Monkeypox: Vaccination clinic resources

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Overview

Quick reference guide on the use of Imvamune® for health care professionals in the context of monkeypox outbreaks in Canada

The Public Health Agency of Canada (PHAC), in partnership with NACI and the Committee to Advise on Tropical Medicine and Travel (CATMAT), has developed a new web page for health care professionals in response to the current multi-country monkeypox outbreak. The content alerts health professionals to the unique aspects of the current outbreak.

The webpage brings together general information about the disease, laboratory diagnosis, use and availability of medical countermeasures and vaccine, infection prevention and control guidance, public health case and contact management guidance, as well as vaccination clinic resources. Updates to the content are anticipated as this outbreak evolves, and new evidence becomes available.

What is Imvamune?

Imvamune [also called Smallpox and Monkeypox Vaccine Modified Vaccinia Ankara-Bavarian Nordic® (live-attenuated, non-replicating) (MVA-BN), Jynneos®, Imvanex®] is a live non-replicating, third-generation smallpox vaccine manufactured by Bavarian Nordic. Imvamune was initially authorized for use in Canada on November 21, 2013, as an Extraordinary Use New Drug (EUND) for use by the Canadian Government in an emergency situation for active immunization against smallpox infection and disease in persons 18 years of age and older who have a contraindication to the first or second generation smallpox vaccines. It was subsequently approved under a supplement to the EUND approval pathway on November 5, 2020 for active immunization against smallpox, monkeypox and related Orthopoxvirus infections and disease in adults 18 years of age and older determined to be at high risk for exposure Footnote 1.

Imvamune differs from previous generations of smallpox vaccines as it is a non-replicating vaccine virus in humans, meaning that based on preclinical studies, it is not able to produce more copies of itself Footnote 2. While Imvamune is capable of replicating to high titers in avian cell lines such as chicken embryo fibroblasts, it is attenuated and has limited replication capability in human cells Footnote 3. As it does not contain replicating viruses, Imvamune cannot spread or cause Orthopoxvirus disease (including smallpox and monkeypox).

Immunogenicity, Efficacy and Effectiveness

There is very limited clinical evidence available to base guidance on for Imvamune use for pre- or post-exposure vaccination in any population.

In the event of a limited vaccine supply, dose-sparing strategies may be considered for some vaccines. Studies have shown that for certain vaccines, dose volume can be reduced by using the intradermal (ID) vaccination route as an alternative to subcutaneous (SC) administration, without the loss of vaccine immunogenicity Footnote 4 Footnote 5.

Recommendations for Use

Pre-exposure vaccination

In the context of an active monkeypox outbreak, it is recommended that vaccination using the Imvamune vaccine should be offered to individuals with the highest risk of infection of monkeypox. For a list of these individuals refer to the NACI Rapid Response: Updated interim guidance on Imvamune® in the context of ongoing monkeypox outbreaks, Recommendation 1.1. Those with a prior documented history of monkeypox infection need not be vaccinated.

In the context of the ongoing monkeypox outbreak and limited vaccine supply, dose sparing strategies should be considered in order to expand vaccination coverage to a broader population currently considered for pre-exposure vaccination. For currently considered dose sparing strategies for pre-exposure vaccination refer to the NACI Rapid Response: Updated interim guidance on Imvamune® in the context of ongoing monkeypox outbreaks, Recommendation 2.1.

In the context of limited Imvamune vaccine supply, it is recommended that off-label intradermal administration (0.1 mL per dose) can be used among immunocompetent adults when given as a second dose following a first dose administered subcutaneously, provided dose sparing and safe administration practices are feasible.

Individuals who are < 18 years of age, at risk of keloid scars, or moderately to severely immunocompromised should be offered Imvamune vaccine using the subcutaneous route of administration only.

When supply is not constrained, it is recommended that Imvamune pre-exposure vaccination should be offered as a two-dose primary series, with at least 28 days between first and second subcutaneous doses, for individuals currently eligible for pre-exposure vaccination.

For the recommended definition of moderately to severely immunocompromised individuals refer to the NACI Rapid Response: Updated interim guidance on Imvamune® in the context of ongoing monkeypox outbreaks, Appendix B.

Post-exposure vaccination

The use of Imvamune as a post-exposure vaccination (also known as post-exposure prophylaxis) continues to be recommended to individuals who have had high risk exposure(s) to a probable or confirmed case of monkeypox, or within a setting where transmission is happening. A post-exposure vaccine dose should be offered as soon as possible and within 4 days of last exposure and can be considered up to 14 days of last exposure. It should not be offered to individuals who are symptomatic and who meet the definition of suspect, probable or confirmed case.

Schedule

Table: Immunization schedule for Imvamune in the context of the 2022 monkeypox outbreak
Dose Number Pre-Exposure VaccinationFootnote a Footnote b Post-Exposure VaccinationFootnote a Footnote b
Immunocompetent adults Moderately to Severely ImmunocompromisedFootnote c and/or < 18 years of age and/or increased risk of keloid scars Immunocompetent adults Moderately to Severely ImmunocompromisedFootnote c and/or < 18 years of age and/or increased risk of keloid scars
Dose 1 0.5mL, SC 0.5 mL, SC 0.5 mL, SC, within 4 days since exposure, can be considered up to 14 days 0.5 mL, SC, within 4 days since exposure, can be considered up to 14 days
Dose 2

0.5mL, SC, 28 days after dose 1 (supply not constrained) 

OR 

0.5mL SC administered ≥ 28 days after dose 1 (constrained supply)  

OR  

0.1 mL, ID (constrained supply only)

0.5mL, SC, 28 days after dose 1 0.5mL, SC (if at ongoing risk of exposure) 0.5mL, SC (if at ongoing risk of exposure)
Table 1 Footnote a

Immunocompetent individuals recommended for Imvamune pre-exposure or post-exposure vaccination should receive a single dose if they have previously been vaccinated with a live replicating first or second generation smallpox vaccine (e.g., as a booster dose). However, individuals considered moderately to severely immunocompromised should receive two doses, regardless of previous smallpox vaccination.

Table 1 Return to footnote a referrer

Table 1 Footnote b

Pre-exposure or post-exposure vaccination is not indicated for individuals who meet the definition of suspect, probable or confirmed monkeypox case or with prior history of infection with monkeypox.

Table 1 Return to footnote b referrer

Table 1 Footnote c

Refer to NACI Rapid Response: Updated interim guidance on Imvamune® in the context of ongoing monkeypox outbreaks, Appendix B: Recommended Definition of Moderately to Severely Immunocompromised Individuals.

Table 1 Return to footnote c referrer

Booster doses and re-immunization

Immunocompetent individuals recommended for Imvamune pre-exposure or post-exposure vaccination should receive a single dose if they have previously been vaccinated with a live replicating first or second generation smallpox vaccine (e.g., as a booster dose). However, individuals considered moderately to severely immunocompromised should receive two doses, regardless of previous smallpox vaccination.

For the recommended definition of moderately to severely immunocompromised individuals refer to NACI Rapid Response: Updated interim guidance on Imvamune® in the context of ongoing monkeypox outbreaks, Appendix B.

Vaccination of Specific Populations

It continues to be recommended that Imvamune vaccine may be offered to the following specific populations:

Refer to Recommendations, Pre-exposure vaccination, Summary of evidence, rationale, and additional consideration in NACI Rapid Response: Updated interim guidance on Imvamune® in the context of ongoing monkeypox outbreaks and Recommendation 3 in the NACI Rapid Response: Interim guidance on the use of Imvamune® in the context of monkeypox outbreaks in Canada for more information on vaccination of specific populations.

Serologic Testing

Serologic testing is not recommended before or after receiving smallpox/monkeypox vaccine.

Administration Practices

Dose

The authorized dose of smallpox and monkeypox vaccine (e.g., Imvamune) is 0.5 mL, in a single use vial of liquid-frozen vaccine, injected via the subcutaneous (SC) route. If fractionating doses (e.g., for dose sparing), the intradermal (ID) injection dose is 0.1 mL.

Composition

The vaccine contains trace amounts of host (egg) cell DNA and protein, benzonase, gentamicin and ciprofloxacin, trometamol and sodium chloride. There are no preservatives or adjuvants added to the formulation. The vaccine is contained in a 2-mL type I borosilicate glass vial (single dose) covered with a sterile bromobutyl rubber stopper, an aluminum cap and protected with a polypropylene closure.

Routes of administration

Subcutaneous (SC): Smallpox/monkeypox vaccine should be administered by SC injection (the authorized route of injection), at any site, but usually in the SC tissue of the upper triceps area of the arm or anterolateral thigh, at a 45° angle. Refer to Vaccine Administration Practices in the Canadian Immunization Guide (CIG) – Part 1 for additional information on SC injection.

Intradermal (ID): In some instances, as an alternative off-label use in the context of limited supply, the ID route with a volume of 0.1 mL may be administered, forming a wheal (a small bubble) in the skin, on the inner surface (dermis) of the forearm at a 5° to 15° angle.

The vaccine must not be administered intravascularly.

Prepare and administer the vaccine

Footnote 6 Footnote 7 Footnote 8

To administer the vaccine intradermally:

  • Personnel involved in preparing and administering the vaccine should be provided adequate training before implementing ID administration.
  • Position the patient. If the administration site is the inner forearm, position the patient's arm with their palm facing up on a flat surface. Their arm should be relaxed with their elbow flexed.
  • Clean the injection site using an antiseptic or alcohol swab in a firm, circular motion. Let the injection site dry completely before proceeding.
  • Pull the skin taut with a non-dominant hand. Place a thumb below the injection site and the middle finger above it. Use these fingers to gently pull the skin taut to ensure easy penetration of the needle.
  • Hold the needle at a 5° to 15° angle Footnote 9. Use the dominant hand to hold the syringe parallel to the patient's arm. The bevel should be facing up. Slightly angle the needle so that it is at a 5° to 15° angle relative to the skin.
  • Insert the needle just under the epidermis. Slowly insert the needle into the patient's skin until the entire bevel is under the skin without aspirating. Once the syringe is in place, remove the non-dominant hand to release the tension surrounding the injection site. Use this hand to push the plunger in to administer the medication.
  • While administering the medication look for the formation of a noticeable pale elevation of the skin known as a wheal. A wheal is an area of the skin that is raised like a blister or bubble. The presence of a wheal 6 mm to 10 mm in diameter indicates that the medicine has been administered into the dermis properly. If a wheal does not form, remove the needle and repeat the procedure in preferably a separate anatomic injection site (different limb) or in the same limb but separated by at least 2.5 cm (1 inch).
  • Remove the needle.
  • Gently pat the site with gauze if there's blood. Try to avoid massaging the injection site, as massaging could cause the vaccine to spread to the underlying subcutaneous tissues.
  • Instruct the patient not to scratch or rub the injection site, since this could dilute the medication or spread it around.

Concurrent administration with other vaccines and products

Currently, no data exist on the concurrent administration of Imvamune with other vaccines. If concurrent administration with another vaccine is indicated, immunization should be done in different limbs.

To minimize the potential risk of interactions or erroneous attribution of an adverse event following immunization (AEFI) to a particular vaccine, it is recommended to administer inactivated (non-live) vaccines > 2 weeks and live vaccines ≥ 4 weeks before or after administration of Imvamune.

Imvamune given as pre-exposure or post-exposure vaccination should not be delayed due to recent receipt of an mRNA COVID-19 vaccine. If vaccine timing can be planned (e.g., prior to employment within a research laboratory), it is recommended that Imvamune be given at least 4 weeks after or before an mRNA vaccine for COVID-19. Refer to the NACI Rapid Response: Interim guidance on the use of Imvamune® in the context of monkeypox outbreaks in Canada for details on concurrent administration guidance.

First generation orthopoxvirus vaccines and mRNA COVID-19 vaccines both have a potential risk of cardiac adverse events (myocarditis). In the clinical trial for the newer generation non-replicating attenuated virus vaccine Imvamune, there were no confirmed cases of myocarditis, pericarditis, endocarditis or any other type of cardiac inflammatory diseases (or related syndromes) recorded. Nonetheless, it would be prudent to wait for a period of at least 4 weeks before or after the administration of mRNA COVID-19 vaccine in order to prevent erroneous attribution of an AEFI to one particular vaccine or the other. This suggested minimum waiting period between vaccines is precautionary at this time. Protection from monkeypox exposure should be prioritized and recent mRNA vaccine receipt should not delay Imvamune post-exposure vaccination or pre-exposure vaccination if protection is urgent.

Preclinical data from previous generation smallpox vaccines showed decreased immune responses when tecovirimat (TPOXX, an antiviral drug from SIGA Technologies) was administered concurrently with earlier generation smallpox vaccines Footnote 10. Due to the differences between previous generation smallpox vaccines and Imvamune, it is unclear if antivirals could impact protection offered by Imvamune.

The optimal timing between administration of Imvamune after receiving immunoglobulins has not been established.

Storage Temperatures, Shelf Life, Shipment and Supportive Temperature Excursion

Refer to Imvamune Product Monograph, Imvamune: Storage temperatures, shelf life, shipment and supportive temperature excursion information and Storage and Handling of Immunizing Agents in Part 1 for additional general information.

Table: Use and overview of key features of Imvamune vaccine according to product monograph
Product brand name and formulation Imvamune
Smallpox and Monkeypox Vaccine
Type of vaccine Modified Vaccinia Ankara-Bavarian Nordic®
(live-attenuated, non-replicating)
Date of authorization in Canada Date of initial approval: November 21, 2013
Date of authorization for Monkeypox as expanded indication: November 5, 2020
Date of latest revision: November 26, 2021
Authorized ages for use Adults 18 years of age and older
Potential allergens Traces of residual host (egg) cell DNA and proteinFootnote a, tromethamine (trometamol, tris)Footnote b, benzonaseFootnote c, gentamicinFootnote d and ciprofloxacinFootnote d.
Adjuvant / Preservatives The vaccine contains no adjuvant or preservatives
Contraindications
  • Individuals who have allergic-type hypersensitivity reactions to this vaccine or to any ingredient in the formulation or component of the container.
  • Individuals who show hypersensitivity reactions after receiving the first dose of the vaccine should not be given the second dose.
Storage
  • Store frozen at -20°C ± 5°C or -50°C ± 10°C or -80°C ± 10°C.
  • After thawing, an unopened vial should be used immediately or can be stored at 2°C –8°C for up to 2 weeks prior to use.
  • Do not refreeze a vial once it has been thawed.
  • Protect from light.
Handling
  • Thaw at room temperature (approximately 10 minutes). The drug product should appear as a pale milky colored homogeneous suspension.
  • The single-dose vial should be swirled gently (not shaken) for at least 30 seconds to ensure homogeneity upon thawing.
  • The vaccine must not be used if any foreign particulate matter is visible.
  • Pre-filing syringes is not recommended; the vaccine should be drawn-up right before administration.
Vial management for fractional dosesFootnote 12 Footnote 13 Footnote 14
  • Punctured vials should be identified properly.
  • Jurisdictions should have protocols to minimize the risk of dose wastage and to reduce the potential of contamination of the vials if single-dose vials are to be used for multiple doses.
  • Vials used for fractional doses should be discarded at the end of the immunization session (or within six hours after opening, whichever comes first) as the vaccine contains no preservatives.
Reconstitution No
Route of administration
  • 0.5 mL subcutaneous injection, at any site (usually in the SC tissue of the upper triceps area of the arm or anterolateral thigh).
  • If dose sparing, 0.1 mL intradermal injection may be administered on the inner surface (dermis) of the forearm.
Syringe and needle selection
  • Allow Imvamune vaccine to thaw at room temperature (approximately 10 minutes). To ensure homogeneity upon thawing, the vial should be swirled gently (not shaken) for at least 30 seconds (see product monograph).
  • For SC injection, withdraw (and administer) a dose of 0.5 mL with a 3 mL syringe and a 25-gauge needle, 1.6 cm (5/8 inch).
  • For ID injection, withdraw (and administer) a dose of 0.1 mL with a low dead volume syringe and either a 26- or 27- gauge needle, 1.3 cm (1/2 inch).
Table 2 Footnote a

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

Table 2 Return to footnote a referrer

Table 2 Footnote b

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.

Table 2 Return to footnote b referrer

Table 2 Footnote c

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.

Table 2 Return to footnote c referrer

Table 2 Footnote d

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

Table 2 Return to footnote d referrer

Refer to additional information contained within the product monograph available through Health Canada's Drug product database.

Safety and Adverse Events

Refer to Vaccine safety and pharmacovigilance in Part 2 of the CIG for additional general information.

Common and local adverse events

Local adverse events at the injection site (including pruritus, erythema, induration and pain) were more common following ID immunization than after IM or SCFootnote 4, whereas systematic reactions were similar overall after ID and IM/SC immunization.

The most common local adverse events following Imvamune immunization (AEFI) are pain, erythema, induration and swelling at the site of injection. The most common systemic AEFI are fatigue, headache, myalgia, and nausea. Most of the reported AEFIs are of mild to moderate intensity and resolve within the first seven days following vaccination.

Most adverse events develop within a few days after receiving the vaccine.

Less common and serious or severe adverse events

Cardiac adverse events of special interest (AESI) were reported to occur in 1.4% (91/6,640) of Imvamune recipients, 0.2% (3/1,206) of placebo recipients who were smallpox vaccine-naïve and 2.1% (16/762) of Imvamune recipients who were smallpox vaccine-experienced. The higher proportion of Imvamune recipients who experienced cardiac AESIs was driven by 28 cases of asymptomatic post-vaccination elevation of troponin-I in two studies that used a different troponin assay than was used in the other previous studies and had no placebo controls. Among the cardiac AESIs reported, cases were considered to be causally related to Imvamune vaccination. The events reported included tachycardia, electrocardiogram T wave inversion, abnormal electrocardiogram, electrocardiogram ST segment elevation, abnormal electrocardiogram T wave, and palpitations. None of the 6 events considered vaccine-related were considered serious. Despite close cardiac monitoring, no confirmed case of myocarditis, pericarditis, endocarditis or any other type of cardiac inflammatory disease (or related syndromes) was recorded.

Guidance on reporting Adverse Events Following Immunization (AEFI)

Vaccine providers are asked to report, through local public health officials, any serious or unexpected adverse event thought to be temporally related to smallpox/monkeypox vaccination. An unexpected AEFI is an event that is not listed in the available product information (the Imvamune Product Monograph) but may be due to the immunization, or a change in the frequency of a known AEFI. Refer to Table 1 in Adverse events following immunization and the User Guide to completion and submission of the AEFI for additional information about AEFI reporting.

Contraindications and precautions

Adverse events following a previous immunization

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

Allergies

An egg allergy is not a contraindication to immunization with vaccines that are manufactured using processes involving eggs.

Additional precautions (e.g., waiting period of 30 minutes) should be taken for patients who are hypersensitive to this vaccine or to any ingredient in the formulation or component of the container.

Concurrent or recent medication including biologics

Combination antiretroviral therapy for HIV

Interactions with other vaccines have not been established. Precautions are discussed above.

Interactions with concomitant administration of immunoglobulins has not been established.

Interactions with other drugs have not been established.

Other situations, underlying conditions

The benefit of protection against infection should be discussed with a healthcare provider and weighed against the potential risk of recurrent myocarditis for individuals with a history of myocarditis/pericarditis linked to a previous dose of live replicating first and second generation smallpox vaccine and/or Imvamune. A precautionary approach is warranted at this time until more information is available.

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 on the safety and efficacy of Imvamune pre-exposure vaccination or post-exposure vaccination in this group. At this time, however, there is no reason to believe that vaccination would have any adverse impact on the vaccine recipient 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 on the safety and efficacy of Imvamune pre-exposure vaccination or post-exposure vaccination in this group. At this time, however, there is no reason to believe that vaccination would have any adverse impact on the vaccine recipient or child in relation to breastfeeding.

The use of Imvamune in immunosuppressed patients is supported by clinical trials which include individuals who are living with human immunodeficiency virus (HIV). Immune response may be diminished in patients with immunodeficiency or patients receiving immunosuppressive therapy. Immunosuppressed populations 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.

The available evidence does not demonstrate any safety concerns for individuals with atopic dermatitis. It is anticipated that some local and systemic reactions may occur at higher frequency.

Initial studies have demonstrated that Imvamune vaccine administered to 120 subjects 56 to 80 years of age have no difference in safety and immunogenicity compared to adults up to 55 years of age.

Adverse reaction management

Refer to the CIG, Part 2 – Vaccine Safety for more information about the assessment and initial management of vaccine recipients who develop acute adverse reactions.

Managing vaccine administration errors or deviations

Footnote 11

If the vaccine has been administered in an incorrect site other than the subcutaneous tissue of the upper triceps area of the arm, or intradermally in the volar aspect of the forearm, the dose does not need to be repeated, though the recipient should be informed of the potential for local and systemic adverse events.

If the vaccine has been administered inadvertently by an incorrect route between the subcutaneous and intradermal route resulting in a lower dose than intended (e.g., 0.1 mL SC), the dose should be repeated immediately via the intended route (e.g., 0.1 mL ID), preferably at a separate anatomic injection site (different limb) or in the same limb but separated by at least 2.5 cm (1 inch).

If the vaccine has been administered but the dose is unknown (leaked out, equipment failure, client pulled away), administer a full repeat dose immediately, preferably at a separate anatomic injection site (different limb) or in the same limb but separated by at least 2.5 cm (1 inch), when the error is discovered.

If the vaccine has been administered with a dose known to be less than intended, administer the remainder of the dose immediately, preferably at a separate anatomic injection site (different limb) or in the same limb but separated by at least 2.5 cm (1 inch) from the first incomplete dose administered and consider it valid.

If the vaccine has been administered with a higher dose than intended (e.g., 0.5 mL ID), the dose does not need to be repeated, though the recipient should be informed of the potential for local and systemic adverse events.

If the vaccine series has been administered with an interval less than the recommended minimum, the additional dose should be considered invalid only in moderately to severely immunocompromised recipients and repeated at the recommended interval from the last. Refer to NACI Rapid Response: Updated interim guidance on Imvamune® in the context of ongoing monkeypox outbreaks, Appendix B: Recommended Definition of Moderately to Severely Immunocompromised Individuals.

If the vaccine series has been administered with an interval greater than the recommended minimum, there is no need to re-start the series (there is no maximum interval).

If the vaccine was administered after improper storage and handling (e.g., temperature excursion), refer to Table 4 of the Imvamune: Storage temperatures, shelf life, shipment and supportive temperature excursion information for more information on the stability of the vaccine. In cases where the information pertaining to the specific scenario is not available (e.g., no confirmation of stability), the dose should be repeated immediately, preferably at a separate anatomic injection site (different limb) or in the same limb but separated by at least 2.5 cm (1 inch).

If the vaccine was administered past the expiration date, refer to Imvamune: Storage temperatures, shelf life, shipment and supportive temperature excursion information for more information on the stability of the vaccine. In cases where the information pertaining to scenario is not available (e.g., no confirmation of stability), the dose should be repeated immediately, preferably at a separate anatomic injection site (different limb) or in the same limb but separated by at least 2.5 cm (1 inch).

References

Footnote 1

"PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: Imvamune Smallpox and Monkeypox Vaccine," Copenhagen (DK): Bavarian Nordic, 26 Nov 2021. [Online]. Available: https://pdf.hres.ca/dpd_pm/00063755.PDF.

Return to footnote 1 referrer

Footnote 2

C. Verheust, M. Goossens, K. Pauwels and D. Breyer, "Biosafety aspects of modified vaccinia virus Ankara (MVA)-based vectors used for gene therapy or vaccination," Vaccine, 2012 Mar 30;30(16):2623,2632. doi: 10.1016/j.vaccine.2012.02.016.

Return to footnote 2 referrer

Footnote 3

A. Volkmann, A.-L. Williamson, H. Weidenthaler, T. P. H. Meyer, J. S. Robertson, J.-L. Excler, R. C. Condit, E. Evans, E. R. Smith, D. Kim and R. T. Chen, "The Brighton Collaboration standardized template for collection of key information for risk/benefit assessment of a Modified Vaccinia Ankara (MVA) vaccine platform," Vaccine, 2021 May 21;39(22):3067,3080. doi: 10.1016/j.vaccine.2020.08.050.

Return to footnote 3 referrer

Footnote 4

J. L. Schnyder, H. M. Garcia Garrido, C. A. De Pijper, J. G. Daams, C. Stijnis, A. Goorhuis and M. P. Grobusch, "Comparison of equivalent fractional vaccine doses delivered by intradermal and intramuscular or subcutaneous routes: A systematic review," Travel Medicine and Infectious Disease, 2021. https://doi.org/10.1016/j.tmaid.2021.102007.

Return to footnote 4 referrer

Footnote 5

e. a. S.E. Frey, "Comparison of lyophilized versus liquid modified vaccinia Ankara (MVA) formulations and subcutaneous versus intradermal routes of administration in healthy vaccinia-naïve subjects," Vaccine, vol. 33, no. 39, pp. 5225-5234, 2015.

Return to footnote 5 referrer

Footnote 6

"How to Give an Intradermal Injection," 12 Nov 2021. [Online]. Available: https://www.wikihow.com/Give-an-Intradermal-Injection#:~:text=Co-authored%20by%20Luba%20Lee%2C%20FNP-BC%2C%20MS%20Last%20Updated%3A,the%20skin%20taut%20and%20angle%20the%20needle%20properly.

Return to footnote 6 referrer

Footnote 7

"JYNNEOS Smallpox and Monkeypox Vaccine - Intradermal Vaccine Preparation and Administration Summary: ALTERNATIVE DOSING REGIMEN," CDC, [Online]. Available: https://www.cdc.gov/poxvirus/monkeypox/files/interim-considerations/guidance-jynneos-prep-admin-alt-dosing.pdf. [Accessed 29 Aug 2022].

Return to footnote 7 referrer

Footnote 8

"Video: How to administer a JYNNEOS vaccine intradermally," Centers for Disease Control and Prevention (CDC), [Online]. Available: https://www.youtube.com/watch?v=TLv1mR6mECQ. [Accessed 6 Sep 2022].

Return to footnote 8 referrer

Footnote 9

Chapter 4: Diagnosis of tuberculosis infection, Canadian Journal of Respiratory, Critical Care, and Sleep Medicine," Canadian Tuberculosis Standards - 8th Edition, 2022. [Online]. Available: https://www.tandfonline.com/doi/full/10.1080/24745332.2022.2036503.

Return to footnote 9 referrer

Footnote 10

A. T. Russo, A. Berhanu, C. B. Bigger, J. Prigge, P. M. Silvera, D. W. Grosenbach and D. Hruby, "Co-administration of tecovirimat and ACAM2000™ in non-human primates: Effect of tecovirimat treatment on ACAM2000 immunogenicity and efficacy versus lethal monkeypox virus challenge," Vaccine, 2020 Jan 16;38(3):644,654. doi: 10.1016/j.vaccine.2019.10.049.

Return to footnote 10 referrer

Footnote 11

"Table 7. Interim recommendations for JYNNEOS vaccine administration errors and deviations," CDC, [Online]. Available: https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/errors-deviations.html#Table7. [Accessed 26 Aug 2022].

Return to footnote 11 referrer

Footnote 12

T. Chotikawanich, T. Kammee and S. Khantee, "The impact of needle size and angle on rubber coring after multiple puncturing of multi-dose propofol vial rubber stoppers," Heliyon, 2022 e09389. https://doi.org/10.1016/j.heliyon.2022.e09389.

Return to footnote 12 referrer

Footnote 13

C. Jarrahian, D. Myers, B. Creelman, E. Saxon and D. Zehrung, "Vaccine vial stopper performance for fractional dose delivery of vaccines," Human Vaccines & Therapeutics, 2017 13(7):1666-1668. doi: https://doi.org/10.1080/21645515.2017.1301336.

Return to footnote 13 referrer

Footnote 14

WHO, "WHO Policy Statement: Multi-dose Vial Policy (MDVP)," 2014. [Online]. Available: https://apps.who.int/iris/bitstream/handle/10665/135972/WHO_IVB_14.07_eng.pdf;sequence=1. [Accessed 06 Sep 2022].

Return to footnote 14 referrer

Sample information sheet for Imvamune (smallpox/monkeypox) vaccine 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 vaccines that are manufactured using processes involving eggs. Consult with your health care provider who may advise on extra precautions.

Are you allergic or do you have a confirmed allergy to tromethamine (trometamol, Tris)Footnote 2, 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., tromethamine (trometamol, Tris)Footnote 2, 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 4 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, including Imvamune, that are 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 usually administered in the subcutaneous tissue of the upper triceps area of your arm. It can also be administered intradermally, on the inner surface of your forearm, forming a small bubble.

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 (if indicated)?

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 (smallpox/monkeypox) vaccine 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 (EUND) 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 in humans 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. This is why EUND vaccines are monitored closely for clinical safety and effectiveness in the post-market phase.

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/Route (0.5 mL/SC or 0.1 mL/ID) Lot number Expiry date Site and route Time given Date given
month/day/year
Given by
name and designation

Imvamune smallpox / monkeypox vaccine

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Comments:

Sample after care sheet for Imvamune (smallpox/monkeypox) vaccine 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 will I get the protective benefits from the vaccine?

When should I return for my next dose of vaccine?

Things to remember

Immunization record

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

1

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2

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3

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