Source: Health Products and Food Branch (CA) Revision Year: 2022
IMVAMUNE is indicated for:
The vaccine may be used for both primary vaccination and revaccination.
Pediatrics (<18 years of age): IMVAMUNE has not been studied in subjects below 18 years of age (Section 7.1.3).
Geriatrics (≥56 years of age): IMVAMUNE has been administered to 120 subjects 56 to 80 years of age. No overall differences in safety and immunogenicity were observed between these subjects and those <56 years of age (Section 7.1.4).
IMVAMUNE should be administered by subcutaneous injection, preferably in the deltoid region of the non-dominant upper arm. The vaccine must not be administered intravascularly.
The primary vaccination schedule in Vaccinia-naïve individuals consists of two doses of 0.5 mL four weeks apart administered by the subcutaneous route.
Individuals previously vaccinated against smallpox with either a replicating smallpox vaccine or IMVAMUNE can be re-vaccinated with a single subcutaneous 0.5 mL dose of IMVAMUNE to boost their immune response.
Since no persistency data beyond two years after priming are available for IMVAMUNE experienced persons, the recommended booster schedule is to administer a single dose of IMVAMUNE every two years (see CLINICAL TRIALS, Study Results POX-MVA-023).
IMVAMUNE has not been studied for pediatric use (Section 7.1.3).
Each vial is for single use only and should not be used for more than one individual. The entire contents of the vial should be injected.
In the absence of compatibility studies this vaccine must not be mixed with other medicinal products.
If the primary vaccination schedule in Vaccinia-naïve individuals is not completed full protection might not be achieved against smallpox, monkeypox, or other related orthopoxvirus. The second dose, if missed, should be given as soon as possible (see CLINICAL TRIALS, Study Results POX-MVA-005).
No case of overdose has been reported.
For management of a suspected drug overdose, contact your regional poison control centre.
Store frozen at -20°C ± 5°C or -50°C ± 10°C or -80°C ± 10°C. Expiry date depends on storage temperature
Can be stored at 2°C – 8°C for up to 2 weeks.
After thawing, the vaccine 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. Store in the original package in order to protect from light.
Do not use after the expiry date shown on the label, unless batch certification documentation allows for use based on an updated expiry date.
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