Planning guidance for administration of COVID-19 vaccine
Introduction
Immunizing all Canadians with COVID-19 vaccine in a timely way will be a major challenge. In support of this massive undertaking, the Public Health Agency of Canada (PHAC) has developed planning guidance for the administration of COVID-19 vaccine. The primary audiences for this guidance are the federal/provincial/territorial (FPT) governments, Indigenous leadership and public health authorities, although the guidance should also be of use to regional and local health authorities, health professional associations, and others involved in COVID-19 vaccine deployment and program implementation.
The goal of Canada's COVID-19 immunization response is to enable as many Canadians as possible to be immunized against COVID-19 as quickly as possible, while ensuring that high-risk populations are prioritized. 
Provinces and territories (PTs) are responsible for administering COVID-19 vaccine to their residents; however, there are also some federal departments (e.g., Department of National Defence, Global Affairs Canada, Correctional Services Canada and Indigenous Services Canada) that provide health services, including immunizations, directly to specific populations. All jurisdictions will work together with partners from many sectors, experts, Indigenous leaders and other Canadians:
- To provide safe and effective vaccines as quickly as possible to all who want them;
- To allocate, distribute and administer vaccines as efficiently, equitably and effectively as possible; and
- To monitor the safety, coverage and effectiveness of COVID-19 vaccine.
The term Canadians is intended to be interpreted broadly. It refers to everyone in Canada, whether or not they are citizens, as well as Canada-based staff and their dependents and locally engaged staff at Canadian missions abroad, and Canadian active duty personnel (Canadian Forces) abroad.
General considerations
There will be many challenges in planning for the administration of COVID-19 vaccine. These include uncertainties around product availability in terms of timelines and quantities, and the need to deal with multiple products with differing presentations, number of doses needed, storage requirements and potentially even different indications for use. The extreme storage and handling requirements of the two vaccine candidates that are expected to be available first will be particularly challenging. All jurisdictions and vaccine providers will need to keep their plans flexible to deal with these uncertainties and changing circumstances as the immunization response rolls out.
Existing immunization programs and prior experience with mass campaigns including the 2009 pandemic provide a strong basis for meeting the challenges involved with administering COVID-19 vaccine. The use of established practices and systems whenever possible to distribute and administer COVID-19 vaccine and monitor adverse reactions and vaccine effectiveness will support the success of the COVID-19 immunization response.
It is recommended that each jurisdiction build on its seasonal influenza immunization strategies, using tailored approaches to deal with the unique needs of key populations, diverse settings and vulnerable populations. Language, age, ability, sex, gender, culture, race and ethnicity, and religious beliefs are aspects of Canada's diversity that may affect the delivery and uptake of vaccine in each jurisdiction.
Specific planning considerations are recommended to identify and address the unique needs of each jurisdiction's populations and communities, to ensure access to COVID-19 vaccine. PTs should collaborate with Indigenous leadership in planning and carrying out the distribution of vaccine to Indigenous populations, including remote and isolated communities.
Vaccine distribution, storage and handling
The manufacturers and Health Canada will provide early estimates of when COVID-19 vaccine will be available and in what quantities. These estimates may be subject to considerable change during the manufacturing and regulatory processes.
A National Operations Centre has been established to manage the logistics of vaccine distribution and tracking across Canada. Distribution of COVID-19 vaccine to the FPT jurisdictions will begin as soon as vaccine is authorized for use and is available from the manufacturer. Amounts to be allocated to PTs and federal departments will follow principles for equitable allocation. Vaccine for second doses will be allocated at the same time as the first dose quantities to ensure that there is sufficient quantity available for the second dose at the appropriate interval after the first dose.

# Vaccine storage and handling
Strict attention must be paid to maintaining cold chain requirements when vaccine is being transported, distributed and stored. Two of the potential vaccine candidates require specialized frozen transport and storage, which will represent some significant logistical challenges in Canada. In this case, stability data will be used to determine how long these vaccines are refrigerator stable after thawing and if they can be transported in the thawed state. These constraints could impact how PTs manage and distribute the vaccine (e.g., need for more frequent, smaller shipments from depots capable of storing and transporting frozen product).
Detailed advice and training materials on storage and handling of the COVID-19 vaccines anticipated for use in Canada will be provided by the manufacturers, and guidelines for safe transport, storage and handling will be updated by PHAC. Jurisdictions should ensure that appropriate cold chain procedures, equipment and capacity are in place by confirming adequate vaccine storage space in purpose-built vaccine refrigerators (and/or freezers as required), management of dry ice in accordance with safe handling practices for hazardous materials, performing routine temperature monitoring and equipment maintenance, and reviewing procedures for transporting vaccine to off-site clinics. If vaccine is to be supplied to community practitioners and health care facilities, their storage and handling procedures should comply with public health requirements. Arrangements for the physical security of vaccine should be made for all stages of vaccine delivery and storage.
Packaging specifications for products are under development. All vaccines will be in multidose vials for the initial rollout. Vials per secondary carton may vary, in addition to packaging details for products with adjuvant (e.g., supplied in separate vials as was the case for H1N1 vaccine). Information on whether products can be repackaged into smaller units for distribution to vaccine providers who cannot manage larger package sizes will be provided when available.
Inventory management at all levels is essential to maximize available vaccine supplies and anticipate future needs. Accurate real-time knowledge of vaccine supply and inventory can allow for adjustments to vaccine shipments or clinic schedules as needed. The inventory system should be able to track vaccine lots so that if needed, specified lots can be put on hold or recalled. Vaccine bar coding could assist in this tracking process.
Recommendations for vaccine use
The National Advisory Committee on Immunization (NACI) will provide expert advice and guidance on the use of COVID-19 vaccines, including identifying key populations for early immunization which will inform vaccine allocation to PTs.  

# Vaccine recommendations
The NACI COVID-19 vaccine statement will be prepared as a living document and be updated as new vaccines or indications for use become available. Key sections in the recommendations will include populations for whom vaccine is particularly recommended, vaccine safety, products available for use, choice of vaccine products and vaccine administration, e.g., dosages and schedules based on clinical trials of the new products.
If passive immunizing agents emerge for prophylaxis, such as monoclonal antibodies or convalescent plasma, NACI will also consider guidance for these products.

# Recommendations on key populations for early immunization
It is anticipated that vaccine will become available in stages and initial quantities will be quite limited. To help planning for the equitable allocation and use of COVID-19 vaccine(s) when limited supplies necessitate recommendations for some groups to be immunized before others, NACI developed . This interim guidance has been subsequently updated  for details on the updated NACI recommendations and sequencing, see .
Sub-prioritization within these populations will be required in the context of vaccine supply limitations and will be carried out in collaboration with the Canadian Immunization Committee. As provinces and territories are responsible for COVID-19 vaccine delivery in their jurisdiction, they will make final decisions that best meet the needs of their respective populations.
Vaccine administration
In a pandemic, it is important to be able to administer vaccine as quickly as it becomes available. There were many challenges with this process during the 2009 H1N1 immunization campaign, especially in the initial management of priority populations when supplies were limited.
The Canadian Immunization Committee (CIC) and its subcommittees will provide advice on the implementation of the COVID-19 immunization response including vaccine administration, and a forum for FPT information sharing and troubleshooting.  

# Planning considerations
The efficient administration of COVID-19 vaccine can be based in large part on established practices such as seasonal influenza programs; however, modifications are needed in the context of COVID-19. These modifications include:
- Adaptions to usual immunization procedures in the presence of COVID-19 activity (e.g., screening; physical distancing; appropriate infection, prevention and control practices; and paperless processes);
- Taking measures to reduce crowding at immunization clinics (e.g., immunization by appointment) and considering other options in appropriate circumstances (e.g., outreach programs, drive-in or drive-through clinics in good weather);
- Using appropriate strategies to reach identified key populations, such as persons in long term care homes and other congregate living settings for seniors, health care workers (HCWs), persons at increased risk of severe illness and death from COVID-19, and Indigenous communities; and
- Maintaining flexibility to deal with unexpected changes in vaccine supply, delivery dates or recommendations.
It is anticipated that PTs will provide direction to regional and local health departments about the range of strategies to be used to provide COVID-19 vaccine to the public. Considerations include the capacity to store the vaccine properly and the need to minimize wastage, given that vaccine will be supplied in multidose vials without preservative.
Vaccines have traditionally been administered by public health nurses and/or by doctors and nurses in primary care; however, most provinces have now expanded pharmacists' scope of practice to include administration of vaccine. Other potential vaccine providers, such as paramedics, may also be needed to provide surge capacity or outreach for the administration of COVID-19 vaccine. PTs may wish to further expand the range of providers who can administer vaccine or to expand the scope of immunization practice of existing providers like pharmacists to additional routes of administration, age groups or settings.
Some additional planning considerations for the administration of COVID-19 vaccine include the following:
- It is anticipated that vaccine will become available in stages, and that there may be ongoing interruptions and changes to scheduled deliveries that will affect supply.
- Historical data from the 2009 influenza pandemic and seasonal influenza immunization campaigns may help jurisdictions estimate vaccine uptake, but uptake can be affected by many factors, especially public perceptions of pandemic impact and vaccine safety. Planning for an average upper limit of 75% vaccine uptake (as recommended in the ) should be adequate in most areas, but uptake may be higher in some jurisdictions and settings.
- Jurisdictions should plan to implement a two-dose program as required for most candidate vaccines. The second dose must be given within a certain time frame and with the same product. Vaccine recipients should be provided with information about how and when to get the second dose and consideration given to use of recall/reminder systems to promote their return.
- As more than one type of COVID-19 vaccine will be used in Canada, for purposes of monitoring safety and vaccine effectiveness, it is essential to record the specific products and vaccine lots supplied to jurisdictions and administered to individuals.
- Information systems are needed to track individual immunizations, including lot numbers, and provide second dose reminders to clients.
- PHAC will be developing fact sheets, informed consent materials and model medical directives for PT use to ensure consistency.
- Jurisdictions should recommend a standard approach to vaccine preparation (e.g., timing/mixing of adjuvant) and infection prevention and control measures with use of multidose vials.
- Jurisdictions should determine human resource requirements and be prepared to activate established mutual aid agreements for HCW surge capacity, if required.
- Staff that might be called upon to administer COVID-19 vaccine should be trained in advance and given opportunities to practise their skills.
- Planners should consider unique approaches for vaccine hesitant individuals in immunization communication strategies.
Detailed advice for planning immunization clinics can be found in the . This document also touches on alternate delivery methods that may be useful in special circumstances.

# Vulnerable and hard to reach populations
Immunization providers will have to reach vulnerable people who may have physical or mental disabilities or low literacy, as well as people who may experience a lack of mobility, homelessness or cultural or social isolation.
Useful strategies include:
- translating immunization materials into appropriate languages;
- having translators available at clinics;
- organizing rides to clinics or providing taxi chits or bus tickets;
- enlisting younger or multilingual family members to assist in communication;
- offering home visits if resources permit;
- holding immunization clinics at food banks or food lines, shelters or other places where vulnerable persons might gather (e.g., drop-in services, consumption treatment centres, pharmacies or clinics providing specific services); and
- working with outreach/mental health/social support case workers.

# Remote and isolated and Indigenous communities
Indigenous Services Canada (ISC) is working to ensure that remote and isolated and other Indigenous communities will have equitable access to COVID-19 vaccine once it is available. This is being done in collaboration with Indigenous partners, regional offices, provinces and territories, and PHAC. 
ISC is also working on guidance for immunization delivery and messaging and education for when vaccine is available. Resources such as *Planning Guidance for Vaccine Clinics during COVID-19 in Indigenous Communities- have been shared across their networks. 

# Ancillary immunization supplies
In preparation for the administration of COVID-19 vaccine, the Government of Canada is securing more than 75 million syringes, needles, alcohol swabs and other supplies (including gauze and sharps containers), enough to provide two doses of COVID-19 vaccine to every Canadian when vaccine is ready.
Monitoring vaccine safety, uptake and effectiveness
The scale of the COVID-19 immunization response warrants careful attention to vaccine safety to minimize risk and maximize the benefits of COVID-19 vaccine. Despite all the knowledge gained about a product pre-market, it is not possible to detect all adverse events following immunization (AEFIs) at that stage, especially if they are very rare. Rapid and continuous post-market vaccine safety surveillance is critical to capture all reports of serious and unexpected AEFIs for all vaccines authorized in Canada and to act on safety signals in a timely way.

# Mechanisms to support post-market vaccine safety surveillance
The approach to COVID-19 vaccine safety will leverage and build upon the infrastructure and systems already in place for monitoring seasonal influenza and other vaccines. Post-marketing surveillance for adverse events is undertaken by PHAC and HC in collaboration with PT partners and other key stakeholders, through the following mechanisms:
- The  is managed by PHAC and is an FPT post-market vaccine safety monitoring system that includes spontaneous, enhanced and active AEFI reporting processes. During the pandemic, this surveillance system will be used to receive AEFI reports from PTs for signal detection, analysis and reporting. Expedited AEFI surveillance will be carried out during and following the administration of COVID-19 vaccine to report aggregate counts of AEFIs on a weekly basis. This will allow PHAC to detect potential safety signals for further investigation sooner than with a standard passive surveillance system.
- The  is a paediatric, hospital-based network administered by the Canadian Paediatric Society. IMPACT conducts active, targeted syndromic surveillance for AEFI considered to be of special importance. All such AEFIs are reported to PHAC and local public health officials and are included in CAEFISS. During a large cale immunization campaign, additional selected diseases or surveillance targets may be added if a connection to vaccine is suspected. IMPACT also conducts national surveillance for vaccine failures and selected vaccine-preventable diseases in children.
AEFI reports must be quickly passed on to PHAC for collation into CAEFISS, with serious events given priority. A vaccine safety signal from AEFI reports could include a new and potentially causal association, or a new aspect of a known association. Safety signals are investigated so that the cause can be assessed and action taken if appropriate. Such actions may include updates to the product monograph, recall of a vaccine lot or revisions to vaccine recommendations or administration practices.

# External networks
Several external networks will also be engaged to monitor COVID-19 AEFIs and conduct special studies on COVID-19 vaccine safety and effectiveness. The  is a collaboration of leading vaccine researchers and institutions in Canada. CIRN networks that will be involved in COVID-19 vaccine safety initiatives include:
- The   CANVAS provides enhanced surveillance by assessing vaccine safety in various age groups immediately following the yearly launch of influenza vaccine campaigns. CANVAS processes can be applied to COVID-19 vaccines.
- The   This is a national network of expert clinicians across the country established to investigate and manage patients with AEFIs or underlying conditions that may be contraindications to immunization.

# Federal Provincial Territorial Vaccine Vigilance Working Group
The Vaccine Vigilance Working Group (VVWG) is a national safety committee that reports to the CIC. It has participants from all PTs and federal immunization programs together with IMPACT, Health Canada regulators and other representatives. The VVWG will play an important vaccine safety role during the COVID-19 immunization response by facilitating the development of guidelines, standards, protocols and best practices to improve FPT post market safety surveillance in Canada. It will share and rapidly disseminate information within the network and to appropriate stakeholders regarding vaccine safety issues or signals.
Measuring vaccine uptake as COVID-19 vaccine is being administered to Canadians allows public health authorities to determine if it is in line with expectations. If uptake is lower than expected, additional strategies or promotional efforts may be needed for specific key populations or in general. The results may also lead to adjustment of recommendations or of vaccine allocations to FPT jurisdictions.
At present, each PT maintains its own system for tracking immunization data using electronic databases or paper-based systems or a combination of both. To support the monitoring of real-time vaccine uptake, key data elements such as age, sex and risk groups should be determined and the relevant information collected from all vaccine recipients, including those immunized by non-public health providers. This information should be rapidly collated and analyzed. Immunization registry development should be actively pursued in jurisdictions without existing registries in order to support the data needs of the COVID-19 immunization response. In September 2020, PHAC offered funding to PTs for registry enhancement of their registries.
The FPT Canadian Immunization Registry and Coverage Network (CIRC), a CIC subcommittee, developed functional standards for immunization registries in 2019, which were endorsed by CIC. CIRC is therefore best positioned to develop data standards and facilitate the collection and sharing of available vaccine uptake reports from jurisdictions during the administration of COVID-19 vaccine. CIRC members have agreed to make weekly reports on the number of vaccine doses administered in their jurisdiction, broken down by recipients' age and gender, as well as the number of doses administered to the populations targeted for early immunization (e.g., long-term care residents, health care workers, Indigenous populations).
Planning is also underway for repeated monthly national coverage surveys through Statistics Canada to estimate PT coverage levels. The COVID-19 Vaccination Coverage Survey will supplement data from PT registries to gain information on knowledge, attitudes and beliefs about COVID-19 immunization among immunized and unimmunized persons, reasons for being immunized or not immunized and sociodemographic information such as ethnicity and Indigenous identity. 
Vaccine effectiveness measures how well a vaccine works when it is in general use in real-life circumstances (unlike the ideal circumstances of a clinical trial where vaccine efficacy is measured). Vaccine effectiveness is usually monitored by studies using a test-negative design; such studies have been used for years to measure the effectiveness of influenza vaccines in Canada. The  and the  of CIRN are well placed to provide similar information on the effectiveness of the COVID-19 vaccine. Special studies may also be conducted in selected populations.
Public and professional communication and engagement
Careful planning to ensure readiness of the general public and the health community for a COVID-19 vaccine should begin well in advance of vaccine availability. In dealing with the uncertainties surrounding a new vaccine, especially products that use a novel technology, early and effective communication is necessary to build trust, correct misinformation and overcome vaccine hesitancy. Maintaining confidence in the COVID-19 immunization program is a major challenge, and concerns and misinformation about COVID-19 vaccines are already beginning to circulate.
Public and professional communications proved to be one of the more challenging aspects of the 2009 influenza pandemic response. Improving communication strategies by applying lessons learned from this experience should result in increased public confidence that translates to higher immunization coverage. These relate to both content and use of effective communication strategies. Immunization information should be communicated in meaningful, culturally relevant and personal terms, and crowd out misinformation.
While all government levels are involved in immunization communications, messaging needs to be coordinated and consistent. Established FPT networks, including the Public Health Network Communications Group, are being used to coordinate the COVID-19 communications response, including immunization issues. The federal government is addressing the overall response and regulatory and safety issues. PTs will focus on the immunization response in their own jurisdiction and regional and local health departments will provide local details.
The communication strategy is being informed through ongoing behavioural research to better understand the knowledge, attitudes and beliefs and decision-making behaviours of Canadians regarding COVID-19 vaccine.  

# Public communication and engagement
The groundwork for public acceptance of COVID-19 vaccine needs to be laid well in advance of actual vaccine availability. All communication strategies should take into consideration the diverse communication needs of population groups based on ethnicity/culture, ability status, language, education/literacy, age and other factors. Both the risk of COVID-19 infection and the risks and benefits associated with immunization, including the contribution of individual immunization to herd immunity, should be communicated effectively. The process and rationale for immunizing people in stages as vaccine becomes available should be carefully explained so that persons eligible for early immunization do not feel like test subjects, and others understand that their turn will come.
Public interest in and concerns over vaccine safety will likely be significant. Provision of detailed information about vaccine regulation and safety monitoring is important and vaccine misinformation should be addressed quickly and aggressively. It is also important to plan for communications in the event of a vaccine safety signal that arises either outside or within Canada.
Multiple strategies, including traditional media, local and ethnic media and social media, should be used to provide immunization program information to engage a diverse audience. Tailored approaches will be needed for vulnerable populations, such as provision of information in multiple formats. Community leaders can be asked to convey accurate information and champion the immunization program. Involvement of stakeholders (e.g., Indigenous health and immigrant/refugee organizations) can help make communications materials and strategies more appropriate for the target audiences.
As vaccine becomes available, messaging about eligibility may be challenging as information is complex and subject to change. Communication should be clear that although the goal is to make vaccine available to all Canadians, it will become available in stages, requiring targeted distribution in a fair and equitable manner.

# Health care sector communication and engagement
Health care providers play a central role in encouraging COVID-19 immunization, especially if they have been immunized themselves or intend to do so. It is important to keep them well informed about the safety and effectiveness of the COVID-19 vaccines being used, so they can present a unified message of strong support from the health care community.
Outreach to health care providers should use trusted sources and networks, and timely updates should be provided, for example through webinars that are being developed on COVID-19 vaccines. Challenges include conveying the need for flexibility because vaccine recommendations may change over time as more information becomes available. Rationale should be provided for recommendations on key populations for early COVID-19 immunization and for differences from other countries (especially the USA). Any PT adaptation of national prioritization recommendations should be clearly explained to practitioners in that jurisdiction.
Engaging the health care sector requires collaboration between jurisdictions:
- FPT and professional association website information should include links to Government of Canada information on the COVID-19 vaccine, such as the regulatory process, vaccine safety, the current product information leaflet and national vaccine recommendations.
- PTs should provide information to vaccine providers within their jurisdiction about the plans for administration of COVID-19 vaccine, including any jurisdictional modifications to the response.
- Regional and local public health authorities can help to ensure that information and guidelines are disseminated to local HCWs and that these workers are provided with details of the local immunization response.