0 | SUMMARY OF UPDATED NACI VACCINE STATEMENT OF APRIL 20, 2021

National Advisory Committee

on Immunization (NACI)

Summary of Updated NACI Vaccine Statement of

April 23, 2021
1 | SUMMARY OF UPDATED NACI VACCINE STATEMENT OF APRIL 20, 2021

Overview
 COVID-19 vaccination is fundamental to ending the pandemic. NACI encourages all
Canadians to get vaccinated to protect themselves, their families, and their communities
from illness, hospitalizations and deaths from COVID-19.

 The AstraZeneca COVID-19 vaccine is authorized for use in Canada for adults 18
years of age and over. Health Canada has determined that it is a safe and effective
vaccine.

 NACI has updated its recommendations on the use of the AstraZeneca vaccine in
light of a rare but serious condition being referred to as Vaccine-Induced Immune
Thrombotic Thrombocytopenia (VITT). Using the most recent data available, NACI
assessed the benefits of the AstraZeneca COVID-19 vaccine in saving lives and
protecting populations against serious complications of COVID-19 and the risks of
VITT.

 In this guidance statement, it is important to note that NACI provides advice on the
use of the AstraZeneca COVID-19 vaccine in the context of the other COVID-19
vaccines currently authorized and available for use in Canada, in order to achieve the
greatest public health benefits.

 As individuals make decisions about vaccination, NACI emphasizes the importance of

providing clear information that supports informed decision-making and considers both the
benefits and risks of vaccination choices. This supports vaccine confidence in a context of
rapid scientific advancement where guidance necessarily changes as new evidence
emerges. Canadians should expect to see NACI modify its guidance as new evidence
becomes available.

 Provinces and territories are responsible for determining their vaccination policies,
and designing and delivering their immunization programs. Jurisdictions consider
NACI’s guidance in their decision-making.

 Based on NACI’s initial technical briefing to provinces and territories, jurisdictions have
already begun to announce their intentions regarding the use of the AstraZeneca COVID-
19 vaccine, reflecting the pressing epidemiological conditions within their jurisdictions.

 At this time and based on current evidence, NACI recommends that the AstraZeneca
COVID-19 vaccine may be offered to individuals 30 years of age and older without
contraindications, if the individual does not wish to wait for an mRNA vaccine and the
benefits outweigh the risk.

 NACI recognizes that public health benefit-risk analyses for the use of the AstraZeneca
COVID-19 vaccine may vary between jurisdictions based on factors such as local COVID-
19 epidemiology; local vaccine supply and logistics; and equity and acceptability
considerations. These factors will change over time.
2 | SUMMARY OF UPDATED NACI VACCINE STATEMENT OF APRIL 20, 2021

 NACI continues to preferentially recommend authorized mRNA COVID-19 vaccines due

to the excellent protection they provide, the absence of safety signals of concern and the
acceptability of the vaccines by people in Canada. NACI notes that Canada has procured
and is expecting enough mRNA vaccines to fully vaccinate the currently eligible Canadian
population before fall 2021.

Background
 NACI has updated its Recommendations on the use of COVID-19 vaccines following reports
of rare but serious blood clots with low levels of blood platelets after the receipt of the
AstraZeneca COVID-19 vaccine. This condition is being referred to as Vaccine-Induced
Immune Thrombotic Thrombocytopenia (VITT).

 Cases of VITT following the use of the AstraZeneca vaccine were first seen in Europe where
the AstraZeneca vaccine has been widely used. As of April 20, 2021, three cases of VITT
have been confirmed in Canada following the administration of more than 700,000 doses of
the AstraZeneca vaccine. The risk of developing VITT does not seem to be related to age or
sex.

 On March 29, 2021, NACI recommended an immediate pause in the use of the AstraZeneca
COVID-19 vaccine in those under 55 years following the reports of VITT in Europe. NACI
made this recommendation out of an abundance of caution while Health Canada and other
global regulators investigated the association of VITT with the AstraZeneca vaccine.
Provincial and territorial Chief Medical Officers of Health unanimously supported this
decision.

 On April 14, 2021, Health Canada released their safety assessment. Health Canada
concluded that very rare events of blood clots associated with low levels of blood platelets
following immunization with the AstraZeneca COVID-19 vaccine may be linked to the
vaccine. Health Canada reaffirmed that the benefits of the AstraZeneca COVID-19 vaccine
outweigh the risks and adjusted the product's labelling to reflect the available scientific
evidence.

 NACI met on April 13, 15, 17 and 20, 2021, to review the most up to date domestic and
international evidence and guidance on VITT, and used Health Canada’s safety assessment
of the AstraZeneca COVID-19 vaccine that was released on April 14, 2021, to inform its
deliberations. NACI assessed the risk of developing and dying from VITT compared to
COVID-19 ICU admissions and deaths that could be prevented by an early dose of the
AstraZeneca COVID-19 vaccine under various COVID-19 incidence rates.

 NACI’s updated recommendations are also informed by Canada’s rapidly changing COVID-
19 epidemiology, including the circulation of variants of concern and hotspot areas; and a
comprehensive analysis of ethics, equity, feasibility and accessibility.

 NACI provides population level advice to help provinces and territories plan immunization
programs in their jurisdictions. NACI recognizes that public health benefit-risk analyses for
the use of the AstraZeneca COVID-19 vaccine may vary between jurisdictions due to their
unique circumstances, including local epidemiology and local vaccine supply.
3 | SUMMARY OF UPDATED NACI VACCINE STATEMENT OF APRIL 20, 2021

 NACI continues to preferentially recommend authorized mRNA COVID-19 vaccines due to

the excellent protection they provide, the absence of any safety signals of concern and the
acceptability of the vaccines by people in Canada. NACI notes that Canada has procured
and is expecting enough mRNA vaccines to fully vaccinate the currently eligible Canadian
population before fall 2021.

 At this time and based on current evidence, NACI recommends the AstraZeneca COVID-19
vaccine may be offered to individuals 30 years of age and older without contraindications if
the individual does not wish to wait for an mRNA vaccine and if the following conditions are
met:
o A benefit-risk analysis determines that the benefit of earlier vaccination with
the AstraZeneca COVID-19 vaccine outweighs the risk of the individual getting
COVID-19 while waiting for an mRNA COVID-19 vaccine;
o The individual provides informed consent once the benefits and risks of VITT
compared to COVID-19 are clearly outlined, including how long the individual will
have to wait for an mRNA vaccine and what public health measures the individual is
able to take to minimize their exposure to the COVID-19 virus; and
o The individual will have to wait a long time in order to receive an mRNA vaccine.

 Provincial and territorial public health officials will determine how the AstraZeneca COVID-
19 vaccine will be used in their respective jurisdictions. Provinces and territories should
adapt NACI’s recommended age threshold based on their local epidemiology. Health
officials can refer to a Risk Assessment Framework for the use of the AstraZeneca vaccine
included in the appendix of NACI’s updated statement.

 Many other countries have either paused the use of the AstraZeneca COVID-19 vaccine or
implemented age restrictions. Actions related to the AstraZeneca COVID-19 vaccine are
expected to differ as countries have different circumstances, including different levels of
COVID-19 activity and different access to COVID-19 vaccines.

 Healthcare professionals should be aware of VITT, including how to diagnose and treat the
condition. There is additional guidance available from the Ontario COVID-19 Science
Advisory Table and Thrombosis Canada.

 Individuals who receive the AstraZeneca COVID-19 vaccine should monitor their health and
immediately seek medical attention if they develop symptoms of VITT, including shortness of
breath, chest or abdominal pain, leg swelling, severe headaches or blurred vision, and skin
bruising or a skin rash. Quick diagnosis and treatment is critical to reduce the risk of
negative outcomes.

 NACI will continue to closely monitor the evolving data around this rare but serious safety
signal following the receipt of the AstraZeneca COVID-19 vaccine. NACI will continue to
update their recommendations as needed.

To see the full update, please visit Recommendations on the use of COVID-19 vaccines.