Bimervax XBB.1.16

Package leaflet: Information for the user

BIMERVAX XBB.1.16 injectable emulsion

COVID-19 vaccine (recombinant, adjuvanted)
damlecovateine
This medicinal product is subject to additional monitoring. This will allow rapid identification of
new safety information. You can help by reporting any side effects you may experience while
receiving this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before receiving this vaccine 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 side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What BIMERVAX XBB.1.16 is and what it is used for
2. What you need to know before receiving BIMERVAX XBB.1.16
3. How BIMERVAX XBB.1.16 is administered
4. Possible side effects
5. How to store BIMERVAX XBB.1.16
6. Contents of the pack and other information

1. What BIMERVAX XBB.1.16 is and what it is used for

BIMERVAX XBB.1.16 is a vaccine used to prevent COVID-19, a disease caused by the
SARS-CoV-2 virus.
BIMERVAX XBB.1.16 is administered to individuals aged 16 years and older.
The vaccine stimulates the immune system (the body's natural defenses) to produce specific
antibodies that act against the virus, providing protection against COVID-19. None of the
ingredients in this vaccine can cause COVID-19.

2. What you should know before receiving BIMERVAX XBB.1.16

BIMERVAX XBB.1.16 must not be administered

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving BIMERVAX XBB.1.16 if:

• you have previously had a severe or potentially life-threatening allergic reaction after receiving any other vaccine injection;
• you have fainted after an injection with a needle;
• you have a high fever (over 38 °C) or a serious infection. However, vaccination may still be given if you have a mild fever or a minor upper respiratory tract infection such as a cold;
• you have bleeding disorders, bruise easily, or are taking a medicine to prevent blood clots (anticoagulants);
• your immune system is not functioning properly (immunodeficiency) or if you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or anticancer drugs).

If you fall under any of the conditions listed above (or if you have any doubts), consult your doctor, pharmacist, or nurse before receiving BIMERVAX XBB.1.16.
Like any vaccine, BIMERVAX XBB.1.16 may not fully protect all individuals who receive it, and it is not known how long protection lasts.
Children and adolescents
BIMERVAX XBB.1.16 is not recommended for children and adolescents under 16 years of age.
Currently, there is no available information on the use of BIMERVAX XBB.1.16 in children and adolescents under 16 years of age.
Other medicines and BIMERVAX XBB.1.16
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines or vaccines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor, pharmacist, or nurse before receiving this vaccine.
Driving and using machines
Some of the adverse reactions of BIMERVAX XBB.1.16 listed in section 4 (Possible side effects) may temporarily reduce your ability to drive or operate machinery.
Wait until these vaccine-related side effects have subsided before driving or operating machinery.
BIMERVAX XBB.1.16 contains sodium, potassium, and polysorbate
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".
This vaccine contains less than 1 mmol (39 milligrams) of potassium per 0.5 mL dose, i.e., essentially "potassium-free".
This vaccine contains 1.18 mg of polysorbate 80 in each dose. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How BIMERVAX XBB.1.16 is administered

Individuals aged 16 years and older
BIMERVAX XBB.1.16 will be administered to you as a 0.5 mL injection into a muscle in the upper arm.
It is recommended to receive BIMERVAX XBB.1.16 as a single dose at least 6 months after a previous dose of a COVID-19 vaccine.
After the vaccine injection, your doctor, pharmacist, or nurse will observe you for approximately 15 minutes to monitor for any signs of an allergic reaction.
If you have any doubts about the use of BIMERVAX XBB.1.16, consult your doctor, pharmacist, or nurse.

Immunocompromised individuals
If the immune system is not functioning properly, additional doses may be administered in accordance with official recommendations.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Most side effects occur within 3 days of vaccination and disappear within a few days of onset. If symptoms persist, consult your doctor, pharmacist or nurse.
Seek urgent medical attention if you experience symptoms of a severe allergic reaction shortly after vaccination. Symptoms may include:

• feeling faint or dizzy
• changes in heart rate
• shortness of breath
• wheezing
• swelling of the lips, face or throat
• swelling with itching under the skin (hives) or skin rash
• nausea or vomiting
• stomach ache

The following side effects may occur with BIMERVAX XBB.1.16:
Very common (may affect more than 1 in 10 people):

• headache
• pain at the injection site
• feeling extremely tired
• muscle pain

Common (may affect up to 1 in 10 people):

• redness, swelling or tenderness at the injection site
• nausea or vomiting
• diarrhoea
• fever
• swollen lymph nodes
• armpit pain

Uncommon (may affect up to 1 in 100 people):

• chills or feeling feverish
• dizziness
• itching at the injection site
• joint pain
• feeling weak or lacking energy
• drowsiness
• itchy skin
• general feeling of being unwell

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

• cold sweats
• unusual skin sensations such as tingling or a crawling sensation (paraesthesia)
• decreased sensation, especially in the skin (hypoesthesia)
• abdominal pain
• pain when swallowing
• allergic reactions such as hives, rash or itching
• bruising at the injection site
• increased sensitivity at the injection site

Not known (frequency cannot be estimated from the available data, based on a single case during clinical trials):

• inflammation of the outer lining of the heart (pericarditis), which may cause difficulty breathing, palpitations or chest pain

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V, including the batch number if available. By reporting side effects, you can help provide more information on the safety of this vaccine.

5. How to store BIMERVAX XBB.1.16

Keep this medicinal product out of the sight and reach of children.
The doctor, pharmacist, or nurse is responsible for the storage of this vaccine and for the proper disposal of unused medicine. The following information on storage, expiry date, use and handling, as well as disposal, is intended for healthcare professionals.
Do not use this vaccine after the expiry date stated on the label after "Exp". The expiry date refers to the last day of that month.
Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. Keep the vials in the outer packaging to protect the medicinal product from light.
Information on handling is described in the section for healthcare professionals at the end of the package leaflet.
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.

6. Package contents and other information

What BIMERVAX XBB.1.16 contains

• Each dose (0.5 mL) contains 40 micrograms of damlecovateine, adjuvanted with SQBA.
• Damlecovateine is a recombinant RBD-spike (S) protein homodimer fusion of SARS-CoV-2 virus (strains Omicron XBB.1.16 - XBB.1.16), produced using recombinant DNA technology.
• SQBA is included in this vaccine as an adjuvant to accelerate and enhance the protective effects of the vaccine. For each 0.5 mL dose, SQBA contains: squalene (9.75 mg), polysorbate 80 (1.18 mg), sorbitan trioleate (1.18 mg), sodium citrate (0.66 mg), citric acid (0.04 mg), and water for injections.
• The other components (excipients) are: disodium phosphate dodecahydrate, potassium dihydrogen phosphate, sodium chloride, potassium chloride, and water for injections. BIMERVAX XBB.1.16 contains potassium, sodium and polysorbate (see section 2).

Description of the appearance of BIMERVAX XBB.1.16 and contents of the pack
The vaccine is a homogeneous, white, injectable emulsion.
0.5 mL of emulsion are supplied in a vial with a rubber stopper and a removable plastic cap.
Each single-dose vial contains one 0.5 mL dose.
Pack: 5, 10 or 20 single-dose vials.
Marketing Authorisation Holder
Hipra Human Health, S.L.U.
Avda. La Selva, 135
17170 Amer (Girona)
SPAIN
Manufacturer
Laboratorios Hipra, S.A.
Avda. La Selva, 135
17170 Amer (Girona)
SPAIN
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
Scan the code with a mobile device to access the package leaflet in multiple languages.
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Or visit the website: www.hipracovidvaccine.com
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

The following information is intended exclusively for healthcare professionals:

Administer BIMERVAX XBB.1.16 by intramuscular injection only, preferably into the
deltoid muscle of the arm.
Traceability
To improve the traceability of biological medicinal products, the name and batch number of the
administered medicine should be clearly recorded.
Instructions for handling and administration
Do not use this vaccine after the expiry date stated on the label after "Exp". The expiry date refers to the last day of that month.
This vaccine must be handled by a healthcare professional using aseptic techniques to ensure sterility of each dose.
Preparation for use

• The vaccine is ready to use.
• Unopened vaccine should be stored at a temperature between 2 °C and 8 °C and kept within the outer carton to protect it from light.
• Immediately before use, remove the vaccine vial from the refrigerator’s outer packaging.

Vial inspection

• Gently rotate the vial before withdrawing the dose. Do not shake.
• Each vial contains a white, homogeneous emulsion.
• Before administration, visually inspect the vaccine for visible particulate matter and/or discoloration. Do not administer the vaccine if either condition is present.

Vaccine administration

• Each vial contains excess product to ensure that a 0.5 ml dose can be withdrawn. Any remaining vaccine in the vial must be discarded.
• Each 0.5 ml dose should be withdrawn into a sterile needle and syringe and administered by intramuscular injection, preferably into the deltoid muscle of the upper arm.
• Do not mix the vaccine in the same syringe with other vaccines or medicinal products.
• Do not pool residual vaccine from multiple vials.

Disposal

• Unused medicine and waste material arising from this medicine should be disposed of in accordance with local regulations.