Imvamune: Uses, Side Effects and Dosage

What IMVAMUNE is used for:

• IMVAMUNE is a vaccine that helps protect against smallpox, mpox and related orthopoxvirus infection and disease

• IMVAMUNE is indicated for individuals 18 years of age and older. This could include individuals:

  • Who are human immunodeficiency virus infected (CD4 ≥ 100 cells/μL)
  • Who have atopic dermatitis

How IMVAMUNE works:

IMVAMUNE is used for vaccination (active immunization) against smallpox, mpox, and other orthopoxviruses. IMVAMUNE activates your immune system to help protect you from smallpox, mpox and orthopoxvirus infection and disease.

IMVAMUNE does not contain replicating viruses and cannot spread or cause orthopoxvirus disease (including smallpox and mpox).

The ingredients in IMVAMUNE are:

Medicinal ingredient(s): Modified Vaccinia Virus (Ankara-Bavarian Nordic)

Non-medicinal ingredients: Sodium chloride, Trometamol, Water for injection

Traces of residual host cell DNA and protein, benzonase, gentamicin and ciprofloxacin

IMVAMUNE comes in the following dosage form(s):

Suspension for injection, at least 0.5 x 10⁸ Inf.U MVA-BN / 0.5 mL dose

Do not use IMVAMUNE if:

• You are below 18 years of age
• You are hypersensitive to this vaccine or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
• You show hypersensitivity reactions after receiving the first dose of the vaccine.
• You have experienced acute febrile conditions if used for non-emergency (pre-event) prophylaxis.

Individuals with the following conditions should discuss vaccination with their physician, who will be able to advise on safe vaccination or on alternative preventative measures to avoid infection with smallpox, mpox or other orthopoxviruses:

• Pregnant or breast-feeding woman

• Persons with fever (temperature above 38.5°C)
• Persons with allergies to the active substance or any of the excipients (see ingredients)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IMVAMUNE. Talk about any health conditions or problems you may have, including if you:

• are or think you are pregnant or if you are breast feeding
• have any known allergies
• have a fever or you think you may be getting a fever

Other warnings you should know about:

• As with any other vaccine, vaccination with IMVAMUNE may not result in protection in all cases.
• As with all vaccines, appropriate medical treatment and supervision should always be available to treat rare cases of anaphylactic reactions following the administration of the vaccine.

• Some people may experience reactions related to anxiety when receiving a vaccine. These can include feeling faint or fainting, fast or deep breathing, or other stress-related reactions. These responses are linked to anxiety about the injection itself rather than the vaccine. For this reason, measures are taken to help prevent injury if someone feels faint or loses consciousness.

  The following adverse events have been observed during the post authorization use of the vaccine:

  • Inflammation of the heart muscle (myocarditis)
  • Inflammation of the lining around the heart (pericarditis)
  • Temporary weakness or drooping on one side of the face (Bell’s palsy)

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with other vaccines have not been established. Concomitant use with immunoglobulins should be avoided.

How to take IMVAMUNE:

• The vaccine is to be given as a single dose by injection under the skin.
• DO NOT INJECT INTRAVASCULARLY

Usual dose:

The primary vaccination series consists of two doses of 0.5 mL each according to the following schedule:

First dose: Day 0

Second dose: 28 days after first dose

Your doctor will advise on the need for a booster dose.

Overdose:

No case of overdose has been reported.

Missed dose:

Make sure you finish the complete vaccination course of two injections. If not, you may not be fully protected against the disease. If you miss a scheduled injection, talk to your doctor and arrange another visit.

Possible side effects from using IMVAMUNE:

These are not all the possible side effects you may have when taking IMVAMUNE. If you experience any side effects not listed here, tell your healthcare professional.

Like all vaccines, IMVAMUNE can cause side effects, although not everybody gets them.

Anaphylactic shock is a rare but very serious event. Although no cases have been observed during clinical development of IMVAMUNE, these events may occur with any injectable vaccine. An allergic reaction causes symptoms in many parts of the body, often starting with tingling or swelling around the mouth and lips. The face and neck may swell and breathing may become difficult. Heartbeat is fast and may be irregular. A rash, hives or redness of the skin may occur and there may be diarrhea. If these symptoms occur, contact your physician or call your emergency services immediately.

The adverse reactions listed below have been observed during clinical studies. The most common side effects reported were at the injection site. Most of the reported adverse reactions are mild to moderate in intensity and resolving without intervention within seven days following vaccination.

Very common side effects reported in at least 1 in 10 persons were:

Injection site pain, Injection site erythema, Injection site swelling, Injection site induration, Injection site pruritus, Fatigue, Myalgia, Headache, Nausea.

Common side effects reported in at least 1 in 100 but less than 1 in 10 persons were:

Rigors/Chills, Injection site nodule, Injection site discolouration, Injection site haematoma, Injection site warmth, Body temperature increased, Pyrexia, Appetite disorder, Pain in extremity, Arthralgia.

Uncommon side effects reported in at least 1 in 1000 but less than 1 in 100 persons were:

Nasopharyngitis, Upper Respiratory Tract Infection, Lymphadenopathy, Sleep Disorder, Dizziness, Paresthesia, Pharyngolaryngeal Pain, Rhinitis, Cough, Diarrhea, Vomiting, Dry Mouth, Rash, Pruritus, Dermatitis, Skin Discolouration, Musculoskeletal Stiffness, Back Pain, Neck Pain, Underarm Swelling, Malaise, Injection Site Irritation, Injection Site Haemorrhage, Flushing, Axillary Pain, Chest Pain, Injection Site Exfoliation, Injection Site Inflammation, Injection Site Paraesthesia, Injection Site Reaction, Troponin I Increased, Hepatic Enzyme Increased, White Blood Cell Count Decreased, Mean Platelet Volume Decreased, Contusion.

Rare side effects reported in less than 1 in 1000 persons were:

Sinusitis, Conjunctivitis, Influenza, Migraine, Peripheral Sensory Neuropathy, Vertigo, Tachycardia, Oropharyngeal Pain, Abdominal Pain, Urticaria, Ecchymosis, Hyperhidrosis, Night Sweats, Subcutaneous Nodule, Angioedema, Muscle Spasms, Musculoskeletal Pain, Muscular Weakness, Injection Site Rash, Oedema Peripheral, Asthenia, Influenza Like Illness, Injection Site Anesthesia, Injection Site Dryness, Injection Site Movement Impairment, Injection Site Vesicles, White Blood Cell Count Increased

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

Your doctor or pharmacist is responsible for storing this vaccine and disposing of any unused product correctly. Do not use after the expiry date stated on the label.

Keep out of reach and sight of children.

If you want more information about IMVAMUNE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.bnvaccines.ca, or contact medical.information_NA@bavarian-nordic.com or by calling 1-833-203-7933.

Imported by: Progress Therapeutics Inc. (ON, Canada)

Date of Authorization: 2026-09-24

Trademarks are owned by Bavarian Nordic A/S.