Monkeypox: Vaccination clinic resources

Samples information sheets and forms for IMVAMUNE vaccination.

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Overview

Samples information sheets and forms for IMVAMUNE vaccination.

Sample information sheet for IMVAMUNE vaccine for smallpox/monkeypox for adults 18 years of age and older

Download the sample information sheet in Word format

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 monkeypox?

How does the IMVAMUNE vaccine protect against monkeypox?

Who can and cannot receive the smallpox/monkeypox vaccine at this time?

Table 1 indicates who should and should not receive the IMVAMUNE 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 National Advisory Committee on Immunization (NACI).

Table 1: Questions and possible recommendations with regard to receiving the IMVAMUNE vaccine

Questions

Possible recommendations

Are you feeling ill today?

Vaccination with IMVAMUNE must be postponed in persons with fever or general malaise.

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

If you received a previous dose of an orthopoxvirus vaccine (Smallpox vaccine; live (freeze-dried), Smallpox vaccine; live (frozen-liquid) and/or IMVAMUNE), did you have any side effects after vaccination (including allergic reactions, hypersensitivity reactions or heart inflammation [myocarditis/pericarditis])?

Individuals who show hypersensitivity reactions after receiving the first dose of the vaccine should not be given the second dose.

IMVAMUNE is not recommended for individuals with a history of myocarditis/pericarditis linked to a previous dose of an orthopoxvirus vaccine as a precautionary approach at this time, until more information is available.

Consult with your health care provider.

Are you allergic to eggs or egg products? Footnote 1 

Allergic reactions are not a contraindication to immunization with egg protein-containing vaccines. Consult with your health care provider who may advise on extra precautions.

Are you allergic or do you have a confirmed allergy to tromethamineFootnote 2 (trometamol, Tris), benzonaseFootnote 3, gentamicinFootnote 4 or ciprofloxacinFootnote 4 which are contained in the IMVAMUNE vaccine?

If you are allergic to tromethamine (trometamol, Tris), benzonase, gentamicin or ciprofloxacin, consult with your health care provider about whether to receive the IMVAMUNE vaccine.

Do you have a suspected but unproven allergy to a vaccine component e.g., tromethamineFootnote 2 (trometamol, Tris), benzonaseFootnote 3, gentamicinFootnote 4 or ciprofloxacinFootnote 4?

If “yes”, you may receive the IMVAMUNE 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 type or other medication given by injection or intravenously in the past?

If "yes", you may receive the IMVAMUNE 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 or breastfeeding?

Pregnant populations may particularly benefit from vaccination as these populations may be at risk for severe outcomes from disease. There is a lack of evidence of safety and efficacy of IMVAMUNE PrEP or PEP in this group, though at this time there is no reason to believe that vaccination would have any adverse impact on parent or fetus.

Breastfeeding populations are not at higher risk for negative outcomes due to monkeypox infection. There are no IMVAMUNE studies in this population. There is a lack of evidence of safety and efficacy of IMVAMUNE PrEP or PEP in this group, though at this time there is no reason to believe that vaccination would have any adverse impact on parent or child in relation to breastfeeding.

Do you have any problems with your immune system or are you taking any medications that can affect your 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

The use of IMVAMUNE in immunosuppressed patients is supported by clinical trials which include individuals who are human immunodeficiency virus (HIV) infected. Immune response may be diminished in HIV positive individuals as well as in other patients with immunodeficiency or patients receiving immunosuppressive therapy.

Immunosuppressed populations (including those infected with HIV) may benefit from vaccination as these populations may be at risk for more severe outcomes depending on the nature of the immunosuppression. Live vaccines are usually contraindicated for immunocompromised populations; however, IMVAMUNE may be recommended in this group as it is considered a non-replicating vaccine.

Do you have skin conditions such as atopic dermatitis?

The use of IMVAMUNE in immunosuppressed patients is supported by clinical trials which include individuals with atopic dermatitis (AD). Evidence is available which has not indicated any safety concerns for individuals with atopic dermatitis. It is anticipated that some local and systemic reactions may come at higher frequency. Some may also experience a flare up or a worsening of their condition.

Have you recently received specific medications for monkeypox treatment (e.g., immunoglobulins)?

Interaction with concomitant administration of immunoglobulins has not been established. If "yes", consult your health care provider.

Have you received another vaccine in the last four weeks or do you anticipate receiving another vaccine in the next 4 weeks?

It is recommended that IMVAMUNE not be given within 4 weeks of an mRNA vaccine for COVID-19. However, in a high-risk exposure scenario, IMVAMUNE PrEP or PEP should not be delayed due to the receipt of an mRNA COVID-19 vaccine. 

Consult your health care provider.

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.

Footnote 1

In Canada, there are several vaccines manufactured by processes involving hens' eggs or their derivatives, such as chick cell cultures.

Return to footnote 1 referrer

Footnote 2

Tromethamine (trometamol, 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 footnote 2 referrer

Footnote 3

Benzonase is used for purification of viral vaccines, viral vectors for vaccine, cell and gene therapy, and oncolytic viruses, removing DNA/RNA from proteins and other biologicals; reduction of viscosity caused by nucleic acids; sample preparation in electrophoresis and chromatography and prevention of cell clumping.

Return to footnote 3 referrer

Footnote 4

Gentamicin and ciprofloxacin are used as antibiotics in the treatment of some bacterial infections.

Return to footnote 4 referrer

How is the vaccine administered?

The vaccine is administered by subcutaneous injection in your arm.

What are the risks of the vaccine?

What should you do before coming to the clinic?

What should you do after receiving the vaccine?

When should I return for my next dose?

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

Sample consent form for IMVAMUNE vaccine or smallpox/monkeypox for adults 18 years of age and older

Download the sample consent form in Word format

IMVAMUNE vaccine has been authorized by Health Canada for active immunization against smallpox, monkeypox and related orthopoxvirus infection and disease under the provision of the Extraordinary Use New Drug regulations in adults 18 years of age and older determined to be at high risk for exposure. EUND vaccines are part of emergency preparedness in Canada where manufacturers may not be required to provide substantial evidence demonstrating the safety and efficacy of the product before being authorized. Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect exactly what will be experienced in practice, including side-effects that may not have been identified previously.

I have read (or it has been read to me) and I understand the "Information sheet for IMVAMUNE (smallpox/monkeypox) vaccine for adults 18 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.

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

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

IMVAMUNE smallpox / monkeypox vaccine

0.5 ml/SC

-

-

-

-

-

-

Comments: 

Sample after care sheet for IMVAMUNE vaccine for smallpox/monkeypox for adults 18 years of age and older

Download the sample after care sheet in Word format

What should I do right after receiving the vaccine?

What should I expect in the next few days?

When should I return for my next dose of vaccine?

Things to remember

Immunization record

Dose  # Date
month/day/year
Vaccine Name and Dose Site
right / left
Give by
name and professional designation

1

-

-

-

-

2

-

-

-

-

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