Recommendations on the use of COVID-19 vaccine(s)

The following highlights key, current information for immunization providers on COVID-19 vaccine. The evidence on COVID-19 disease and vaccines is evolving. Evidence from clinical trial data is limited due to limitations in the size and duration of follow-up of trial populations; however, studies are ongoing. NACI will continue to monitor the data and update its recommendations as needed. Please refer to the remainder of the Statement for details.

What
Novel coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Anyone can be infected with SARS-CoV-2. However, some populations are at increased risk of exposure to the virus (e.g., due to living or work settings), and some populations are at increased risk of severe disease and death due to biological (e.g., advanced age, pre-existing medical conditions) and social (e.g., low socioeconomic status, belonging to a racialized population) factors that may intersect. Risk factors for exposure and severe disease may overlap, further increasing risk. Any combination of these factors, as well as varying access to health care services, has the potential for disproportionate consequences for specific populations.
Currently authorized vaccine: Pfizer BioNTech COVID-19
This vaccine is authorized for use in Canada for individuals 16 years of age and older.
In clinical trials, the vaccine is efficacious in the short-term against symptomatic, confirmed COVID-19 disease; trials are ongoing. Protection offered by the first dose is lower than the efficacy achieved after the second dose. Peak humoral and specific cellular immune responses occur after the second dose.There is currently insufficient evidence on the duration of protection and on the efficacy of this vaccine in preventing death, hospitalization, infection and reducing transmission of SARS-CoV-2, although studies are ongoing.
No serious safety concerns have been identified to date in clinical trials; however, studies are ongoing. Some adverse events are very common and were reported to affect more than 10% of people who receive the vaccine. However, they are mild or moderate and transient, resolving within a few days. These include: pain at the injection site, fatigue, headache, muscle pain, chills, joint pain, and fever. Some adverse events, including fever, are more frequent after the second dose.
There is currently minimal evidence to inform on differences in vaccine efficacy or safety between those with and those without prior evidence of SARS-CoV-2 infection at the time of vaccination.

Who
NACI makes the following recommendations:
A complete vaccine series of currently authorized COVID-19 vaccine should be offered to:
Individuals in the authorized age group without contraindications to the vaccine. In the context of limited vaccine supply, initial doses of COVID-19 vaccine(s) should be prioritized for the key populations outlined in NACI's Guidance on the Prioritization of Initial Doses of COVID-19 Vaccine(s).
A complete vaccine series of COVID-19 vaccine may be offered to:
Individuals in the authorized age group without contraindications to the vaccine who have had previously PCR-confirmed SARS-CoV-2 infection. In the context of limited vaccine supply, initial doses may be prioritized for those who have not had previously PCR-confirmed SARS-CoV-2 infection. Testing for previous SARS-CoV-2 infection is not needed prior to COVID-19 vaccination.
COVID-19 vaccine should not be offered to the following populations excluded from clinical trials until further evidence is available. However, if a risk assessment deems that the benefits of vaccine outweigh the potential risks for the individual (e.g. where the risk of severe outcomes of COVID-19 and risk of exposure to SARS-CoV-2 is high) or for the fetus/infant (in the case of pregnancy/breastfeeding) and if informed consent includes discussion about the insufficient evidence in this population, then a complete series of authorized COVID-19 vaccine may be offered to individuals in the following populations:
Immunosuppressed due to disease or treatment or suffering from autoimmune disorder
Pregnant or breastfeeding
Adolescents 12 to 15 years of age

NACI also recommends that:
All individuals should continue to practice recommended public health measures for prevention and control of SARS-CoV-2 infection and transmission regardless of vaccination with COVID-19 vaccine, at this time, due to insufficient evidence on the duration of protection and effectiveness of COVID-19 vaccines in preventing asymptomatic infection and reducing transmission of SARS-CoV-2.

Routine immunization programs and immunization with other vaccines recommended by NACI should continue during the COVID-19 pandemic with mitigation of risks of COVID-19 transmission during the immunization process as outlined in the Interim guidance on continuity of immunization programs during the COVID-19 pandemic.

Clinical trials assessing COVID-19 vaccines should continue to be encouraged to include individuals with potential vulnerabilities to disease related to biological (e.g., pre-existing medical conditions, frailty, pregnancy and breastfeeding, immunocompromised), and social (e.g., residence in long term care facilities or crowded/remote locations, belonging to a racialized population, occupation) factors to ensure that vaccine options are informed by robust safety, immunogenicity, and efficacy data as outlined in NACI's guidance on Research Priorities for COVID-19 Vaccines to Support Public Health Decisions.

In addition to ongoing vaccine pharmacovigilance activities in Canada with Phase 4 clinical trials and post-marketing studies, additional research and surveillance of COVID-19 vaccination, particularly in populations not currently included in clinical trials (e.g., pregnant, breastfeeding, immunocompromised, seniors living in congregate care settings, children and adolescents) is recommended. Furthermore, NACI recommends the continuation of clinical trials and ongoing follow-up of participants for as long as it is ethically feasible to determine the level of immunity needed to prevent disease, duration of protection, efficacy in different sub-populations, and medium- and long-term safety.
NACI continues to recommend the following elements to guide ethical decision-making, as outlined in NACI's guidance on Key Populations for Early COVID-19 Immunization:

Efforts should be made to increase access to immunization services to reduce health inequities without further stigmatization or discrimination, and to engage systemically marginalized populations and racialized populations in immunization program planning.
Jurisdictions should ensure close and rapid monitoring of safety, coverage and effectiveness of the vaccine(s) in different key populations, as well as effective and efficient immunization of populations in remote and isolated communities.
Efforts should be made to improve knowledge about the benefits of vaccines in general and of COVID-19 vaccine(s) specifically once available, address misinformation, and communicate transparently about COVID-19 vaccine allocation decisions.

How
Currently authorized COVID-19 vaccine is administered intramuscularly in a two-dose schedule with the second dose administered according to the schedule in Table 2.
Attempts should be made to complete the vaccine series with the same vaccine product.
Serologic testing is not needed before or after receipt of a COVID-19 vaccine to assess susceptibility to SARS-CoV-2 or immune response to the vaccine.
COVID-19 vaccines should not be given simultaneously with other live or inactivated vaccines at this time, unless other vaccines are required for post-exposure prophylaxis.
COVID-19 vaccines should not be given simultaneously with monoclonal antibodies or convalescent plasma.

Why
The COVID-19 pandemic has caused significant morbidity and mortality, as well as social and economic disruption in Canada and worldwide.
The authorized COVID-19 vaccine that is recommended for use by NACI in this Statement has demonstrated safety and efficacy against symptomatic laboratory-confirmed COVID-19 disease.