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: January 18, 2021
Last updated: January 21, 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

  • Primary care providers and patients can be confident. Standards of safety, efficacy, and quality have not been compromised to expedite the approval of COVID-19 vaccines.
  • Health Canada oversight of COVID-19 vaccines will NOT stop at approval. Health Canada will monitor the vaccine’s safety and effectiveness now and into the future.
  • Research into the value of mRNA for vaccinations has been progressing for over ten years. Though the new vaccine is the first mRNA vaccine approved for use in humans, mRNA has been successfully used in cancer treatments.

Click on the sections below to get started:

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Availability, rollout and prioritization in Ontario New

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When will primary care providers get the vaccine?

In Ontario’s plan, all healthcare workers are to be vaccinated in Phase 1, which is targeted to span from January to the end of March. However, it is hoped that the increasing number of doses available and the opening of new vaccine sites will accelerate the vaccination timeline.

Currently, vaccines are available to healthcare workers and essential caregivers who work in hospitals, long-term care homes, retirement homes, and other congregate settings caring for seniors.

The next group of healthcare workers will be the rest of the “priority sectors,” which includes primary care. Priority sectors are those that have direct, in-person patient care, a higher level of urgency and criticality, and a higher likelihood of engaging in higher exposure risk procedures, among other factors (MOH, January 8, 2021).

When will primary care providers be administering the vaccine?

In the current plan, vaccination in primary care practices is scheduled to begin in April with Phase 2, though large primary care practices may be administering the vaccine as early as March. Phase 2 vaccinations would include the following patient groups:

  • Older adults, beginning with those > 80 years of age and decreasing in five-year increments
  • Individuals living and working in high-risk congregate settings
  • Frontline essential workers (e.g., first responders, teachers, food processing industry)
  • Individuals with high-risk chronic conditions and their caregivers
  • Other populations and communities at greater risk of COVID-19

Distribution and logistics

Vaccination targets

Phase 1 (December – end of March)

Approximately 1.5 million long-term care residents, staff, and other employees; health care workers; adults in First Nations, Métis, and Inuit populations; adult chronic home care recipients

Phase 2 (End of March – end of July)

8.5 million essential workers, adults (75+, 60-75), at-risk populations, followed by adults 16-60

Phase 3 (August and beyond)

Remaining eligible Ontarians

Expected doses

The manufacturing and supply chain delay for the Pfizer-BioNTech vaccine will affect Ontario’s vaccination schedule. The impact will vary week to week, with the Ministry of Health estimating:

  • Week of Jan 25: No doses expected (originally 242,775 expected Jan 11-31)
  • Feb 1-15: 45-55% reduction in expected Pfizer dose delivery (originally 571,350 expected in February)

Ontario is still on track for the Moderna schedule:

  • January 11-31: 56,700 doses
  • February: 170,700 doses

To mitigate the effects of the delay, the province will:

  • Reallocate available doses of the Moderna vaccine to more regions.
  • Extend the interval between doses of the Pfizer vaccine in some situations to ensure that everyone who has had a first shot will have access to their second. 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.

Vaccination operations

Public Health Units will lead local vaccination distribution, with hospitals continuing to lead vaccination of hospital-based physicians and healthcare workers. The 34 Public Health Units in the province are in the process of identifying primary care vaccination leads.

Clinic locations

Vaccine clinics are currently not open to the public. Additional hospital sites and Public Health Units will be opened to provide vaccines in regions with the highest rates of COVID-19 infection. Clinic locations:

  • Brantford General Hospital
  • Grand River Hospital
  • Halton Healthcare
  • Hamilton Health Sciences
  • Humber River Hospital
  • Kingston General Hospital
  • Lakeridge Health
  • London Health Sciences Centre
  • Mackenzie Health
  • Michael Garron Hospital
  • Niagara Health – St. Catharines site
  • Ottawa Hospital
  • Royal Victoria Regional Health Centre
  • Scarborough Health Network
  • Southlake Regional Health Centre
  • Sunnybrook Health Sciences Centre
  • Thunder Bay Regional Health Sciences Centre
  • Trillium Health Partners
  • University Health Network in Toronto
  • Unity Health Toronto
  • William Osler Health System
  • Windsor Regional Hospital
Metro Toronto Convention Centre “Proof-of-Concept” site

Under the direction of the Ministry of Health, Toronto and Toronto Public Health launched a ‘proof-of-concept’ immunization clinic on Monday, January 18, 2021 – however, recent delays in the delivery of the Pfizer-BioNTech vaccine has temporarily shut the clinic.

The clinic will help test and adjust immunization clinic setup in non-hospital settings, ensuring safety and increasing efficiency in advance of wider immunization (City of Toronto, January 11, 2021).

The goals of this site are:

  • Vaccination of 250 people per day, in accordance with provincial allocations of COVID-19 vaccine
  • Test clinic operations with a sample group of healthcare workers, identified in accordance with the Province’s Ethical Framework for COVID-19 vaccine prioritization, including frontline shelter workers and harm-reduction and Streets to Homes staff who support some of Toronto’s most vulnerable residents.
  • Develop a clinic playbook collaboration with provincial and hospital partners after 6 weeks of operation, to be provided to the province for use in establishing other immunization clinics both in Toronto and across Ontario.

In future phases, the province will establish other clinic types in order promote swift vaccination:

  • On-site clinics for northern and remote First Nation communities, on-reserve Indigenous residents, and adult chronic home care recipients
  • Mobile sites for congregate living facilities and urban Indigenous communities
For greater detail about vaccine rollout, prioritization, and availability, see:

Emerging evidence: specific populations, allergic reactions and extended vaccine dosage interval New

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Immunocompromised populations

Why has this been in the news?

The authorization of Pfizer-BioNTech and Moderna COVID-19 mRNA vaccines 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.

Both the Pfizer-BioNTech and Moderna COVID-19 mRNA 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 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.
  • 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 (MOH, January 8, 2021; NACI, December 23, 2020; CDC, January 6, 202; CRA, December 31, 2020).

Pregnant and breastfeeding women

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 vaccines are not hypothesized to be a risk to the breastfeeding infant (MOH, January 8, 2021; NACI, January 12, 2020; SOGC, January 11, 2021; OSOG/OMA-OG, 2021).

How does this apply to my practice?

Key takeaway: For pregnant and breastfeeding women in the authorized age group, the choice to receive the vaccine resides with the patient and should be made after informed counselling and consent with their primary care provider. Providers should document this discussion, but patients do not have to provide the vaccination site with a note from their provider (MOH, January 8, 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, January 12, 2020).
    • 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, January 11, 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 an mRNA COVID-19 vaccine (SOGC, January 11, 2021; NACI, January 12, 2020).

COVID-19 vaccine 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 115,000 total doses administered in Canada, there have been five serious adverse events following vaccination, including anaphylaxis (Health Canada, January 2021).
  • The U.S. has recorded a rate of 11.1 cases of anaphylaxis per million doses, with 71% occurring within 15 minutes of vaccination (CDC, January 6, 2021).
  • As millions of doses of both vaccines 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.

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, Jan 12, 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.

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.

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)

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 4 times that many.
  • COVID-19 is very contagious and can cause serious illness. More than 14,000 Canadians and close to 300,000 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

  • Even if you had COVID-19 in the past, it is uncertain how long the antibodies will last. You should still get the vaccine to protect yourself and others.

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

Neither the Pfizer-BioNTech vaccine or the Moderna vaccine has been tested in pregnant women, so more studies are needed. There is no known mechanism to suggest that it could affect fertility negatively, just that evidence is limited. The women who were included in the Pfizer study and found out were pregnant after having had the vaccine, have not had any known adverse events so far. However, the potential harm of COVID-19 is well-established. Let’s discuss the benefits and risks and come to a decision together.

  • The Pfizer-BioNTech vaccine has not been tested in children. The clinical trial included people aged 16 and over.
  • Currently, it is not recommended that the vaccine be administered to children under 16, as children often need a different dose than adults and may show stronger immune reactions. More data are expected in 2021.

References

  • The Moderna vaccine has not been tested in children. The clinical trial included people aged 18 and over.
  • Currently, it is not recommended that the vaccine be administered to children under 18, as children often need a different dose than adults and may show stronger immune reactions.

References

  • The Pfizer-BioNTech vaccine trials included patients aged over 65, and the efficacy was very similar to the younger age group, with older patients experiencing slightly fewer side effects like local reactions, headaches and body aches.

References

  • The Moderna vaccine trials included patients aged over 65, and the efficacy was 86.4% – similar to the younger age group.
  • Older patients experienced slightly fewer side effects like local reactions, headaches and body aches.

References

 

  • Health Canada has not made a recommendation that anyone with a history of severe allergic reactions should avoid the Pfizer-BioNTech vaccine. There is no evidence that people with allergies to non-vaccine ingredients are at higher risk of allergy to the vaccine.
  • However, those with a known allergy to a component of the vaccine is a contraindication should not get this vaccine.
  • The Pfizer-BioNTech vaccine is contraindicated in those with a known diagnosis of anaphylaxis to polyethylene glycol.
  • It is always advised to wait 15-20 minutes after receiving a vaccine, since an allergic reaction or anaphylaxis is always a possible reaction to any medication or vaccination.
  • There are many vaccines currently under development. Some patients may be allergic to an ingredient in one, but not another. Health Canada has purchase agreements with six other vaccines that are different from the Pfizer-BioNTech vaccine.

References

  • It’s 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.

References

Vaccine ingredients and efficacy

  • No. It does not contain mercury, formaldehyde, aluminum, or fetal cells.
  • For a list and explanation of the ingredients in the Pfizer-BioNTech vaccine, please see Vaccine ingredients

References

  • No. It does not contain mercury, formaldehyde, aluminum, or fetal cells.
  • The ingredients of the vaccine are:
    • Medicinal ingredient: mRNA-1273 SARS-CoV-2
    • Non-medicinal ingredients:
      • 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC)
      • acetic acid
      • cholesterol
      • PEG2000 DMG (1,2-dimyristoyl-rac-glycerol,methoxy-polyethyleneglycol)
      • lipid SM-102
      • sodium acetate
      • sucrose
      • tromethamine
      • tromethamine hydrochloride
      • water for injection

References

  • 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 VUI-202012/01(UK) and 501Y.V2 (South Africa) in Canada.

Although early data suggests that these variants may be more easily transmitted, there is currently no evidence to suggest that the approved vaccines will not be effective against the new variants of the virus.

Research is ongoing to learn more about these variants (PHAC, January 9, 2021; Johns Hopkins Center for Health Security, January 8, 2021)

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 45,000 people and the Moderna trial over 30,000.
  • 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.
  • I have reviewed the steps taken and have full faith in it. Myself, my colleagues, and my family will be taking or have taken the vaccine. Health Canada is known to have a rigorous and thorough approval process to ensure the safety of all Canadians.

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 vaccine 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

  • Most 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. Reactions at the injection site will improve by 48-72 hours.
  • Around 1 in 10 people will feel like they want to take acetaminophen or ibuprofen.
  • Less often, people may experience enlarged lymph nodes (1 in 100). Other rare side effects include anaphylaxis, especially if someone has a history of a severe allergy.

Very common side effects (may affect more than 1 in 10 people)

  • Pain at injection site (84.1%*)
  • Fatigue (62.9%*)
  • Headache (55.1%*)
  • Muscle pain (38.3%*)
  • Chills (31.9%*)
  • Joint pain (23.6%*)
  • Fever (14.2%*)
Uncommon side effects (may affect up to 1 in 100 people)
  • Enlarged lymph nodes (0.008%**)

References

 

*subset (n=8183)
**subset (n=7960)

  • Most 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.
  • The majority of local and systemic adverse reactions had a median duration of 1 to 3 days.

Most frequently reported side effects

  • Pain at injection site (92%)
  • Fatigue (70%)
  • Headache (64.7%)
  • Muscle pain (61.5%)
  • Chills (5%)

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 trial had over 45,000 people and the Moderna trial over 30,000.

References

  • 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.
  • Studies have been reassuring that there are no serious adverse effects for the duration of clinical trials in tens of thousands of people so far. 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.

References

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)

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
  • 43,651 total participants (21,823 receiving vaccine and 21,828 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 (43,651). This can contribute to slightly different statistics being reported by different sources.
  • For the number of patients in each subsection, see Pfizer-BioNTech COVID-19 vaccine product monograph (Pfizer-BioNTech, December 9, 2020).
Participant demographics
  • 41% were between 56 and 85 years old
  • 42% were of diverse racial 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. The most commonly reported side effects were:

Very common side effects (may affect more than 1 in 10 people):

  • Pain at injection site (84.1%*)
  • Fatigue (62.9%*)
  • Headache (55.1%*)
  • Muscle pain (38.3%*)
  • Chills (31.9%*)
  • Joint pain (23.6%*)
  • Fever (14.2%*)

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. A minimum of 19 days between the first and second dose with a recommended interval 21-28 days
  • If administration of the second dose of the vaccine is delayed, it should be administered as soon as possible.
  • In general, regardless of the time between doses, 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.
  • Do not mix the Pfizer-BioNTech COVID-19 vaccine with other vaccines/products in the same syringe.

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 (5 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 [77°F]) (see STORAGE, STABILITY AND DISPOSAL section).
  • 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, the vial contains 5 doses of the vaccine (0.3 mL each).
  • 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 +2 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, Dec 4, 2020).
  • Similar to other immunizations, ask patients to wait for 15 minutes following administration in order to monitor for adverse events, such as anaphylaxis.

Storage, stability and disposal

Frozen vials prior to use
  • Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials (after dilution each vial contains 5 doses of 0.3 mL) arrive in thermal containers with dry ice. To ensure all appropriate safeguards are in place, refer to the Dry Ice Safety Data Sheet and the Pfizer-BioNTechCOVID-19 Vaccine Storage and Handling Reference Guide provided (also available at CVDvaccine.ca).
  • Once received, remove the vial cartons immediately from the thermal container and store in the freezer between -80°C to -60°C (-112°F to -76°F).
  • 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, multiple dose vials of Pfizer-BioNTech COVID-19 Vaccine 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 in less time. 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, the multiple dose vial 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, multiple dose vials of Pfizer-BioNTech COVID-19 Vaccine 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.
  • During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light (Product monograph, including patient medication information: Pfizer-BioNTech COVID-19 vaccine (2020).
  • 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, December 23, 2020).
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. The most commonly reported side effects were:

  • 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)*

*Rates calculated after second dose given, all other rates included first or second dose.

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 one month (28 days) later. 
  • If administration of the second dose of the vaccine is delayed, patients should speak to their healthcare professional.
  • In general, regardless of the time between doses, 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.
  • Do not reconstitute, mix or dilute the Moderna COVID-19 vaccine with other vaccines/products.

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 4, 2020).
  • Similar to other immunizations, ask patients to wait for 15 minutes following administration in order to monitor for adverse events, such as anaphylaxis.

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.
  • 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

Top resources

Pfizer-BioNTech COVID-19 vaccine
Moderna COVID-19 vaccine
General vaccine information (development and approval process, availability, etc.)

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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