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Vimkunya 40 microgram/dose Suspension for injection in pre-filled syringe

⚠ 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 Chikungunya virus (chikv) virus-like particles (vlp) adsorbed on aluminium hydroxide, hydrated may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Chikungunya virus (chikv) virus-like particles (vlp) adsorbed on aluminium hydroxide, hydrated
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

VIMKUNYA is a vaccine used to prevent disease caused by the chikungunya virus in people 12 years of age and older. VIMKUNYA is a vaccine that contains part of the 'outer coating' of the chikungunya virus. This 'outer coating' is not infectious and cannot cause chikungunya disease but teaches the immune system (the body's natural defences) how to protect itself against the virus that causes chikungunya disease. Chikungunya disease is caused by the chikungunya virus, which is transmitted through the bite of infected mosquitoes. The disease is found in countries across Asia, Africa and the subtropical regions of the Americas. Most people infected with the virus develop fever, rash, and severe pain in multiple joints that typically resolve between one to two weeks, but symptoms may last for months or years.

2.

What you need to know before you take it

e VIMKUNYA

You should not receive VIMKUNYA if you are allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given VIMKUNYA if:

  • you have ever had a severe allergic reaction (hypersensitivity) or breathing problems after any other vaccine administration.
  • you have ever fainted following any injection.
  • you have a severe illness or infection with a high temperature (over 38 °C). You can still have your vaccination if you have a mild fever or upper airway infection like a cold.
  • you have a weakened immune system (immunodeficiency), or you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or cancer medicines). 1

–

you have a problem with bleeding or bruising (such as thrombocytopenia or haemophilia) or if you are taking an anticoagulant (a medicine to prevent blood clots).

Children VIMKUNYA is not for use in children under 12 years of age. There is no information available on the use of VIMKUNYA in this age group. Other medicines and VIMKUNYA Tell your doctor if you are taking, have recently taken or might take any other medicines or vaccines. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this vaccine. Driving and using machines Some of the possible side effects of VIMKUNYA listed in section 4 of this leaflet may temporarily reduce your ability to drive or use machines. Wait until any effects of the vaccine have worn off before you drive or use machines. VIMKUNYA contains sodium and potassium This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodiumfree'. This vaccine contains less than 1 mmol (39 mg) potassium per dose, that is to say essentially 'potassium-free'.

3.

How to take it

VIMKUNYA is given as a single injection into the large muscle of the upper arm. It is best to get the injection in the non-dominant arm. If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them. Seek urgent medical attention if you have symptoms of a severe allergic reaction after receiving the vaccine. Symptoms may include:

  • feeling faint or light-headed
  • changes in your heartbeat
  • shortness of breath
  • wheezing
  • swelling of your lips, face, or throat
  • itchy swelling under the skin (hives) or rash
  • feeling sick (nausea) or vomiting
  • stomach pain. The following side effects may also occur after receiving this vaccine: Very common (may affect more than 1 in 10 people)
  • pain at injection site
  • tiredness (fatigue)
  • headache
  • muscle pain (myalgia). 2

Common (may affect up to 1 in 10 people)

  • chills (shivering)
  • joint pain (arthralgia)
  • general feeling of discomfort (malaise)
  • feeling sick (nausea). Uncommon (may affect up to 1 in 100 people)
  • redness, bruising or swelling where the injection is given
  • fever
  • dizziness
  • nasal congestion
  • skin rash Rare (may affect up to 1 in 1 000 people)
  • pins and needles or tingling sensations (paraesthesia)
  • pain in extremities
  • diarrhoea
  • lip swelling
  • swollen lymph nodes (lymphadenopathy)
  • diarrhoea and vomiting (gastroenteritis)
  • sore throat (oropharyngeal pain)
  • runny nose (rhinorrhoea) 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5.

How to store it

VIMKUNYA

Keep this vaccine out of the sight and reach of children. Your doctor, pharmacist or nurse is responsible for storing this medicine and disposing of any unused product correctly. The following information is intended for healthcare professionals. Do not use this vaccine after the expiry date which is stated on the label after EXP. Store in a refrigerator (2 °C to 8 °C). Do not freeze. Keep the syringe in the outer carton in order to protect from light. In-use stability data indicate that the vaccine is stable for 4 hours when stored at temperatures from 8 °C to 25 °C and for at least 24 hours when stored at 0 °C to 2 °C. After this time, the vaccine must be discarded. Do not throw away any vaccines via wastewater or household waste. Your doctor, pharmacist or nurse will dispose of this vaccine. These measures will help protect the environment.

3

6.

Contents of the pack and other information

What VIMKUNYA contains Each 0.8 ml dose contains 40 micrograms protein of chikungunya virus (CHIKV) virus-like particles1,2 adsorbed on aluminium hydroxide, hydrated. 1

produced in human embryonic kidney cells by recombinant DNA technology derived from CHIKV Senegal strain 37997 consisting of CHIKV capsid protein (C) and envelope proteins E1 and E2. 2

Aluminium hydroxide, hydrated containing per 0.8 ml dose: approximately 300 micrograms Al3+. Aluminium hydroxide, hydrated is included in the vaccine as an adsorbent. Adsorbents are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine. The other ingredients (excipients) are: sucrose, dipotassium phosphate, potassium dihydrogen phosphate, sodium citrate, and water for injections. See Section 2 "the vaccine contains sodium and potassium". What VIMKUNYA looks like and contents of the pack 1 dose of VIMKUNYA suspension for injection contains 0.8 ml. Pack size: 1 single-dose pre-filled syringe. Prior to shaking, the vaccine is a clear liquid with white precipitate.

Marketing Authorisation Holder Bavarian Nordic A/S Philip Heymans Alle 3 DK-2900 Hellerup Denmark Manufacturer Bavarian Nordic A/S Hejreskovvej 10A 3490 Kvistgaard Denmark

This leaflet was last revised in March 2026.

Other sources of information Detailed information on this medicine is available on the MHRA web site: https://www.mhra.gov.uk ———————————————————————————————————————–The following information is intended for healthcare professionals only: Administer VIMKUNYA intramuscularly only, preferably in the deltoid muscle of the upper arm. Do not administer intravenously, intradermally, or subcutaneously. Posology 4

A single intramuscular dose of 0.8 ml should be administered. Handling instructions and administration 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. The vaccine should be handled by a healthcare professional using aseptic technique to ensure the sterility of each dose. Do not mix VIMKUNYA with any other vaccine in the same syringe or vial. Storage conditions:

  • Store in a refrigerator (2 °C to 8 °C).
  • Do not freeze.
  • Keep the syringe in the outer carton in order to protect from light. Preparation for use:
  • Remove vaccine carton from refrigerator (2 °C to 8 °C).

Inspect the pre-filled syringe

  • Remove the pre-filled syringe tray from carton.
  • Take the pre-filled syringe out of the tray by holding the syringe barrel.
  • Inspect the pre-filled syringe for any abnormal appearance or leakage. If any defects are found, do not use the pre-filled syringe.
  • VIMKUNKA is a clear liquid with white precipitate prior to agitation.
  • Shake the pre-filled syringe vigorously immediately before use to obtain a homogeneous suspension. After shaking, the suspension should be a white, cloudy liquid with no visible foreign particulate. Inspect the suspension for discoloration and particulate. Do not administer the vaccine if any of these are present. Administer the vaccine
  • Hold the pre-filled syringe barrel with the nozzle facing up, position and gently unscrew the Luer lock cap of the pre-filled syringe. Do not attempt to snap or pull the tip off as this may damage the syringe.
  • This package does not contain a needle. Use a sterile needle of the appropriate size to ensure an intramuscular injection depending on the patient's size and weight.
  • Attach the sterile needle to the pre-filled syringe and ensure the needle fits securely on the syringe. 5

• • • • •

VIMKUNYA appears as a homogeneous white cloudy suspension with no visible foreign particulate after shaking. If the vaccine is not a homogenous suspension, shake the syringe vigorously to resuspend prior to administration. Administer the entire dose as an intramuscular (IM) injection in the deltoid muscle of the upper arm, by smoothly depressing the plunger rod and maintaining pressure on the rod until the full contents of the syringe are expelled to complete the injection. VIMKUNYA is for intramuscular (IM) administration only. Do not administer intravenously, intradermally, or subcutaneously. The injection must be administered within 4 hours after removal of the pre-filled syringe from the refrigerator (2 °C to 8 °C). In-use stability data indicate that the vaccine is stable for 4 hours when stored at temperatures 8 °C to 25 °C and for at least 24 hours when stored at 0 °C to 2 °C. After this time, the vaccine must be discarded.

Discard

  • Discard syringe after use.
  • Discard this vaccine if not used within 4 hours after removal of the pre-filled syringe from 2 °C to 8 °C storage. Disposal
  • Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

6

Frequently asked questions about Vimkunya 40 microgram/dose Suspension for injection in pre-filled syringe

How do I take Vimkunya 40 microgram/dose Suspension for injection in pre-filled syringe?

Vimkunya 40 microgram/dose Suspension for injection in pre-filled syringe comes as oral solution containing 40mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Vimkunya 40 microgram/dose Suspension for injection in pre-filled syringe?

The active substance in Vimkunya 40 microgram/dose Suspension for injection in pre-filled syringe is chikungunya virus (chikv) virus-like particles (vlp) adsorbed on aluminium hydroxide, hydrated.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Vimkunya 40 microgram/dose Suspension for injection in pre-filled syringe, 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 Vimkunya 40 microgram/dose Suspension for injection in pre-filled syringe 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: chikungunya virus (chikv) virus-like particles (vlp) adsorbed on aluminium hydroxide, hydrated
  • Official document: view the original leaflet on emc →
Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Chikungunya virus (chikv) virus-like particles (vlp) adsorbed on aluminium hydroxide, hydrated (1 medicine)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

VIMKUNYA is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older.

The use of this vaccine should be in accordance with official recommendations.

4.2. Posology and method of administration

Posology

A single dose of 0.8 ml should be administered.

Elderly

No dose adjustment is required in elderly individuals ≥ 65 years of age.

Paediatric population

The safety and efficacy of VIMKUNYA in children below 12 years of age have not been established. No data are available.

Method of administration

The vaccine should be administered by intramuscular (IM) injection in the deltoid muscle.

VIMKUNYA must not be injected intravenously, intradermally, or subcutaneously.

The pre-filled syringe should be vigorously shaken immediately before use to obtain a homogeneous suspension.

For instructions on handling and the disposal of waste material, see section 6.6.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of VIMKUNYA.

Immunocompromised individuals

The safety and efficacy of VIMKUNYA has not been assessed in patients with immunodeficiency and patients using systemic immunosuppressive therapies. It is not known whether individuals with impaired immune responsiveness, including individuals receiving immunosuppressive therapy, will elicit the same response as immunocompetent individuals to the vaccine regimen.

Anxiety-related reactions

As with all injectable vaccines, 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.

Concurrent illness

Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.

Thrombocytopenia and coagulation disorders

As with other intramuscular injections, the vaccine should be given with caution to individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular injection in these individuals.

Limitations of vaccine effectiveness

As with any vaccine, protection may not be elicited after vaccination in all persons. It is recommended to continue personal protection measures against mosquito bites after vaccination.

Excipients

Potassium

This vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially 'potassium-free'.

Sodium

This vaccine 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 medicinal products have been performed.

Concomitant administration of VIMKUNYA with other vaccines has not been studied.

4.6. Fertility, pregnancy and lactation

Pregnancy

In animal studies, no vaccine-related adverse effects on embryofetal development were observed in rats and rabbits; some postnatal effects of unknown clinical relevance were seen only in rabbits (see section 5.3).

There is limited amount of data from the use of VIMKUNYA in pregnant women. These data are not sufficient to conclude on the absence of potential effects of VIMKUNYA on pregnancy, embryo-foetal development, parturition and post-natal development.

Decisions to administer VIMKUNYA during pregnancy should take into consideration the individual's risk of exposure to wild-type CHIKV, gestational age, and risks to the foetus or neonate.

Breast-feeding

It is unknown if VIMKUNYA is excreted in human milk. A risk to the breastfed child cannot be excluded. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VIMKUNYA and any potential adverse effects on the breastfed child from VIMKUNYA.

Fertility

No specific studies have been performed on fertility.

Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see section 5.3).

4.7. Effects on ability to drive and use machines

No studies on the effects on ability to drive or operate machines have been performed. However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines.

4.8. Undesirable effects

Summary of the safety profile

The most common local adverse reaction at the injection site after vaccine administration was injection site pain (24.0%). The most common systemic adverse reactions observed after vaccination were fatigue (17.8%), headache (16.7%) and myalgia (16.5%) (Table 1).

Tabulated list of adverse reactions

The tabulated summary of the adverse reactions following administration of VIMKUNYA (Table 1) is based on an analysis of the pooled safety data gathered from three completed phase 2 studies and two completed phase 3 studies on 3 522 participants ≥ 12 years old who received VIMKUNYA. Of these, 3 141 individuals received a single 40 micrograms dose of VIMKUNYA. These participants were followed up for serious adverse events over the entire study period of 182 days.

Adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class. The adverse reactions reported 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

- Very rare < 1/10 000

Table 1: Adverse reactions reported following administration of VIMKUNYA

MedDRA system organ class

Adverse reaction

Frequency

General disorders and administration site conditions

Injection site pain

Very common

Fatigue

Very common

Chills

Common

Malaise

Common

Injection site redness

Uncommon

Injection site swelling

Uncommon

Pyrexia

Uncommon

Injection site bruising

Uncommon

Nervous system disorders

Headache

Very common

Dizziness

Uncommon

Paraesthesia

Rare

Musculoskeletal and connective tissue disorders

Myalgia

Very common

Arthralgia

Common

Pain in extremity

Rare

Gastrointestinal disorders

Nausea

Common

Diarrhoea

Rare

Lip swelling

Rare

Blood and lymphatic system disorders

Lymphadenopathy

Rare

Infections and infestations

Gastroenteritis

Rare

Respiratory, thoracic and mediastinal disorders

Nasal congestion

Uncommon

Oropharyngeal pain

Rare

Rhinorrhoea

Rare

Skin and subcutaneous tissue disorders

Rash

Uncommon

Paediatric population – adolescents

Of the 3 522 clinical study participants administered VIMKUNYA, 6.2% (N = 217) were between 12 to < 18 years of age who received one dose of 40 micrograms of VIMKUNYA with a follow up of 182 days. The safety profile in adolescents is similar to the overall safety profile in adults.

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 the Yellow Card Scheme.

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

No case of overdose has been reported in clinical trials. In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

⚠ Not the same combination. This medicine contains Chikungunya virus (chikv) virus-like particles (vlp) adsorbed on aluminium hydroxide, hydrated. 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.

  • Antidral partial — not the same combinationAluminii chloridum
  • Gelatum Aluminii phosphorici Aflofarm partial — not the same combinationAluminii phosphas · skin / topical
  • Gelatum Aluminii phosphorici partial — not the same combinationAluminii phosphas · skin / topical

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. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Vimkunya 40 microgram/dose Suspension for injection in pre-filled syringe. 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.

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