Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
IMVANEX no less than 50,000,000 iu/ vial
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Modified vaccinia ankara – bavarian nordic live virus may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
IMVANEX is a vaccine used to prevent smallpox, mpox and disease caused by vaccinia virus in adults. When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection in the form of antibodies against the smallpox, mpox and vaccinia viruses. IMVANEX does not contain smallpox virus (Variola) or mpox virus or vaccinia viruses. It cannot spread or cause smallpox, mpox or vaccinia infection and disease. 2.
What you need to know before you take it
IMVANEX
You must not receive IMVANEX: •
if you are allergic or have previously had a sudden life-threatening allergic reaction to the active substance or any of the other ingredients of this medicine (listed in section 6) or chicken protein, benzonase, gentamicin or ciprofloxacin which may be present in the vaccine in very small amounts.
Warnings and precautions Talk to your doctor or nurse before receiving IMVANEX: • if you have atopic dermatitis (see section 4). • if you have HIV infection or any other condition or treatment leading to a weakened immune system. • If you are feeling nervous about the vaccination process or have ever fainted following any needle injection. The protective efficacy of IMVANEX against smallpox, mpox and disease caused by vaccinia virus has not been studied in humans. 1
In case of illness with high temperature, your doctor will postpone the vaccination until you are feeling better. The presence of a minor infection, such as a cold, should not require postponement of the vaccination, but talk to your doctor or nurse first. IMVANEX may not fully protect all people who are vaccinated. Prior vaccination with IMVANEX may modify the cutaneous response ('take') to subsequently administered replication-competent smallpox vaccine resulting in a reduced or absent take. Other medicines or vaccines and IMVANEX Tell your doctor or nurse if you are taking or have recently taken any other medicines or if you have recently received any other vaccine. Pregnancy and breast-feeding If you are a pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask to your doctor for advice. The use of this vaccine during pregnancy and breast-feeding is not recommended. However, your doctor will assess whether the possible benefit in terms of preventing smallpox, mpox and disease caused by vaccinia virus would outweigh the potential risks to you and your foetus/baby. Driving and using machines There is no information on the effect of IMVANEX on your ability to drive or use machines. However, it is possible that if you experience any of the side effects listed in section 4, then some of these may affect your ability to drive or use machines (e.g. dizziness). IMVANEX contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. 3.
How to take it
You can be given this vaccine whether or not you have received smallpox vaccination in the past. The vaccine will be injected under the skin, preferably into the upper arm, by your doctor or a nurse. It must not be injected into a blood vessel. If you have never been vaccinated against smallpox, mpox or vaccinia viruses: • You will receive two injections. • The second injection will be given no less than 28 days after the first. • Make sure you complete the vaccination course of two injections. If you have previously been vaccinated against smallpox, mpox or vaccinia viruses: • You will receive one injection. • If your immune system is weakened, you will receive two injections, with the second injection no less than 28 days after the first. If you miss an appointment for your injection of IMVANEX If you miss a scheduled injection, tell your doctor or nurse and arrange another visit. If you have any further questions on the use of this vaccine, ask your doctor or nurse. 2
4.
Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them. Serious side effects Contact a doctor immediately, or go immediately to the emergency department of your nearest hospital if you experience any of the following symptoms: • difficulty in breathing • dizziness • swelling of the face and neck. These symptoms may be a sign of a serious allergic reaction. Other side effects If you already have atopic dermatitis, you may experience more intense local skin reactions (such as redness, swelling and itching) and other general symptoms (such as headache, muscle pain, feeling sick or tired), as well as a flare-up or worsening of your skin condition. The most common side effects reported were at the site of injection. Most of them were mild to moderate in nature and resolved without any treatment within seven days. If you get any of the following side effects, tell your doctor. Very common (may affect more than 1 in 10 people): • headache, • aching muscles, • feeling sick, • tiredness, • pain, redness, swelling, hardness or itching at the injection site. Common (may affect up to 1 in 10 people): • chills, • fever, • joint pain, pain in extremities, • loss of appetite, • lump, discolouration, bruising or warmth at the injection site. Uncommon (may affect up to 1 in 100 people): • nose and throat infection, upper respiratory tract infection, • swollen lymph nodes, • abnormal sleep, • dizziness, abnormal skin sensations, • muscle stiffness, • sore throat, runny nose, cough, • diarrhea, vomiting, • rash, itch, skin inflammation, • bleeding, irritation, • underarm swelling, feeling unwell, flushing, chest pain, pain in the armpit, • increase of cardiac laboratory values (like Troponin I), liver enzyme increased, white blood cell count decreased, mean platelet volume decreased. Rare (may affect up to 1 in 1 000 people): • sinus infection, 3
• • • • • • • • • • • • • • • • • • • • • • • • • • • •
influenza, redness and discomfort in the eye, hives (nettle rash), skin discolouration, sweating, skin bruising, night sweats, lump in skin, back pain, neck pain, muscle cramps, muscle pain, muscle weakness, swelling of the ankles, feet or fingers, faster heartbeat, ear and throat ache, abdominal pain, dry mouth, spinning sensation (vertigo), migraine, nerve disorder causing weakness, tingling or numbness, drowsiness, scaling, inflammation, abnormal skin sensation, reaction at the injection site, rash, numbness, dryness, movement impairment, vesicles at the injection site, weakness, influenza like illness, swelling of the face, mouth and throat, white blood cell count increased, bruising.
Unknown (cannot be estimated from the available data): • temporary one-sided facial drooping (Bell's palsy). Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or App Store. By reporting side effects you can help provide more information on the safety of this vaccine. 5.
How to store it
IMVANEX
Keep this medicine out of the sight and reach of children. Do not use this vaccine after the expiry date which is stated on the label after Exp. The expiry date refers to the last day of that month. Store in a freezer (at -20°C +/-5°C or -50°C +/-10°C or -80°C +/-10°C). Expiry date depends on storage temperature. Do not refreeze the vaccine once thawed. After thawing, the vaccine can be stored at 2°C-8°C in the dark for up to 2 months within the approved shelf-life prior to use. Store in the original package to protect from light.
4
6.
Contents of the pack and other information
What IMVANEX contains One dose (0.5 ml) contains: The active substance is Modified Vaccinia Ankara – Bavarian Nordic Live virus1, no less than 5 x 107 Inf.U* *infectious units 1 Produced in chick-embryo cells The other ingredients are: trometamol, sodium chloride, and water for injections. This vaccine contains trace residues of chicken protein, benzonase, gentamicin and ciprofloxacin. What IMVANEX looks like and contents of the pack Once the frozen vaccine has been thawed, IMVANEX is a light yellow to pale white, milky suspension for injection. IMVANEX is provided as a suspension for injection in a vial (0.5 ml). IMVANEX is available in pack containing 10 single dose vials or 20 single dose vials. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Bavarian Nordic A/S Philip Heymans Alle 3 DK-2900 Hellerup Denmark tel +45 3326 8383 e-mail [email protected] Manufacturer Bavarian Nordic A/S Hejreskovvej 10A, 3490 Kvistgaard Denmark This leaflet was last revised in November 2024. This medicine has been authorised under 'exceptional circumstances'. This means that because of the rarity of this disease, it has been impossible to get complete information on this medicine. The MHRA will review any new information on this medicine every year and this leaflet will be updated as necessary. Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu and on MHRA web site: https://products.mhra.gov.uk/search/?search=IMVANEX ————————————————————————————————————————–The following information is intended for healthcare professionals only: Instructions for preparation and administration of the vaccine: The vial should be allowed to reach a temperature between 8°C and 25°C before use. Swirl gently before use. Visually inspect the suspension prior to administration. In case of any particles and/or abnormal appearance, the vaccine should be discarded. Each vial is for single use. 5
A dose of 0.5 ml is withdrawn into a syringe for injection. After thawing, the vaccine can be stored at 2°C-8°C in the dark for up to 2 months within the approved shelf-life prior to use. Do not refreeze the vaccine once thawed. In the absence of compatibility studies, this vaccine must not be mixed with other vaccines.
6
Frequently asked questions about IMVANEX no less than 50,000,000 iu/ vial
What is the active substance in IMVANEX no less than 50,000,000 iu/ vial?
The active substance in IMVANEX no less than 50,000,000 iu/ vial is modified vaccinia ankara – bavarian nordic live virus.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for IMVANEX no less than 50,000,000 iu/ vial, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get IMVANEX no less than 50,000,000 iu/ vial without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: modified vaccinia ankara – bavarian nordic live virus
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Active immunisation against smallpox, mpox and disease caused by vaccinia virus in adults (see sections 4.4 and 5.1).
The use of this vaccine should be in accordance with official recommendations.
4.2. Posology and method of administration
Posology
Primary vaccination (individuals previously not vaccinated against smallpox, mpox or vaccinia viruses)
A first dose of 0.5 ml should be administered on an elected date.
A second dose of 0.5 ml should be administered no less than 28 days after the first dose, see sections 4.4 and 5.1.
Booster vaccination (individuals previously vaccinated against smallpox, mpox or vaccinia viruses)
There are inadequate data to determine the appropriate timing of booster doses. If a booster dose is considered necessary then a single dose of 0.5 ml should be administered, see sections 4.4 and 5.1.
Special population
Immunocompromised patients (e.g. HIV infected, patients under immunosuppressive therapy) who have been previously vaccinated against smallpox, mpox or vaccinia viruses should receive two booster doses. The second booster vaccination should be given no less than 28 days after the first booster dose.
Paediatric population
The safety and efficacy of IMVANEX in children below 18 years have not been established.
No data are available.
Method of administration
Immunisation should be carried out by subcutaneous injection, preferably into the upper arm.
For instructions on administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or trace residues (chicken protein, benzonase, gentamicin and ciprofloxacin).
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity and anaphylaxis
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Concurrent illness
Immunisation should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not result in the deferral of vaccination.
General recommendations
IMVANEX should not be administered by intravascular injection.
Limitations of vaccine effectiveness
The protective efficacy of IMVANEX against smallpox, mpox and disease caused by vaccinia virus has not been studied in humans, see section 5.1
A protective immune response may not be elicited in all vaccinees.
There are inadequate data to determine the appropriate timing of booster doses.
Prior vaccination with IMVANEX may modify the cutaneous response ('take') to subsequently administered replication-competent smallpox vaccine resulting in a reduced or absent take, see section 5.1.
Individuals with atopic dermatitis
Individuals with atopic dermatitis developed more local and general symptoms after vaccination (see section 4.8)
Immunocompromised individuals
Data have been generated in HIV infected individuals with CD4 counts ≥ 100 cells/µl and ≤ 750 cells/µl. Lower immune response data have been observed in HIV infected individuals compared to healthy individuals (see section 5.1). There are no data on the immune response to IMVANEX in other immunosuppressed individuals.
Two doses of IMVANEX given at a 7-day interval showed lower immune responses and slightly more local reactogenicity than two doses given at a 28-day interval. Therefore, dose intervals of less than 28 days should be avoided.
Anxiety-related reactions
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies with other vaccines or medicinal products have been performed. Therefore, concomitant administration of IMVANEX with other vaccines should be avoided.
The concomitant administration of the vaccine with any immunoglobulin including Vaccinia Immune Globulin (VIG) has not been studied and should be avoided.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are limited data (less than 300 pregnancy outcomes) from the use of IMVANEX in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of IMVANEX during pregnancy. Administration of IMVANEX in pregnancy should only be considered when the potential benefits outweigh any potential risk to the mother and fetus.
Breast-feeding
It is not known whether IMVANEX is excreted in human milk. As a precautionary measure, it is preferable to avoid the use of IMVANEX during breast-feeding. Administration of IMVANEX during breast-feeding should only be considered when the potential benefits outweigh any potential risks to the mother and baby.
Fertility
Animal studies did not reveal any evidence of impaired female and male fertility.
4.7. Effects on ability to drive and use machines
There is no information on the effect of IMVANEX on the ability to drive or use machines. However, some of the undesirable effects mentioned in section 4.8 may affect the ability to drive or use machines (e.g. dizziness).
4.8. Undesirable effects
Summary of the safety profile
The safety of IMVANEX has been assessed in 20 clinical trials in which 5 261 Vaccinia-naïve individuals received two doses of no less than 5 x 107 Inf.U four weeks apart while 534 Vaccinia- and IMVANEX-experienced individuals received a single booster dose.
The most common adverse reactions observed in clinical trials were injection site reactions and common systemic reactions typical for vaccines which were mild to moderate in intensity and resolved without intervention within seven days following vaccination.
Adverse reaction rates reported after either vaccination dose (1st, 2nd or booster) were similar.
Tabulated list of adverse reactions
Adverse reactions from all clinical trials are listed according to the following frequency:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1 000 to <1/100)
Rare (≥1/10 000 to <1/1 000)
Unknown (cannot be estimated from the available data)
Table 1 Adverse reactions reported in completed clinical trials (N = 7 082 subjects) and post-authorisation experience with IMVANEX
MedDRA System Organ Class
Very common
(≥1/10)
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1 000 to <1/100)
Rare
(≥1/10 000 to <1/1 000)
Unknown
(cannot be estimated from the available data)
Infections and infestations
-
-
Nasopharyngitis
Upper respiratory tract infection
Sinusitis
Influenza
Conjunctivitis
Blood and lymphatic system disorders
-
-
Lymphadenopathy
-
Metabolism and nutrition disorders
-
Appetite disorder
-
-
Psychiatric disorders
-
-
Sleep disorder
-
Nervous system disorders
Headache
-
Dizziness
Paresthesia
Migraine
Peripheral sensory neuropathy
Somnolence
Acute peripheral facial paralysis (Bell's palsy)
Ear and labyrinth disorders
-
-
-
Vertigo
Cardiac disorders
-
-
-
Tachycardia
Respiratory thoracic and mediastinal disorders
-
-
Pharyngolaryngeal pain
Rhinitis
Cough
Oropharyngeal pain
Gastrointestinal disorders
Nausea
-
Diarrhoea
Vomiting
Dry mouth
Abdominal Pain
Skin and subcutaneous tissue disorders
-
-
Rash
Pruritus
Dermatitis
Urticaria
Skin discolouration
Hyperhidrosis
Ecchymosis
Night sweats
Subcutaneous nodule
Angioedema
Musculoskeletal and connective tissue disorders
Myalgia
Pain in extremity
Arthralgia
Musculoskeletal stiffness
Back pain
Neck pain
Muscle spasms
Musculoskeletal pain
Muscular Weakness
General disorders and administration site conditions
Injection site pain
Injection site erythema
Injection site swelling
Injection site induration
Injection site pruritus
Fatigue
Rigor/Chills
Injection site nodule
Injection site discolouration
Injection site haematoma
Injection site warmth
Underarm swelling
Malaise
Injection site haemorrhage
Injection site irritation
Flushing
Chest pain
Axillary pain
Injection site exfoliation
Injection site inflammation
Injection site paraesthesia
Injection site reaction
Injection site rash
Oedema peripheral
Asthenia
Injection site anesthesia
Injection site dryness
Injection site movement impairment
Influenza like illness
Injection site vesicles
Investigations
-
Body temperature increased
Pyrexia
Troponin I increased
Hepatic enzyme increased
White blood cell count decreased
Mean platelet volume decreased
White blood cell count increased
Injury, poisoning and procedural complications
-
-
-
Contusion
Description of selected adverse reactions
Individuals with atopic dermatitis (AD)
In a non-placebo controlled clinical trial that compared the safety of IMVANEX in individuals with AD to healthy individuals, individuals with AD reported erythema (61.2%) and swelling (52.2%) at the injection site with a higher frequency than healthy individuals (49.3% and 40.8%, respectively). The following general symptoms were reported more frequently in individuals with AD compared to healthy individuals: headache (33.1% vs. 24.8%), myalgia (31.8% vs. 22.3%), chills (10.7% vs. 3.8 %), nausea (11.9% vs. 6.8%), and fatigue (21.4% vs. 14.4%).
7% of the individuals with AD in clinical trials with IMVANEX experienced a flare-up or worsening of their skin condition during the course of the trial.
Rash
IMVANEX may trigger local rashes or more widespread eruptions. Events of rash after vaccination (related cases observed in 0.4% of subjects) with IMVANEX tend to occur within the first days after vaccination, are mild to moderate in intensity and usually resolve without sequelae.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via a Yellow card. Reporting forms and information can be found on the Yellow Card Scheme (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or App Store and include batch/Lot number if available.
4.9. Overdose
No case of overdose has been reported.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Modified vaccinia ankara – bavarian nordic live virus. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- BCG - medac prescription partial — not the same combinationVACCIN BCG · taken by mouth
- BCG VACCINE prescription partial — not the same combinationVACCIN BCG · injection / infusion
- ONKO BCG 100 prescription partial — not the same combinationVACCIN BCG · taken by mouth
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Onko BCG 100BCG vaccinum 100 mg
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about IMVANEX no less than 50,000,000 iu/ vial. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.