Planning guidance for immunization clinics for COVID-19 vaccines: Sample information sheets, consent forms, after care sheets

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Pfizer-BioNTech Comirnaty and Moderna Spikevax Omicron XBB.1.5 COVID-19 mRNA vaccines

Information sheet

Download in Word format the sample information sheet for Pfizer-BioNTech Comirnaty and Moderna Spikevax Omicron XBB.1.5 COVID-19 mRNA vaccines

Please read this information sheet carefully and ensure all your questions have been answered by a health care provider before you or your child receives the vaccine.

What is COVID-19?

COVID-19 is an infectious disease caused by a coronavirus (SARS-CoV-2). COVID-19 was recognized for the first time in December 2019 and spread around the world to cause a pandemic. The virus that causes COVID-19 is mainly passed from an infected person to others when the infected person coughs, sneezes, sings, talks or breathes. It is important to note that infected people can spread the infection even if they have no symptoms.

Symptoms of COVID-19 can include cough, shortness of breath, fever, chills, tiredness, diarrhea, vomiting and loss of smell or taste. Some people infected with the virus have no symptoms at all, while others have symptoms that range from mild to severe.

Even people with no or mild COVID-19 symptoms may feel unwell for a long time after a COVID-19 infection with symptoms such as tiredness, memory problems, shortness of breath, headache, and change in taste and smell. Prolonged symptoms after a SARS-CoV-2 infection are referred to as post-COVID-19 condition and can occur in adults and less commonly in children.

Children are less likely to get severely ill than adults, but they can still get sick and require hospitalization, and rarely they can be admitted to the intensive care unit or can die from their infection. Children can also develop a rare complication called Multisystem Inflammatory Syndrome in Children (MIS-C) which often requires admission to an intensive care unit.

How do the Pfizer-BioNTech Comirnaty and Moderna Spikevax vaccines protect against COVID-19?

The vaccines enable our body to produce protection (such as antibodies) to help keep us from becoming severely sick or hospitalized if we are exposed to the COVID-19 virus. The vaccines use a new method called messenger RNA (mRNA) to help our body make protection against the virus. Being vaccinated can also help prevent post-COVID-19 condition.

Who can and cannot receive the COVID-19 vaccine at this time?

The National Advisory Committee on Immunization (NACI) has recommended that the mRNA vaccines (Pfizer-BioNTech Comirnaty and Moderna Spikevax) are preferred because they work very well and we are now very familiar with their safety profile.

Table 1 indicates who should and should not receive the mRNA vaccines and provides some questions you may be asked before vaccination and possible recommendations based on your response. These recommendations are based on the advice of NACI.

Note: "you" refers to the individual being vaccinated.

Table 1: Questions and possible recommendations with regard to receiving the Pfizer-BioNTech Comirnaty Omicron XBB.1.5 or Moderna Spikevax Omicron XBB.1.5 COVID-19 vaccines
Questions Possible recommendations

Are you feeling ill today?

Vaccinations should be postponed in someone who may have COVID-19 to prevent spreading infection to others at the clinic.

Talk with your health care provider about any symptoms you may have. Your health care provider will advise you when the vaccine should be provided.

Have you had a COVID-19 infection?

It is important for people with previous COVID-19 infection to be vaccinated to help prevent becoming infected again. After a COVID-19 infection, NACI suggests waiting 8 weeks to start or complete your primary series (or 4 to 8 weeks for people who are immunocompromised). For those who are previously vaccinated, NACI suggests waiting 6 months after SARS-CoV-2 infection to receive a subsequent dose, although shorter intervals may be recommended by your health care provider.

If your child has had Multisystem Inflammatory Syndrome in Children (MIS-C), the vaccine can be given when all their symptoms have resolved or 3 months have passed from the start of their symptoms, whichever is longest.

Did you have any side effects after any previous dose of COVID-19 vaccine?

It may be possible for people with previous allergic reactions to a COVID-19 vaccine to receive that same type of vaccine again. Consult with your health care provider.

If you had myocarditis or pericarditis (inflammation of the heart or lining of the outside of the heart) after a previous dose of an mRNA vaccine, consult with your health care provider. A repeat COVID-19 vaccine is generally not recommended. If a repeat vaccine is offered, the Pfizer-BioNTech Comirnaty vaccine is the preferred vaccine.

Are you allergic to polyethylene glycol (PEG)Table 1 Footnote a (which is contained in the Pfizer-BioNTech Comirnaty and Moderna Spikevax vaccines)?

See footnotes for more details

If you are allergic to polyethylene glycol (PEG), it may be possible for you to receive an mRNA vaccine. Consult with your health care provider.

Are you allergic to tromethamine (trometamol or Tris)Table 1 Footnote b (which is contained in the Pfizer-BioNTech Comirnaty vaccine and Moderna Spikevax vaccines)?

See footnotes for more details

If you are allergic to tromethamine (trometamol or Tris), it may be possible for you to receive an mRNA vaccine. Consult with your health care provider.

Do you have a suspected but unproven allergy to a vaccine component (polyethylene glycol [PEG]Table 1 Footnote a, trometamol or TrisTable 1 Footnote b)?

See footnotes for more details

If "yes", you may receive an mRNA COVID-19 vaccine. You will be asked to wait in the clinic for 30 minutes after receiving the vaccine to make sure you are feeling well.

Have you had an allergic reaction to another vaccine (another type of COVID-19 vaccine or a non-COVID-19 vaccine) or other medication given by injection or intravenously in the past?

If "yes", you may receive an mRNA COVID-19 vaccine. You will be asked to wait in the clinic for 30 minutes after receiving the vaccine to make sure you are feeling well.

Are you or could you be pregnant?

No safety concerns particular to pregnancy have been identified with the mRNA COVID-19 vaccines based on real world data. The benefit of vaccination in this population has been demonstrated to outweigh any potential theoretical risk.

Do you have any problems with your immune system or take any medications that can affect the immune system (e.g., high dose steroids, chemotherapy, some arthritis medications)?

Ask the health care provider if you are not sure about your medical conditions

People with problems with their immune systems may have a reduced immune response to the COVID-19 vaccine. An additional dose may be recommended for the primary series for immunocompromised individuals, compared to the age-based recommendations for those who are not immunocompromised.

Do you have a bleeding disorder or take any medications that could affect blood clotting?

Ask the health care provider if you are not sure about your medical conditions

If "yes", the health care worker may hold the site where the needle is given for longer to prevent bleeding and bruising.

Are you feeling particularly anxious or afraid of the needle?

Let the health care provider know if you are feeling particularly anxious or concerned. They can take steps to help you feel more comfortable receiving the vaccine.

Have you ever felt faint or fainted after a past vaccination or medical procedure?

If "yes", the health care provider may vaccinate you lying down to prevent you from fainting.

Table 1 - Footnote a

Polyethylene glycol (PEG) can rarely cause allergic reactions and is found in products such as over the counter (e.g., cough syrup, laxatives) and prescription medications, medical bowel preparation products for colonoscopy, skin care products, dermal fillers, cosmetics, contact lens solutions, and products such as ultrasound gel. Note that this is not a complete list. PEG can also be found in foods or drinks but has not been reported to cause allergic reactions from foods or drinks.

Return to Table 1 Footnote a referrer

Table 1 - Footnote b

Tromethamine (trometamol or Tris) may very rarely cause allergic reactions and is found in some medications injected to do tests (contrast media) as well as other medications taken by mouth or injection, and some creams and lotions. Note that this is not a complete list.

Return to Table 1 Footnote b referrer

How is the vaccine administered?

The vaccine is given using a needle, usually in the muscle in the upper arm or, less commonly, in the thigh. The thigh is the recommended site for children 6 months to less than 1 year of age.

If you are not previously vaccinated, the number of doses you will receive will depend on your age, and if you have problems with your immune system. If you started the vaccine series with an earlier vaccine but did not complete the series, you should complete it with the XBB.1.5 vaccine. Tables 2 and 3 of the Updated guidance on the use of COVID-19 vaccines in individuals who have not previously been vaccinated against COVID-19 provide information on the number and timing of doses recommended.

If you have been previously vaccinated with a primary series, a dose of XBB.1.5 COVID-19 vaccine is recommended 6 months following previous COVID-19 vaccination or SARS-CoV-2 infection (whichever is later). Shorter intervals (i.e., 3 months to less than 6 months) following previous vaccination or infection have also not been shown to pose a safety risk.

What are the risks of the vaccine?

Side effects can develop within a few days after receiving vaccines. Although most side effects are not serious, they may make you feel unwell for a few days; they will go away on their own. Some common and expected side effects include one or more of the following:

  • pain, redness or swelling where the needle was given
  • tiredness
  • headache
  • muscle pain
  • joint pain
  • chills
  • fever
  • diarrhea, nausea or vomiting
  • swollen glands in the underarm

Rarely allergic reactions can occur after receiving a vaccine. Symptoms of an allergic reaction include:

  • difficulty breathing
  • hives (bumps on the skin that are often very itchy)
  • swelling of your face, tongue or throat

The clinic staff are prepared to manage an allergic reaction should it occur. Seek immediate medical care if you develop any of these symptoms.

Inflammation of the heart or the lining of the outside of the heart (myocarditis or pericarditis) have rarely been reported after mRNA vaccines. Most cases are mild and symptoms resolve quickly after seeking medical care.

The risks of myocarditis or pericarditis from mRNA vaccines are higher:

  • after the second dose
  • within a week of vaccination
  • in adolescents and young adults (less than 30 years of age)
  • in males than females
  • after Moderna Spikevax compared to after Pfizer-BioNTech Comirnaty in adolescents and young adults, based on information from previous vaccines used in the primary series

Myocarditis or pericarditis after COVID-19 vaccination in children is uncommon.

Seek medical attention immediately if you develop any of the following:

  • chest pain
  • shortness of breath
  • fast or irregular heartbeat

Bell's palsy (weakened or inability to move the muscles of the face) has rarely been reported after mRNA vaccines. Seek medical attention if you experience facial weakness or drooping or other symptoms involving the face.

Other side effects such as unusual sensations (such as numbness or tingling), dizziness or skin rashes have also been reported.

It is important to note that you cannot get COVID-19 infection from the vaccine.

What should you do before coming to the clinic?

Make sure that you wear a short-sleeve shirt or top with sleeves that are easy to roll up.

To prevent feeling faint while being vaccinated, make sure not to skip a meal before coming to the clinic.

A mask should be worn. A medical mask or N95 or KN95 respirator are preferred.

Bring any identification required by the clinic, such as your health card.

Bring your immunization record with you.

What should you do after receiving the vaccine?

You will be asked to wait at least 15 minutes after receiving the vaccine to be sure you are feeling well. Longer waiting times of 30 minutes may be recommended if there is concern about a possible vaccine allergy. Inform a health care provider right away if you feel unwell while waiting. You should not leave the clinic for at least 15 to 30 minutes after receiving your vaccine, based on the recommendation of the health care provider, and should not leave if you are feeling unwell.

Once you leave the clinic, call 9-1-1 right away if you develop any serious symptoms or symptoms of an allergic reaction such as hives (bumps on the skin that are often very itchy), swelling of your face, tongue or throat, or difficulty breathing. Inform your health care provider or local public health department of any concerning side effects after receiving the vaccine.

Seek medical care right away if you develop symptoms that could be myocarditis or pericarditis such as chest pain, shortness of breath or a fast or irregular heartbeat.

Continue to follow the recommendations of local public health officials to prevent the spread of COVID-19.

If possible, wait at least 2 weeks after vaccination or completing your COVID-19 vaccination series before starting drugs that suppress your immune system, as recommended by your health care provider.

Keep your immunization record in a safe place.

When should the next dose of COVID-19 vaccine be given?

For the primary series for children 6 months to under 5 years of age who are not immunocompromised, the National Advisory Committee on Immunization (NACI) recommends 8 weeks between the 2 doses of Moderna Spikevax or 3 doses of Pfizer-BioNTech Comirnaty.

For the primary series for children 6 months to under 5 years of age who are moderately to severely immunocompromised, NACI recommends 4 to 8 weeks between the 3 doses of Moderna Spikevax (or 4 doses of Pfizer-BioNTech Comirnaty, although this is not the preferred product).

For the primary series for those 5 years of age and older who are not immunocompromised, only 1 dose of XBB.1.5 vaccine is recommended, while 2 doses 4 to 8 weeks apart are recommended for those who are moderately to severely immunocompromised.

A different schedule may be advised if you started a primary series with an earlier COVID-19 vaccine and are completing it with 1 or more XBB.1.5 vaccines. Consult with a health care provider.

At this time, individuals whose primary series included the XBB.1.5 COVID-19 vaccine do not require further doses once the primary series is complete. As well, individuals who were previously vaccinated and then received an XBB.1.5 vaccine do not require any further doses at this time.

After a SARS-CoV-2 infection, NACI suggests waiting 8 weeks to start or complete the primary series (or 4 to 8 weeks for people who are moderately to severely immunocompromised) and 6 months after the infection to receive a subsequent dose for those who were previously vaccinated. Shorter intervals may also be used based on recommendations from your health care provider.

It is very important to stay up to date with all recommended COVID-19 vaccines. Your health care provider or local public health department can provide advice about vaccine recommendations if you have questions.

Bring your immunization record with you when you come for your next dose.

If you have any questions, please speak with the person providing the vaccine or contact: Insert contact information.

Consent form

Download in Word format the sample consent form for Pfizer-BioNTech Comirnaty and Moderna Spikevax Omicron XBB.1.5 COVID-19 mRNA vaccines

  • Last name:
  • First name:
  • Health card number / First Nations Status Card Number:
  • Phone number:
  • Email address:
  • Street address:
  • City:
  • Province:
  • Postal code:
  • Date of birth:
    • Month
    • Day
    • Year
  • Age:
  • Gender/Sex: (insert choice per data collection preferences)

Note: "you" refers to the individual being vaccinated.

  • How many doses of COVID-19 vaccine(s) have you had before?
  • Specify the name and date of the last COVID-19 vaccine you received, if known.
    • Name of vaccine:
    • Date: (month / day / year)
  • Are you feeling ill today?
    • No
    • Yes
    • If yes, please provide details
  • Have you had a COVID-19 infection?
    • No
    • Yes
    • If yes, please indicate the date the symptoms started and when you tested positive, if known (based on your most recent infection if you have had more than one infection)
  • Did you have any side effects after any previous dose of COVID-19 vaccine (including allergic reactions, heart inflammation [myocarditis or pericarditis])?
    • No
    • Yes
    • No previous dose
    • If yes, please provide details
  • Do you have an allergy to or could you be allergic to polyethylene glycol (PEG)*?
    *Polyethylene glycol (PEG) can rarely cause allergic reactions and is found in products such as over the counter (e.g., cough syrup, laxatives) and prescription medications, medical bowel preparation products for colonoscopy, skin care products, dermal fillers, cosmetics, contact lens solutions, and products such as ultrasound gel. Note that this is not a complete list. PEG can also be found in foods or drinks but has not been reported to cause allergic reactions from foods or drinks.
    • No
    • Yes
    • If yes, please provide details
  • Do you have a known or possible allergy to tromethamine (trometamol or Tris)**?
    **Tromethamine (trometamol or Tris) may very rarely cause allergic reactions and is found in some medications injected to do tests (contrast media) as well as other medications taken by mouth or injection, and some creams and lotions. Note that this is not a complete list.
    • No
    • Yes
    • If yes, please provide details
  • Have you had an allergic reaction to another vaccine (another type of COVID-19 vaccine or a non-COVID-19 vaccine) or other medication given by injection or intravenously in the past?
    • No
    • Yes
    • If yes, please provide details
  • Are you or could you be pregnant?
    • No
    • Yes
    • N/A
  • Do you have any problems with your immune system or take any medications that can affect the immune system (e.g., high dose steroids, chemotherapy, some arthritis medications)?
    Ask the health care provider if you are not sure about your medical conditions
    • No
    • Yes
    • Uncertain
    • If yes, please provide details
  • Do you have a bleeding disorder or take any medications that could affect blood clotting?
    Ask the health care provider if you are not sure about your medical conditions
    • No
    • Yes
    • Uncertain
    • If yes, please provide details
  • Are you particularly anxious or concerned about receiving the vaccine?
    • No
    • Yes
    • If yes, please provide details
  • Have you ever felt faint or fainted after a past vaccination or medical procedure?
    • No
    • Yes
    • If yes, please provide details

I have read (or it has been read to me) and I understand the "Information sheet for Pfizer-BioNTech Comirnaty and Moderna Spikevax Omicron XBB.1.5 COVID-19 mRNA vaccines". I have had the opportunity to ask questions and to have them answered to my satisfaction.

I consent to receiving the vaccine (Pfizer-BioNTech Comirnaty XBB.1.5 or Moderna Spikevax XBB.1.5).

I consent to my child receiving the vaccine (Pfizer-BioNTech Comirnaty XBB.1.5 or Moderna Spikevax XBB.1.5).

  • Signature / signature of parent or guardian:
  • Print name:
  • Date of signature:
  • If signing for someone other than yourself, indicate your relationship to that other person:

I confirm that I am the parent / legal guardian or substitute decision maker.

Additional questions to help understand the populations receiving the COVID-19 vaccine

1. Race/ethnicity: Please check the applicable boxes

This information is being requested to help ensure that the vaccine is being provided in a way that is available to everyone who would like to receive it.

  • Black (e.g., African, Afro-Caribbean, African Canadian descent)
  • East/Southeast Asian (e.g., Chinese, Korean, Japanese, Taiwanese descent or Filipino, Vietnamese, Cambodian, Thai, Indonesian, other Southeast Asian descent)
  • Indigenous (e.g., First Nations, Inuk/Inuit, Métis descent)
  • Latino (e.g., Latin American, Hispanic descent)
  • Middle Eastern (e.g., Arab, Persian, West Asian descent - i.e., Afghan, Egyptian, Iranian, Lebanese, Turkish, Kurdish)
  • South Asian (e.g., South Asian descent - i.e., East Indian, Pakistani, Bangladeshi, Sri Lankan, Indo-Caribbean)
  • White (e.g., European descent)
  • Other, specify:
  • Prefer not to answer
  • Unknown

If Indigenous, please indicate which Indigenous identity:

  • First Nations
  • Métis (includes member of a Métis organization or Settlement)
  • Inuk/Inuit
  • Other Indigenous, specify:
  • Prefer not to answer
  • Unknown

Do you reside in a First Nations Community (on reserve or Crown land) or Inuit Community?

  • Yes
  • No
  • Prefer not to answer
  • Unknown

2. Do you have any underlying medical conditions (heart disease, lung disease, cancer, high blood pressure, diabetes, problems with your immune system, taking medication that affects your immune system, kidney disease, liver disease)?

  • Yes
  • No
  • Prefer not to say
  • Not certain
For clinic use only
Vaccine Dose Lot number Expiry date Site and route Time given Date given
month/day/year
Given by
name and designation
no data  no data no data no data no data no data no data no data

Comments:

Any legal notice required including with regard to confidentiality of the information.

After care sheet

Download in Word format the sample after care sheet for Pfizer-BioNTech Comirnaty and Moderna Spikevax Omicron XBB.1.5 COVID-19 mRNA vaccines

What should I do right after receiving the vaccine?

Note: "you" refers to the individual being vaccinated.

Wait for at least 15 minutes after receiving your vaccine. Longer waiting times of 30 minutes may be recommended if there is concern about a possible vaccine allergy. Though uncommon, fainting or allergic reactions can occur after vaccination. Symptoms of an allergic reaction include hives (bumps on the skin that are often very itchy), swelling of your face, tongue or throat, or difficulty breathing. The clinic staff are prepared to manage these events should they occur.

Immediately inform a health care provider at the clinic if you feel unwell while waiting. Do not leave the clinic if you are feeling unwell.

Continue to follow the recommendations of local public health officials to prevent the spread of COVID-19.

Use the alcohol-based hand rub to clean your hands before leaving the clinic.

Do not operate a vehicle or other form of transportation for at least 15 to 30 minutes after being vaccinated (as advised by the health care provider) or if you are feeling unwell.

What to expect in the next few days?

Side effects can develop in the few days after receiving the vaccine. Although most of these side effects are not serious to your health, they may make you feel unwell for a few days; they will go away on their own.

  • The most common side effect is pain where the needle was given; swelling or redness where the needle was given may also occur. A cool, damp cloth or wrapped ice pack where the vaccine was given may help.
  • Other symptoms may include tiredness, headache, muscle pain, joint pain, chills, fever, diarrhea, nausea, vomiting or swollen glands in the underarm.
  • If needed, pain or fever medication (such as acetaminophen) may help with pain or fever.
  • Check with your health care provider or local public health department in your community if you need advice about medication.

Serious side effects after receiving the vaccine are rare. However, should you develop any serious symptoms or symptoms that could be an allergic reaction, call 9-1-1 right away. Symptoms of an allergic reaction include:

  • difficulty breathing
  • hives (bumps on the skin that are often very itchy)
  • swelling of the face, tongue or throat

Seek medical care immediately if you develop symptoms that could indicate heart inflammation (myocarditis or pericarditis) such as:

  • chest pain
  • shortness of breath
  • fast or irregular heartbeat

Bell's palsy (weakened or inability to move the muscles of the face) has rarely been reported after mRNA vaccines. Seek medical attention if you experience facial weakness or drooping or other symptoms involving the face.

Other side effects such as unusual sensations (such as numbness or tingling), dizziness or skin rashes have also been reported.

If you have any concerns about the symptoms you develop after receiving the vaccine, contact your health care provider or the local public health department for advice. Any serious side effects after vaccination should be reported to your local public health department.

If you need to receive additional doses of COVID-19 vaccines, tell the person providing the next dose about any side effects you experienced.

When should the next dose of COVID-19 vaccine be given?

For the primary series for children 6 months to under 5 years of age who are not immunocompromised, the National Advisory Committee on Immunization (NACI) recommends 8 weeks between the 2 doses of Moderna Spikevax or 3 doses of Pfizer-BioNTech Comirnaty.

For the primary series for children 6 months to under 5 years of age who are moderately to severely immunocompromised, NACI recommends 4 to 8 weeks between the 3 doses of Moderna Spikevax (or 4 doses of Pfizer-BioNTech Comirnaty, although this is not the preferred product).

For the primary series for those 5 years of age and older who are not immunocompromised, only 1 dose of XBB.1.5 vaccine is recommended, while 2 doses 4 to 8 weeks apart are recommended for those who are moderately to severely immunocompromised.

A different schedule may be advised if you started a primary series with an earlier COVID-19 vaccine and are completing it with 1 or more XBB.1.5 vaccines. Consult with a health care provider.

At this time, individuals whose primary series included the XBB.1.5 COVID-19 vaccine do not require further doses once the primary series is complete. As well, individuals who were previously vaccinated and then received an XBB.1.5 vaccine do not require any further doses at this time.

After a SARS-CoV-2 infection, NACI suggests waiting 8 weeks to start or complete the primary series (or 4 to 8 weeks for people who are moderately to severely immunocompromised) and 6 months after the infection to receive a subsequent dose for those who were previously vaccinated. Shorter intervals may also be used based on recommendations from your health care provider.

It is very important to stay up to date with all recommended COVID-19 vaccines. Your health care provider or local public health department can provide advice about vaccine recommendations if you have any questions.

Bring your immunization record with you for all vaccines and tell the person providing the vaccine about any side effects after previous doses.

Things to remember

Continue to follow the recommendations of local public health officials to prevent the spread of COVID-19.

If possible, wait at least 2 weeks after vaccination or completing the vaccination series before starting drugs that suppress the immune system, as recommended by your healthcare provider.

Keep your immunization record in a safe place.

Novavax Nuvaxovid for those 12 years of age and older

Information sheet

Download in Word format the sample information sheet for the Novavax Nuvaxovid COVID-19 vaccine for those 12 years of age and older

Please read this information sheet carefully and ensure all your questions have been answered by a health care provider before receiving the vaccine.

What is COVID-19?

COVID-19 is an infectious disease caused by a coronavirus (SARS-CoV-2). COVID-19 was recognized for the first time in December 2019 and has since spread around the world to cause a pandemic. The virus that causes COVID-19 is mainly passed from an infected person to others when the infected person coughs, sneezes, sings, talks or breathes. It is important to note that infected people can spread the infection even if they have no symptoms.

Symptoms of COVID-19 can include cough, shortness of breath, fever, chills, tiredness, diarrhea, vomiting and loss of smell or taste. Some people infected with the virus have no symptoms at all, while others have symptoms that range from mild to severe.

Even people with no or mild COVID-19 symptoms may feel unwell for a long time after a COVID-19 infection with symptoms such as tiredness, memory problems, shortness of breath, headache, and change in taste and smell. Prolonged symptoms after a SARS-CoV-2 infection are referred to as post-COVID-19 condition and can occur in adults and children.

How does the Novavax Nuvaxovid vaccine protect against COVID-19?

The Novavax Nuvaxovid vaccine is a protein-based vaccine. It contains part of the coronavirus, the spike protein that is on the surface of the virus, and an adjuvant called Matrix-M, which helps create a stronger immune response.

Our body recognises the spike protein as a threat and produces protection against it, such as antibodies, which help keep us from becoming sick if we are exposed to the SARS-CoV-2 virus.

Clinical trials showed that beginning 7 days after the second dose, the Novavax vaccine lowered the chance of getting sick by 90%, including helping to prevent people from getting seriously ill.

Who can and cannot receive the COVID-19 vaccine at this time?

The National Advisory Committee on Immunization (NACI) has recommended that the mRNA vaccines (Pfizer-BioNTech Comirnaty and Moderna Spikevax) are preferred for both the initial series and the booster doses because they work very well and we are now very familiar with their safety profile. Novavax Nuvaxovid can be used for people who are unable or unwilling to receive an mRNA vaccine.

Table 2 indicates who should and should not receive the Novavax Nuvaxovid vaccine and provides some questions you may be asked before being vaccinated and possible recommendations based on your response. These recommendations are based on the advice of the NACI.

Note: "you" refers to the individual being vaccinated.

Table 2: Questions and possible recommendations with regard to receiving the Novavax Nuvaxovid COVID-19 vaccine
Questions Possible recommendations

Are you feeling ill today?

Vaccinations should be postponed in someone who may have COVID-19 in order to prevent spreading infection to others at the clinic.

Talk with your health care provider about your symptoms. Your health care provider will advise you when you are able to receive the vaccine.

Have you had a COVID-19 infection?

It is important for people with previous COVID-19 infection to be vaccinated to help prevent becoming infected again. After a COVID-19 infection, NACI suggests waiting 8 weeks to start or complete your initial series (or 4 to 8 weeks for people who are immunocompromised) and 6 months to receive your booster dose.

Did you have any side effects after any previous dose of COVID-19 vaccine?

It may be possible for people with previous allergic reactions to a COVID-19 vaccine to receive another vaccine type or the same vaccine type again. Consult with your health care provider.

If you had inflammation of the heart or lining of the outside of the heart (myocarditis/pericarditis) after a previous dose of a COVID-19 vaccine, consult with your health care provider. A repeat COVID-19 vaccine is generally not recommended. If a repeat vaccine is offered, the Pfizer-BioNTech vaccine is the preferred vaccine.

Are you allergic to polysorbate 80Table 2 Footnote 1 (which is contained in the Novavax Nuvaxovid COVID-19 vaccine)?

See footnote for more details

If you are allergic to polysorbate 80, consult with your health care provider about whether to receive the Novavax Nuvaxovid COVID-19 vaccine.

Do you have a suspected but unproven allergy to a vaccine component (e.g., polysorbate 80Table 2 Footnote 1)?

See footnote for more details

If "yes", you may receive the Novavax Nuvaxovid COVID-19 vaccine. You will be asked to wait in the clinic for 30 minutes after receiving the vaccine to make sure you are feeling well.

Have you had an allergic reaction to another vaccine (another type of COVID-19 vaccine or a non-COVID-19 vaccine) or other medication given by injection or intravenously in the past?

If "yes", you may receive the Novavax Nuvaxovid COVID-19 vaccine. You will be asked to wait in the clinic for 30 minutes after receiving the vaccine to make sure you are feeling well.

Are you or could you be pregnant?

Evidence is now available from real world use of mRNA vaccines in people who are pregnant. The benefit of vaccination in this population has been demonstrated to outweigh any potential theoretical risk. There is more evidence regarding the safety of mRNA vaccines than the Novavax Nuvaxovid vaccine, including for people who are pregnant, so an mRNA vaccine is preferred by NACI.

Do you have any problems with your immune system or take any medications that can affect the immune system (e.g., high dose steroids, chemotherapy, some arthritis medications)?

Ask the health care provider if you are not sure about your medical conditions

You may have a reduced immune response to the COVID-19 vaccine series, so for people who are moderately to severely immunocompromised, three mRNA doses are recommended for the initial vaccination series given with an interval of 4 to 8 weeks between doses. Novavax may be used for those who are unwilling or unable to receive an mRNA vaccine however there is currently limited evidence on the safety and effectiveness of the Novavax vaccine in this population while there is evidence on the safety and effectiveness of mRNA vaccines.

NACI has indicated that 3 doses of Novavax Nuvaxovid may be offered to those who are moderately to severely immunocompromised, based on clinical discretion. Talk with your health care provider if receiving the Novavax vaccine.

In addition to vaccination of the person who is immunocompromised, all other eligible family members and close contacts should be vaccinated, and the whole family should continue to follow public health measures.

Do you have a bleeding disorder or take any medications that could affect blood clotting?

Ask the health care provider if you are not sure about your medical conditions

If "yes", the health care worker may hold the site where the needle is given for longer to prevent bleeding and bruising.

Are you feeling particularly anxious or afraid of the needle?

Let the health care provider know if you are feeling particularly anxious or concerned. They can take steps to help you feel more comfortable receiving the vaccine.

Have you ever felt faint or fainted after a past vaccination or medical procedure?

If "yes", the health care provider may vaccinate you lying down to prevent you from fainting.

Table 2 - Footnote 1

Polysorbate 80 can rarely cause allergic reactions and is found in products such as medical preparations (e.g., vitamin oils, tablets, and anticancer agents), and cosmetics. Note that this is not a complete list.

Return to Table 2 Footnote 1 referrer

How is the vaccine administered?

The vaccine is given using a needle, usually in the muscle in the upper arm. For those who are not immunocompromised, two doses are recommended for the initial series. The recommended interval between the first and second dose is 8 weeks.

If Novavax Nuvaxovid is being used for people who are moderately to severely immunocompromised and who are unable or unwilling to receive an mRNA vaccine, three doses may be offered in the initial series with each dose given 4 to 8 weeks apart. There is currently limited evidence on the use of the Novavax Nuvaxovid vaccine in this population. Talk with your health care provider or local public health department if receiving the Novavax vaccine.

Novavax Nuvaxovid can be used as a booster dose for people who are unable or unwilling to receive an mRNA vaccine and are 18 years of age and over. It can be given at least 6 months after the initial vaccine series or 6 months from a previous booster dose.

What are the risks of the vaccine?

Side effects can develop within a few days after receiving vaccines. Although most side effects are not serious, they may make you feel unwell for a few days; they will go away on their own. Some common and expected side effects include one or more of the following:

  • pain, redness or swelling where the needle was given
  • headache
  • nausea or vomiting
  • muscle pain
  • joint pain
  • tiredness
  • fever
  • chills

Rarely allergic reactions can occur after receiving a vaccine. Symptoms of an allergic reaction include:

  • difficulty breathing
  • hives (bumps on the skin that are often very itchy)
  • swelling of your face, tongue or throat

The clinic staff are prepared to manage an allergic reaction should it occur. Seek immediate medical care if you develop any of these symptoms.

Inflammation of the heart or the lining on the outside of the heart (myocarditis/pericarditis) have rarely been reported after mRNA vaccines and after the Novavax Nuvaxovid vaccine. Most cases are mild and symptoms resolve quickly after seeking medical care.

Based on experience with the mRNA vaccines, the risks of myocarditis/pericarditis are higher:

  • after the second dose
  • within a week of vaccination
  • in adolescents and young adults (less than 30 years of age)
  • in males than females
  • after Moderna compared to after Pfizer-BioNTech in adolescents and young adults

To minimize the risk of myocarditis/pericarditis during the primary vaccination series, an optimal interval of at least 8 weeks between vaccine doses is recommended. Pfizer-BioNTech Comirnaty is the preferred product for the initial series in persons who are 5 to 29 years of age.

Seek medical attention immediately if you develop any of the following:

  • chest pain
  • shortness of breath

Unusual sensations (such as numbness or tingling) have also been reported after vaccination.

It is important to note that you cannot get COVID-19 infection from the vaccine.

What should you do before coming to the clinic?

Make sure to wear a short-sleeve shirt or top with sleeves that are easy to roll up.

To prevent feeling faint while being vaccinated, make sure not to skip a meal before coming to the clinic.

A mask should be worn. A medical mask or N95 or KN95 respirator are preferred.

Bring any identification required by the clinic, such as your health card.

Bring your immunization record with you.

What should you do after receiving the vaccine?

You will be asked to wait at least 15 minutes after receiving the vaccine to be sure you are feeling well. Longer waiting times of 30 minutes may be recommended if there is concern about a possible vaccine allergy. Inform a health care provider right away if you feel unwell while waiting. You should not leave the clinic for at least 15 to 30 minutes after receiving your vaccine, based on the recommendation of the health care provider, and should not leave if you are feeling unwell.

Once you leave the clinic, call 9-1-1 right away if you develop any serious symptoms or symptoms of an allergic reaction such as hives (bumps on the skin that are often very itchy), swelling of your face, tongue or throat, or difficulty breathing. Inform your health care provider or local public health department of any concerning side effects after receiving the vaccine.

Seek medical care right away if you develop symptoms that could be myocarditis/pericarditis such as chest pain, shortness of breath or a fast or irregular heartbeat.

Continue to follow the recommendations of local public health officials to prevent the spread of COVID-19.

If possible, wait at least two weeks after vaccination or completing your COVID-19 vaccination series before starting drugs that suppress your immune system, as recommended by your health care provider.

Keep your immunization records in a safe place.

When should the next dose of COVID-19 vaccine be given?

NACI has recommended that the best time to receive your second dose is 8 weeks after your first dose.

If Novavax Nuvaxovid is being used for people who are moderately to severely immunocompromised and who are unable or unwilling to receive an mRNA vaccine, three doses may be offered in the initial series with each dose given 4 to 8 weeks apart. There is currently limited evidence on the use of the Novavax vaccine in this population. Talk with your health care provider or local public health department if receiving the Novavax Nuvaxovid vaccine.

Novavax Nuvaxovid is authorized as a booster dose for those 18 years of age and over. For adults unable or unwilling to receive an mRNA vaccine, Novavax boosters can be given 6 months from the last dose in the initial series or 6 months from a previous booster dose. For those 5 to 17 years of age, an mRNA vaccine should be used if they are eligible for a booster dose.

After a COVID-19 infection, NACI suggests waiting 8 weeks to start or complete the initial series (or 4 to 8 weeks for people who are immunocompromised) and 6 months to receive a booster dose.

It is very important to stay up to date with all recommended COVID-19 vaccines. Your health care provider or local public health department can provide advice about recommended vaccine doses if you have questions.

Bring your immunization record with you when you come for your next dose.

If you have any questions, please speak with the person providing the vaccine or contact: Insert contact information.

Consent form

Download in Word format the consent form for the Novavax Nuvaxovid COVID-19 vaccine for those 12 years of age and older

  • Last name:
  • First name:
  • Health card number / First Nations Status Card Number:
  • Phone number:
  • Email address:
  • Street address:
  • City:
  • Province:
  • Postal code:
  • Date of birth:
    • Month
    • Day
    • Year
  • Age:
  • Gender/Sex: (insert choice per data collection preferences)

Note: "you" refers to the individual being vaccinated.

  • How many doses of COVID-19 vaccine(s) have you had before?
    • None
    • One
    • Two
    • Three
  • If you have previously received a COVID-19 vaccine, specify the name(s) and date(s) of the previous COVID-19 vaccine(s) you have received, if known.
    • Name of vaccine:
    • Date: (month / day / year)
    • Name of vaccine:
    • Date: (month / day / year)
    • Name of vaccine:
    • Date: (month / day / year)
  • Are you feeling ill today?
    • No
    • Yes
    • If yes, please provide details
  • Have you had a COVID-19 infection?
    • No
    • Yes
    • If yes, please indicate when the symptoms started and when you tested positive, if known
  • Did you have any side effects after any previous dose of COVID-19 vaccine (including allergic reactions, heart inflammation [myocarditis/pericarditis])?
    • No
    • Yes
    • No previous dose
    • If yes, please provide details
  • Are you allergic or could you be allergic to polysorbate 80*?
    *Polysorbate 80 can rarely cause allergic reactions and is found in products such as medical preparations (e.g., vitamin oils, tablets, and anticancer agents), and cosmetics. Note that this is not a complete list.
    • No
    • Yes
    • If yes, please provide details
  • Have you had an allergic reaction to another vaccine (another type of COVID-19 vaccine or a non-COVID-19 vaccine) or other medication given by injection or intravenously in the past?
    • No
    • Yes
    • If yes, please provide details
  • Are you or could you be pregnant?
    • No
    • Yes
    • N/A
  • Do you have any problems with your immune system or take any medications that can affect the immune system (e.g., high dose steroids, chemotherapy, some arthritis medications)?
    Ask the health care provider if you are not sure about your medical conditions
    • No
    • Yes
    • Uncertain
    • If yes, please provide details
  • Do you have a bleeding disorder or take any medications that could affect blood clotting?
    Ask the health care provider if you are not sure about your medical conditions
    • No
    • Yes
    • Uncertain
    • If yes, please provide details
  • Are you particularly anxious or concerned about receiving the vaccine?
    • No
    • Yes
    • If yes, please provide details
  • Have you ever felt faint or fainted after a past vaccination or medical procedure?
    • No
    • Yes
    • If yes, please provide details

I have read (or it has been read to me) and I understand the "Information sheet for the Novavax Nuvaxovid COVID-19 vaccine for those 12 years of age and older". I have had the opportunity to ask questions and to have them answered to my satisfaction. I consent to receiving the vaccine.

  • Signature:
  • Print name:
  • Date of signature:
  • If signing for someone other than yourself, indicate your relationship to that other person:

I confirm that I am the parent / legal guardian or substitute decision maker.

Additional questions to help understand the populations receiving the COVID-19 vaccine

  1. Race/ethnicity: Please check the applicable boxes

    This information is being requested to help ensure that the vaccine is being provided in a way that is available to everyone who would like to receive it.

    • Black (e.g., African, Afro-Caribbean, African Canadian descent)
    • East/Southeast Asian (e.g., Chinese, Korean, Japanese, Taiwanese descent or Filipino, Vietnamese, Cambodian, Thai, Indonesian, other Southeast Asian descent)
    • Indigenous (e.g., First Nations, Inuk/Inuit, Métis descent)
    • Latino (e.g., Latin American, Hispanic descent)
    • Middle Eastern (e.g., Arab, Persian, West Asian descent - i.e., Afghan, Egyptian, Iranian, Lebanese, Turkish, Kurdish)
    • South Asian (e.g., South Asian descent - i.e., East Indian, Pakistani, Bangladeshi, Sri Lankan, Indo-Caribbean)
    • White (e.g., European descent)
    • Other, specify:
    • Prefer not to answer
    • Unknown
      If Indigenous, indicate which Indigenous identity:
    • First Nations
    • Métis (includes member of a Métis organization or Settlement)
    • Inuk/Inuit
    • Other Indigenous, specify:
    • Prefer not to answer
    • Unknown
      Do you reside in a First Nations Community (on reserve or Crown land) or Inuit Community?
    • Yes
    • No
    • Prefer not to answer
    • Unknown
  2. Do you have any underlying medical conditions (heart disease, lung disease, cancer, high blood pressure, diabetes, problems with your immune system, taking medication that affects your immune system, kidney disease, liver disease)?
    • Yes
    • No
    • Not certain
    • Prefer not to say
For clinic use only
Vaccine Dose Lot number Expiry date Site and route Time given Date given
month/day/year
Given by
name and designation

Novavax Nuvaxovid COVID-19 vaccine

0.5 ml

no data no data no data no data no data no data
no data  no data no data no data no data no data no data no data
no data  no data no data no data no data no data no data no data

Comments:

Any legal notice required including with regard to confidentiality of the information.

After care sheet

Download in Word format the sample after care sheet for the Novavax Nuvaxovid COVID-19 vaccine for those 12 years of age and older

What should I do right after receiving the vaccine?

Note: "you" refers to the individual being vaccinated.

Wait for at least 15 minutes after receiving your vaccine. Longer waiting times of 30 minutes may be recommended if there is concern about a possible vaccine allergy. Though uncommon, fainting or allergic reactions can occur after vaccination. Symptoms of an allergic reaction include hives (bumps on the skin that are often very itchy), swelling of your face, tongue or throat, or difficulty breathing. The clinic staff are prepared to manage these events should they occur.

Immediately inform a health care provider at the clinic if you feel unwell while waiting. Do not leave the clinic if you are feeling unwell.

Continue to follow the recommendations of local public health officials to prevent the spread of COVID-19 while at the clinic.

Use the alcohol-based hand rub to clean your hands before leaving the clinic.

Do not operate a vehicle or other form of transportation for at least 15 to 30 minutes after being vaccinated (as advised by the health care provider) or if you are feeling unwell.

What to expect in the next few days?

Side effects can develop in the few days after receiving the vaccine. Although most of these side effects are not serious, they may make you feel unwell for a few days; they will go away on their own.

The most common side effect is pain where the needle was given; swelling or redness where the needle was given may also occur. A cool, damp cloth or wrapped ice pack where the vaccine was given may help.

Other symptoms may include headache, nausea or vomiting, muscle pain, joint pain, tiredness, chills or fever.

If needed, pain or fever medication (such as acetaminophen) may help with pain or fever. Check with your health care provider or local public health department if you need advice about medication.

Serious side effects after receiving the vaccine are rare. However, should you develop any serious symptoms or symptoms that could be an allergic reaction, call 9-1-1 right away. Symptoms of an allergic reaction include:

  • difficulty breathing
  • hives (bumps on the skin that are often very itchy)
  • swelling of the face, tongue or throat

Seek medical care immediately if you develop symptoms that could indicate heart inflammation (myocarditis/pericarditis) such as:

  • chest pain
  • shortness of breath
  • fast or irregular heartbeat

Unusual sensations (such as numbness or tingling) have also been reported after vaccination.

If you have any concerns about the symptoms you develop after receiving the vaccine, contact your health care provider or local public health department for advice. Any serious side effects after vaccination should be reported to your local public health department.

If you need to receive additional doses of COVID-19 vaccines, tell the person providing the next dose about any side effects you experienced.

When should the next dose of COVID-19 vaccine be given?

The National Advisory Committee on Immunization (NACI) has recommended that the best time to receive your second dose is 8 weeks after your first dose.

If Novavax Nuvaxovid is being used for people who are moderately to severely immunocompromised and who are unable or unwilling to receive an mRNA vaccine, three doses may be offered in the initial series with each dose given 4 to 8 weeks apart. There is currently limited evidence on the use of the Novavax vaccine in this population. Talk with your health care provider or local public health department if receiving the Novavax Nuvaxovid vaccine.

Novavax Nuvaxovid is authorized as a booster dose for those 18 years of age and over. For adults unable or unwilling to receive an mRNA vaccine, Novavax boosters can be given 6 months from the last dose in the initial series or 6 months from a previous booster dose. For those 5 to 17 years of age, an mRNA vaccine should be used if they are eligible for a booster dose.

After a COVID-19 infection, NACI suggests waiting 8 weeks to start or complete the initial series (or 4 to 8 weeks for people who are immunocompromised) and 6 months to receive a booster dose.

It is very important to stay up to date with all recommended COVID-19 vaccines. Your health care provider or local public health department can provide advice about recommended vaccine doses if you have questions.

Bring your immunization record with you for all vaccines and tell the person providing the vaccine about any side effects you experienced after previous doses.

Things to remember

Continue to follow the recommendations of local public health officials to prevent the spread of COVID-19.

If possible, wait at least two weeks after vaccination or completing your vaccination series before starting drugs that suppress your immune system, as recommended by your healthcare provider.

Keep this sheet or other immunization record in a safe place.

Immunization record

  • Name of client:
  • Date of birth of client (month/day/year):
  • Health card number / First Nations Status Card Number:
Immunization record
Dose number Date
month/day/year
Vaccine name and dose Lot number Site
right / left
Given by
name and professional designation

1

no data no data no data no data no data

2

no data no data no data no data no data

3

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4

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