OPA’s Supplementary Frequently Asked Questions on the Administration of Publicly Funded COVID-19 Vaccines in Ontario Pharmacies

This FAQ is designed to complement the Ministry’s Executive Officer Notices and accompanying Questions and Answers documents and as such may not provide an exhaustive list of Questions and Answers. For more information, please consult the following:

Most Recent Updates:

  • Version 14.0 – July 12, 2021
    Pharmacy Participation – Questions 4 and 7 | Program Supplies – Questions 3, 4 and 6 | AstraZeneca COVID-19 Vaccine – Question 6 | Scheduling and Patient Eligibility – Questions 5, 6, 7, 8, 14 and 15 | Administration of Vaccine – Questions 4, 6, 7, 10, 13 and 14

Please note that information provided in this FAQ is subject to change as discussions with government are ongoing. We will continue to update this document as necessary and identify changes as they become available.

Pharmacy Participation

For the initial launch of the vaccination program in March 2021, 327 pharmacies in three public health units (Toronto, Windsor-Essex County and Kingston, Frontenac and Lennox & Addington) were selected to participate. As a result of the short turnaround time for onboarding, the Ministry had decided to select pharmacies from these public health units who were currently participating in the Universal Influenza Immunization Program (UIIP) as they would have already been inspected for cold chain management and approved by their local public health unit. Due to the overwhelming response from pharmacies who were ready and willing to help with vaccination efforts, OPA, the Neighbourhood Pharmacy Association of Canada (Neighbourhood Pharmacies) and the Ministry worked closely together to select stores based on an equitable process.

In total, 472 sites were submitted for consideration through a call for nominations that was shared through OPA’s Owners Advisory Council and Board of Directors and with members of the Neighbourhood Pharmacies. These sites consisted of 321 corporate and 151 independent/banner pharmacies. A systematic methodology was applied to the selection of participating sites including ensuring equitable representation from both corporate and independent/banner pharmacies as well as utilizing influenza vaccine administration claims data obtained from the Ministry for the 2019/2020 and 2020/2021 flu seasons as a surrogate marker to inform discussions on individual pharmacy capacity. The pharmacies in each category (corporate and independent) were ranked from highest to lowest by the average number of flu vaccinations administered per day, recognizing the urgent need for pharmacies to administer a fixed allocation of vaccine within a 2.5-week time period, and prioritized for selection to participate in the initial launch of publicly funded administration of COVID-19 vaccines.

The selection process for phase 1 of the pharmacy rollout focused on high performing pharmacies to ensure no wastage since there was a fixed amount of vaccine that had to be administered within a short time frame before they expired. The number of stores was based on each store receiving a box of 500 doses and administering on average 40 vaccinations per day. The three regions were selected as they were the farthest along with their vaccination plans and liaising with pharmacies. It continues to be OPA’s shared goal with government to have all pharmacies participating when supply is available. Phase 2 will address any gaps and ensure there are pharmacies in all priority areas and vulnerable neighbourhoods.

Following the successful initial launch of COVID-19 vaccine administration in pharmacies, OPA has been working closely with the Ontario government and other stakeholders to expand the pharmacy initiative to include pharmacies from across the province. On April 1, 2021, an additional 371 pharmacies were onboarded to the program as part of phase 2 of the pharmacy vaccine rollout. Pharmacy eligibility and selection criteria can be found in the Executive Officer Notice: Information on the Rollout of Publicly Funded COVID-19 Vaccines in Ontario Pharmacies. In collaboration with the Ministry, the 34 public health units (PHUs) identified the number of stores for their regions to be selected in phase 2 and identified the hotspot areas. OPA and Neighbourhood Pharmacies worked with the Ministry to select the pharmacies in the 34 PHU’s using a robust and consistent methodology to ensure fairness. The criteria included identifying stores that were high performers during the Universal Influenza Immunization Program (UIIP) with a mix of pharmacy type and regional footprint to ensure rural and urban areas were covered. A minimum of three pharmacies were selected to participate in each PHU with more pharmacies in hotspot areas. A full list of participating pharmacies can be found on the Ministry’s COVID-19 pharmacy vaccine locations webpage.

As OPA has articulated to members in the past, our goal for the COVID-19 vaccination program is to allow all pharmacies who want to participate the opportunity to do so. In total, as of July 9, 2021, there were 2,512 pharmacies participating in the program. Additional pharmacies interested in participating will continue to be onboarded moving forward. Pharmacy information will not be uploaded onto the ministry’s website locator until vaccine supply is available at the pharmacy.

For those pharmacies who have not applied but are interested in participating, on April 2, the Ministry put out a call for applications. The selection criteria and process was the same as in previous phases and is outlined in the Executive Officer Notice: Information on the Rollout of Publicly Funded COVID-19 Vaccines in Ontario Pharmacies. Interested pharmacies should consult the Pharmacy Readiness Checklist and the COVID-19 Vaccine – Quick Information for Pharmacies documents for more information. Additional information and instructions on where to send the completed COVax Access Agreement can be found in the DDD Notice No. 21046.  

OPA continues to work with the Ministry on the next steps of the rollout including initial discussions on the winding down of mass immunization clinics. We have provided the Ministry with information on how the program is currently being operationalized in different pharmacies as well as pharmacy-specific considerations to help gauge the capacity of the pharmacy channel to support the next phase of the program. In addition, OPA is advocating for a more streamlined administration process and underscoring the challenges with the current reimbursement rate. OPA will continue to update members as new information arises from these discussions.

Unfortunately, due to time and capacity constraints, inspections by public health units for adherence to cold chain management processes are not feasible at this time. As such, the Ministry has decided that only pharmacies who are currently participating in the UIIP 2020/21 season will be eligible for selection as a participating pharmacy for the administration of COVID-19 vaccination.

OPA recognizes that some pharmacies may not be participating in this season’s UIIP due to various reasons, e.g., new openings after the UIIP application deadline, and have highlighted this for the Ministry. OPA would like to update members that as of May 14, 2021, the UIIP applications for the 2021/22 season are open with a deadline to apply by July 11, 2021 at 11:59 pm. Pharmacies who may not have been eligible before for the COVID-19 vaccine administration program may become eligible to participate once they receive approval for the UIIP. These stores will have the opportunity to be onboarded to the COVID-19 vaccination program in late summer/early fall after local public health units have submitted all approvals for the UIIP. OPA recognizes that in some exceptional circumstances, there may be a need for an earlier onboarding and will continue to work with the Ministry on how to support the onboarding of pharmacies to meet the needs of local communities. For more information about the UIIP and to apply, please consult the Ministry’s website.

For the initial launch of the program, it was determined that an average of 40 injections per day would be required in order to administer all 500 doses, which had an expiry of April 2, 2021, that were provided to participating pharmacies. Moving forward, the Ministry expects that participating pharmacies have the capacity and ability to administer vaccine supply quickly and effectively to not only support patient access and priority areas, but also to expedite the delivery of vaccinations to all Ontarians. An example would be the ability to administer on average 30-40 injections per day. In addition to ensuring that the selection process for pharmacies was fair and equitable, this expectation was also used to ensure that there would be no wastage of vaccine and that the pharmacy channel’s capacity for more shots in arms was maximized. Exceptions may be made at the discretion of the Ministry as required. This guidance may be revised moving forward depending on vaccine supply and how the pandemic evolves. However, please note that this throughput is not mandatory and pharmacies who may not be able to achieve this due to specific reasons will not be suspended from the program.

Following successful initial pilots of both Pfizer-BioNTech and Moderna vaccines the Ministry has now expanded to providing all pharmacies enrolled in the COVID-19 vaccination program mRNA vaccines. All pharmacies are now eligible to receive Moderna COVID-19 vaccines, however, deliveries of Pfizer-BioNTech are still limited to the pharmacies that were originally allocated supply. For more information, pharmacies are asked to contact their corporate/chain/banner head office. Pharmacies without access to corporate/chain/banner head office support may contact OPA for support.

OPA has developed the Pharmacy Playbook for COVID-19 Vaccine Administration which was presented during a table-top exercise with representatives from the Ministry of Health, the Ministers’ COVID-19 Vaccine Distribution Task Force and various public health units. This comprehensive document addresses operational considerations required to support the successful implementation of COVID-19 vaccine administration in pharmacies as well as workflow considerations presented in table format to help illustrate the process incorporating important factors such as vaccine inventory management, scheduling, screening, obtaining informed consent, IPAC measures, etc. Additionally, OPA has created a pharmacy sign that participating pharmacies may wish to use to notify their patients of the availability of COVID-19 vaccine administration at their location.

OPA will continue to monitor the program and will update and develop new tools and resources as required.

Program Supplies

Pharmacies participating in the administration of publicly funded COVID-19 vaccine administration may order PPE by accessing the Remedy online intake form. It is important to note that this supply should only be used to support the activity of pharmacies administering the publicly funded COVID-19 vaccine, and that there is an allocation framework in place depending on the current supply and not all orders for PPE may be filled. Pharmacies that belong to a banner or chain corporation should work through their corporate head office, who may centrally coordinate order and facilitate distribution. Independent pharmacies may order directly from the website. Please note that this is the same form/process of accessing PPE as the one used for the UIIP Program. There are three options on the Ministry form and pharmacies must select either:

  • Critical Personal Protective Equipment (PPE) / Swab Kit Requests; OR
  • Critical Personal Protective Equipment (PPE) / Swab Kit Requests with West LHIN(s) (if they belong to the West LHIN region)

DO NOT select the “Vaccination Supplies Requests” option as that will result in orders not being filled and pharmacies will be sent a message to select the PPE option belonging to their region which will delay fulfilling the order.

As stated in the Ministry’s Questions and Answers for: Administration of Publicly Funded COVID-19 vaccine in Ontario Pharmacies, there is an allocation framework in place for access to PPE depending on the current supply. OPA has partnered with two PPE suppliers – RONCO and Safe Direct, to ensure pharmacy professionals have continued access to medical-grade PPE. Pharmacies can now order a variety of products, including masks, face shields, gowns and gloves with the option to order large or small quantities and no restrictions on the number of times an order can be placed. Additional details about ordering from OPA’s partners can be found on the OPA webpage. If you have any questions or concerns, please contact us at 416-441-0788, or toll-free at 1-877-341-0788 option 1 or email us at [email protected].

Pharmacies participating in the administration of publicly funded COVID-19 vaccines will be provided with the following vaccine ancillary supplies:

  • BD Eclipse Needle with SmartSlip Technology, 23G x 1 1/4inch (0.6mm x 30mm) Injection Needle
  • BD Eclipse Needles with SmartSlip Technology, 25G x 1 (0.5mm x 25mm) Injection Needle
  • BD 3mL Syringe with Luer-Lok Tip
  • LDS PHAC 1mL Syringe with Luer-Lok Tip (for Pfizer-BioNTech COVID-19 vaccine)
  • 1mL Syringe with Luer-Lok Tip (for US-labelled Moderna COVID-19 vaccine)
  • Tech Choice 70% Isopropyl Alcohol Prep Pads or LernaPharm Loris Antiseptic Isopropyl Alcohol Pads
  • Covidien Curity Sheer Adhesive Bandage (7/8inch)
  • Covidien Dermacea Non-Woven Gauze Sponges 4-Ply (2 inch x 2 inch)
  • Sharps Container (22.7L)
  • Covidien SharpSafety Sharps Container 3 Gallons (or 11.3L)

Pharmacies do not have to order these supplies from the Ministry; they will be shipped based on vaccine allocations. However, due to different delivery requirements, these supplies may not arrive at the same time as vaccine deliveries. Please also note that at times, these supplies may be available in limited quantities and they will be provided as long as stock is available. Pharmacies who do not receive enough supplies are encouraged to order their own supplies through their own pharmacy channels in order to continue vaccine administration. Additionally, pharmacies are required to continue with their current disposal procedures for sharps returns as this is not within the scope of the Ministry at this time.

Although the pharmacy program started with only the COVISHIELD/AstraZeneca COVID-19 vaccines being made available, through OPA’s advocacy efforts to introduce mRNA vaccines into the pharmacy channel, currently, four COVID-19 vaccine products are listed as available through the Ministry’s pharmacy program: COVISHIELD, AstraZeneca COVID-19 Vaccine, Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 vaccine.

Both mRNA vaccines were rolled out to pharmacies through pilot programs which started on April 30, 2021 for Pfizer-BioNTech and May 6, 2021 for Moderna. Although the original intent was to run the initial pilots for 2-3 weeks, following tremendous success at participating pharmacies, the Ministry decided to accelerate their expansion plans to additional pharmacies. This includes pharmacies that were participating in the administration of AstraZeneca COVID-19 vaccines as well as all the other pharmacies that have been onboarded to date. All pharmacies are now eligible to receive Moderna COVID-19 vaccines, however, deliveries of Pfizer-BioNTech are still limited to the pharmacies that were originally allocated supply of this vaccine.

For the expansion to mRNA vaccines, timing for initial deliveries and vaccine quantities will be dependent on supply. Distributors will be in touch with the stores to confirm their deliveries.

Due to variable levels of vaccine availability, stores may not receive stock immediately after being onboarded to the COVaxON system. Stores will be contacted by their respective distributor once supply is available for distribution. As there may also be regional differences in allocation, pharmacies may wish to check with their distributor for specific details on their region.

OPA continues to work closely with the Ministry to address concerns regarding pharmacy allocations and to underscore the importance of predictable and reliable supply. As we work to shift the distribution model from one based on auto shipment to one based on demand, OPA would like to remind pharmacies receiving distribution through McKesson (pharmacies part of the Shoppers Drug Mart distribution channel should contact their distributor for more information) that McKesson has now shifted all ordering for COVID-19 vaccines to a pre-booking process. All participating pharmacies should be receiving communications directly from McKesson to submit pre-book requests to receive vaccine supply for the following week and this process will be utilized on a weekly basis to ensure pharmacies have greater control in managing supply in place of the auto shipment method. Pharmacies must submit their pre-book requests on time to ensure the weekly delivery of vaccine supply. Pharmacies will receive communication prior to the delivery to confirm the delivery day. Patient appointments should not be confirmed until delivery timing and the final order amount has been confirmed by McKesson as orders may be adjusted based on review with the Ministry and stock availability. Please refer to the following for specific ordering and allocation information based on the vaccine product:

 

AstraZeneca

A limited supply of AstraZeneca COVID-19 vaccine is available for ordering through a quantity pre-book and must be ordered as a quantity of 10 vials (100 doses).

 

Pfizer-BioNTech

Pfizer-BioNTech COVID-19 vaccine is available for ordering through a quantity pre-book and can be ordered in quantities of 25 vials (150 doses) or 50 vials (300 doses).  Please note, for the week of July 5, pharmacies that have been administering Pfizer-BioNTech vaccines did not receive deliveries of Pfizer vaccine due to a disruption in the expected deliveries to Canada however, deliveries of Pfizer are expected to resume the week of July 12.

 

Moderna

As a result of increased Moderna supplies in Ontario, OPA is pleased to inform pharmacy professionals that the pharmacy channel has received additional allocations for distribution. As such, all participating pharmacies, including those that were originally allocated Pfizer-BioNTech, are able to order doses of Moderna vaccines through a quantity pre-book. This was welcome news as OPA has been advocating for an increase to pharmacy allocations to meet patient demand. OPA has also confirmed that moving forward there will be no limit to the quantity that pharmacies can order, however, pharmacies should only order as many units as they require for the week. One unit contains 10 vials of the US packaged Moderna vaccine which contains 14 doses/vial (i.e., 1 unit = 140 doses, 2 units = 280 doses, 3 units = 420 doses, and 4 units = 560 doses). Please note that requesting Moderna vaccine will not affect these stores’ abilities to order Pfizer vaccine, i.e., pharmacies that originally were allocated Pfizer could potentially have three vaccine products in stock (Pfizer, Moderna and AstraZeneca).

In the coming months as local Public Health mass immunization clinics begin to ramp down their vaccine administration based on regional direction OPA will continue to work closely with the Ministry to ensure that pharmacies are supported to be able to meet the needs of their patients and the public.

Pharmacies who have been notified by their distributor that they will receive a delivery but have yet to actually receive it should contact their distributor to inquire as to why the delivery has not arrived as anticipated. If possible, pharmacies should wait for their deliveries unless they receive confirmation from their distributor about a change in delivery date. This is especially important for mRNA vaccines as extra transport of these vaccines are problematic due to the special storage and handling requirements.

At this time, transferring publicly funded COVID-19 vaccines between stores is not permitted unless specifically approved by the Ministry under exceptional circumstances (e.g., where there is a risk of vaccine wastage). Please note that the Pfizer-BioNTech COVID-19 vaccine CANNOT be transferred further to another store due to the special transportation requirements for storage and handling. The Moderna COVID-19 vaccine can only be transferred in exceptional circumstances and must be ministry approved prior to any transfer.

Pharmacies that need to transfer vaccine to another participating pharmacy must adhere to vaccine storage and handling guidelines as well as specific references to transferring the vaccine. Only unused vials (i.e., not punctured) can be transferred. Doses can only be transferred within their local public health region and the transferring pharmacy must notify the ministry by sending an email request to [email protected] that includes:

  • the pharmacy contact information (including ON Provider #) of the site transferring the doses
  • pharmacy contact information of the site (including ON Provider #) receiving the transfer
  • number of doses to be transferred
  • vaccine name, lot # and expiry date
  • reason for the transfer

Once the transfer is approved, the doses that are transferred must also be logged into the COVaxON system for proper system-wide inventory management.

Please note, pharmacies who are receiving additional allocations from PHUs do not need to contact the OPDP to request approval of these transfers, but will be required to follow the appropriate processes to transfer the inventory in COVaxON. These approval requests will be initiated by the PHUs to the Ministry. Pharmacies are not allowed to transfer or accept transfers of vaccine from primary care providers or their local public health units without ministry approval.

Pharmacies with any other concerns regarding excess inventory should contact their corporate head office or OPA as soon as possible to discuss potential options.

AstraZeneca COVID-19 Vaccine

On May 11, 2021, Dr. David Williams, Ontario’s Chief Medical Officer of Health issued a statement announcing that effective immediately, Ontario will be pausing the rollout and administration of the first doses of the AstraZeneca vaccine. The health and safety of Ontarians remains a top priority and this decision was made out of an abundance of caution due to an observed increase of a rare blood clotting condition known as vaccine-induced immune thrombotic thrombocytopenia (VITT) linked to the AstraZeneca vaccine. As of May 8, the rate of VITT was approximately 1 per 100,000. However, more recent data indicated that the rate was closer to approximately 1 per 60,000 doses administered. Therefore, as a result of this incidence change and considering the increasing supply of mRNA vaccines coming into the province and the downward trend in case counts, the Ministry decided to pause the administration of AstraZeneca COVID-19 vaccines. More information can be found in the Ministry’s statement. Dr. David Williams, Ontario’s Chief Medical Officer of Health, has also shared a memo to provide additional context and rationale behind this decision and the Ministry issued a Questions and Answers document to support healthcare professionals with speaking to patients about this change. (Update: Since this decision was made, the rate of VITT in Canada after a first dose has increased to approximately 1 in 55,000 doses administered.)

The right thing to do to protect yourself and those around you is to get vaccinated with the vaccine you were eligible to receive. Pharmacy professionals may wish to explain to patients that based on the much higher risks of COVID-19 infection recently observed in Ontario including hospitalization, serious illness and death, those who received their first dose with the AstraZeneca vaccine did absolutely the right thing to prevent illness, and to protect their families, loved ones and communities. For additional support with speaking to your patients about the AstraZeneca/COVISHIELD COVID-19 vaccines, please refer to the Ministry’s Questions and Answers document.

On June 17, 2021, NACI updated their recommendations on the use of COVID-19 vaccines in Canada. Specifically, for first doses, NACI recommends that:

  • An mRNA vaccine (Pfizer-BioNTech, Moderna) is preferred to start a vaccine series, unless there is a contraindication, for example, because of an allergy to an mRNA vaccine or its components.
  • A viral vector vaccine (AstraZeneca, Janssen) may be offered to start a vaccine series when an mRNA vaccine is inaccessible or contraindicated, for example, because of an allergy to an mRNA vaccine or its components.

Based on this guidance, with respect to the use of AstraZeneca/COVISHIELD COVID-19 vaccine for first doses, although Ontario has paused the administration of first doses of publicly funded AstraZeneca/COVISHIELD COVID-19 vaccines in Ontario pharmacies (Executive Officer Notice dated May 11, 2021), the administration of first doses of the AstraZeneca/COVISHIELD COVID-19 vaccine is not suspended for individuals with allergies to an mRNA vaccine. Therefore, pharmacy professionals may administer AstraZeneca/COVISHIELD COVID-19 vaccines as first doses to individuals who are 18 years of age or older at the time of vaccination and who have a confirmed allergy to components of the mRNA vaccines, if the individual has been assessed by an allergist/immunologist and the pharmacy has received a completed COVID-19 Vaccination: Allergy Form along with a vaccine administration care plan that has been completed by the allergist/immunologist which must include the types of parameters the pharmacy should meet to provide safe vaccination administration prior to administrating the COVISHIELD/AstraZeneca vaccine. If in the professional opinion of the pharmacy professional who is performing the clinical assessment the pharmacy can meet the needs of the patient as outlined by the vaccine administration care plan, then they can proceed with administration of the AstraZeneca/COVISHIELD COVID-19 vaccine. Pharmacies must keep all completed forms and accompanying documentation with the patient’s file for documentation purposes. Pharmacy professionals who have patients who need to be assessed by an allergist/immunologist should be referred to their primary care provider or local public health unit (PHU) who can refer them to an allergist/immunologist who is specifically seeing patients with reactions to the COVID-19 vaccines.

As of June 14, 2021, the Ontario government, in consultation with the Chief Medical Officer of Health and other health experts, including the Ontario Science Advisory Table, announced that they are further accelerating the second dose interval for individuals who received their first dose of an AstraZeneca COVID-19 vaccine to eight weeks, with informed consent, from the previous guidance of 12 weeks. This decision was based on emerging clinical evidence about the administration of two doses of different vaccines, as supported by the National Advisory Committee on Immunization (NACI). Evidence from multiple studies indicates that mixing of COVID-19 vaccines (receiving an mRNA vaccine after an AstraZeneca vaccine) at dosing intervals between eight and 12 weeks is safe and demonstrates a beneficial immune response. However, there is evidence that a longer interval between two doses of the AstraZeneca vaccine (such as a 12-week interval) provides higher protection. Please note that individuals with certain health conditions as documented in a letter from a health care provider, may receive their second dose as early as 4 weeks. For more information about second dose eligibility, please refer to the COVID-19 Vaccine Series Second Dose Eligibility Quick Reference.

 

On June 17. 2021, NACI updated their recommendations on the use of COVID-19 vaccines in Canada. Specifically, for second doses, NACI recommends that:

  • Individuals who received a first dose of an mRNA vaccine (Pfizer-BioNTech, Moderna) should be offered the same mRNA product for their second dose. If the same product is not readily available, or the product used for the first dose is unknown, another mRNA vaccine is considered interchangeable and should be used to complete the series.
  • An mRNA vaccine is now preferred as the second dose for individuals who received a first dose of the AstraZeneca/COVISHIELD vaccine, based on emerging evidence of a potentially better immune response from this mixed vaccine schedule and to mitigate the potential risk of VITT associated with viral vector vaccines.
  • People who received two doses of AstraZeneca/COVISHIELD vaccine can rest assured that the vaccine provides good protection against infection and very good protection against severe disease and hospitalization.

OPA has confirmed with the Ministry that at the current time, there is no change to the Ministry guidance with respect to the choices available for second doses for those who received AstraZeneca/COVISHIELD COVID-19 vaccine as their first dose. In other words, patients who received a first dose of the AstraZeneca/COVISHIELD vaccine may receive either AstraZeneca/COVISHIELD vaccine or an mRNA vaccine (Pfizer-BioNTech or Moderna) for their second dose if at least 8 weeks have passed since their first doses, unless they have a health condition that allows them to be eligible for an earlier second dose or a second dose is contraindicated. In such cases, patients should be provided with the necessary information about the risks and benefits of each choice taking into account factors such as but not limited to available guidance, evidence, vaccine availability, and patient-specific factors, so that they can make an informed decision. Documentation of this discussion, which includes any relevant notes and receipt of the informed consent for administration from the patient, should be kept in the patient profile with the administration record. Some resources to help guide the discussion include:

It is important to note that patients who had AstraZeneca as the first dose, can safely receive either AstraZeneca, Moderna or Pfizer-BioNTech for their second dose for strong protection. NACI has stated that people who have received one or both doses of AstraZeneca/COVISHIELD vaccine can rest assured that the vaccine provides good protection against infection and very good protection against severe disease and hospitalization. These individuals did the right thing to prevent illness, and to protect their families, loved ones and communities. All COVID-19 vaccines available in the province, including AstraZeneca, have been determined to be safe and effective by Health Canada, and have been shown to prevent serious illness, hospitalization and death associated with COVID-19 and to ensure maximum protection against COVID-19 and the Delta variant. Ontarians should get vaccinated as soon as they can and book their second dose as soon as they are eligible.

The updated provincial guidance now permits the administration of AstraZeneca/COVISHIELD COVID-19 to individuals who received the Pfizer-BioNtech or Moderna mRNA vaccine for their first dose and had a severe allergic reaction or anaphylaxis to that vaccine. In such cases, pharmacy professionals may administer AstraZeneca/COVISHIELD COVID-19 vaccines as a second dose to individuals who are 18 years of age or older at the time of vaccination and who have a confirmed allergy to components of the mRNA vaccines, if the individual has been assessed by an allergist/immunologist and the pharmacy has received a completed COVID-19 Vaccination: Allergy Form along with a vaccine administration care plan that has been completed by the allergist/immunologist which must include the types of parameters the pharmacy should meet to provide safe vaccination administration prior to administrating the COVISHIELD/AstraZeneca vaccine. If in the professional opinion of the pharmacy professional who is performing the clinical assessment the pharmacy can meet the needs of the patient as outlined by the vaccine administration care plan, then they can proceed with administration of the AstraZeneca/COVISHIELD COVID-19 vaccine. Pharmacies must keep all completed forms and accompanying documentation with the patient’s file for documentation purposes. Pharmacy professionals who have patients who need to be assessed by an allergist/immunologist should be referred to their primary care provider or local public health unit (PHU) who can refer them to an allergist/immunologist who is specifically seeing patients with reactions to the COVID-19 vaccines.

With respect to when these individuals would be eligible for their second dose, please note that they would be eligible for their second dose using the AstraZeneca/COVISHIELD COVID-19 vaccine if at least 21 days have passed since their first dose with the Pfizer-BioNTech vaccine or at least 28 days have passed since their first dose with the Moderna vaccine.

Vaccine Storage and Handling

Each local public health unit (PHU) will decide whether temperature logs for the refrigerator(s) storing publicly funded COVID-19 vaccine doses need to be submitted. Participating pharmacies should check with their local PHU to determine what the specific requirements are. In addition, pharmacies should contact their local PHU if any new equipment (i.e., refrigerators) have been added and are being used to hold publicly funded vaccines that were not previously inspected by the local PHU as part of the UIIP so that arrangements can be made for an inspection as necessary.

On May 19, 2021, Health Canada authorized a submission from Pfizer-BioNTech to allow its COVID-19 vaccine to be stored at regular refrigerated temperatures (2-8°C) at the point of use for up to one month (31 days) as long as the vial is not diluted. Since that time, the Pfizer-BioNTech COVID-19 Vaccine product monograph and the Ministry’s documents on COVID-19: Vaccine Storage and Handling Guidance and Administration of Pfizer-BioNTech COVID-19 Vaccine have been updated to reflect the new storage information for thawed vials stored in the refrigerator prior to dilution.

 

On June 9, 2021, the storage information for Moderna was updated in the product monograph so that punctured vials can now be used for up to 24 hours following the first puncture stored at room temperature or refrigerated compared to only 6 hours previously. Since then, the Ministry’s documents on COVID-19 Vaccine Storage and Handling Guidance and Administration of Moderna COVID-19 Vaccine document have been updated to reflect this change.

Scheduling and Patient Eligibility

At this time, pharmacies will be using their own booking systems to schedule vaccine appointments. The online booking system and provincial customer service desk that launched on March 15 will only be used to support appointment bookings at mass immunization clinics. To support pharmacies, OPA has partnered with MedEssist Ltd. to offer a digital health solution that will enable community pharmacies across Ontario to meet the immediate demand for COVID-19 vaccinations. This effective patient-first, digital health solution is a web-based tool that can also be accessed on mobile. As Canada’s first and only inventory-based, patient-triaging platform for pharmacies, MedEssist’s system is designed to enable pharmacies to operate more efficiently and provide exceptional patient care while minimizing vaccine wastage. MedEssist’s innovative system has helped pharmacies across Canada to successfully manage a record-breaking flu vaccination campaign in 2020. More details and additional resources will be shared shortly. In the meantime, for more information, please send your inquiries to [email protected].

Pharmacies will be using their own booking systems to book patient appointments to receive COVID-19 vaccinations. Therefore, appointment times should be scheduled to coincide with the times that vaccine administration would be offered. Additionally, pharmacy staff should be made aware of the hours that COVID-19 vaccine administration would be available in order to communicate the information to patients. Pharmacies are reminded that participating pharmacies are expected to have the capacity and ability to administer, at minimum, an average of 30-40 injections per day. These considerations must be taken into account when determining vaccine administration times and appointment availabilities to avoid vaccine wastage.

As part of the Ministry’s program for the administration of publicly funded COVID-19 vaccinations in pharmacies, there are no restrictions that limit the hours of operations and pharmacies are strongly encouraged to support the administration of the COVID-19 vaccine 24 hours a day/7 days a week, where permissible. However, pharmacies that will be operating outside of their normal business hours are required to submit a written request to the Ontario College of Pharmacists (OCP) to notify them of this change. The Designated Manager or Director Liaison of the pharmacy should update the hours when completing the annual pharmacy renewal or if they have already completed the annual renewal, an email should be sent to Pharmacy Applications & Renewals at [email protected] detailing the name, address and accreditation number of the pharmacy, the new hours of operation and the effective date of the change. This applies even if the pharmacy is only administering vaccinations outside of normal operating hours, (e.g., booking COVID-19 vaccination appointments an hour before they normally open but not providing any other pharmacy services during this time). Any questions relating to changing of hours (increase or decrease) can be forwarded to [email protected] as well.

It is recommended that pharmacies provide COVID-19 vaccinations by pre-booked appointments, however, pharmacies may choose to offer walk-in appointments if that suits their business needs. As the Ministry’s online pharmacy location finder will only direct patients to either a booking site or to call the pharmacy to book or inquire about procedures related to walk-in appointments, pharmacies are encouraged to communicate their booking procedures via voice recording on the pharmacy’s phone system, on the pharmacy’s website and/or by adapting OPA’s signage for the pharmacy. It is important to remember that regardless of the booking procedure, pharmacies are responsible for informing and educating the public on COVID-19 which includes ensuring that infection prevention and control measures are followed, e.g., limiting the number of people in the pharmacy, maintaining physical distancing between patients waiting in lines, etc. Pharmacies should also consider the need to manage the number of doses remaining to ensure no vaccine is wasted when determining the appropriateness to permit walk-ins.

In addition, for second doses, pharmacies are reminded that as part of the documentation requirements listed in the EO notice, a written or electronic record of the COVID-19 immunization administration must be provided to the patient, which includes the pharmacy’s contact information and date and time for the second scheduled dose (if applicable) at the same pharmacy location.

Yes. Scheduling of second doses and providing the date and time of this second dose appointment at the same pharmacy location to patients is a mandatory requirement for participating pharmacies. In addition, patients must be provided with instructions on how they can reach the pharmacy in the event they need to reschedule as well as how the pharmacy will reach them should there be a need to reschedule due to issues such as vaccine supply. With the recent government announcements about the plans to accelerate second dose appointments, OPA is working closely with the Ministry to ensure a consistent supply of vaccine doses will be delivered to pharmacies to meet patient demand for second doses. Additionally, as a result of increased Moderna supplies in Ontario all participating pharmacies, including those that were originally allocated Pfizer-BioNTech, will be able to order additional doses of Moderna vaccines through a quantity pre-book.

For additional guidance on second doses for all 2-dose COVID-19 vaccine series in Ontario based on current vaccine availability, please refer to the COVID-19 Vaccine Series Second Dose Eligibility Quick Reference which outlines the recommended dosing intervals for each vaccine based on which population group the patient falls under. Ontarians who are eligible for their second doses may choose to return to the same site or channel where they received their first dose for their second dose appointment or may choose to book an appointment at a different site or channel including through pharmacies. Pharmacies booking second dose appointments for patients who did not receive their first dose at the same location should remind individuals to cancel any pre-booked second dose appointments at other locations if applicable.

Second doses of COVID-19 vaccines should be scheduled according to manufacturer recommendations and/or based on public health guidance. Since March 10, 2021, with limited exceptions, Ontario had been following NACI’s recommendations that in the context of limited supply of COVID-19 vaccines, the dosing interval between the first and second doses should be extended to four months for all Health Canada approved vaccines to maximize the number of individuals benefiting from the first dose of vaccine. For more information, please consult the Ministry’s document on Extension of the Second Dose.

On May 28, 2021, based on the increase of COVID-19 vaccine supply in Canada, NACI updated their recommendation on extended dose intervals to indicate that second doses should be offered as soon as possible, with priority given to those at highest risk of severe illness and death from COVID-19 disease after or concurrent with first doses for all remaining eligible populations. Subsequently, the government announced plans to accelerate second dose appointments beginning on May 31, 2021.

As of July 5, 2021, all Ontarians aged 12 years and over are eligible to book a second dose appointment with the interval between the first and second doses dependent on the vaccine product received for their first dose. Please refer to the COVID-19 Vaccine Series Second Dose Eligibility Quick Reference for more information.

Additionally, individuals with certain health conditions (refer to the Vaccine Clinical Advisory Group (VCAG) Recommendations on Exceptions to Extended Dose Intervals for COVID-19 vaccines for more information) continue to be eligible for a second dose at the interval as indicated in the product monographs for COVID-19 vaccines. These individuals include recipients of, undergoing or imminently starting:

  • Transplants (including solid organ transplant and hematopoietic stem cell transplants)
  • Hemodialysis or peritoneal dialysis
  • An anti-CD20 agent (e.g., rituximab, ocrelizumab, ofatumumab)
  • Stable, active treatment (chemotherapy, targeted therapies, immunotherapy) for malignant hematologic disorders (this excludes individuals receiving solely hormonal therapy and/or radiation therapy)
  • Stable, active treatment (chemotherapy, targeted therapies, immunotherapy) for non-hematologic malignant solid tumors (this excludes individuals receiving solely hormonal therapy and/or radiation therapy)

With respect to when exactly the second doses for these special populations should be scheduled, it may depend on multiple factors and be patient specific. Pharmacy professionals should use their professional judgement to determine the most appropriate duration between doses and may wish to consider information from references such as:

The timing of the vaccine may also be decided in collaboration with the treating provider in order to optimize the immune response from the vaccine series and minimize delays in management of the individual’s underlying condition. Of note, patient populations eligible for the shortened second dose interval due to medical reasons will require a letter from the hospital clinic/specialist to confirm that they are eligible to get a second dose appointment at the monograph interval, identifying the reason for the exception. The letter should be presented at both the first and second dose appointments. Pharmacies should keep on file a copy of this letter as well as any documentation to support this decision.

Pharmacy professionals are reminded that it is mandatory for pharmacies to have second dose appointments scheduled for patients prior to them leaving after receiving their first dose as per the documentation requirements listed in the EO notice, which state that a written and electronic (if applicable) record of the COVID-19 immunization administration must be provided to the patient, which includes the pharmacy’s contact information and date and time for the second scheduled dose (if applicable) at the same pharmacy location. In addition, patients must be provided with instructions on how they can reach the pharmacy in the event they need to reschedule as well as how the pharmacy will reach them should there be a need to reschedule due to issues such as vaccine supply.

As of July 5, 2021, youth aged 12 to 17 are eligible to book an accelerated second dose appointment if at least 21 days have passed since their first dose. Please note that currently these individuals are only eligible to receive Pfizer-BioNTech vaccine.

Patients are strongly encouraged to receive their second dose at the same pharmacy location where they received their first dose. To facilitate this, pharmacies should either schedule second dose appointments at the same time as booking for first doses or schedule the second dose appointment before the patient leaves the pharmacy after receipt of their first dose.

However, to ensure patients can receive the vaccine at a time and place that is convenient for them, Ontarians eligible for an accelerated second dose may choose to return to the same site or channel where they received their first dose for their second dose appointment or may choose to book an appointment at a different site or channel including through pharmacies. Pharmacy professionals should follow the provincial guidance when it comes to scheduling second dose appointments and try to accommodate patients who may have gotten their first dose elsewhere where possible. Pharmacies booking second dose appointments for patients who did not receive their first dose at the same location should remind individuals to cancel any pre-booked second dose appointments at other locations if applicable.

No. As long as the patient meets the eligibility criteria as outlined in the EO notice, no other proof of residency is required. Patients who do not have Ontario health cards must bring in an alternate form of valid government-issued identification or one of the following acceptable forms of identification which includes their name and date of birth, such as:

  • Birth Certificate
  • Employee ID
  • First Nations ID
  • Passport
  • MRN (Medical Record Number)
  • Out of Province ID
  • Driver’s License

Pharmacy professionals are still required to document the vaccine administration information for individuals who do not have Ontario health cards in COVaxON along with the alternate form of identification. Please note that for billing purposes, the proxy ID should be used for the claim submission to the HNS and not the other forms of identification.

No. The proxy ID should only be used in cases where a patient does not have an Ontario health card number. Patients with an Ontario health card number are required to provide this to the pharmacy so that a claim for reimbursement through the HNS can be submitted.

No. As per the Moderna COVID-19 vaccine product monograph, Moderna is only indicated for use in individuals 18 years of age and older. The safety and efficacy in individuals under 18 years of age has not yet been established. Therefore, individuals must be 18 years of age or older at the time of vaccination in order to receive the Moderna COVID-19 vaccine. If a patient is 17 years of age and are turning 18 in 2021, the pharmacist may wish to refer the patient to another location administering Pfizer-BioNTech COVID-19 vaccine where the patient may be eligible.

No. As per the Pfizer-BioNTech COVID-19 vaccine product monograph, Pfizer-BioNTech is only indicated for use in individuals 12 years of age and older. The safety and efficacy in individuals under 12 years of age has not yet been established. Therefore, individuals must be 12 years of age or older at the time of vaccination in order to receive the Pfizer-BioNTech COVID-19 vaccine. Studies are currently being conducted to further evaluate the safety, tolerability and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children 6 months to 11 years of age with results expected in the second half of 2021.

Any patient who meets the eligibility criteria as outlined in the Executive Officer Notice titled “Administration of the Publicly Funded COVID-19 Vaccines in Ontario Pharmacies – Eligibility” are eligible to receive COVID-19 vaccine through participating pharmacies. There is no requirement for pharmacies to validate the address of a patient to determine eligibility. However, please note that on March 14, 2021, the Ministry had indicated that it is expected that pharmacies would be focusing on vaccinating their own patients and local community. Pharmacies should use their judgement to support providing vaccinations to those within their region.

To help guide the scheduling of vaccine appointments, pharmacy professionals should use their professional judgement to determine patient priority taking into consideration various factors including but not limited to:

  • NACI’s updated recommendation on extended dose intervals that based on the increase of COVID-19 vaccine supply in Canada, second doses should be offered as soon as possible, with priority given to those at highest risk of severe illness and death from COVID-19 disease after or concurrent with first doses for all remaining eligible populations.
  • Provincial guidance on second dose eligibility
  • Patient specific factors (e.g., individual risk factors, residents of Delta hot spot areas, etc.)

Pharmacy professionals who encounter patients who received COVID-19 vaccinations outside of Ontario/Canada should refer to the COVID-19 Guidance for Individuals Vaccinated outside of Ontario/Canada document which provides approaches to be undertaken by healthcare providers in various scenarios. In these situations, proof of immunization is required to verify the COVID-19 vaccine product received outside of Canada or Ontario. Second doses for all individuals who received a first COVID-19 vaccine dose outside of Canada or Ontario should still follow the intervals recommended by Ontario. Although no data are available on the safety or efficacy of receiving a COVID-19 vaccine currently authorized in Canada after receipt of a non-Health Canada authorized COVID-19 vaccine, in some circumstances people who received a COVID-19 vaccine not currently authorized by Health Canada may be offered revaccination with a Health Canada authorized vaccine.

It is important to note that individuals who have received a partial or complete COVID-19 vaccine series outside of Ontario or Canada should contact their local public health unit (PHU) to have their COVID-19 immunization record documented into COVaxON. Historical first doses must be entered by the PHU into COVaxON prior to booking a second dose appointment. OPA will update members if the guidance changes and pharmacies are provided the authority to document non-Ontario stock and out of province historical doses in COVaxON.

Administration of Vaccine

As per the EO notice, there is an expectation that vaccine administration occurs at the location of the participating pharmacy premise. The pharmacy is permitted to administer publicly funded vaccines supplied by their distributor in a nearby location (e.g., an adjacent pharmacy parking lot) as long as they are able to ensure adherence to public safety and relevant Ministry policy/direction (including infection prevention and control measures) and any Ontario College of Pharmacist (OCP) standards, policies or guidelines. However, pharmacies are encouraged to review the details of their insurance coverage with their individual providers as appropriate to clarify if coverage would be extended to locations outside of the four walls of the pharmacy. For pharmacies insured under OPA’s store insurance program, premises would typically include the parking lot of the pharmacy insured. 

Pharmacy professionals are reminded that the location of administration (i.e., inside the pharmacy or in the pharmacy parking lot) must be included as part of the pharmacy documentation of the vaccine administration.

In most cases, pharmacies are expected to administer the COVID-19 vaccine within the pharmacy premise where vaccine storage requirements can be maintained. However, in exceptional circumstances where a patient is immobile and requests the pharmacist to visit their home to perform the vaccine administration, the pharmacist is permitted to conduct a home visit to administer the COVID-19 vaccine (Pfizer-BioNTech, Moderna or second doses of AstraZeneca/COVISHIELD), as long as this is a one-on-one visit, and the patient does not reside in a congregate setting. In such cases, a single dose of Pfizer-BioNTech or Moderna vaccine may be transported in a syringe whilst adhering to the storage and handling guidelines regarding transport of vaccines. The pharmacy must also ensure public safety, vaccine handling and storage requirements (e.g., specific references to transferring vaccines) as well as adhere to relevant Ministry policy/direction and any Ontario College of Pharmacist (OCP) standards, policies or guidelines. Pharmacists are reminded that documentation of this request, the rationale for the decision and the geographical location of the vaccine administration must be documented as part of the pharmacy documentation. As the guidance with respect to the use of AstraZeneca COVID-19 vaccine for first doses has been updated to allow its use as a first dose for individuals with allergies to an mRNA vaccine, OPA has confirmed with the Ministry that a home visit under the above criteria would also be permitted in these cases.

OPA is also advocating for the government to expand the current program to enable pharmacies to deliver mobile clinics outside of the pharmacy in order to reach more patients within the community. OPA will continue to apprise members of any updates when it becomes available.

Yes. Consent may be given directly, either orally or in writing, by an informed patient or their substitute decision maker as long as it is obtained from each vaccine recipient according to the standards, requirements and any associated guidance of the Regulated Health Professions Act, the Pharmacy Act, and the Ontario College of Pharmacists (OCP). Members may refer to the OCP’s Administering a Substance by Injection or Inhalation guideline as well as the Ministry’s Pre-Screening Assessment Tool for Health Care Providers for more information on informed consent to treatment. In addition, for the administration of COVID-19 vaccines, pharmacy professionals are reminded that documentation of the consent must be done not only in the patient record at the pharmacy, but also in COVaxON. Please refer to OPA’s Pharmacy Playbook for COVID-19 Vaccine Administration for a sample workflow on how to integrate the documentation requirements into practice.

Prior to the appointment, pharmacies are encouraged to provide patients with the following, if possible (in situations where this cannot be done, these documents should be provided to the patient upon arrival at the pharmacy for their appointment):

In addition, if the patient received the AstraZeneca COVID-19 vaccine as their first dose and is returning for their second dose, the COVID-19 Vaccine Information for Individuals that received a first dose of the AstraZeneca COVID-19 vaccine/COVISHIELD vaccine document should also be provided. This consent form is specific to the administration of second doses of AstraZeneca/COVISHIELD COVID-19 vaccine and is used to help facilitate the discussion between the pharmacy professional and the patient when considering their second dose and to confirm the patient’s understanding of their options so that they can provide informed consent. It must be used in conjunction with the COVID-19 Vaccine Consent Form to ensure appropriate documentation of the informed consent received from the patient.

If the patient is a youth (aged 12-17), the following documents should be provided:

Pharmacy professionals are reminded that although this information may be provided beforehand, when the patient arrives for their appointment, it is important to conduct another active screen of the patient for COVID-19, ensure that all screening questions have been answered and inputted into COVaxON and that all patient questions/concerns are addressed in order to obtain informed consent. Please refer to OPA’s Pharmacy Playbook for COVID-19 Vaccine Administration for more information and a sample workflow.

Pharmacies participating in the administration of publicly funded COVID-19 vaccinations must enter all information pertaining to the administration into COVaxON. COVAXON is the database that will capture all COVID-19 vaccine administration for the province. As such, information related to vaccine administration and inventory supply must be entered into this system. The fee paid to pharmacies for administering the COVID-19 vaccine includes pharmacy services related to accessing and using the Provincial COVID-19 Vaccine Solution-COVAXON. For more information about the requirements for accessing and using COVaxON please refer to the COVID-19 Vaccine Agreement.

Although this is not a mandatory field, it is encouraged to be completed whenever possible as this allows for primary care providers to access the vaccination status of their patients. Data sharing pathways for primary care providers are enabling health care providers to view a patient’s COVID-19 vaccination information. Work is underway to ensure a report of patients who received their vaccine since December 2020 is provided to primary care providers to support patient enrollment models for first or second doses. OPA is in discussions with the Ministry to advocate for pharmacy access to the vaccination status of their patients also in order to help support more targeted efforts to increase vaccination uptake in the province.

Although this is not a mandatory field, it is encouraged to be completed whenever possible as this information will help with planning and guiding policy decisions for the upcoming school year.

The “Authorized by” box is meant to capture the name of the supervising pharmacist in situations where the COVID-19 vaccine is administered by a pharmacy intern, student or technician.

Low dead-volume syringes and/or needles are designed to reduce wastage and should be used when extracting doses from Pfizer-BioNTech COVID-19 vaccine vials in order to facilitate extraction of 6 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. For more information about low dead-volume syringes and/or needles as well as steps and suggested tips on drawing 6 doses per Pfizer-BioNTech vaccine vial, please consult this information sheet.

Although it is generally not routine practice to pool vaccine to complete a dose for multi-dose vials of vaccines, there are benefits to extracting additional doses given the high COVID-19 case counts in Ontario and limited COVID-19 vaccine.  As an interim measure, an additional dose of COVID-19 vaccine may be extracted from up to 3 vials of the same vaccine using aseptic technique. Every effort should be made to withdraw the entire residual volume from one vial, before entering the next vial. The antigenicity and therefore, efficacy of the vaccine is not affected by accessing multiple vials to obtain an additional dose. For more information about the aseptic technique and the criteria that must be met in order to undertake this extraction of an additional dose from up to 3 vials of the same vaccine, please refer to the Ministry’s COVID-19 Vaccine Storage and Handling Guidelines, Appendix E. Please note that in these situations, special attention must be paid to the recommendations and parameters in the Guideline to ensure the safety, efficacy and integrity of the vaccine and to avoid the risk of contamination as these vaccines do not contain preservatives. In addition, it is important to ensure that there is appropriate documentation and labelling and that additional doses are entered into COVaxON.

OPA strongly encourages that wherever possible, pharmacy professionals be utilized to assist with the administration of COVID-19 vaccinations through pharmacies. However, in specific situations where a pharmacy may choose to employ other health care providers (HCPs) to provide COVID-19 vaccines in the pharmacy, they are permitted to do so under the pharmacy program provided this other health care provider has the authority to administer the COVID-19 vaccine by injection under Ontario law and have injection training. Please note that when submitting a claim through the HNS, the name of a Part A pharmacist must still be identified in the prescriber field regardless of which health care provider administered the vaccine. For more information about the requirements in these situations, please refer to Question 18 of the Ministry’s Questions and Answers for: Administration of Publicly Funded COVID-19 Vaccine in Ontario Pharmacies.

As per NACI’s guidance on the Interchangeability of authorized COVID-19 vaccines, individuals who received a first dose of an mRNA vaccine (Pfizer-BioNTech or Moderna) should be offered the same mRNA vaccine for their second dose. If the same mRNA vaccine is not readily available or unknown, another mRNA vaccine recommended for use in that age group can be considered interchangeable and should be offered to complete the vaccine series. The previous dose should be counted, and the series need not be restarted. The Ministry has provided further guidance that “readily available” means easily available at the time of vaccination without delay or vaccine wastage. Practically, this means that the next available mRNA vaccine should be provided when the patient is ready and eligible to receive their second dose. If both vaccines are simultaneously available, the same vaccine should be used for both the first and second doses. This is because there is established data from clinical trials showing very high vaccine efficacy (94-95%) when the first and second doses of vaccine are the same product. However, if only an alternate mRNA vaccine product is available at the time of the second dose, a different mRNA vaccine can be used for the second dose. Please note that when a different vaccine product is used to complete the vaccine series, the earliest interval at which the vaccine can be given is the Health Canada product monograph authorized interval of the vaccine used for the first dose (i.e., 21 days where Pfizer-BioNTech is the first dose, 28 days where a Moderna COVID-19 vaccine is the first dose, and 4-12 weeks where AstraZeneca/COVISHIELD COVID-19 vaccine is the first dose). Both mRNA COVID-19 vaccines authorized for use in Canada (Pfizer-BioNTech and Moderna) have the same mechanism of action, have very similar side effect profiles and are highly effective against COVID-19 infection, hospitalization, and death. Pharmacy professionals should ensure patients understand which product they are receiving, have the opportunity to ask questions, and understand the risk of delaying their second dose. 

Please refer to the Ministry’s Q&A for Health Care Providers on Mixed COVID-19 mRNA Vaccine Schedules as well as the Patient Fact Sheet for more information to support the discussion with patients. In addition, the Vaccine Administration documents for the Pfizer-BioNTech and Moderna COVID-19 vaccines have been updated to include Point-of-Care Guidance for an alternate mRNA vaccine product.

In all cases, although a specific form for documentation of situations for mixing and matching of mRNA vaccines is not currently available, following the discussion with the patient about mixing and matching, the decision and rationale should be documented along with the patient consent for administration of a different mRNA vaccine product.

There have been international reports of myocarditis and pericarditis  following vaccination with COVID-19 mRNA vaccines. On June 30, 2021, Health Canada updated the Pfizer-BioNTech and Moderna product monographs to describe very rare reports of myocarditis and pericarditis following vaccination. Cases of myocarditis and/or pericarditis following immunization with COVID-19 vaccines have been reported in a small number of people in Canada and internationally. These reports are very rare and investigations into the association between myocarditis/pericarditis and mRNA vaccines continue. Most reported cases to date have followed vaccination with an mRNA vaccine (Pfizer-BioNTech and Moderna) and, based on an analysis of international cases, have occurred more often after the second dose and in younger male adults and adolescents. The Canadian evidence is expected to evolve as more people in these populations are vaccinated. Available short-term follow-up data show that these events were typically mild and treatable and involved symptoms such as chest pain, shortness of breath, or palpitations (feelings of having a fast-beating, fluttering or pounding heart); however, information on long-term outcomes is not yet available. Health Canada reassures Canadians that COVID-19 vaccines continue to be safe and effective at protecting them against COVID-19. The benefits of COVID-19 vaccines continue to outweigh their potential risks, as scientific evidence shows that they reduce deaths and hospitalizations due to COVID-19. The Government of Canada encourages people to get vaccinated and to complete their vaccine series as soon as they are eligible. For more information, please consult Health Canada’s Advisory.

In light of these changes, on July 2, 2021, the National Advisory Committee on Immunization (NACI) released updates to their Recommendations on the use of COVID-19 Vaccines and Summary of updated vaccine statement to provide updated advice on second doses for individuals who experienced myocarditis and/or pericarditis after receiving a first dose of an mRNA vaccine. NACI continues to strongly recommend that a complete series with an mRNA vaccine should be offered to all eligible individuals without contraindications, including those 12 years of age and older. The Pfizer-BioNTech vaccine is approved for use in people 12 years and over and the Moderna vaccine is approved for use in people 18 years of age and over. NACI is now also recommending the following:

  • Informed consent for people receiving an mRNA vaccine should include a discussion about the very rare risk of myocarditis and/or pericarditis following immunization and patients should be advised to seek immediate medical attention if they develop symptoms, which may include chest pain, shortness of breath, or the feeling of a fast, pounding or fluttering heartbeat. Cases typically occur within a week after the receipt of an mRNA vaccine dose, more commonly after a second dose. Any potential cases should be investigated with medical assessment regardless of timing from vaccination to onset.
  • 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.

The evidence on this safety signal and investigations into an association between myocarditis and/or pericarditis and the mRNA COVID-19 vaccines continue to evolve. NACI will continue to monitor the evidence and will update recommendations as needed. In addition, weekly updates on national data can be found on PHAC’s website. Public Health Ontario (PHO) is also monitoring this issue as part of enhanced COVID-19 vaccine safety surveillance and produces a weekly summary of all COVID-19 AEFIs in Ontario, including myocarditis/pericarditis.

For more information please refer to the COVID-19 Vaccine Information SheetCOVID-19 Vaccine Information Sheet: For Youth (age 12-17)Administration of Pfizer-BioNTech COVID-19 Vaccine and Administration of Moderna COVID-19 Vaccine. Members may also consult Public Health Ontario’s Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines resource and the Myocarditis/Pericarditis FAQ resource for Health Care Providers from SickKids.  

On June 29, 2021, Health Canada updated the AstraZeneca and COVISHIELD product monographs and issued a Health Product Risk Communication and Advisory to highlight that capillary leak syndrome (CLS) has been observed very rarely following vaccination with the AstraZeneca COVID-19 Vaccine and provide further guidance for healthcare professionals and vaccine recipients. Patients who have previously experienced episodes of CLS should not be vaccinated with AstraZeneca COVID-19 Vaccine or COVISHIELD. Healthcare professionals should be alert to the signs and symptoms of CLS. CLS is a very rare disorder, which is frequently life threatening, characterised by a dysfunctional inflammatory response, endothelial dysfunction, extravasation of fluid from the vascular space to the interstitial space leading to shock, hemoconcentration, hypoalbuminemia and consequent organ failure. Patients with an acute episode of CLS following vaccination require urgent medical attention and treatment. Intensive supportive therapy is usually warranted. Individuals vaccinated with AstraZeneca COVID-19 Vaccine or COVISHIELD should be instructed to seek immediate medical attention if they develop symptoms such as rapid swelling of the arms and legs, sudden weight gain and feel faint due to low blood pressure. In addition, information about thrombosis and thrombocytopenia (rare adverse reactions to the vaccine) has been updated on the label, recommending to healthcare professionals that individuals with thrombocytopenia following vaccination with the AstraZeneca COVID-19 vaccine should be investigated for signs of thrombosis, and similarly individuals who present with thrombosis should be investigated for thrombocytopenia.  Health Canada continues to work closely with the manufacturer and international regulators to review data as it becomes available on these rare events. The benefits of the AstraZeneca COVID-19 Vaccine and COVISHIELD in protecting Canadians from COVID-19 continue to outweigh the risks and Canadians are encouraged to get immunized with any of the COVID-19 vaccines that are authorized and available in Canada.

Documentation and Billing

No. All users of COVaxON are expected to have and use their own user account. The name of the individual who administered the vaccine (i.e., the vaccinator) must be entered into COVaxON regardless of whether they are a pharmacist, pharmacy student, pharmacy intern or pharmacy technician. However, if the vaccine was administered by a qualified pharmacy professional who is not a pharmacist, the name of the supervising pharmacist should be captured in the “Authorized by” box on the COVID-19 Vaccine Consent Form. In addition, when submitting the claim for payment to the HNS, the Pharmacist ID of the injection-trained supervising pharmacist must be used.

Pharmacy professionals are required to maintain a complete and accurate patient record which would include documentation of the COVID-19 vaccine administration. For more information about expectations for documentation in pharmacy practice, please consult OCP’s Documentation Guidelines. At this time, the information entered into COVaxON is not downloadable and therefore, pharmacies must also keep a record of the vaccine administration in an alternate format within the pharmacy files. Pharmacies may choose to use the Ministry’s COVID-19 Vaccine Consent Form to help capture some of the required information, however, please note that as this form is not specific to the pharmacy sector, there are some documentation requirements specific to the pharmacy program that are not captured by this form, including:

  • Expiry date
  • Signature of the immunizer
  • Documentation that written (and electronic if applicable) proof of immunization was provided

This information must be documented on the form as per the EO Notice. In addition, pharmacies are reminded that both the name and address of the pharmacy must be included as both are required pieces of information for pharmacy documentation in addition to the geographical location of administration (i.e., in pharmacy, pharmacy parking lot, patient’s home). Please refer to OPA’s Pharmacy Playbook for COVID-19 Vaccine Administration for a sample workflow on how to integrate the documentation requirements into practice.

As part of the documentation requirements listed in the EO notice, a written and electronic (if applicable) record of the COVID-19 immunization administration must be provided to the patient, which includes the pharmacy’s contact information and date and time for the second scheduled dose (if applicable) at the same pharmacy location. As the record from COVaxON is the official proof of immunization, it must be provided to the patient. Pharmacies should provide patients with the option of receiving either a print-out or electronic version of the COVaxON record. Of note, currently this record from COVaxON does not include the pharmacy’s contact information nor the appointment information for the second dose. For pharmacies who are providing a print-out of this record to the patient, the pharmacy’s contact information and second dose appointment date and time must be added to the print-out. Alternatively, pharmacies may choose to provide a separate written record of immunization (along with the printed or emailed COVaxON proof of immunization record) to the patient that contains all the required information. Please note that although patients with a green Ontario photo health card have access to their receipts online through the provincial system, pharmacies are still required to provide a written record following administration.

To meet this requirement, after providing the written and electronic (if applicable) COVID-19 immunization record to the patient, pharmacy professionals should document that this step has been completed and how it was provided (written and electronic if applicable) with the patient’s administration record for audit purposes. Please note that although patients with a green Ontario photo health card have access to their receipts online through the provincial system, pharmacies are still required to provide a written record following administration.

Pharmacy professionals who have first aid training are permitted to administer epinephrine auto-injectors for emergency treatment after administration of the COVID-19 vaccine and regardless of who administered it, the epinephrine auto-injector will be reimbursed by the Ministry for this purpose. However, it is important to note that when submitting the claim through the HNS, the name of the Part A pharmacist who administered or supervised the administration must be included in the prescriber field.

The date of service for the COVID-19 vaccine administration claim for payment must be the same as the date the vaccine was administered, therefore the claim should, if possible, be submitted on the same day as the administration. However, the HNS can process online transactions for publicly funded services on any of the most recent seven calendar days, including the current date. This means that a claim for the COVID-19 vaccine could be submitted today for a service date in the past (as long as it is within the past 7 days). For example, if the current date is March 24, a claim with a transaction date of March 17 will be rejected (i.e., response code “A1 – Claim too old”); whereas a transaction date of March 18 will be accepted.

For ODB drug claims, if more than seven calendar days have elapsed after the drug was supplied and the pharmacy was unable to verify that the drug was for an eligible person until more than 7 days after the dispensing event, the pharmacy could submit their claim for payment manually with a paper-based submission, in accordance with paragraph 1 of subsection 24(2) of O. Reg. 201/96 under the Ontario Drug Benefit Act. However, no manual paper claims will be accepted for COVID-19 vaccine administration at the pharmacy as per the . Therefore, the pharmacy can only submit the COVID-19 vaccine administration claim up to 7 days from the service date electronically through the HNS.

Insurance

For pharmacists, pharmacy interns, pharmacy students and pharmacy technicians who have OPA’s Individual Professional Liability Insurance (PLI), coverage will be provided as long as the insured individual is practicing within their scope and in accordance with the COVID-19 Vaccine Agreement with the Ministry. For more information about your coverage, please contact [email protected]. As the terms and conditions of coverage may vary between plans, it is recommended that pharmacy professionals who have individual PLI with other carriers check with their individual plans regarding coverage.

The OPA Store Insurance Program automatically provides entity professional liability coverage for pharmacies that are participating in the administration of publicly funded COVID-19 vaccines. This coverage protects you or other licensed individuals in your employ from negligent acts, errors or omissions as long as the individuals were practicing within their scope and in accordance with the COVID-19 Vaccine Agreement with the Ministry as part of the pharmacy’s business activities. For more information about your coverage, please contact [email protected]. As the terms and conditions of coverage may vary between plans, it is recommended that pharmacy professionals who have store insurance with other carriers check with their individual plans regarding coverage.

COVaxON

Pharmacies with questions related to COVaxON should contact the Pharmacy IT department of their corporate/chain/banner head office for further assistance. Pharmacies without access to corporate/chain/banner head office support may contact OPA for support.

Pharmacies with requests to change user profile information on COVaxON should submit the request to the COVaxON Support Team at [email protected] either through their ONEMail account or through their designated Corporate Office contact who is listed as a COVax Trainer. Only requests received via these two mechanisms will be accepted in order to verify that the individual requesting the change is authorized to do so.

All clients should be checked out of COVaxON as part of their final step in the dose administration process (after receiving their dose and monitoring for AEFI). This step is important in order to generate a proof of vaccination (receipt) for the patient. To assist with this process, if it is the same pharmacy professional who checks in a patient, administers the vaccine, and checks out a patient, the pharmacy should use the ‘simplified flow’ process which automatically launches the “check out” step. If the simplified flow process is not used or is closed before finishing the check out, pharmacy staff can also check out the patient by going back into the client record, selecting “Check Out” and following the regular check out process. 

Alternatively, as of June 4, 2021, if a client is not properly checked out of COVaxON, the system will automatically check the client out 7 days after they received their dose.  

  • “Dose 1 Administered” – after 7 days in this status, the system will automatically update to “Dose 1 Checked Out”. This will allow the patient to be checked in if/when they arrive for their second dose.
  • “Dose 2 Administered” – after 7 days in this status, the system will automatically update to “Dose 2 Checked Out”. The status bar will indicate “Completed” when all doses in the series have been completed. It will also be indicated under Client Status below the Client’s Name.

This status change will be tracked in the “Person Account History” and can be viewed if necessary.

Duplicates are detected in the system if there is an exact match on the health card number, OR a combination of other demographics:

  • Name match on 2 or more of the first name (exact or approximate), and last name (exact or approximate)
  • And one of: date of birth (exact match), postal code (exact match), OR phone number (exact match, the phone number and the phone type match)

In this situation, the pharmacy should follow these steps:

  • Select the “view duplicates” hyperlink and review the record of the duplicate. Determine the root cause of the duplicate record and confirm they are two different patients.
  • A) If it is the same patient, leverage the existing record to add additional information and proceed to the next steps.
  1. B) If the confirmed client record does not exist and the duplicate record reviewed is not actually a duplicate client, follow the workarounds below to create a file for the new client:

If the root cause is DOB + name: Add 2 spaces at the end of the first and last name. If the error persists and the client has a middle name, add the middle name after the first name.

If the root cause is postal code/address + name: Do not enter the postal code or remove the address if it is auto populated. It should allow you to successfully save the client record. Once the record is created, you can add the postal code or address afterwards.

If the root cause is name (same/similar first and last name): Add 2 spaces at the end of the first and last name. If the error persists and the client has a middle name, add the middle name after the first name. If the error still persists, add the first, middle and last name in the last name field.

Note that these workarounds are not a permanent solution and will be addressed in future system enhancements.

Pharmacies that are receiving supply from their local PHU directly need to enter and log this inventory differently than supply delivered by pharmaceutical distributors (i.e., McKesson and Shoppers Drug Mart). As these vaccine supplies are not new shipments, but rather transfers between two Authorized Organizations (i.e., from PHU to the pharmacy location), a new shipment and inventory should not be created. Instead, the pharmacy must accept the transfer of the vaccine (and diluent if applicable) and change the Storage Location under the Location section of the Inventory page from the PHU freezer to the pharmacy’s refrigerator to indicate removal of the inventory from the storage unit belonging to the PHU. For more information about how to accept a transfer of inventory, please refer to the COVaxON Inventory Management Job Aid.

Effective June 4, on the first week of each month, the Ministry of Health will mark a pharmacy’s COVaxON account inactive if it has been dormant, i.e., no activity for 30 days. To reinstate the inactive account, the contact person for the pharmacy, i.e., the person who originally completed the User Template, should contact their corporate/chain/banner head office for further assistance. Pharmacies without access to corporate/chain/banner head office support may contact OPA for support. Please note that requests to reactivate an inactive account received from individual users directly will not be accepted.

Selection of the appropriate reason for immunization (RIM) is important to ensure that the data collected can be accurately used to assess population vaccination rates. As such, the Ministry has identified a need to standardize RIM entry in COVaxON and has provided a guidance document to assist with identifying the most appropriate RIM to select. This guidance document provides definitions and considerations of different RIMs and has a flowchart to help guide RIM selection.

The Ministry is in the process of reviewing all data entered into the COVaxON database to ensure consistency and accuracy. The first round of bulk remediation for common issues took place the week of June 14 and fixed the majority of data issues. However, some issues specific to individual files will need to undergo manual remediation and all authorized organizations, including public health units, hospitals, and pharmacies, will be responsible for remediating their own records.

As such, some pharmacies may have received or will be receiving a remediation request which includes a remediation guide and an Excel file of the records to be updated. Pharmacies with questions should contact the Pharmacy IT department of their corporate/chain/banner head office for assistance. Pharmacies without access to corporate/chain/banner head office support may contact OPA.

Additional Questions

Participating pharmacies who would like to make changes to their pharmacy information on the Ministry’s COVID-19 pharmacy vaccine locations webpage should send their requests directly to the Ministry at [email protected]. Please use the email subject line: “COVID-19 Vaccination Webpage Change Request” and include the following:

  • Change requested (e.g., typo, new phone # or URL, etc.)
  • Pharmacy name, address, ON Provider # (mandatory)

Requests may take at least 24 hours to be processed and reflected on the webpage.

For billing inquiries, pharmacies should contact: ODB Pharmacy Help Desk at 1-800-668-6641.

For inquiries about the program or materials, pharmacies can contact the Ministry at [email protected].

Members of OPA can also access our Practice Support Network at [email protected].

Participating pharmacies who would like to be permanently or temporarily removed from the COVID-19 vaccine administration program should contact the Ministry via email at [email protected] to make the request. For those requesting temporary removal, please indicate this in your initial email and once the pharmacy is ready to resume the service, the pharmacy can send a follow-up email to the same email address to inform the Ministry to restart the service.