COVID-19: Vaccines

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This resource is revised often and new content is added regularly to guarantee that the latest evidence and regulatory recommendations are included. The CEP is committed to ensuring this information is accurate and up to date.
Last reviewed: March 2, 2021
Last updated: March 2, 2021

COVID-19 vaccine authorization

Health Canada has authorized the first COVID-19 vaccines for use in Canada after a thorough and rigorous review of the evidence to ensure the vaccines meet the standards of safety, quality and efficacy for authorization in Canada. Health Canada will continue to monitor the safety of the vaccines after they are available.

Key messages

  • Lead by example. Get the COVID-19 vaccine yourself as soon as it is offered to you to protect yourself, your patients, and your community.
  • Advise patients to receive the vaccine. Communication by trusted health professionals about the importance of vaccines is the most effective way to counter vaccine hesitancy. Tell your patients you will get or have already received the vaccine.
  • Be an educator. Be prepared to answer patient questions and address concerns about the vaccine.

Click on the sections below to get started:

Vaccination operations New

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Rollout

Dose delivery schedule

As of February 18, 2021, Ontario has received 512,655 doses of the Pfizer-BioNTech vaccine and 170,600 doses of the Moderna vaccine (683,255 total doses). Delivery of the AstraZeneca vaccine will begin within the first few weeks of March. Amounts may fluctuate, and the numbers will be updated as quantities and timing of deliveries are confirmed.

  • March-May: Approx. 6.5M Pfizer/Moderna, 20M AstraZeneca

For upto-date delivery numbers, see:

Vaccine distribution

Based on the province’s COVID-19 Vaccination Distribution Plan, Ontario is in the process of transitioning from Phase 1 to Phase 2. Vaccine delivery in each region will vary (see Local rollout below).

Phase 1: High-risk populations
When:

December 2020 – March 2021*

Who:

Immediate priority:

  • staff, essential caregivers and any residents that have not yet received a first dose in:
    • long-term care homes
    • high-risk retirement homes
    • First Nations elder care homes
  • alternative level of care patients in hospitals who have a confirmed admission to a long-term care home, retirement home or other congregate care home for seniors
  • health care workers identified as highest priority, followed by very high priority (including primary care; see COVID-19: Guidance for Prioritizing Health Care Workers for COVID-19 Vaccination (MOH, February 9, 2021))
  • Indigenous adults in northern remote and higher risk communities (on-reserve and urban)

Once all reasonable steps have been taken to complete first doses of interested individuals in the immediate category:

Where:

To vaccine people as quickly as possible, vaccination will continue to be provided in the following:

  • hospitals
  • on-site clinics for:
    • northern and remote First Nations communities
    • on-reserve Indigenous residents
    • adult chronic home care recipients
  • mobile sites for:
    • congregate living facilities
    • urban Indigenous communities
Phase 2: Mass delivery
When:

April – July 2021*

Who:

~ 8.7 million people from the following groups:

  • older adults, beginning with those 75 years of age and decrease in five-year increments
  • people who live and work in high-risk congregate settings (e.g., shelters, community living, etc.)
  • frontline essential workers, including first responders, education workers and the food processing industry
  • other populations and communities facing barriers related to the determinants of health who are at greater COVID-19 risk
Where:

Over the coming months, more sites are being added to vaccinate as many people as quickly as possible. Vaccines will be available at:

  • municipally-run vaccination sites
  • hospitals
  • mobile vaccination sites
  • pharmacies
  • clinics
  • primary care settings
  • community locations, such as community health centres and Aboriginal health access centres
Phase 3: Steady state
When:

August – December 2021*

Who:

Remaining Ontarians who wish to be vaccinated

Where:

Primary care, pharmacies and public health clinics

Provider education

Educate yourself about the vaccines and common questions patients have.

Vaccination operations

Vaccination sites

Public Health Units (PHUs) will lead local vaccination distribution in partnership with health and municipal sectors, with hospitals continuing to lead vaccination of hospital-based physicians and healthcare workers. PHU-led vaccination will include a combination of mass vaccination sites, mobile teams, and pharmacies. For primary care, collective “mini-mass vaccination clinics” of several practice working together is a format under consideration. The 34 Public Health Units in the province are in the process of identifying primary care vaccination leads. Most PHUs have up-to-date information regarding the current regional vaccination status on their websites. Some PHUs have already started vaccinating the next priority groups. 

The following PHUs have released their vaccination plans:

If you are interested in supporting vaccine rollout in your area:

Vaccination timeline

The Task Force gave this conservative timeline estimate. Some PHUs have indicated they will begin sooner; see PHU vaccination plans for more information. Timelines are dependent on stability of vaccine supply and subject to be condensed or expanded based on pace.

  • ~March 21: vaccinations begin for people 80 years and over
  • April 15: vaccinations begin for people 75 years old and over
  • May 1: vaccinations begin for people 70 years old and over
  • June 1: vaccinations begin for people 65 years and over
  • July 1: vaccinations begin for people 60 years and over

Vaccination logistics

Online portal

  • Timeline: Around March 15, MOH will launch the online portal (COVaxON) and telephone booking system
  • COVaxON and EMR: For the time being, the vaccination database, COVaxON, will not be EMR-integrated. This is due to the fact that the COVax software will need to respond quickly to changes and updates and to minimize support demands. It is possible that integration opportunities will be explored over time. In the meantime, MOH is exploring mechanisms to ensure primary care providers have access to up-to-date vaccination information about their patients.
  • Training and onboarding: when more vaccines become available, MOH will issue login credentials to primary care providers who indicate they will be administering COVID vaccines. This will be done in collaboration with local public health units.

Identifying patient groups

  • While many details are yet to be determined, primary care providers can start preparing by querying their EMR to identify patients 80+ (the first priority age group). Public communications from the province and PHUs will also be deployed to notify patients 80+ about how/where to book and get vaccinated. eHealth Centre of Excellence has developed Vulnerable Population EMR Resources to assist primary care with the identification and prioritization of patients from their roster for the COVID-19 vaccination. See Digital Health Supports for COVID-19 for more information.
  • As the vaccination of healthcare workers is key to the larger vaccination effort, consider proactively reaching out to any patients who are healthcare providers to encourage them to be vaccinated.

Patient communications

Patients have a lot of questions about when they can get the vaccine, as well as how safe it is, side effects, etc. Two types of communications are recommended at this time:

Logistical communications about vaccination appointments
  • Check your local PHU vaccination plan to get the most up-to-date information.
  • It may be necessary to take a multi-pronged approach based on the needs of patients and what is feasible within your practice. 
  • Send an email/secure messaging blast, and update website and email signatures with information about vaccine appointments and link to local PHU.
  • Consider using mass texting services to connect with patients for information about vaccine appointments and link to local PHU.
    • Sample text: “COVID-19 Vaccine Update: We are currently not booking vaccinations. Check [local PHU page] for up-to-date information on local vaccination plans. Please avoid calling in an attempt to schedule vaccinations at this time.”
Communications about vaccine safety, side effects, and other common questions
  • Share patient-facing resources about vaccine safety. CEP’s Patient Vaccine Resources collection includes multilingual short infographics and videos as well as comprehensive FAQ’s, available in French, Arabic, Punjabi, Chinese, Indigenous languages, and more, as well as resources specific to Indigenous and Black communities.
  • OCFP developed a sample email you can use as a base for designing your patient communications about COVID-19 vaccine questions
  • See below for more support and training in developing patients’ vaccine confidence.

Vaccine confidence

As trusted healthcare providers, primary care providers are key to achieving widespread vaccination.

Emerging evidence: specific populations, adverse events and vaccine dosage interval New

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AstraZeneca and older adults

At present, NACI does not recommend the use of this vaccine in individuals ≥65 years and older due to limited information on the vaccines efficacy in this age group (NACI, March 1, 2021). This decision comes from the fact that there was a relatively small number of participants aged 65 years or over who were recruited into the clinical trials and there were only a few cases of COVID-19 in either the vaccine or the control group in this age category. As a result of this, the confidence interval on the efficacy estimate is very wide. More precise efficacy estimates for this age group are expected soon, from both ongoing trials and vaccine effectiveness studies in countries that are currently using this vaccine (AstraZeneca, February 2021; WHO, February 10, 2021).

COVID-19 Variants and vaccines

Through increased global monitoring, new COVID-19 variants have been identified. Variants of viruses are common and changes to the genetic material of the virus are expected over time.

The currently identified COVID-19 variants include:

  • B.1.1.7 or VOC-202012/01 originating in the United Kingdom
  • B.1.351 or 501Y.V2 originating in South Africa
  • P.1 originating in Brazil
  • B.1.429 or CAL.20C originating in California

These variants contain multiple mutations, including some in the receptor-binding domain (RBD) of the spike protein. The virus uses the spike protein’s RBD to enter cells, and most vaccines specifically target the RBD, which raises theoretical concerns over vaccine efficacy. RBD mutations include the N501Y, K417N/T, L452R and E484K mutations:

  • The N501Y mutation is found in all B.1.1.7, B.1.351, and P.1 variants (PHO, February 3, 2021).
  • The E484K mutation is found in all P.1 and B.1.351 variants, and has recently been found in some B.1.1.7 variants in the UK (BMJ, February 5 2021). This mutation has been associated with potential escape from the immune system (PHO, February 3, 2021).

Emerging evidence suggests that some variants of COVID-19 may have an impact on the efficacy of approved COVID-19 vaccines, however more research is required (Health Canada, February 1, 2021). Pfizer-BioNTech, AstraZeneca and Moderna are all conducting research to update their vaccines to protect against emerging variants, particularly variant B.1.351 (PHO, February 7, 2021).

Evidence limitations

Most studies on variants and vaccine efficacy test antibodies taken from vaccine recipients to determine their ability to neutralize synthetic spike proteins that are designed to resemble those of the variants. However, neutralization studies may not be an accurate proxy for vaccine efficacy; it is possible for a person with a reduced neutralizing antibody response to be fully immune (PHO, February 7, 2021).

So far, antibodies from vaccine recipients appear to be less effective at neutralizing the spike proteins of variants, with the largest decreases in neutralization observed with the B.1.351 variant (PHO, February 3, 2021; PHO, February 7, 2021). This pattern has been seen using antibodies from Pfizer-BioNTech, Moderna, AstraZeneca, and Johnson & Johnson vaccine recipients (PHO, February 7, 2021). 

An unpublished, non-peer-reviewed clinical trial evaluating the AstraZeneca vaccine suggested that it provides little protection against mild-moderate disease caused by the B.1.351 variant. However, the sample size in this trial was small, and it did not test the vaccine’s efficacy against severe disease or hospitalization (medRxiv pre-print, February 12, 2021).

Extended time between vaccine doses

In an effort to vaccinate many people as quickly as possible, cities and countries around the world are making the decision to extend the interval between doses for the Moderna and Pfizer-BioNTech vaccines.

In Ontario, this practice has been enacted in response to the recent manufacturing and supply chain delays for the Pfizer vaccine, until the dosage delivery schedule returns to its intended targets. The new schedule (for the Pfizer vaccine only) is as follows:

  • Residents and staff at long-term care and high-risk retirement homes who have received their first dose of the Pfizer vaccine will receive a second dose in 21 to 27 days.
  • All others who receive the Pfizer vaccine will receive their second dose between 21 and 42 days after the first.

This action is in accordance with NACI’s recent guidance, which offered the following evidence summary and rationale: (NACI, March 1, 2021)

  • Vaccine efficacy of one dose against symptomatic COVID-19 disease calculated starting 14 days after dose 1 has been found to be 92.3% for the Pfizer-BioNTech vaccine (95% CI: 69 to 98%) and 92.1% for the Moderna vaccine (95% CI, 68.8 to 99.1%).
  • Efficacy analyses in the Pfizer-BioNTech clinical trial included participants that received their second dose within 19-42 days after their first dose, and the majority of participants in the Moderna clinical trial received their second dose between 21 to 42 days after the first.
  • While the immune response of a delayed second dose for the COVID-19 vaccines is unknown, with other vaccines, immune response is either similar or improved when the second dose is administered after a longer interval.
  • Principles of immunology, vaccine science, and historical examples demonstrate that delays between doses do not result in a reduction in final antibody concentrations nor a reduction in durability of memory response for most multi-dose products.
Evidence limitations
  • Limited numbers and narrow window of follow-up time (as small as one week) require these results to be interpreted with caution.
  • Duration of protection of the first dose is unknown. If the interval between doses is extended, it is possible that breakthrough disease may begin to occur before the second dose is given.

Immunocompromised populations

Why has this been in the news?

The authorization of COVID-19 vaccines (Pfizer-BioNTech, Moderna, and AstraZeneca) and release of their clinical trial details has prompted discussion of who may receive the vaccine based on questions about populations that were included and excluded from the clinical trials.

All three of the vaccine trials:

How does this apply to my practice?

Acknowledging the lack of available evidence, due to the risk of COVID-19 a number of professional organizations recommend that:

  • Individuals within the authorized age groups with autoimmune conditions, immunodeficiency conditions or who are immunosuppressed (due to treatment or autoimmune disorder) may choose to receive the vaccine after informed counselling and consent if a risk assessment deems that the benefits outweigh the potential risks for the individual.
  • Patients receiving treatments that may affect the immune system should be offered vaccination after counselling and informed consent from their treating providers, including a discussion of their vaccination timing in relation to other treatments or possible treatment modifications.
  • There is currently no evidence to indicate whether disease-modifying anti-rheumatic drugs (DMARDs) should be withheld during COVID-19 vaccination. Risk of disease flare should be considered by the treating provider (NACI, March 1, 2021; MOH, February 12, 2021; CDC, January 6, 202; CRA, December 31, 2020).

Pregnant and breastfeeding individuals

Why has this been in the news?

Pregnant and breastfeeding individuals require special considerations for COVID-19 vaccination. Because they were not included in the Phase III clinical trials, there is no data on adverse outcomes of the vaccines on this patient population at this time, though mRNA and viral vector vaccines are not hypothesized to be a risk to the breastfeeding infant (MOH, February 12, 2021; NACI, March 1, 2021; SOGC, February 15, 2021; OSOG/OMA-OG, 2021).

How does this apply to my practice?

Key takeaway: For pregnant and breastfeeding individuals in the authorized age group, the choice to receive the vaccine resides with the patient and should be made after informed counselling with a healthcare provider familiar with their pregnancy. Providers should document this discussion, but patients do not have to provide the vaccination site with a note from their provider (MOH, February 12, 2021).

Further guidance is available on nuanced cases for this population:

  • For patients who determine pregnancy between vaccine doses:
    • NACI recommends that completion of the series should be delayed until after pregnancy, unless risk factors for increased exposure or severe COVID-19 are present and informed consent for vaccination is obtained (NACI, March 1, 2021).
    • SOGC recommends that decision to give a second dose should be based on the results of an individual risk assessment, and that the pregnancy should not be terminated based on having received the vaccine (SOGC, February 15, 2021).
  • For patients planning a pregnancy:
    • The COVID-19 vaccination series should be completed before pregnancy to help ensure maximal efficacy. There is currently no evidence to guide the time interval between the completion of the COVID-19 vaccine series and conception. In the face of scientific uncertainty, NACI recommends it may be prudent to delay pregnancy by 28 days or more after the administration of the complete two-dose vaccine series of a COVID-19 vaccine (SOGC, February 15, 2021; NACI, March 1, 2021).
  • For patients planning the timing of vaccination during pregnancy:
    • SOGC recommends to wait 14 days after any other vaccine before receiving a COVID-19 vaccine, however because of the pandemic simultaneous or closer interval of administration may be considered. The SOGC also recommends that after receiving a COVID-19 vaccine dose, where possible to wait 28 days before receiving any other vaccine, unless a vaccine is required urgently (SOGC, February 15, 2021).
    • SOGC recommends that time-sensitive interventions such as administration of anti-D immunoglobulin and blood products should not be delayed on account of recent COVID-19 vaccination (SOGC, February 15, 2021).
  • For patients impacted by limited vaccine supply:
    • There are no physiologic reasons to anticipate that the effect of delaying the second dose of the COVID-19 vaccine would be different for a pregnant individual compared to a non-pregnant individual. Pregnant individuals may resume their vaccine series the same as the non-pregnant population in situations of supply chain interruptions (SOGC, February 15, 2021).
Emerging evidence
  • Pfizer and BioNTech recently announced that the first participants were vaccinated in a “global Phase 2/3” study to evaluate the safety and efficacy of their vaccine in preventing COVID-19 in healthy pregnant individuals 18 years of age and older. The trial will include approximately 4,000 participants and the vaccine will be administered between 24 to 34 weeks of gestation (Pfizer, February 18, 2021; Johns Hopkins Center for Health Security, February 19, 2021).
  • A recent study (of 1,417 individuals who recently gave birth) provides evidence that pregnant individuals may be able to pass IgG antibodies against SARS-CoV-2 to their fetus. The study did not explicitly evaluate the ability to transfer antibodies developed as a result of vaccination; however, the researchers indicate that the results align with similar studies on transplacental transfer of vaccine-conferred antibodies for other diseases. Further research is necessary to determine the recommended timing for vaccination of pregnant individuals in order to achieve sufficient transplacental transfer of SARS-CoV-2 antibodies to the fetus (JAMA Pediatrics, January 29, 2021; Johns Hopkins Center for Health Security, February 2, 2021).

Adverse events and allergic reactions

Why has this been in the news?

International safety monitoring of the Pfizer-BioNTech and Moderna vaccines has identified a small number of cases of anaphylaxis after the vaccine.

  • Out of over 1.2 million total doses administered in Canada, the rate of serious adverse reaction (including anaphylaxis) is 0.011%(Health Canada, February 2021).
  • The U.S. has recorded the rate of anaphylaxis for both vaccines to be 4.5 per million, within the range of other vaccines such as influenza or herpes. (CDC, Feb 19, 2021)
  • In the UK, 6.9 million doses of the AstraZeneca vaccine and 8.3 million of the Pfizer vaccine have been administered, with a rate of 3-5 reported adverse events (serious and non-serious) per 1,000 doses. (Weekly Summary, Government of the UK, Feb 25, 2021)
  • As millions of doses have been given worldwide, the Canadian Society of Allergy and Clinical Immunology (CSACI) identifies the risk for serious allergic reaction as low (CSACI, January 5, 2021).
How does this apply to my practice?

With any vaccine, the potential for allergic reactions exists. Currently, Health Canada does not recommend receipt of either vaccine for the following populations:

  • Persons with proven immediate or anaphylactic hypersensitivity to any component of the vaccine or its container, including polyethylene glycol.
  • Individuals with a history of anaphylaxis after previous administration of the vaccine.

Ensuring patient confidence in vaccines New

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PrOTCT PLAN for the COVID-19 vaccine discussion

As a primary care provider, you are the key to a successful COVID-19 vaccination campaign. These evidence-based responses to common questions will help you in your role as a community ambassador to promote widespread vaccination.

In all patient encounters, communicate that you and the members of your healthcare team have already gotten or are planning to get vaccinated.

“What do you think of the new vaccine(s)? Do you think I should get it? Is it safe?”

When patients ask these questions, it may be tempting to dive into answering. This framework will help approach these conversations thoughtfully to achieve a positive, effective interaction that builds trust while sharing important information.

Understanding vaccine hesitancy in Black communities

For Ontario providers

Use the following billing codes when counselling your patients about COVID-19 vaccine(s)/hesitancy:

  • K080, 081, 082 (telephone/video)
  • K013 (in person)

Understanding vaccine hesitancy in Indigenous communities

Addressing patient questions about…

COVID-19 risk and transmission

  • COVID-19 is much more serious than the flu. In Canada, the flu kills roughly 3,500 patients per year. In less than a year, COVID-19 has killed 5 times that many.
  • COVID-19 is very contagious and can cause serious illness. More than 19,000 Canadians and close to 450,000 Americans have died of COVID-19.
  • Even if a young and healthy person does not die of COVID-19 infection, they may have long term complications from COVID-19, affecting multiple organ systems. Long-term effects include memory loss, fatigue, body aches, unexplained breathing difficulties, and damage to the lungs and heart. Clinics have already been set up to support the many COVID-19 patients who, although they are no longer infected, cannot go back to work or live a normal life.
  • Even if a young and healthy person does not develop severe COVID-19 infection, you may still pass on the virus to someone who will. If you are vaccinated, you’re helping protect the people around you.
  • Vaccination is the only way to end this pandemic. I and all the members of the healthcare team around you have gotten/will be getting immunized. You can protect yourself, your loved ones, and your community by getting vaccinated.

References

  • The information on this is still developing. At this time, we know that it typically takes a few weeks for the body to develop immunity after vaccination. Therefore, it is possible that a person could be infected with the virus that causes COVID-19 just before or just after vaccination and then get sick because the vaccine did not have enough time to provide protection.
  • That being said, we also know that the vaccines protect most vaccinated people from getting sick with COVID-19. For those who still get sick, they appear to get a milder case. However, studies are ongoing as to how the vaccine affects how contagious infected people are.
  • It is important to continue public health measures of distancing and masking even after vaccination, until scientific experts say it is safe to stop.

References

mRNA vaccines

  • The purpose of any vaccine is to mimic the infection, get the body to build immunity to the virus but not cause the illness. The vaccine will train the immune system to recognize COVID-19 and respond quickly if you are ever exposed to the actual COVID-19 virus.
  • mRNA is something we already rely on in our bodies. On a regular basis, mRNA (messenger RNA) carries genetic messages from the DNA to the ribosomes – the “kitchen” of each cell, where the proteins we need for everyday life are made. mRNA is the recipe that carries information for protein production. Our immune system “reads” our proteins to develop antibodies.
  • A COVID-19 mRNA vaccine contains the genetic material to make the “spike protein” that instructs the immune system to develop antibodies against COVID-19. This spike protein does not cause disease: rather, once our immune system sees the spike protein made, it builds antibodies to it. The vaccine does not stay in your body and does not change your own body in any way. After the protein is made, the cell breaks down the recipe instructions (mRNA).

References

  • mRNA vaccines do not change your DNA. Human beings do not have the enzymes to convert RNA into DNA. In fact, our cells have enzymes that destroy the mRNA after the protein is made – which is why the vaccine doesn’t stay in your body for long.

References

Special populations and contraindications

The Pfizer-BioNTech, Moderna and the AstraZeneca vaccine have not been tested in pregnant individuals, so more studies are needed. However, there were individuals included in the Pfizer-BioNTech and Moderna studies who found out they were pregnant after having had the vaccine and have not had any adverse events so far. Let’s discuss the benefits and risks and come to a decision together.

For references and further information, see our Top Resources.

Health Canada, Pfizer-BioNTech, Moderna, and AstraZeneca do not currently recommend administering the vaccines to children. Children often need a different dose than adults and may show stronger immune reactions.

However, as the Pfizer-BioNTech trial collected some limited data was collected on children 12-15, Health Canada has stated that children in this age group may be given a full course of the Pfizer-BioNTech vaccine only if:

  • they are at very high risk of severe outcomes of COVID-19 due to a pre-existing medical condition known to be associated with increased risk of hospitalization or mortality, and
  • are at increased risk of exposure (e.g., due to living in a congregate care facility), and
  • if a risk assessment deems that the benefits outweigh the potential risks, and
  • if informed consent with the individual and the parent or guardian includes discussion about the insufficiency of evidence on the use of COVID-19 vaccines in this population.

For references and further information, see our Top Resources.

At this time, only the Pfizer-BioNTech and Moderna vaccine trials included patients aged over 65, and the efficacy for both vaccines was very similar to the younger age group. The AstraZeneca vaccine trial currently has limited information on the efficacy of this vaccine in individuals ≥65 years of age.

  • For the Pfizer-BioNTech vaccine, efficacy in adults 65 and over was 94.7%.
  • For the Moderna vaccine, efficacy in adults 65 and over was 86.4%.

For references and further information, see our Top Resources.

Severe allergic reactions and anaphylaxis are very rare with the COVID-19 vaccines, occurring in only 0.004% of doses given. Unless you have a history of allergic reaction to components of the vaccine, or to the first dose of the vaccine, Health Canada recommends vaccination.

It is always advised to wait at least 15 minutes after receiving a vaccine, since an allergic reaction or anaphylaxis is always a possible reaction to any medication or vaccination. For those with a history of allergies, even to food, pets or other non-medical causes, waiting 30 minutes after receiving a vaccine is recommended.

There are many vaccines currently under development. Some patients may be allergic to an ingredient in one, but not another. On this site you can also review the vaccine ingredients in non-medical terms for both the Pfizer-BioNTech, Moderna and vaccines AstraZeneca and learn more about propylene glycol.

For references and further information, see our Top Resources.

It is important that new vaccines be tested in diverse populations to ensure that they are safe and effective for all.

  • In both the Pfizer-BioNTech and Moderna trials, approximately 20% of the participants were people of colour, and participants were both racially and ethnically diverse.
  • In the United Kingdom and Brazil AstraZeneca trials, approximately 7% and 33% of the participants were people of colour, respectively. Ethnicity of participants was not reported.

For references and further information, see our Top Resources.

Vaccine ingredients and efficacy

  • No. Vaccinated individuals can still be infected, but vaccination greatly reduces the risk of infection, and reduces the risk of an infection progressing to the more severe form of the disease.

The Canadian and provincial governments are monitoring cases of new COVID-19 variants in Canada.

Early data suggests that these variants may be more easily transmitted and may impact the severity of disease. There is some evidence to suggest that some variants of COVID-19 may have an impact on the efficacy of approved COVID-19 vaccines.

Additional research is ongoing to learn more about these variants (Health Canada, February 1, 2021; CDC, January 15, 2021).

  • The AstraZeneca clinical trials show protection starts from approximately 3 weeks after receiving the first dose and persists up to 12 weeks. A second dose should be given at a 4-to-12-week interval after the first dose, with evidence that suggests the vaccine increases effectiveness with longer intervals between doses.
  • Pfizer-BioNTech’s clinical trials show that individuals may not be optimally protected until at least 7 days after their second dose of vaccine, given 21 days after the first dose.
  • Moderna’s clinical trials show that individuals may not be optimally protected until after receiving the second dose of the vaccine, given 28 days after the first dose.

References

Religious beliefs

Some patients may have questions regarding their religion and receiving COVID-19 vaccines.

The approved COVID-19 vaccines do not contain any food products or gelatin and are considered recommended or permissible by many religious organizations (South Asian Covid Task Force and COVID-19 Made Simple, 2021).

Many religious organizations have issued statements that encourage COVID-19 vaccination for the health and safety of individuals and their communities, following the advice of patients’ healthcare providers.

These organizations include:

Vaccine availability

  • The pandemic – and the lockdowns and public health measures – will not end until the majority of Canadians are vaccinated. To ensure we can vaccinate everyone as quickly as possible, it is important that people access the vaccine the first time it is offered to them.
  • Canada has ordered more than enough vaccines – we have purchased more shots per person than any other country in the world! We will be getting those vaccines delivered over time. The implementation plan of those vaccines is designed to most efficiently end this pandemic. You can feel confident that when you are offered one, it is because it is the right time for you to get it. This is your chance to do your part to end the pandemic and get back to normalcy quickly.
  • If you wait to get vaccinated and get infected in the meantime, you may end up in hospital – which would put more strain on the system than getting the vaccine.
  • If Canadians wait to get the vaccine, the pandemic will keep going – and that includes the restrictions, inability to see family and friends, send your kids to school, travel.
  • If Canadians wait to get the vaccine, more people will die.

References

Vaccine development and approval process

  • No steps were skipped in the process of developing, testing, approving, and producing the vaccines.
  • Canada’s best independent scientists have thoroughly reviewed all the data before approving the vaccines as safe and effective for Canadians.
  • The vaccines were produced faster than before not because of skipped steps but because of never-before-seen levels of collaboration and funding around the world invested in this effort. Normally, vaccine clinical trials need 6000-8000 people for the approval process.
    • The Pfizer-BioNTech trial had over 43,000 people.
    • The Moderna trial had over 30,000 people.
  • Unlike with other vaccines that go one step at a time and then plan the next step, for the COVID-19 vaccines, governments invested in having companies plan all the steps at the beginning and build up their manufacturing capacity right away.

References

  • The use of mRNA for vaccines and treatment of disease has been around for a while – that’s one of the reasons why these vaccines could be developed so quickly. mRNA vaccines have been used in animal models for influenza, Zika, Rabies, CMV and others, and in humans for cancer treatment and cancer vaccine clinical trials.
  • mRNA vaccines are like CD players that can play any kind of CD – classical music, rap or pop. The scientists had the CD player before COVID-19 hit. Once they figured out the Coronavirus CD, they could place it into the player and make the vaccine a lot faster than before, since they used what was known and built on it.

References

  • The pharmaceutical companies manufacture the vaccine and sponsor and conduct the clinical trials, but all vaccine clinical trials must have an independent data and safety monitoring board review the vaccine efficacy and unblind the data.
  • As the trial is completed, Health Canada reviews all safety and efficacy data before allowing the vaccine to be used in the Canadian population.
  • After a vaccine has been approved for use and made available, its safety is continuously monitored by healthcare providers and Canada-wide networks specifically designed for safety. Health Canada monitors national and international vaccine safety reports and will update information about the vaccine as it becomes available.

References

Side effects

  • The vaccines cannot give you COVID-19 or any other infectious disease. None of the licensed vaccines so far use the live virus that causes COVID-19.
  • It is still possible to contract COVID-19 after you have been vaccinated. Like with other vaccinations, it takes a few weeks for the body to build immunity after vaccination. Someone could be infected with the virus just before or just after vaccination and get sick, because the vaccine didn’t have enough time to provide protection.

References

  • With any of the approved vaccines people can expect to feel a sore arm, a bit of tiredness and a mild headache as the vaccine starts to work. Some people will feel muscle aches, chills, or a mild fever.
  • For more information on how common side effects were in the Pfizer-BioNTech clinical trial, see its Clinical Trial Details.
  • For more information on how common side effects were in the Moderna clinical trial, see its Clinical Trial Details.

References

  • Among the almost 22,000 vaccinated with the Pfizer-BioNTech COVID-19 vaccine, there were 4 cases of Bell’s palsy. This number of Bell’s palsy cases is consistent with the expected rate in the general population and did not suggest it was caused by the vaccine. Three cases occurred within one month after both doses were completed, and one case occurred later than one month after both doses were completed, and all four patients recovered.
  • More research will be conducted as this was the only “imbalanced” occurrence that happened more in the vaccine arm of the study than the placebo arm.
  • Those with previous history of Bell’s palsy may still take this vaccine.

References

  • Yes. Mild side effects are common for all vaccines.
  • There could be soreness and swelling which for some might be significant (sometimes from shoulder to elbow). In these cases:
    • Use cold compresses over the site.
    • Know that local reactions, even big ones, improve by 48-72 hours. If the reaction worsens at 72 hours or has not disappeared in 5 days, seek medical attention.
    • Even though sometimes this reaction can look like an infection, the risk of skin/local infection from a vaccine needle is very small. These reactions do not need any antibiotics in the first 72 hours.
    • If the swelling progresses rapidly, is associated with breathing problems, or makes you very concerned about an allergic reaction, seek urgent medical attention and/or call 9-1-1.

Vaccine safety and adverse events

It is true that some vaccines in the past were associated with adverse events and then removed from the market. Those vaccines were not tested in nearly as many people as the COVID-19 vaccines. Normally, vaccine clinical trials need 6000-8000 people for the approval process: the Pfizer-BioNTech and Moderna trial tested the vaccine in 30-40,000 people each. Since the approval of different vaccines worldwide, millions have now received the vaccines, and serious reactions have been extremely rare.

Health Canada provides ongoing safety monitoring for the vaccines. You can see the most recent data at COVID-19 vaccine safety in Canada (Health Canada).

  • Since the vaccines are new, studies are ongoing to determine how long the immunity lasts or if there are long-term side effects. The long-term data we’re still waiting for is more about long-term efficacy (how long immunity lasts) than long-term safety.
  • It is very unlikely for long-term effects to develop, as these initial vaccines are not live vaccines and side effects most often present in the first few days after vaccination.

Polyethylene glycol (PEG) allergies are rare. PEG is a common ingredient found in many products, and most people use these products without having any allergic reactions.

If you have used any of the following medications without allergies, you are not allergic to PEG:

  • Extra Strength Tylenol, Tylenol EZ tabs, Tylenol Gel Caps
  • Advil Liqui-Gels
  • Benadryl 25 or 50mg pink caplets
  • Laxaday
  • Go-Lytely
  • Reactine 5 or 10mg tablets
  • Enteric coated daily low dose aspirin (81 mg)

To identify PEG on a label, look for:

  • “Polyethylene glycol”
  • PEG followed by a number (PEG-40).
  • PEG followed by a number and then another ingredient name (PEG-20 cocamine)
  • Complex PEG compounds with many slashes, but will always contain “PEG” (BIS-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone)

Questions specific to Indigenous communities

It’s natural to question the motive as to reasons why Indigenous Peoples are identified as a priority.

Along with healthcare workers and residents of long-term care/retirement homes, Indigenous Peoples have been identified as a priority population because evidence shows they are among those at greatest risk of serious, life-threatening implications if they contract COVID-19.

Moreover, chronic medical conditions with a greater prevalence among Indigenous Peoples such as respiratory disease, heart disease, diabetes, kidney and liver disease, have been found to be at greater risk of more severe outcomes from COVID-19 (IPHCC, 2021).

Types of COVID-19 vaccines New

There are four main categories of COVID-19 vaccines that are under development (GAVI, 2021):

  • Nucleic acid vaccines, which include mRNA vaccines and DNA vaccines
  • Subunit vaccines, which include protein subunit vaccines and virus-like particle (VLP) vaccines
  • Viral vector vaccines
  • Whole virus vaccines, which include inactivated vaccines and live-attenuated vaccines

Different types of vaccines offer different advantages and disadvantages, in terms of how easy they are to manufacture and store, as well as the level of immunity they invoke (GAVI, 2021).

Click for details:

Are there other vaccines of this type available in Canada?

  • No. These are the first mRNA vaccines available in Canada.

Are there COVID-19 vaccines of this type approved by Health Canada?

How many COVID-19 vaccines of this type are in the clinical trials stages of development?

How do these vaccines work?

  • mRNA vaccines contain genetic material from the COVID-19 virus (called mRNA) that gives human cells instructions to make specific COVID-19 proteins.
  • After our cells make copies of the protein, our cells destroy the mRNA.
  • The human immune system learns to recognize these COVID-19 proteins and develops antibodies and white blood cells against them, which provides immunity against COVID-19 in the future.

Are these “whole virus” vaccines?

  • No. mRNA vaccines only contain part of COVID-19’s genetic material (mRNA), and do not contain any of its proteins.

Can these vaccines cause COVID-19 disease?

  • No. mRNA vaccines don’t contain the entire COVID-19 genome or any of its proteins, all of which are necessary for COVID-19 to cause disease.

What are some of the advantages and disadvantages of this type of vaccine?

  • Advantages:
    • Immune response is strong as it involves B cells and T cells
    • No live components, so no risk of the vaccine triggering disease
    • Relatively easy to manufacture
  • Disadvantages:
    • Some RNA vaccines require ultra-cold storage
    • Never been licensed in humans
    • Booster shots may be required

Are there other vaccines of this type available in Canada?

  • No. There are no DNA vaccines approved in Canada for diseases other than COVID-19.

Are there COVID-19 vaccines of this type approved by Health Canada?

  • No. There are no COVID-19 vaccines of this type approved by Health Canada at this time.

How many COVID-19 vaccines of this type are in the clinical trials stages of development?

How do these vaccines work?

  • DNA vaccines contain genetic material (DNA) that gives human cells instructions to make specific COVID-19 proteins.
  • The DNA is first inserted into a circular piece of bacterial DNA, which is called a plasmid (these are widely used in genetic engineering).
  • Plasmids are then injected into a person’s muscle. Different vaccines use different approaches to make sure that the plasmid can enter human cells once inside the muscle.
  • Once the plasmid is inside our cells, our cells make copies of the COVID-19 protein.
  • The human immune system learns to recognize these COVID-19 proteins and develops antibodies and white blood cells against them, which provides immunity against COVID-19 in the future.

Are these “whole virus” vaccines?

  • No. DNA vaccines only contain genetic material (DNA) with some of COVID-19’s genes, and do not contain any of its proteins.

Can these vaccines cause COVID-19 disease?

  • No. DNA vaccines don’t contain the entire COVID-19 genome, or any of its proteins, all of which are necessary for COVID-19 to cause disease.

What are some of the advantages and disadvantages of this type of vaccine?

  • Advantages:
    • Immune response is strong as it involves B cells and T cells
    • No live components, so no risk of the vaccine triggering disease
    • Relatively easy to manufacture
  • Disadvantages
    • Never been licensed in humans
    • Booster shots may be required

Are there other vaccines of this type available in Canada?

  • Yes, including the SHINGRIX shingles vaccine.

Are there COVID-19 vaccines of this type approved by Health Canada?

  • No. There are no COVID-19 vaccines of this type approved by Health Canada at this time.

How many COVID-19 vaccines of this type are in the clinical trials stages of development?

How do these vaccines work?

  • Subunit vaccines contain pieces of the COVID-19 virus (in this case, pieces of COVID-19 proteins).
  • The human immune system learns to recognize these proteins and creates antibodies, which provides immunity against COVID-19 in the future.
  • Because the COVID-19 proteins cannot infect cells, only part of the immune system (i.e. antibodies) can react to them. Adjuvant medications and/or booster doses may be required.

Are these “whole virus” vaccines?

  • No. Protein subunit vaccines only contain pieces of specific COVID-19 proteins, and do not contain all of its proteins, or any genetic material.

Can these vaccines cause COVID-19 disease?

  • No. Protein subunit vaccines don’t contain all of COVID-19’s proteins, or any of its genes, all of which are necessary for COVID-19 to cause disease.

What are some of the advantages and disadvantages of this type of vaccine?

  • Advantages:
    • Well-established technology
    • Suitable for people with compromised immune systems
    • No live components, so no risk of the vaccine triggering disease
    • Relatively stable
  • Disadvantages
    • Relatively complex to manufacture
    • Adjuvants and booster shots may be required
    • Determining the best antigen combination (i.e., mix of protein pieces) takes time

Are there other vaccines of this type available in Canada?

  • Yes, including all HPV vaccines.

Are there COVID-19 vaccines of this type approved by Health Canada?

  • No. There are no COVID-19 vaccines of this type approved by Health Canada at this time.

How many COVID-19 vaccines of this type are in the clinical trials stages of development?

How do these vaccines work?

  • Virus-like particle vaccines contain COVID-19 proteins that are assembled into something resembling a COVID-19 virus, but without COVID-19’s genetic material.
  • The human immune system learns to recognize these COVID-19 proteins and develops antibodies and white blood cells against them, which provides immunity against COVID-19 in the future.

Are these “whole virus” vaccines?

  • No. Although virus-like particle vaccines physically resemble the virus to a degree, they do not contain any of COVID-19’s genetic material, and do not contain all of its proteins.

Can these vaccines cause COVID-19 disease?

  • No. Virus-like particle vaccines don’t contain all of COVID-19’s proteins, or any of its genes, all of which are necessary for COVID-19 to cause disease.

What are some of the advantages and disadvantages of this type of vaccine?

  • Advantages:
    • Immune response is strong as it involves B cells and T cells
    • Suitable for people with compromised immune systems
    • No live components, so no risk of the vaccine triggering disease
  • Disadvantages:
    • Relatively complex to manufacture
    • Relatively temperature sensitive, so careful storage necessary

Are there other vaccines of this type available in Canada?

  • No. There are no viral vector vaccines approved for other human diseases in Canada, there are viral vector vaccines available in other countries, such as the Merck Ebola vaccine.

Are there COVID-19 vaccines of this type approved by Health Canada?

How many COVID-19 vaccines of this type are in the clinical trials stages of development?

How do these vaccines work?

  • Viral vector vaccines contain a weakened version of a live virus that is not the COVID-19 virus. This weakened virus (which is often an adenovirus), is called a “viral vector”, and has genetic material from the COVID-19 virus inserted inside it.
  • Once the viral vector is inside human cells, the COVID-19 genetic material gives cells instructions so that they can make specific COVID-19 proteins.
  • The immune system learns to recognize these proteins and develops antibodies and white blood cells against them, which provides immunity against COVID-19 in the future.

Are these “whole virus” vaccines?

  • No. Viral vector vaccines only contain certain genetic material from COVID-19, not the entire genome, and the protein “shell” containing these pieces of genetic material belongs to a different type of virus (e.g., a harmless adenovirus).

Can these vaccines cause COVID-19 disease?

  • No. Viral vector vaccines don’t contain the entire COVID-19 genome or any of its proteins, all of which are necessary for COVID-19 to cause disease.

What are some of the advantages and disadvantages of this type of vaccine?

  • Advantages:
    • Immune response is strong as it involves B cells and T cells
    • Well-established technology
  • Disadvantages:
    • Previous exposure to the vector (e.g., adenovirus) could reduce effectiveness
    • Relatively complex to manufacture

Are there other vaccines of this type available in Canada?

  • Yes, including all flu shots (nasal spray is live-attenuated).

Are there COVID-19 vaccines of this type approved by Health Canada?

  • No. There are no COVID-19 vaccines of this type approved by Health Canada at this time.

How many COVID-19 vaccines of this type are in the clinical trials stages of development?

How do these vaccines work?

  • Inactivated vaccines contain whole COVID-19 viruses whose genetic material has been destroyed by heat, chemicals or radiation.
  • These viruses cannot infect cells and replicate, and therefore may be safer than live-attenuated vaccines for those who are immunocompromised.
  • Because the inactivated viruses cannot infect cells, only part of the immune system (i.e. antibodies) can react to them. Adjuvant medications and/or booster doses may be required.

Are these “whole virus” vaccines?

  • Yes, but the virus is not live as its genetic material has been destroyed.

Can these vaccines cause COVID-19 disease?

  • No. Inactivated vaccines cannot cause COVID-19 disease because the COVID-19 genetic material has been destroyed.

What are some of the advantages and disadvantages of this type of vaccine?

  • Advantages:
    • Well-established technology
    • Suitable for people with compromised immune systems
    • No live components, so no risk of the vaccine triggering disease
    • Relatively simple to manufacture
    • Relatively stable
  • Disadvantages
    • Booster shots may be required

 

Are there other vaccines of this type available in Canada?

  • Yes, including all MMR and MMRV vaccines.

Are there COVID-19 vaccines of this type approved by Health Canada?

  • No. There are no COVID-19 vaccines of this type approved by Health Canada at this time.

How many COVID-19 vaccines of this type are in the clinical trials stages of development?

How do these vaccines work?

  • Live-attenuated vaccines use a form of the COVID-19 virus that has been weakened in the laboratory, which can still grow and replicate, but causes mild or no illness.
  • Because these are live COVID-19 viruses, they are able to infect human cells, and the human immune system can respond to these viruses almost as well as it does to the “wild-type” virus.
  • The weakened virus enters human cells, and provides instructions so that cells make specific COVID-19 proteins.
  • The immune system learns to recognize these proteins and develops antibodies and white blood cells against them, which provides immunity against COVID-19 in the future.

Are these “whole virus” vaccines?

  • Yes, but the virus has been weakened so that it only produces mild or no illness.

Can these vaccines cause COVID-19 disease?

  • Yes. In very rare cases, the live-attenuated virus may mutate and revert back to a more pathogenic form.

What are some of the advantages and disadvantages of this type of vaccine?

  • Advantages:
    • Immune response is strong as it involves B cells and T cells
    • Well-established technology
    • Relatively simple to manufacture
  • Disadvantages:
    • Unsuitable for people with compromised immune systems
    • May trigger disease in very rare cases
    • Relatively temperature sensitive, so careful storage necessary

Oxford-AstraZeneca viral vector vaccine New

Jump to:

The AstraZeneca vaccine showed 59.5% efficacy in preventing SARS-CoV-2 infection and is used both for preventing the occurrence of COVID-19 infection and diminishing the severity of the infection. For information on preparation, administration, storage, stability and disposal, see Point-of-care guidance.

Clinical trial details

Enrollment

Study COV002 (United Kingdom)

Study COV003 (Brazil)

Participant demographics

Study COV002 (United Kingdom)

  • 7.4% were 65 years of age or older
  • 7.55% were from communities of colour
  • 35.9% had 1 or more of the following comorbidities at baseline: BMI 30kg/m2 or higher, cardiovascular disorder, respiratory disease or diabetes

Study COV003 (Brazil)

  • 2.5% were 65 years of age or older
  • 33.5% were from communities of colour
  • 36.5% had 1 or more of the following comorbidities at baseline at baseline: BMI 30kg/m2 or higher, cardiovascular disorder, respiratory disease or diabetes
Time followed

At the time of the interim primary efficacy analysis, participants had been followed for symptomatic COVID-19 disease for a median of 63 days (range: 16-94 days) after the second dose, corresponding to exposure of 921 person-years in the AstraZeneca COVID-19 Vaccine and 925 person-years in the control group.

Protection

Individuals may not be optimally protected until after receiving the second dose of the vaccine.

Efficacy
  • In participants who received two standard doses of the vaccine (SD/SD) or the corresponding control, vaccine efficacy from 15 days-post second dose was 62.1%.
  • Based on an updated analysis (data cut-off December 7, 2020), vaccine efficacy was 59.5% in participants who received two standard doses with the second dose administered 4 to 12 weeks after the first dose.
Serious side effects

Serious adverse events were experienced by 0.7% of subjects in the AstraZeneca COVID-19 Vaccine group and 0.8% of subjects in the control group.

Non-serious side effects

In clinical studies with the vaccine, most side-effects were mild-to-moderate and resolved within a few days. When compared with the first dose, adverse reactions reported after the second dose were milder and reported less frequently. Reactogenicity was generally milder and reported less frequently in older adults (≥65 years old).

 

Most frequently reported adverse reactions in subjects 18 years of age and older:

  • injection site tenderness (75.3%)
  • injection site pain (54.2%)
  • fatigue (62.3%)
  • headache (57.5%)
  • myalgia (48.6%)
  • malaise (44.2%)
  • pyrexia (33.6%)
  • chills (31.9%)
  • arthralgia (27.0%)
  • nausea (21.9%)

Contraindications and precautions

The AstraZeneca vaccine is contraindicated for:
  • Individuals who have had an allergic reaction to a previous dose of the vaccine.
  • Individuals who have had a severe allergic reaction to any of the medicinal ingredients or any of the other ingredients in this vaccine.
  • Vaccination should be deferred in symptomatic individuals with confirmed or suspected SARS-CoV-2 infection, or those with symptoms of COVID-19. To minimize the risk of COVID-19 transmission, symptomatic individuals who arrive at an immunization clinic should be instructed to follow current local public health measures and be encouraged to get tested.
  • Individuals who have received another vaccine (not a AstraZeneca COVID-19 vaccine) in the past 14 days.
  • Individuals outside of the authorized age group (< 18).
Precautions should be taken with:
  • Patients who have a bleeding problem, bruise easily or use a blood-thinning medication.
  • Patients with a history of fainting. Procedures should be in place to prevent injury from fainting and manage syncopal reactions.
  • Individuals who have experienced a severe allergic reaction, including anaphylaxis after any other vaccine injection.
  • Patients who are ≥65 years of age. See AstraZeneca and older adults.
  • Patients who are pregnant or breastfeeding. See Pregnant and breastfeeding women.
  • Patients who are immunocompromised, due to disease or treatment. See Immunocompromised populations

Point-of-care guidance

  • The vaccine is administered through an intramuscular injection into the upper arm.
  • In order to be optimally effective in preventing SARS-CoV2 infection, the vaccine must be administered twice: a single dose of the vaccine is administered followed by a second single dose between 4 and 12 weeks later.
  • If administration of the second dose of the vaccine is delayed, patients should speak to their healthcare provider. It is important that individuals receive their second dose of the vaccine.
    • For most vaccines, interruption of a vaccine series does not require restarting the series as delays between doses do not result in a reduction in final antibody concentrations for most multi-dose products.
    • However, maximum protection may not be attained until the complete vaccine series has been administered.
  • The vaccine series should be completed with the same COVID-19 vaccine product.

If a patient experiences a side effect following immunization, such as hives, swelling of the mouth and throat, trouble breathing, hoarseness, wheezing, high fever (over 40oC), convulsions, seizures, or other serious reactions:

Preparation

  • The AstraZeneca COVID-19 vaccine does not contain any preservative.
  • The vaccine can be stored in a refrigerator  (2 to 8ºC). Do not freeze the vaccine.
  • After first opening, use the vial within:
    • 6 hours when stored at room temperature (up to 30ºC), or
    • 48 hours when stored in a refrigerator (2 to 8ºC ).
  • The vial can be re-refrigerated, but the cumulative storage time at room temperature must not exceed 6 hours. The vial must be discarded if the total cumulative storage time after opening exceeds 48 hours.  The vaccine must be used by the expiration date on the label.
  • AstraZeneca COVID-19 Vaccine must not be reconstituted, mixed with other medicinal products, or diluted.
AstraZeneca COVID-19 Vaccine
  • Type of vaccine: COVID-19 Viral Vector-based
  • Date of authorization in Canada: February 26, 2021
  • Authorized ages for use: 18 years of age and older
  • Dose: 0.5 mL each
  • Schedule: 2 doses, 4-12 weeks apart
  • Booster doses: No evidence on the need for an additional booster after the 2-shot series
  • Route of administration: Intramuscular (IM) into the deltoid muscle of the upper arm
  • Primary storage requirements: refrigerated (2 to 8ºC) in the outer carton to protect from light. Do not freeze.
  • Formats available: Multiple dose vial of 10 or 8 doses (one dose is 0.5 mL)
  • DRUG INTERACTIONS: No interaction studies have been performed

Administration

  • Visually inspect the AstraZeneca COVID-19 Vaccine for particulate matter and discolouration prior to administration. The vaccine is a colourless to slightly brown, clear to slightly opaque solution. Iff the solution is discoloured or visible particles are observed, discard the vial.
  • Each AstraZeneca vaccine dose of 0.5 mL is administered intramuscularly in the deltoid muscle by syringe.
  • It is normal for liquid to remain in the vial after withdrawing the final dose.
  • Remind patients to continue to practice recommended public health measures for prevention and control of SARS-CoV-2 infection and transmission regardless of receipt of COVID-19 vaccine, 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 (NACI, December 18, 2020).
  • Similar to other immunizations, ask patients to wait for 15 minutes following administration in order to monitor for adverse events, such as anaphylaxis.
  • For patients with a history of anaphylaxis not related to vaccines or injectable medications (e.g., allergies to food, pets), a waiting period of 30 minutes is recommended.

Storage, stability and disposal

Unpunctured Vials
  • The AstraZeneca COVID-19 vaccine should be stored  in a refrigerator (2 to 8ºC)  in the outer carton  to protect from light. Do not freeze the vial.  Use the product before the expiration date on the vial label.
Punctured Vials
  • Once punctured, the vial can be stored:
    • at room temperature (up to 30ºC) for 6 hours
    • in a refrigerator (2 to 8ºC ) for 48 hours
  • The vial can be re-refrigerated but the cumulative storage time at room temperature must not exceed 6 hours.
  • The vial must be discarded if total cumulative storage time after opening exceeds 48 hours.
  • The vaccine must be used by the expiration date on the label.
Disposal
  • Any unused vaccine or waste material should be disposed of in accordance with local requirements.

Pfizer-BioNTech mRNA vaccine New

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The Pfizer-BioNTech mRNA vaccine showed 95% efficacy in preventing SARS-CoV-2 infection and is used both for preventing the occurrence of COVID-19 infection and diminishing the severity of the infection. For information on preparation, administration, storage, stability and disposal see Point-of-care guidance.

Clinical trial details

Enrollment
Participant demographics
  • 41% were between 56 and 85 years old
  • Were of diverse racial and ethnic backgrounds:
    • White (83%)
    • Black or African American (8.8%)
    • American Indian or Alaska native (0.6%)
    • Asian (4.4%)
    • Native Hawaiian or other Pacific Islander (0.2%)
    • Multiracial (2.3%)
  • Participants with pre-existing stable disease were included (disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment)
  • Participants with known stable infection were included, including those with HIV, hepatitis B, and hepatitis C virus
Time followed
  • At the time of the final primary efficacy analysis, participants had been followed for symptomatic COVID-19 disease for a median of 2 months, corresponding to 2,214 person-years for the PfizerBioNTech COVID-19 vaccine and 2,222 person-years in the placebo group.
Protection
  • Based on the results of the clinical trials, the best protection is not achieved until 7 days after the second dose, but it remains unknown how long the protection will last.
Efficacy
  • 95%, with no difference in efficacy observed between men and women or across different age groups, races or ethnicities.
Serious side effects
  • Overall, serious adverse events were reported in 0.6% of vaccine recipients and 0.5% of placebo recipients.
Non-serious side effects
  • Side effects observed during the clinical trials were typically mild, commonly reported side effects of vaccines and do not pose a risk to health. Overall, solicited side effects were more frequent in vaccine recipients compared to placebo, more frequent after the second dose compared to the first, and more frequent in adults 18 to 55 years of age than in those 56 years of age and above.
  • Very common side effects (may affect more than 1 in 10 people):
    • Pain at injection site: 84.1% (vs. 7.7-14.0% in placebo)*
    • Fatigue: 62.9% (vs. 16.8-33.4% in placebo)*
    • Headache: 55.1% (vs. 13.9-33.7% in placebo)*
    • Muscle pain: 38.3% (vs. 5.3-10.8% in placebo)
    • Chills: 31.9% (vs. 2.8-6.4% in placebo)*
    • Joint pain: 23.6% (vs. 3.7-6.1% in placebo)*
    • Fever: 14.2% (vs. 0.2-0.9% in placebo)*
  • Uncommon side effects (may affect up to 1 in 100 people):
    • Enlarged lymph nodes

Contraindications and precautions

The Pfizer-BioNTech COVID-19 vaccine is contraindicated for:
  • Individuals with a history of anaphylaxis after previous administration of the vaccine.
  • Persons with proven immediate or anaphylactic hypersensitivity to any component of the vaccine or its container, including polyethylene glycol.
  • Vaccination should be deferred in symptomatic individuals with confirmed or suspected SARS-CoV-2 infection, or those with symptoms of COVID-19. To minimize the risk of COVID-19 transmission, symptomatic individuals who arrive at an immunization clinic should be instructed to follow current local public health measures and be encouraged to get tested.
  • Acutely ill individuals, as a precautionary measure.
  • Individuals who have received another vaccine (not a COVID-19 vaccine) in the past 14 days.
  • Individuals outside the authorized age group (< 16).
Precautions should be taken with:
  • Patients who have a bleeding problem, bruise easily or use a blood-thinning medication.
  • Patients with a history of fainting. Procedures should be in place to prevent injury from fainting and manage syncopal reactions.
  • Individuals who have experienced a serious allergic reaction, including anaphylaxis, to another vaccine, drug or food, should talk to their health professional before receiving the vaccine.
  • Patients who are pregnant or breastfeeding. See Pregnant and breastfeeding women.
  • Patients who are immunocompromised, due to disease or treatment. See Immunocompromised populations.
  • Patients with suspected hypersensitivity or non-anaphylactic allergy to COVID-19 vaccine components. Consultation with an allergist is advised prior to vaccination.

Point-of-care guidance

  • As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of this vaccine.
  • The vaccine is administered through an intramuscular injection into the upper arm.
  • In order to be optimally effective in preventing SARS-CoV2 infection, the vaccine must be administered twice: a single dose of the vaccine is administered followed by a second single dose 21 days later.
  • If administration of the second dose of the vaccine is delayed, it should be administered as soon as possible.
    • For most vaccines, interruption of a vaccine series does not require restarting the series as delays between doses do not result in a reduction in final antibody concentrations for most multi-dose products.
    • However, maximum protection may not be attained until the complete vaccine series has been administered.
  • The vaccine series should be completed with the same COVID-19 vaccine product.

If a patient experiences a side effect following immunization, such as hives, swelling of the mouth and throat, trouble breathing, hoarseness, wheezing, high fever (over 40oC), convulsions, seizures, or other serious reactions.

Pfizer-BioNTech COVID-19 Vaccine
  • Type of vaccine: COVID-19 mRNA
  • Date of authorization in Canada: December 9, 2020
  • Authorized ages for use: 16 years of age and older
  • Dose: 30 mcg of mRNA per 0.3 mL (after dilution)
  • Schedule: 2 doses, a minimum of 19 days apart (recommended interval 21-28)
  • Booster doses: No evidence on the need for an additional booster after the 2-shot series
  • Route of administration: Intramuscular (IM)
  • Primary storage requirements: -80°C to -60°C
  • Formats available: Multi-dose vial (6 doses) preservative free
  • Usage limit post-dilution: 6 hours from time of dilution at 2°C to 25°C
  • DRUG INTERACTIONS: No interaction studies have been performed

Preparation

  • The Pfizer-BioNTech COVID-19 vaccine multiple dose vial contains a frozen suspension that does not contain preservative and must be thawed and diluted prior to administration.
  • Vials may be thawed in the refrigerator (2°C to 8°C), or at room temperature (up to 25°C).
  • Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles. DO NOT SHAKE. Before dilution, the vial should be gently inverted ten times to mix.
  • Sterile 0.9% Sodium Chloride Injection, USP is not packaged with the vaccine and must be sourced separately. DO NOT USE BACTERIOSTATIC STERILE 0.9% SODIUM CHLORIDE INJECTION OR ANY OTHER DILUENT.
  • The contents of the vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form the Pfizer-BioNTech COVID-19 Vaccine. The vial should be gently inverted ten times to mix.
  • After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that a vial contains 5 doses of 0.3 mL. Health Canada has approved a label change rendering the 5 dose statement outdated.
    • Low dead-volume syringes and/or needles can be used to extract 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.
  • After dilution, the vaccine will be an off-white suspension. Inspect vials to confirm there are no particulates and no discolouration is observed.
  • Time and date of dilution must be recorded on the vial label. Any unused vaccine must be discarded 6 hours after dilution.
  • Vaccine must be stored between 20°C and 25°C.
  • Strict adherence to aseptic techniques must be followed.

Administration

  • Visually inspect each dose in the dosing syringe prior to administration. The diluted vaccine will be an off-white suspension.
  • During the visual inspection:
    • verify the final dosing volume of 0.3 mL, and
    • confirm there are no particulates and that no discolouration is observed.
  • If the visual inspection fails, do not administer the vaccine.
  • Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly in the deltoid muscle.
  • Do not inject the vaccine intravascularly, subcutaneously or intradermally.
  • Remind patient to continue to practice recommended public health measures for prevention and control of SARS-CoV-2 infection and transmission regardless of receipt of COVID-19 vaccine, 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 (NACI, December 18, 2020).
  • Similar to other immunizations, ask patients to wait for 15 minutes following administration in order to monitor for adverse events, such as anaphylaxis.
  • For patients with a history of anaphylaxis not related to vaccines or injectable medications (e.g., allergies to food, pets), a waiting period of 30 minutes is recommended.

Storage, stability and disposal

Frozen vials prior to use
  • Vials must be kept frozen between -80°C to -60°C (-112°F to -76°F) and protected from light, in the original cartons, until ready to use.
  • If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage when consistently refilled to the top of the container with dry ice. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. The thermal container maintains a temperature range of -90°C to -60°C (-130°F to -76°F). Storage within this temperature range is not considered an excursion from the recommended storage condition.
Thawed vials prior to dilution
  • Prior to dilution, vials may be thawed and stored in the refrigerator [2°C to 8°C (35°F to 46°F)]. A carton of 25 vials or 195 vials may take up to 2 or 3 hours to thaw in the refrigerator, respectively, whereas a fewer number of vials will thaw faster. Vials may be stored in the refrigerator for up to 5 days (120 hours).
  • Frozen vials may also be thawed at room temperature [up to 25°C (77°F)]. Prior to dilution, vials may be stored at room temperature for no more than 2 hours.
  • During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
  • Thawed vials can be handled in room light conditions. Do not refreeze thawed vials (see Preparation and Administration).
Vials after dilution
  • After dilution, vials must be stored between 2°C to 25°C (35°F to 77°F) and used within 6 hours from the time of dilution.
  • Any vaccine remaining in vials must be discarded after 6 hours.
  • After dilution, the vaccine vials can be handled in room light conditions.
  • Do not freeze. If the vaccine is frozen, it must be discarded.

Vaccine ingredients

Nucleic Acids
  • mRNA

This is the active ingredient of the vaccine. It contains the instructions your body needs to build antibodies to help protect you against COVID-19.

Lipids
  • ALC-0315 = ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
  • ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide*
  • 1,2-Distearoyl-sn-glycero-3-phosphocholine
  •  Cholesterol

These ingredients are lipids, a type of fat that forms a protective shell around the active ingredient, mRNA, and allows it to “slide” into cells so it can work.

Salts
  • Dibasic sodium phosphate dihydrate
  • Monobasic potassium phosphate
  • Potassium chloride
  • Sodium chloride

These ingredients are salts that are used as stabilizers for the vaccine to help maintain its pH close to that of a person’s body.

Sugar
  • Sucrose

Sucrose is a type of sugar that is used as a stabilizer to help the vaccine particles keep their shape when they are frozen.

Water
  • Water for injection

Water is used to mix the vaccine ingredients into a liquid that can be injected into the body.

Moderna mRNA vaccine New

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The Moderna COVID-19 vaccine showed 94.1% efficacy in preventing SARS-CoV-2 infection and is used both for preventing the occurrence of COVID-19 infection and diminishing the severity of the infection. For point-of-care guidance on preparation, administration, storage, stability and disposal, see Point of-care guidance.

Clinical trial details

Enrollment
  • 30,351 total participants (15,181 receiving vaccine and 15,170 receiving placebo)
  • Note that some participants were excluded from efficacy and safety analyses, therefore not all statistics are based on the total number of participants (30,351). This can contribute to slightly different statistics being reported by different sources.
  • For the number of patients in each subset, see the Moderna COVID-19 vaccine product monograph (Moderna, February 19, 2021).
Participant demographics
  • 25.3% were 65 years of age or older
  • 36.2% were from communities of colour
  • 22.6% had at least one high risk condition, including: chronic lung disease, moderate to severe asthma, significant cardiac disease, severe obesity, diabetes, liver disease, and HIV infection
Time followed
  • At the time of the final primary efficacy analysis, participants had been followed for symptomatic COVID-19 disease for a median of 2 months after the second dose, corresponding to 3,304.9 person-years for the Moderna COVID-19 vaccine and 3,273 person-years in the placebo group.
Protection
  • Individuals may not be optimally protected until after receiving the second dose of the vaccine.
Efficacy
  • In participants 65 years of age and older, efficacy was 86.4%, compared to 94.1% overall among all trial participants 18 years or older
  • No difference in efficacy was observed between men and women or across different races or ethnicities.
Serious side effects
  • Overall, serious adverse events were reported in 1.0% of vaccine recipients and 1.0% of placebo recipients.
Non-serious side effects
  • Side effects observed during the clinical trials were typically mild, commonly reported side effects of vaccines and do not pose a risk to health. Overall, solicited side effects were more frequent in vaccine recipients compared to placebo, more frequent after the second dose compared to the first, and more frequent in adults 18 to 64 years of age than in those 65 years of age and above.
  • Most commonly reported side effects:
    • Pain at injection site: 88.4% (vs.17.0% in placebo)*
    • Fatigue: 68.5% (vs. 36.1% in placebo)
    • Headache: 63.0% (vs. 36.5% in placebo)
    • Myalgia: 59.6% (vs. 20.1% in placebo)
    • Arthralgia: 44.8% (vs.17.2% in placebo)
    • Chills: 43.4% (vs. 9.5% in placebo)
    • Fever: 14.8% (vs. 0.6% in placebo)
    • Swollen lymph nodes: 14.0% (vs 3.9% in placebo)*

Contraindications and precautions

The Moderna COVID-19 vaccine is contraindicated for:
  • Individuals with a history of anaphylaxis after previous administration of the vaccine.
  • Individuals with proven immediate or anaphylactic hypersensitivity to any component of the vaccine or its container, including polyethylene glycol.
  • Individuals who have received another vaccine (not a Moderna COVID-19 vaccine) in the past 14 days.
  • Individuals outside of the authorized age group (< 18).
  • Symptomatic individuals with confirmed or suspected SARS-CoV-2 infection, or those with symptoms of COVID-19. To minimize the risk of COVID-19 transmission, symptomatic individuals who arrive at an immunization clinic should be instructed to follow current local public health measures and be encouraged to get tested.
Precautions should be taken with:
  • Patients who have a bleeding problem, bruise easily or use a blood-thinning medication.
  • Patients with a history of fainting. Procedures should be in place to prevent injury from fainting and manage syncopal reactions.
  • Individuals who have experienced a serious allergic reaction, including anaphylaxis, to another vaccine, drug or food, should talk to their health professional before receiving the vaccine.
  • Patients who are pregnant or breastfeeding. See Pregnant and breastfeeding women.
  • Patients who are immunocompromised, due to disease or treatment. See Immunocompromised populations.
  • Patients with suspected hypersensitivity or non-anaphylactic allergy to COVID-19 vaccine components. Consultation with an allergist is advised prior to vaccination.

Point-of-care guidance

  • As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of this vaccine.
  • The vaccine is administered through an intramuscular injection into the upper arm.
  • In order to be optimally effective in preventing SARS-CoV2 infection, the vaccine must be administered twice: a single dose of the vaccine is administered followed by a second single dose 28 days later.
  • If administration of the second dose of the vaccine is delayed, it should be administered as soon as possible.
    • For most vaccines, interruption of a vaccine series does not require restarting the series as delays between doses do not result in a reduction in final antibody concentrations for most multi-dose products.
    • However, maximum protection may not be attained until the complete vaccine series has been administered.
  • The vaccine series should be completed with the same COVID-19 vaccine product.

If a patient experiences a side effect following immunization, such as hives, swelling of the mouth and throat, trouble breathing, hoarseness, wheezing, high fever (over 40oC), convulsions, seizures, or other serious reactions:

Moderna COVID-19 Vaccine
  • Type of vaccine: COVID-19 mRNA
  • Date of authorization in Canada: December 23, 2020
  • Authorized ages for use: 18 years of age and older
  • Dose: 0.5mL dose containing 100 mcg of mRNA
  • Schedule: 2 doses, 28 days apart
  • Booster doses: No evidence on the need for an additional booster after the 2-shot series
  • Route of administration: Intramuscular (IM) into the deltoid muscle of the upper arm
  • Primary storage requirements: -25oC to -15oC in the original carton to protect from light
  • Formats available: Multiple dose vial (5 mL, containing 10 doses of 0.5 mL)
  • DRUG INTERACTIONS: No interaction studies have been performed

Preparation

  • The Moderna COVID-19 Vaccine multiple-dose vial contains a frozen suspension that does not contain a preservative and must be thawed prior to administration.
  • Thaw the required number of vials in refrigerated conditions between 2° to 8°C for 2 hours and 30 minutes. After thawing, let vial stand at room temperature for 15 minutes before administering. Alternatively, thaw at room temperature between 15° to 25°C for 1 hour.
  • Do not refreeze.
  • Swirl vial gently after thawing and between each withdrawal. Do not shake.
  • The Moderna COVID-19 Vaccine must not be reconstituted, mixed with other medicinal products, or diluted.

Administration

  • Visually inspect each dose of the Moderna COVID-19 Vaccine in the dosing syringe prior to administration. The white to off-white suspension may contain white or translucent product related particulates.
  • During the visual inspection:
    • Verify the final dosing volume of 0.5 mL.
    • Confirm there are no other particulates, and that no discoloration is observed.
    • If the visual inspection fails, do not administer the vaccine.
  • Administer the Moderna COVID-19 Vaccine intramuscularly.
  • Remind patients to continue to practice recommended public health measures for prevention and control of SARS-CoV-2 infection and transmission regardless of receipt of COVID-19 vaccine, 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 (NACI, December 18, 2020).
  • Similar to other immunizations, ask patients to wait for 15 minutes following administration in order to monitor for adverse events, such as anaphylaxis.
  • For patients with a history of anaphylaxis not related to vaccines or injectable medications (e.g., allergies to food, pets), a waiting period of 30 minutes is recommended.

Storage, stability and disposal

Frozen vials prior to use
  • The Moderna COVID-19 vaccine should be stored at temperatures of -25ºC to -15ºC in the original carton to protect from light. Do not store on dry ice or below -40ºC.
Unpunctured vials
  • Unpunctured vials can be stored refrigerated between 2° to 8°C for up to 30 days prior to first use.
  • Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for up to 12 hours.
  • During storage, vials should be protected from light.
  • Do not refreeze thawed vials.
Punctured vials
  • Once punctured, the vial can be stored at room temperature or refrigerated
  • Punctured vials must be discarded after 6 hours. Do not refreeze.
  • Any unused vaccine or waste material should be disposed of in accordance with local requirements.

Vaccine ingredients

Nucleic acid
  • mRNA

This is the active ingredient of the vaccine. It contains the instructions your body needs to build antibodies to help protect you against COVID-19.

Lipids
  • Lipid SM-102
  • PEG2000 DMG (1,2-dimyristoyl-rac-glycerol,methoxy-polyethyleneglycol)*
  • 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC)
  • Cholesterol

These ingredients are lipids, a type of fat that forms a protective shell around the active ingredient, mRNA, and allows it to “slide” into cells so it can work.

Salts, Acids, and Acid Stabilizers
  • Sodium acetate (Salt)
  • Acetic acid (Acid)
  • Tromethamine (Acid stabilizer)
  • Tromethamine hydrochloride (Acid stabilizer)

These ingredients are used as stabilizers for the vaccine to help maintain its pH close to that of a person’s body.

Sugar
  • Sucrose

Sucrose is a type of sugar that is used as a stabilizer to help the vaccine particles keep their shape when they are frozen

Water
  • Water for injection

Water is used to mix the vaccine ingredients into a liquid that can be injected into the body

Patient resources New

This is not an exhaustive list of COVID-19 patient-facing resources. These resources were selected as they meet key criteria identified by CEP’s partners, stakeholders and Information experts: authoritative sources, short formats, engaging design, multilingual translations, and focus on key messaging. To combat information overload, we are strictly curating this list to avoid redundancy. Additions, updates and substitutions will be made on a case-by-case basis according to alignment with selection criteria.

Comprehensive vaccine FAQs
  • COVID-19 Vaccine (City of Hamilton): FAQs on safety and effectiveness of the COVID-19 vaccine, and links to resources simplifying the science of vaccines. Does include some Hamilton-specific information.
  • COVID-19 Vaccine Fact Sheet (City of Toronto): Not limited to Toronto-specific information. Vaccine FAQs and info sheet on benefits, side effects, ingredients and allergies, as well as vaccinations while pregnant or breastfeeding, with health conditions, or with previous COVID-19 infection. See “COVID-19 Fact Sheet and Translations” section for short info sheet available in 32 languages including English, French, Spanish, Arabic, and Chinese.
Multilingual information sheets
Resources for Black communities

 

Resources for Indigenous communities

Top resources New

These supporting materials and resources are hosted by external organizations. The accuracy and accessibility of their links are not guaranteed. CEP will make every effort to keep these links up to date.

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