Vimkunya

Package leaflet: Information for the user

VIMKUNYA injectable suspension in pre-filled syringe

recombinant, adsorbed chikungunya vaccine
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any adverse reactions you experience while taking this medicine. See the end of section 4 for information on how to report adverse reactions.
Please read this leaflet carefully before receiving this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What VIMKUNYA is and what it is used for
2. What you need to know before receiving VIMKUNYA
3. How VIMKUNYA is administered
4. Possible side effects
5. How to store VIMKUNYA
6. Contents of the pack and other information

1. What VIMKUNYA is and what it is used for

VIMKUNYA is a vaccine used to prevent disease caused by the chikungunya virus in individuals 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 non-infectious and cannot cause chikungunya, but it trains the immune system (the body's natural defenses) to protect against the virus that causes chikungunya.
Chikungunya is a disease caused by the chikungunya virus, which is transmitted through the bite of an infected mosquito. The disease is present in countries in Asia, Africa, and the subtropical regions of the Americas. Most people infected with the virus develop fever, rash, and severe joint pain affecting multiple joints, which usually resolve within one or two weeks; however, symptoms may last for months or years.

2. What you need to know before using VIMKUNYA

Do not receive VIMKUNYA if you are allergic to the active substance or to any of the other
components 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 receiving any other vaccine;
• you have ever fainted after an injection;
• you have a serious illness or infection with high fever (over 38 °C). If you have a mild fever or an upper respiratory tract infection such as a cold, you may still be vaccinated;
• you have a weakened immune system (immunodeficiency) or are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or anticancer medicines);
• you have bleeding problems or a tendency to bruise easily (e.g. thrombocytopenia or haemophilia), or you are using anticoagulants (medicines to prevent blood clots).

Children
VIMKUNYA is not indicated for use in children under 12 years of age. There is no available
information 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.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor before receiving 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 operate machinery.
Wait until any possible effects of the vaccine have worn off before driving or using machinery.
VIMKUNYA contains sodium and potassium
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.

3. How VIMKUNYA is administered

VIMKUNYA is administered as a single injection into the large muscle of the upper arm. The injection should preferably be given in the non-dominant arm.
If you have any doubts about the use of this vaccine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everybody experiences them.
Contact a doctor immediately if you experience symptoms of a severe allergic reaction after receiving the vaccine. Symptoms may include:

• feeling faint or mental confusion
• changes in heart rate
• shortness of breath
• wheezing
• swelling of the lips, face, or throat
• swelling and itching under the skin (urticaria) or skin rash
• feeling unwell (nausea) or vomiting
• stomach ache.

The following side effects may also occur after receiving this vaccine.
Very common (may affect more than 1 in 10 people)

• pain at the injection site
• tiredness
• headache
• muscle pain (myalgia)

Common (may affect up to 1 in 10 people)

• chills
• joint pain (arthralgia)
• general feeling of discomfort (malaise)
• feeling unwell (nausea)

Uncommon (may affect up to 1 in 100 people)

• redness, bruising, or swelling at the injection site
• fever
• dizziness
• nasal congestion
• skin rash

Rare (may affect up to 1 in 1,000 people)

• sensation of pins and needles or tingling (paraesthesia)
• limb pain
• diarrhoea
• swelling of the lips
• enlarged lymph nodes (lymphadenopathy)
• diarrhoea and vomiting (gastroenteritis)
• sore throat (oropharyngeal pain)
• runny nose (rhinorrhoea)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VIMKUNYA

Keep this vaccine out of the sight and reach of children.
The doctor, pharmacist, or nurse is responsible for the storage of the medicine and the proper disposal of unused product. The following information is intended for healthcare professionals.
Do not use this vaccine after the expiry date stated on the label after Exp./EXP.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep the syringe in the outer packaging to protect the medicine from light.
In-use stability data indicate that the vaccine remains stable for 4 hours when stored at temperatures between 8 °C and 25 °C, and for at least 24 hours when stored at temperatures between 0 °C and 2 °C. After this period, the vaccine must be discarded.
Do not dispose of any vaccine via wastewater or household waste. The doctor, pharmacist, or nurse will dispose of the vaccine properly. This will help protect the environment.

6. Package contents and other information

What VIMKUNYA contains
Each 0.8 mL dose contains 40 micrograms of chikungunya virus (CHIKV) protein as
virus-like particles adsorbed onto hydrated aluminium hydroxide.
Produced in human embryonic kidney cells using recombinant DNA technology;
derived from the CHIKV Senegal 37997 strain and composed of the capsid (C) protein and the
envelope proteins E1 and E2 of CHIKV.
Hydrated aluminium hydroxide content per 0.8 mL dose: approximately 300 micrograms of Al.
The vaccine contains hydrated aluminium hydroxide as an adsorbent. Adsorbents are substances included
in some vaccines to accelerate, enhance and/or prolong the protective effects of the vaccine.
The other components (excipients) are: sucrose, dipotassium phosphate, potassium dihydrogen phosphate,
sodium citrate and water for injections. See section 2 “VIMKUNYA contains sodium and
potassium”.
Description of the appearance of VIMKUNYA and contents of the pack
1 dose of VIMKUNYA injectable suspension contains 0.8 mL.
Pack: 1 pre-filled single-dose syringe.
Before being shaken, the vaccine appears as a clear liquid with a white precipitate.
Marketing Authorisation Holder
Bavarian Nordic A/S
Philip Heymans Alle 3
DK-2900 Hellerup
Denmark
Manufacturer
Bavarian Nordic A/S
Hejreskovvej 10 A
DK-3490 Kvistgaard
Denmark
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu.
You can also scan the QR code with a mobile device to access the package leaflet in
multiple languages, or visit the following URL
QR code to be inserted

The following information is intended exclusively for healthcare professionals:

Administer VIMKUNYA by intramuscular injection only, preferably into the deltoid muscle of the upper arm. Do not administer intravenously, intradermally, or subcutaneously.
Dosage
A single 0.8 mL intramuscular dose must be administered.
Instructions for handling and administration
Do not use this vaccine after the expiry date stated on the label after Scad./EXP. The expiry date refers to the last day of that month.
The vaccine must be handled by a healthcare professional using aseptic techniques to ensure sterility of each dose.
Do not mix VIMKUNYA with other vaccines in the same syringe or vial.
Storage conditions:

• Store in a refrigerator (2 °C - 8 °C).
• Do not freeze.
• Keep the syringe in the outer packaging to protect the medicinal product from light.

Preparation for use:

• Remove the vaccine carton from the refrigerator (2 °C - 8 °C). Flange of

finger rest
Rubber stopper Adapter
Luer lock
Rigid cap Glass cylinder Rubber plunger Plunger rod
Inspection of the pre-filled syringe

• Remove the pre-filled syringe tray from the carton.

• Remove the pre-filled syringe from the tray by holding the cylinder.

• Inspect the pre-filled syringe for any leakage or abnormal appearance. If any defect is present, do not use the pre-filled syringe.

• Before shaking, VIMKUNYA appears as a clear liquid with a white precipitate.

• Shake the pre-filled syringe vigorously immediately before use to obtain a homogeneous suspension. After shaking, the suspension should appear as a white, cloudy liquid, free from visible foreign particles. Inspect the suspension for changes in color and presence of particles. If any of these conditions are present, do not administer the vaccine.
  Administration of the vaccine

• Hold the pre-filled syringe by the cylinder with the nozzle pointing upwards, and gently unscrew the Luer lock cap of the pre-filled syringe. Do not attempt to tear or break off the tip, as this may damage the syringe.

• This package does not contain a needle. Use a sterile needle of appropriate size for intramuscular injection, based on the patient's size and weight.

• Attach the sterile needle to the pre-filled syringe and ensure the needle is securely fixed to the syringe.

• After shaking, VIMKUNYA appears as a homogeneous white, cloudy suspension, free from visible foreign particles. If the vaccine does not appear as a homogeneous suspension, shake the syringe vigorously to resuspend the product before administration.

• Administer the entire dose by intramuscular (i.m.) injection into the deltoid muscle of the upper arm, applying steady pressure on the plunger rod and maintaining pressure until all the contents of the syringe have been expelled, thus completing the injection.

• VIMKUNYA is for intramuscular (i.m.) administration only. Do not administer intravenously, intradermally, or subcutaneously.

• The injection must be administered within 4 hours of removing the pre-filled syringe from the refrigerator (2 °C - 8 °C).

• Use-phase stability data indicate that the vaccine remains stable for 4 hours when stored at temperatures between 8 °C and 25 °C, and for at least 24 hours when stored at temperatures between 0 °C and 2 °C. After this period, the vaccine must be discarded.

Disposal

• Dispose of the syringe after use.
• If not used within 4 hours of removing the pre-filled syringe from storage at 2 °C - 8 °C, the vaccine must be discarded.

Waste disposal

• Unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.