles ....................................................................................8
Medical Directive for Obtaining Consent, Administering Vaccine and to Manage
Anaphylaxis .......................................................................................................................9
Management of Anaphylaxis ...........................................................................................9
11.0. VACCINATION POST COVID-19 INFECTION ...............................................................................9
12.0. CONSENT FOR SECOND DOSES ................................................................................................9
13.0. REPORTING ADMINISTERED DOSES .......................................................................................10
14.0. VACCINE ELIGIBILITY AND PAYMENT FOR SERVICES .........................................................12
15.0. COVID-19 VACCINE ERRORS ....................................................................................................12
Vaccine Error Prevention ...............................................................................................12
Inadvertent Vaccine Administration Errors..................................................................13
Guidance for Vaccine Administration Errors ...............................................................14
16.0. ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI) .......................................................18
Side Effects Post COVID-19 Vaccination......................................................................18
Reporting Adverse Events .............................................................................................20
17.0. RESOURCES ................................................................................................................................20
APPENDIX A – “CHEAT SHEET TABLE”: A GUIDE FOR IMMUNIZERS .............................................22
APPENDIX B – AEFI PROCESS MAP ......................................................................................................26
....................................................................................................................................................................26New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
NEW BRUNSWICK COVID-19 CLINIC GUIDE FOR IMMUNIZERS
Changes, compiled July 23, 2021.
• Section 1.0: Shortened the guide’s title, included the purpose of the document and its intended
audience
• Former Section 2.0: Moved Clinic Planning section to the NB COVID-19 Community Clinic
Planning Guide” with the exception of 2.8.5 and 2.8.6
• Removed Table 3 and 4 with COVID-19 Product information and replaced with general guidance
on schedules, doses and administration of COVID-19 vaccines.
• Former Section 3.0: Moved Clinic Operations section to the “NB COVID-19 Community Clinic
Planning Guide”
• Former Appendix A “PH NB COVID-19 Immunization Clinic Application Approval Form” moved
to the “NB COVID-19 Community Clinic Planning Guide”
• Former Appendix B “Medical Supplies and PPE” moved to the “NB COVID-19 Community Clinic
Planning Guide”
1.0. PURPOSE
The purpose of this document is to provide clinical guidance about COVID-19 vaccination in New
Brunswick. The primary target audience for this document areall Health and Allied Health Care
Practitionners who are immunizing with COVID-19 vaccines and are referred to as “Immunizers”
throughout this Guide. For information on how to plan a community immunization clinic, pop up
clinic or other alternate immunization clinic sites, please refer to the New Brunswick COVID-19
Community Clinic Planning Guide which was adapted from the Public Health Agency of Canada
(PHAC). This clinical guide is meant to complement and does not replace information provided
in the New Brunswick Immunization guide, NACI’s Recommendation on the Use of COVID-19
vaccines or the vaccine Product Monograph. General healthcare professional COVID-19
resources can be found on the GNB Vaccines website.
2.0. VACCINE SOP ON TRANSPORTATION AND RECEIPT
It is important that clinic sites are equipped to ensure the integrity and effectiveness of the vaccine
(i.e. cold chain and other procedures).
Please refer to Standard Operating Procedures on Transportation of COVID-19 Vaccines and
the National Vaccine Storage and Handling Guidelines for Immunization Providers – 2015 for
information on how to properly handle and transport vaccines.
Once frozen, thawed mRNA or viral vector vaccines are received at the site, they must immediately be
stored in a ultra-low freezer, freezer or refrigerator suitable for vaccine storage for the product. A
purpose-built vaccine storage unit (i.e. ultra-low freezer, freezer, pharmacy, lab-style or
laboratory-grade refrigerator) is the standard for storage of vaccines. Domestic refrigerators are
not designed to meet the requirements for vaccine storage. For information on temperature
excursions, please refer to the product monographs on GNB’s Website: Vaccine Resources for
Healthcare Professionals. If there is a risk of a temperature excursion or if any interruption in cold
chain occurs contact the Vaccine Operation Centre (VOC): VOC-opsDesk@GNB.CA,
Telephone: 833-414-2369, After Hours (17:00) 506-440-0774.
July 23, 2021 1New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
It is important that clinic sites are equipped to ensure the integrity and effectiveness of the vaccine
(i.e. cold chain and other procedures).
Vaccines – storage and handling and maintaining cold chain to prevent
temperature excursions (portable freezers and refrigeration)
Special attention will be required for the storage and handling of COVID-19 vaccines, as
some COVID-19 vaccines may require storage at ultra-low temperatures (- 80°C) or
freezer temperatures (- 25°C to -15°C), while others will require + 2 to 8°C storage, as per
manufacturers’ specifications. The vaccines requiring storage at ultra-low or freezer
temperatures will have specified periods of time where they can be stored at + 2 to 8°C
prior to use. The carton, box or vial should be labelled with time and date refrigerated
temperature or freezer starts for ultra-low temperature vaccines. Please go to COVID-19:
Interim national vaccine storage, handling and transportation guidelines for ultra-low
temperature and frozen temperature COVID-19 vaccines for guidance on storage,
handling, and transportation of ultra-low temperature COVID-19 vaccines.
Protocols will be required for monitoring and recording the vaccine storage temperature at
designated frequencies during the clinic, particularly if the vaccine is being stored in
vaccine coolers or insulated bags, instead of in a refrigerator. Assign a specific staff
member to monitor and record vaccine temperatures at specified frequencies, including
on arrival and at the end of the clinic and periodically during the clinic, as per jurisdictional
requirements of the province or territory.
Vaccines may have specified time frames when they can be kept at room temperature,
used once mixed with diluent or adjuvant, used once the vial is punctured and/or when
pre-loaded into a syringe. The start time and end time for these time frames should be
written down and the paper stuck to or kept close to the product so that the time frames
can be closely monitored. Mixed vaccine vials and pre-loaded syringes that are not being
used immediately may need to be stored in an insulated bag or cooler or may be able to
be stored at room temperature, based on the manufacturer’s recommendations. If stored
in an insulated bag or cooler, these should have frozen packs and an appropriate
insulating barrier (e.g., bubble wrap, crumpled paper, Styrofoam peanuts) which is
positioned so that the vaccine vial or pre-loaded syringes do not touch the frozen packs to
prevent freezing the vaccine. If the vaccine remains in the insulated bag for more than an
hour, temperature should be monitored and recorded.
Please refer to the Guidelines for Use: COVID-19 Vaccines and Portable Freezers for
more information on packing and using portable freezers with COVID-19 vaccines in the
frozen state (-25°C to -15°C). Refer to New Brunswick Immunization Program Guide
(NBIPG) for storage and handling of 2°C to 8°C vaccines or the current National Vaccine
Storage and Handling Guidelines for Immunization Providers for information on cold chain
management, vaccine storage, temperature monitoring and transportation requirements.
Vaccines stored at ultra-low temperatures (-80°C) or in a freezer (-20°C) will need to be
thawed before use and cannot be refrozen. Manufacturer’s instructions should be followed
regarding the thawing process in the refrigerator and/or at room temperature. Each
vaccine has a limited number of days when they can be maintained at +2°C to 8°C before
administration. Therefore, a sufficient supply to accommodate the anticipated needs of the
clinic should be thawed and available at the clinic. The date the product was thawed and
the date which it should be used by should be clearly marked on the thawed vial and/or
2 July 23, 2021New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
outer package. Some vaccines may be required to be at room temperature before
administering.
There are exceptional circumstances when clients are unable to attend clinic sites, where
immunizers may require transporting and administering COVID-19 vaccines in prefilled
syringes. For more information, please refer to the Department of Health’s Exceptional
Circumstances Policy: Prefilling syringes for onward transportation COVID-19 vaccine
doses.
A Vaccine Command Centre has been created to address vaccine concerns, i.e. shipment
issue, power outages, vaccine excursions, etc. To contact the Vaccine Operation Control
Center:
Email: VOC-opsDesk@GNB.CA
Telephone: 833-414-2369
After Hours (17:00) 506-440-0774
Heat or cold exposure can cause damage to COVID-19 vaccines in storage. It is important
that, when they occur, the appropriate actions take place to preserve the integrity of the
vaccines. When temperature excursions occur, the user at the vaccine delivery site should
follow the actions outlined in Section 6.1 of the National Vaccine Storage and Handling
Guidelines for Immunization Providers – 2015.
The only thermometers and temperature recording devices recommended for monitoring
the temperatures within vaccine storage units are ones that provide continuous recording
or min/max readings that are properly monitored as described in Section 3.6.1 of
the National Vaccine Storage and Handling Guidelines for Immunization Providers – 2015.
Vaccine efficacy is best assured when the number of times vaccines are handled and
transported is minimized. If the transportation of vaccines to another location is required,
it is critical that vaccine potency is protected by maintaining cold chain at all times.
Vaccines should be transported in insulated containers that have been tested and qualified
for vaccine use, ensuring that they are capable of maintaining the vaccine at the correct
temperatures for the necessary duration. For a list of the various materials that are
required when packing and distributing vaccines, refer to Section 9.3.3 of the National
Vaccine Storage and Handling Guidelines for Immunization Providers – 2015.
3.0. SCHEDULES, DOSES AND ADMINISTRATION OF COVID-19 VACCINES
COVID-19 vaccine product information is highly subject to change. For detailed, up-to-date
information about storage and handling of COVID-19 vaccines, please refer to the Canadian
Product Monograph, which is available in French and English on Health Canada’s Drug Product
Database by Drug Identification number or under criteria, select “Schedule” COVID-19 - IO -
Authorization. Product information can also be found on the federal government’s covid-
vaccine.canada.ca website, or on the product monograph within each carton.
US Labelling of COVID-19 Vaccine
Important Canadian-specific information is absent from the US-labelled vial and carton
(see the ‘Information for healthcare professionals’ section below). Information regarding
the vaccine name, description of pharmaceutical form, volume of vial fill and storage
July 23, 2021 3New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
conditions are different on the US labels. Continue to reference the Canadian Product
Monograph for all product information for use in Canada.
Please note that the expiration date is not printed on the US vial and carton labels.
Healthcare professionals must verify the expiration date prior to vaccination. For
Canadian-specific labelling information on the Moderna COVID-19 vaccine, the expiration
date information can be found at www.modernacovid19global.com/ca
4.0. REDUCING UNNECESSARY VACCINE WASTAGE
Direction to reduce unnecessary vaccine wastage given at clinics and pharmacies is based on
New-Brunswick’s Vaccine Strategy Planning Principles.
• Secure Transportation: To ensure that vaccine wastage is minimized please review the,
SOP Transportation of COVID Vaccines and the Exceptional Circumstances Policy: Pre-
filling syringes for onward transportation COVID-19 vaccine doses
• Integrity: Vaccine should be transported for just in time use for planned clinics, not for
secondary storage at another facility. The main supply of vaccine should be housed at
regional hospital location or with McKesson.
• Reduce Wastage: Have back up waiting lists for additional vaccine recipients in the event
of no shows or extra doses, with final option to provide to those available in the area at the
time.
Extra doses
A plan, such as a wait list, should be made regarding the use of any extra vaccine that
may be available at end of clinic.
Mixing and pooling of vials
Residual amounts of diluted vaccines may be noted in some vaccine vials.
Shortfall and delays in COVID-19 vaccine supply precipitated the option of pooling
vaccine across two or more vials to maximize the number of doses available. Public
Health New-Brunswick is supportive of Immunizers practicing dose pooling, when
necessary, as per the following:
• Adhere to aseptic technique while handling the vaccine and minimize contact with vials
and minimize the number of vial punctures to reduce the risk of contamination.
• Perform hand hygiene before handling the vaccine
• Ensure the same person who is preparing the doses will be pooling the vials.
• When drawing up from the multi-dose vial, for initial and subsequent uses, firmly and
briskly wipe the surface of the rubber seal with an alcohol swab, being sure to apply
friction, and allow it to dry for at least 10 seconds.
• Rotate the insertion point of the needle across various locations of the vial septum for
each withdrawal to reduce leakage of vaccine.
• Obtain a full dose of either vaccine products using up to a maximum of 3 separate vials
of the same vaccine product (example Pfizer with Pfizer; Moderna with Moderna;
AstraZeneca/COVISHIELD are interchangeable). In addition, the pooled vaccine
product must come from vials that share the same lot number.
• Vials should be in use at approximately the same time and pooling of residual vaccine
4 July 23, 2021New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
from two or more vials must occur as soon as possible following first vial puncture, i.e.,
it is not recommended to save multiple vials with residual volume for pooling at the end
of the period of viability of the vaccine.
• Only vials containing residual volume are to be used to prepare a full dose when
using multiple vials to constitute a single dose.
• Residual volume should not be added to contents from a different vial that still contains
at least one full dose of the vaccine to maximize retrieval of doses and offer
immunization to larger numbers of individuals.
• To assist with the withdrawal of residual vaccine from the multi-dose vial, invert the vial
and ensure the end of the needle is below fluid level and situated in the groove of the
vial stopper. Once the residual vaccine is withdrawn, remove the needle from the vial
and expel the air bubble(s).
• Check the syringe carefully to ensure that it contains the total dose volume
recommended before administering the dose
Reporting Wastage
The federal government requires that the province reports all vaccine wastage on a
weekly basis. All those who are have been allocated vaccine doses are required to share
vaccine wastage information with Public Health to fulfill this federal requirement. For RHA,
LTC and First Nations clinics, all wasted doses should be captured in the Clinic Tracking
worksheets in the COVID Immunization SharePoint site.
For community pharmacies, the Vaccine Wastage Report located on the Drug Information
System’s Community Pharmacy SharePoint site must be completed when wastage
occurs. If reporting wastage for more than one brand of COVID-19 Vaccine (e.g. Moderna
and Pfizer), or reporting wastage for different Lot numbers, multiple entries are required.
5.0. HEALTH CANADA APPROVED AND NON-APPROVED VACCINES FOR COVID-19
COVID-19 vaccines authorized for use by Health Canada:
• AstraZeneca (Vaxzevria, AZD1222, Covishield)
• Janssen (Johnson & Johnson)
• Moderna (mRNA-1273)
6.0. PFIZER-BIONTECH (COMIRNATY, TOZINAMERAN, BNT162B2)
To be considered fully vaccinated, individuals entering Canada must have received the full series
of a vaccine-or a combination of vaccines accepted by the Government of Canada. However,
there are other vaccines that have received regulatory approval across the globe. To ensure that
those that are traveling into the province are protected against COVID-19, individuals are advised
to get fully vaccinated in their respective countries. Individuals who have received a COVID-19
vaccine approved by the World Health Organization (WHO) will not be offered any further
immunization at this time and until further guidance is received from NACI. The list of accepted
vaccines may expand in the future.
Vaccines not currently accepted for fully vaccinated status in Canada:
• Bharat Biotech (Covaxin, BBV152 A, B, C)
• Cansino (Convidecia, Ad5-nCoV)
• Gamalaya (Sputnik V, Gam-Covid-Vac)
July 23, 2021 5New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
• Sinopharm (BBIBP-CorV, Sinopharm-Wuhan)
• Sinovac (CoronaVac, PiCoVacc)
• Vector Institute (EpiVacCorona)
• Other
Individuals who received an incomplete series with a non-Health Canada approved vaccine (i.e.
one dose in a two-dose series) will be advised of the risks versus benefits and offered full
revaccination with a new COVID-19 vaccine through the publicly funded NB immunization
program.
7.0. VACCINE INTERCHANGEABILITY
The Public Health Agency of Canada released a Summary of the Rapid Response, on June 1st,
2021, with updated recommendations from the National Advisory Committee on Immunization
(NACI) on the interchangeability of authorized COVID-19 vaccines (also referred to as ‘mixed
vaccine schedules’). These recommendations are based on current scientific evidence and
NACI’s expert opinion.
mRNA COVID-19 vaccine
For those who have received an mRNA COVID-19 vaccine as a first dose, an authorized mRNA
COVID-19 vaccine (Pfizer-BioNTech or Moderna) for that age group will be offered as a second
dose.
AstraZeneca/COVISHIELD COVID-19 vaccine
For those who received mRNA COVID-19 vaccine as a first dose, an authorized mRNA
vaccine for that age group will be offered as a second dose.
For those who received AstraZeneca/COVISHIELD COVID-19 vaccine as a first dose
regardless if they are under 55 years or 55 years and older, an mRNA COVID-19 vaccine will be
offered for the second dose. Only offer an AstraZeneca/COVISHIELD COVID-19 vaccine if an
individual refuse a mRNA vaccine or if a mRNA vaccine is contraindicated.
For all second doses, if the individual chooses a different vaccine for the second dose, the
previous dose should be counted, and the series not be restarted. The individual is considered
fully vaccinated.
Differently manufactured AstraZeneca/COVISHIELD vaccine products are comparable and
interchangeable by Health Canada. This means, one AstraZeneca product can be given as a first
dose and another AstraZeneca product be given as a second dose. See product monographs.
8.0. NB RECOMMENDED INTERVAL FOR COVID-19 VACCINES APPROVED BY HEALTH
CANADA
As per NACI, the second dose of vaccine should be administered at least 28 days apart. On March
3rd, 2021, NACI released a new statement - Rapid Response: Extended dose intervals for
COVID-19 vaccines to optimize early vaccine rollout and population protection in Canada. By
6 July 23, 2021New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
implementing an extended four-month (16 weeks) interval strategy. 1
NB’s Current N.B.’s Maximum
Dose 1 Dose 2 Interval as of June Vaccine Dose
21, 2021 Interval
Pfizer Pfizer 28 Days 14 weeks
Moderna Moderna 28 Days 14 weeks
Pfizer Moderna 28 Days 14 weeks
Moderna Pfizer 28 Days 14 weeks
AstraZeneca/
Moderna 28 days 14 weeks
COVISHIELD
AstraZeneca/
Pfizer 28 days 14 weeks
COVISHIELD
AstraZeneca/ AstraZeneca/
8 Weeks 14 weeks
COVISHIELD COVISHIELD
Note:
• As per the Product Monograph, the minimum interval between 1st and 2nd doses of the Pfizer-
BioNTech vaccine is 19 Days for a valid dose. However, New Brunswick prefers that a
minimum interval of 21 days between mRNA vaccines.
• If dose one is an mRNA product, the second dose must be another mRNA product.
• There is no grace period for the validity of the minimal intervals.
• For more information on NB’s vaccine roll out plan, visit the GNB website vaccine section.
9.0. CONTRAINDICATIONS AND PRECAUTIONS
Healthcare providers at the clinic should also be consulted if the client has contraindications to
immunization or medical questions. NACI provides Recommendations on the use of COVID-19
Vaccines which includes contraindications and precautions. Please refer to Appendix A for a
companion document that can be used with the Product Monograph for contraindication and
precaution recommendations in a clinic setting.
10.0. ANAPHYLAXIS MANAGEMENT
Anaphylaxis is a serious, potentially life-threatening allergic reaction to foreign antigens; it has
been proven to be causally associated with vaccines with an estimated frequency of 1.3 episodes
per million doses of vaccine administered. Anaphylaxis is often preventable and should be
anticipated in every vaccine. Those administering vaccines must have protocols in place that
include prevention, early recognition and treatment; as well as documentation of severe allergic
reactions and anaphylaxis.
1 Refer to GNB’s Memo on Extended COVID-19 vaccine Interval and NACI’s Recommended immunization schedule
for COVID-19 vaccine and Recommendations on the use of COVID-19 vaccines - Canada.ca
July 23, 2021 7New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
Prevention of anaphylaxis is critically important. Pre-vaccination assessment includes screening
for a history of anaphylaxis post-vaccination, a serious adverse event following a dose of a
COVID-19 vaccine and/or identification of potential high-risk factors. The assessment should
include questions about possible allergy to any component or container of the scheduled
vaccine(s) in order to identify if there is a contraindication to administration.
Anaphylaxis Contraindication
The National Advisory Committee on Immunization (NACI) provides Recommendations
on the use of COVID-19 vaccines. Table 4 lists potential non-medicinal ingredients in
authorized COVID-19 vaccines that have been associated with allergic reactions in other
products.
For a comprehensive list of components in the vaccine and packaging, please consult the
product leaflet or information contained within the product monograph available through
Health Canada's Drug Product Database.
Clients with a history of anaphylaxis post-immunization or who have had an allergic
reaction to any component in any of the COVID vaccines, should consult with their
healthcare provider for a risk assessment prior to being immunized. Refer to
Contraindications, Precautions and Concerns in the CIG, Part 2 - Vaccine Safety for
additional general information.
Anaphylaxis Planning Principles
For situations in which the risk of severe reaction is high, the primary care provider should
conduct a risk assessment to deem if the benefits outweigh the potential risks for the
individual. The primary care provider should consult with the Regional Medical Officer of
Health with any questions. When an individual has experienced an adverse event from
their first dose of the COVID-19 vaccine and an AEFI was completed, the Medical Officer
of Health will provide advice for the second dose. The Medical Officer of Health may
recommend that the second dose be provided in a controlled setting.
If vaccination is advised in a controlled setting and informed consent is provided, the
healthcare provider should collaborate with relative partners within the Regional Health
Authority (RHA) to plan for immunization of the client. Local Public Health office in Horizon
and Vitalité will arrange immunization in a location where advanced medical care can be
promptly provided (i.e. a hospital setting). The process for immunization may vary by
region.
Careful planning for vaccination in a critical care setting should include measures that
mitigate vaccine wastage. To ensure there is no vaccine wastage, immunizers should
ensure the number of individuals to be vaccinated are equal to the number of doses
provided in a vile, i.e. arranging a micro-clinic to immunize a group of high risk people or
a mix of high risk individuals with those that are not high-risk and meet eligibility criteria.
The immunizer should also have a contingency plan for unexpected interruption or delay,
i.e. weather event or a no-show, that may contribute to vaccine wastage.
The immunizer who is an expert in immunization should verify the client’s two identifiers,
review health status, provide information about the vaccine to be given and obtain the
client’s consent as per standards in the New Brunswick Immunization Program Guide.
Most instances of anaphylaxis to a vaccine begin within 30 minutes after administration of
8 July 23, 2021New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
the vaccine. Therefore, if vaccination is advised, an extended period of observation post-
vaccination of at least 30 minutes should be provided.
Should anaphylaxis post-immunization to a COVID-19 vaccine occur, protocols for
treatment and management of anaphylaxis in the primary care setting must be followed
and an Adverse Event Following Immunization (AEFI) completed. For a multi-series
vaccine, the Regional Medical Officer of Health is to advise whether another dose is
advised.
Medical Directive for Obtaining Consent, Administering Vaccine and to
Manage Anaphylaxis
In some clinic settings, a medical directive may be needed. A medical directive is a written
order that pertains to any client who meets the criteria outlined in the medical directive. It
allows a healthcare provider authorized to perform a controlled act (e.g., immunization,
administration of epinephrine) to delegate the performance of that act to another
healthcare provider or group of healthcare providers. For more information, please refer
to the Medical Directive for the Provision of Immunization Services.
Management of Anaphylaxis
All healthcare providers administering vaccines must be familiar with the anaphylaxis
protocols for their clinic sites, which includes the use of appropriate medications. The
guidelines may be accompanied by a dosage sheet in the event of an anaphylactic
reaction, which summarizes the dosage according to age and weight for the various drugs.
See the Protocol for Management for Immunization-Related Anaphylaxis in Non-Hospital
Settings which is found on the New-Brunswick Immunization Program Guide (NBIPG)
online under Appendices 5.1. In all clinic settings immunizers must also follow their
employers’ policies related to anaphylaxis management.
11.0. VACCINATION POST COVID-19 INFECTION
There are many studies underway to better understand the antibody response after a COVID-19
infection. For those who are experiencing COVID-19 symptoms and/or have a confirmed COVID-
19 infection, vaccination with a COVID-19 vaccine is recommended once symptoms are resolved
and cleared by Public Health.
12.0. CONSENT FOR SECOND DOSES
Clinic leadership will need to be established to provide overall management, planning and
organization of clinic operations for successful second dose clinics. When vaccine recipients
return for their second dose, it is important that the informed consent process is in place. This
includes reviewing vaccine information with any updated information and providing time for clients’
questions. It should also include a review of the consent form. Sections 2 and 3 of the consent
forms consists of a pre-vaccine assessment which is to be conducted at each immunization dose
encounter. Since most COVID-19 vaccines require a second dose, it I important to make it as
easy as possible for the client to receive the second dose.
July 23, 2021 9New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
Procedure
All clients should provide to the immunizer a signed immunization record that includes the
date and the vaccine they received.
For RHA’s:
• Review the client’s documentation of first dose. If the client has an immunization sheet,
review it. The interval between doses should be reviewed to ensure the appropriate time has
lapsed; the vaccine type should also be reviewed. Please see guidance in section 2.9 on
Vaccine Interchangeability. If the client has no immunization record and there is no evidence
of a first dose administration documented in PHIS, then the client should be considered un-
immunized and a first dose offered.
• Review vaccine information. Review the pre-information vaccine sheet thoroughly with the
client. For best practice and informed consent, ensure the client is aware of the most up to
date information and is allowed time to ask questions.
• Obtain a new consent for the second dose (unless you have access to the original consent
form). This will ensure the pre-vaccine assessment is complete. The client and the immunizer
are to sign the new consent form. After consent is obtained, document the second dose and
provide the immunization record (either a new record or a previous record with the
documented first dose) to the client.
For Pharmacies:
• Review the client’s documentation of first dose. If the client has an immunization sheet,
review it. The interval between doses should be reviewed to ensure the appropriate time has
lapsed; the vaccine type should also be reviewed. Please see guidance in section 2.9 on
Vaccine Interchangeability. If the client has no immunization record, ask where the first dose
was given. If the client’s first dose was given at another pharmacy, a record of that
administration should be available in DIS. If there is no evidence of a first dose is available in
DIS, Horizon or Vitalité has access to all COVID-19 immunizations done in N.B. Advise the
client to go to a Horizon or Vitalité clinic for the second dose.
• Review vaccine information. Review the pre-information vaccine sheet thoroughly with the
client. For best practice and informed consent, ensure the client is aware of the most up to
date information and is allowed time to ask questions.
• Obtain a new consent for the second dose (unless you have access to the original
consent form). This will ensure the pre-vaccine assessment is complete. The client and the
immunizer are to sign consent form for second dose. After consent is obtained, document the
second dose and provide the immunization record (either a new record or a previous record
with the documented first dose) to the client.
13.0. REPORTING ADMINISTERED DOSES
All administered doses must be recorded in the Public Health Information System (PHIS) on the
day of administration.
10 July 23, 2021New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
RHA Led Clinics:
Immunizers in RHA led clinics are to enter the information directly into the Public Health
Information Solution (PHIS) or to send to the PHIS Data entry team to enter. The information
entered into PHIS includes the agent administered, the date of administration, the lot number and
expiry date with all other relevant information. Please remember these key points when adding a
COVID-19 immunization in PHIS:
• Perform a thorough search when attempting to locate a client in PHIS. When the contents on
the consent form do not match the PHIS search result, send the consent form to
COVIDDataEntry@gnb.ca for further investigation.
• When searching by Medicare number and a different client name is displayed in the search
results, DO NOT overwrite that name. Create a new client record OR send the consent form
to COVIDDataEntry@gnb.ca
• When entering an immunization record and a similar record already exists that you are not
sure is correct, send the consent form to COVIDDataEntry@gnb.ca.
The COVID Data Entry team is dedicated to assist with entering COVID-19 immunizations into
PHIS. The main goal is to have the most accurate and up-to-date data in the system. Please refer
to COVID Data Entry FAQs v0.5.
Community Pharmacy Clinics:
Immunizations in community pharmacy clinics will be captured using the drug dispense message
transmitted to the DIS from the local pharmacy information system (PIS). DIS does not capture
lot number and expiry date and therefore, is not captured in PHIS. Staff investigating AEFIs have
been trained to start with the PHIS record and to reach out to the administering pharmacy to
capture additional details including lot number and route of administration as part of any
investigation.
In exceptional circumstances, if the date of entry is later than actual day of administration, the drug
dispense date must be adjusted. This may require “back dating” the dispense date in the pharmacy
information system.
New Brunswick residents without a Health Card Number (HCN) such as NB Medicare, other HCN
issued out of province, or a federally administered identifier (Veterans Affairs, RCMP, National
Insured Health Benefits, etc.) are eligible to receive a COVID-19 vaccine. Clients may be added
to the local pharmacy system and synchronized to the NB Client Registry/DIS, leaving the HCN
field blank but providing the minimum data set (first name/last name, date of birth, current address
with postal code, and phone number). EXCEPTION –Jean Coutu Pharmacy locations must enter
the word MISSING or ABSENT to indicate no HCN and provide the minimum data set.
Pharmacies are required to identify the following groups within their Pharmacy management
system for provincial reporting purposes: Rotational Workers, NB Truckers, Frequent Border
Crossers and Pregnant persons. To identify receipt of vaccine for rotational workers, NB
Truckers and Frequent Border Crossers, please enter the appropriate code into the SIG field of
your pharmacy management system. This will send the information to DIS during prescription
entry for the vaccine. For the process to identify pregnant persons, please follow the direction
provided by your pharmacy information system vendor.
July 23, 2021 11New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
Group Code for SIG Field
NB Trucker CVTR
Frequent Border Crosser CVBC
Rotational Worker CVRW
14.0. VACCINE ELIGIBILITY AND PAYMENT FOR SERVICES
COVID-19 vaccination is a publicly funded program. Any individual living in N.B. during the
pandemic is eligible to receive the COVID-19 vaccine for free. This includes Canadian citizens,
permanent residents, temporary visitors or international students. Proof of residency, a minimum
stay in the province, or a N.B. Medicare card is not required.
Community Pharmacy Clinics:
Claims for payment are to be submitted as required under the New Brunswick Prescription Drug
Program (NBPDP) Plan “I”. For individuals from out-of-province temporarily residing in New
Brunswick and who have not been issued a NB Medicare number, enter “999 999 999” in place
of the Medicare number.
15.0. COVID-19 VACCINE ERRORS
Vaccine Error Prevention
A vaccine administration error is any preventable event that may cause or lead to
inappropriate use of vaccine or client harm.
Immunizers can develop competency in vaccine safety by:
• integrating knowledge about the COVID-19 vaccine, including its development and
evaluation into their practice
• providing evidence-based information on the benefits and risks of vaccines.
• implementing the information provided in the product monograph.
• integrating recommendations provided by the National Advisory Committee on
Immunization and the province
• implementing the “6 Rights” and applying the National guidelines for immunization
practices: Canadian Immunization Guide
• anticipating, identifying, reporting and managing vaccine errors and AEFI as
appropriate to their practice setting.
Immunizers should recall the “6 Rights” when administering COVID-19 vaccines.
Examples include:
Right Client Authorized age group
Right Medication Same vaccine for both doses
Right Route Deltoid muscle (preferred) or Anterolateral thigh
Right Dosage Authorized dose volume
Right Time Recommended dose interval and timing of other vaccines
Right Documentation Consent, Client immunization Record and Data Entry
12 July 23, 2021New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
Due to the variety of COVID-19 vaccines that are available globally and in Canada, it is
important for immunizers to verify with their clients if they have received any doses of a
COVID-19 vaccine. When a client comes for a second dose, the immunizer must verify
the information on the client’s record of immunization, review the contents of the product
information sheet with the client and obtain another consent to ensure that the client is
given the right vaccine at the right time. If a client presents to the clinic without a record
of immunization, immunizers (depending on the practice setting) must check either DIS
or PHIS for a record. If a record is not found, the client should be directed to receive the
second dose of the COVID-19 vaccine from the same provider that provided the first dose
(whenever possible).
Inadvertent Vaccine Administration Errors
COVID-19 vaccines that are administered in a manner that differs from the
recommendations of the manufacturer and/or the National Advisory Committee on
Immunization (NACI) is referred to as vaccine administration errors. This document builds
on guidance developed by CDC’s Interim Clinical Considerations for Use of COVID-19
Vaccines Currently Authorized in the United States and the guidance developed by Public
Health Ontario, with input from the Canadian Immunization Committee and the National
Advisory Committee on Immunization.
There is limited evidence to guide the management of these situations. This document
provides guidance only. Provincial / territorial protocols may differ from this
guidance document and clinical judgement in particular situations may also result
in different management decisions than outlined below.
This document is to be used only to manage errors that have already occurred. The
product monograph and recommendation from the National Advisory Committee on
Immunization should be followed when administering COVID-19 vaccines.
Steps to be taken after an error is recognized
Following the identification of an inadvertent vaccine administration error, healthcare
providers should:
• Inform the recipient of the vaccine administration error as soon as possible after it is
identified. The recipient should be informed of any implications/ recommendations for
future doses, and possibility for local or systemic reactions and impact on the
effectiveness of the vaccine (if applicable and as known). If the client is under the care
of a healthcare provider, the healthcare provider should be notified as well.
• Report all errors or near miss incidents in accordance with the employers’ medication
error and/or professional regulatory body’s required quality management system.
Errors are also to be reported to the Canadian Medication Incident Reporting and
Prevention System (CMIRPS).
• If an inadvertent vaccine administration error results in an adverse event following
immunization (AEFI), complete the jurisdiction’s AEFI form and submit it to the local
public health authority. Information on AEFI reporting is provided here.
• Determine how the vaccine administration error occurred and implement strategies to
prevent it from happening again.
• Serologic testing to assess vaccine-induced immunity following COVID-19 vaccine
errors to guide management decisions is generally not recommended. Providers are
July 23, 2021 13New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
encouraged to contact their local public health authority for advice if considering using
serology to investigate an error.
• Additional resources on vaccine administration practices can be found in the Canadian
Immunization Guide.
Guidance for Vaccine Administration Errors
Interim guidance on how to
Type Administration error consider the dose and
recommended action
Site/route • Incorrect site (i.e., site other • Consider this a valid dose.
than the deltoid muscle • Inform the recipient of the error
[preferred site] or and the potential for local and
anterolateral thigh [alternate systemic adverse events and
site]) that the dose is considered
acceptable.
• Incorrect route (e.g., • Consider this a valid dose.
subcutaneous) • Inform the recipient of the error
and potential for local and
systemic adverse events and
that the dose is considered
acceptable.
Age • Use at a younger age than Pfizer-BioNTech vaccine:
authorized by Health Canada • Consider this a valid dose.
and/or recommended by • Give the second dose at the
NACI recommended interval for your
jurisdiction if the client is at
least 12 years of age or when
authorized for the client’s age
(if authorization is extended to
below 12 years of age).
Moderna vaccine:
• Consider this a valid dose.
• Give second dose at the
recommended interval for your
jurisdiction if the client is at
least 16 years of age or when
authorized for the client’s age
(if authorization extended to
below 16 years of age).
AstraZeneca/COVISHIELD
vaccines:
• Consider this a valid dose.
• Do not give a second dose at
this time. Await NACI
recommendations.
14 July 23, 2021New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
Interim guidance on how to
Type Administration error consider the dose and
recommended action
Co- • COVID-19 vaccine dose • Both the COVID-19 and the
administration administered on the same other vaccine are considered
day, or 28 days before or 14 valid.
days after another vaccine
(i.e., a non-COVID-19
vaccine) unauthorized by a
healthcare provider or
specialist (i.e. vaccine for
prophylaxis, allergy serum or
biologics.)
• Two doses of a COVID-19 • Inform the recipient of the
Intervals too close together in time potential for local and systemic
(including on the same day) adverse events.
• If the second dose of Pfizer
was administered 19 or more
days after the first dose of
Pfizer, consider both doses
valid and the series complete.
• If the second dose of Moderna
was administered 21 or more
days after the first dose of
Moderna, consider both doses
and the series complete.
• If the second dose of a mRNA
vaccine is different than the
first dose of mRNA vaccine
given and was administered 21
or more days, consider both
doses valid and the series
complete.
• For AstraZeneca, if the second
dose given was an mRNA
vaccine and was administered
more than 28 days after the
first dose, consider the second
dose valid and the series
complete.
• When the above minimal
interval is not met, the dose is
considered invalid. Repeat a
dose at the recommended
interval for N.B. (counting from
the date of the invalid dose). If
a significant local or systemic
reaction from the invalid dose
occurs, consult an
allergist/immunologist before
repeating. When repeating
the dose, inform the recipient
July 23, 2021 15New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
Interim guidance on how to
Type Administration error consider the dose and
recommended action
of the potential for local and
systemic adverse events.
• Second dose administered • If administration of the second
later than the NACI extended dose of a COVID-19 vaccine is
interval (i.e. more than 4 delayed beyond 4 months, the
months after the first dose) second dose should be
provided as soon as possible.
No further doses are required.
Mixed vaccines • A different vaccine used for • Consider both doses valid
for first and the first and second dose regardless of the type of
second doses vaccine used for the first and
second doses. The vaccine
series is considered complete*.
Dosage • Higher-than-authorized dose • Consider this dose valid.
(see Diluent volume administered • Inform the recipient of the
section below potential for local and systemic
for specific adverse events**
information
regarding Pfizer- • Lower-than-authorized dose • If less than a full dose is
BioNTech and volume administered (e.g. administered, consider it
the diluent) leaked out, equipment invalid.
failure, recipient pulled away) • Administer a full repeat dose
immediately in the opposite
arm. Inform the recipient of the
potential for local and systemic
adverse events**
• Correct amount of diluent • As long as the correct dosage
added, but more or less than drawn up per dose (and the
the authorized number of correct amount of diluent was
doses obtained from the vial. used, if applicable) the doses
are considered valid.
Storage and • Dose administered after • Contact the manufacturer for
Handling improper storage and guidance. If the manufacturer
handling (e.g., temperature provides information
excursion) suggesting the dose should be
considered invalid and if that
seems appropriate based on
clinical judgement, a repeated
dose may be given as soon as
possible in the opposite arm.
Inform the recipient of the
potential for local and systemic
adverse events. **
16 July 23, 2021New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
Interim guidance on how to
Type Administration error consider the dose and
recommended action
• Dose administered past the • Contact the manufacturer for
expiration/beyond use date guidance. If the manufacturer
provides information
suggesting that the dose
should be considered invalid
and if that seems appropriate
based on clinical judgement, a
repeated dose may be given
as soon as possible in the
opposite arm. Inform the
recipient of the potential for
local and systemic adverse
events.**
Diluent (Pfizer- • Incorrect diluent type (e.g., • Contact the manufacturer for
BioNTech only) sterile water, bacteriostatic guidance. If the manufacturer
0.9% NS) provides information
suggesting that the dose be
considered invalid and if that
seems appropriate based on
clinical judgement, a repeated
dose may be given as soon as
possible in the opposite arm.
Inform the recipient of the
potential for local and systemic
adverse events.**
• ONLY diluent administered • Inform the recipient that no
(i.e., sterile 0.9% sodium vaccine was administered.
chloride) Administer the authorized
(appropriately diluted) dose as
soon as possible in the
opposite arm.
• Too much diluent • If more than 2.0 mls of diluent
administered (more than 2.0 added, consider this an invalid
mls of diluent) (based on 0.3 dose.
ml dose administered) • Administer a full repeat dose
immediately in the opposite
arm. Inform the recipient of the
potential for local and systemic
adverse events.**
• No diluent or less than the • Consider this dose valid.
recommended diluent, • Inform the recipient of the
resulting in higher than the potential for local and systemic
authorized dose (based on adverse events.**
0.3 ml dose administered)
* Note that this recommendation currently only applies to vaccines authorized for use in Canada. Guidance on
vaccines not authorized for use. In Canada is pending. Refer to NACI Rapid Response: Interchangeability of
Authorized COVID-19 Vaccines.
July 23, 2021 17New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
** If the client requires a final dose to complete the series, follow the recommendations of your jurisdiction as
per the timing of the last dose after the previous dose (whether it was valid or not). The client should be advised
regarding the potential for local and systemic adverse events following the final dose. If the client who requires
a final dose has developed a significant local or systemic reaction from an earlier dose, the decision to
administer the final dose should be assessed on a case-by-case basis in consultation with an
allergist/immunologist.
16.0. ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI)
An AEFI is any medical occurrence in a vaccine that follows immunization which does not
necessarily have a causal relationship with the administration of the vaccine. The adverse event
may be any unfavorable and/or unintended sign, abnormal laboratory finding, symptom or
disease (Health Canada).
Side Effects Post COVID-19 Vaccination
Most side effects following immunization with a COVID-19 vaccine are considered mild to
moderate and on average do not last more than three days. For common and expected
side effects following a COVID-19 vaccine immunization, please refer to the specific
COVID-19 manufacturer product monograph, the pre-vaccine information sheet and/or
the aftercare sheet.
Those administering vaccines should ensure that the vaccine recipients or their
parents/guardians are advised to notify clinic staff, or if they have left the clinic, call their
doctor/nurse practitioner or go to the nearest hospital emergency department if they
develop any serious side-effects or common side-effects that last longer than 72 hours
after vaccination. The healthcare provider will do an assessment and provide medical
advice. If the healthcare provider thinks the symptoms are related to the vaccine that was
given an AEFI is to be completed.
COVID-19 Vaccine Delayed Onset Rash
Incidents of a delayed rash onset post immunization with mRNA vaccines has been widely
reported. These rashes are mild and have been observed more frequently following
immunization with a Moderna vaccine. Some reported rashes developed soon after
vaccination, while others have arisen up to 14 days after. Rashes that required medical
intervention or treatment are considered reportable and require an AEFI. When reporting
these rashes, the temporal criteria specified in the Appendix 5.0 Summary of Reporting
Criteria, located in the New- Brunswick Immunization Program Guide (NBPIG), a rash is
reportable between 0-7 days following an inactivated vaccine.
The Public Health Agency of Canada (PHAC) is currently reviewing the national reporting
guidelines on COVID-19 Adverse Events, including temporal criteria for rashes with a
delayed onset. PHAC will be issuing an updated AEFI reporting user guide that will include
a COVID-19 specific annex. Until this review is finalized at the Federal level, Public Health
NB is accepting a notifiable time limit for rashes following COVID-19 vaccines for up to 14
days.
Vaccine Induced Thrombotic Thrombocytopenia (VITT)
Incidents of a rare, catastrophic side-effect known as Vaccine Induced Thrombotic
Thrombocytopenia (VITT) has been reported within 6 weeks of vaccination with a viral
18 July 23, 2021New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers
vector vaccine (like AstraZeneca/COVISHIELD). Those administering vaccines should
ensure that the vaccine recipients are to seek immediate medical attention if any of the
following symptoms develop: shortness of breath; chest pain; arm or leg swelling or
discoloration; persistent abdominal pain; sudden onset of severe or persistent worsening
headaches or blurred vision; tiny red or purple spots on the skin, resembling bruises (other
than the site of vaccination. This event is considered a serious AEFI and must be reported
verbally and in writing within one working day.
Myocarditis/Pericarditis
In Canada, there have been a small number of reports of pericarditis or myocarditis
following vaccination with a COVID-19 mRNA vaccine. Myocarditis (inflammation of the
heart muscle) and pericarditis (inflammation of the lining around the heart) following
vaccination with COVID-19 mRNA vaccines has also been reported internationally. In
Israel and the United States, the association between myocarditis and pericarditis is mainly
being noted in younger men (generally under 30 years of age) after the second dose of a
mRNA vaccine typically after the manufacturer-authorized dosing interval. Cases of
myocarditis and pericarditis reported after receipt of COVID-19 mRNA vaccines have been
generally mild and the majority of cases with documented follow-up have resolved. The
information from ongoing international surveillance and investigations thus far indicates
that they have occurred:
• More commonly after the second dose
• Usually within 4-7 days after vaccination
• Mainly in older adolescent and young adults
• More often in males compared to females.
NACI is now recommending the following:
• NACI continues to recommend a two-dose mRNA vaccine schedule for adults and
adolescents, with the interval for adolescents being the same for adults.
• Informed consent for people receiving an mRNA vaccine should include a discussion
about the very rare risk of myocarditis and/or pericarditis following immunization.
• As a precaution, NACI recommends that individuals who experienced myocarditis
and/or pericarditis after a first dose of an mRNA vaccine should wait to get their second
dose until more information is available
Healthcare providers should consider myocarditis and pericarditis in evaluation of acute
chest pain or pressure, arrhythmias, shortness of breath or other clinically compatible
symptoms after vaccination. Please see Communique to Health Practitioners: Reports of
Myocarditis/Pericarditis after COVID-19 vaccination (June 3, 2021) for more information
about diagnosis and reporting.
Capillary Leak Syndrome (CLS)
Very rare cases of capillary leak syndrome (CLS) have been reported following
immunization with the AstraZeneca COVID-19 vaccine. Some affected patients had a
previous diagnosis of CLS. CLS is a serious, potentially fatal condition characterized by
acute episodes of limb edema, hypotension, hemoconcentration and hypoalbuminemia.
Individuals with a history of CLS should not receive the AstraZeneca/COVISHIELD
COVID-19 vaccine.
Vaccine Injury Support Program (VISP)
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