Bimervax

Package leaflet: Information for the user

BIMERVAX injectable emulsion

COVID-19 vaccine (recombinant, adjuvanted)
selvacovatein
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 experience while using this
medicinal product. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you are given this vaccine because 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 get any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What BIMERVAX is and what it is used for

BIMERVAX is a vaccine used to prevent COVID-19, a disease caused by the SARS-CoV-2 virus.
BIMERVAX is administered to individuals aged 16 years and older who have previously received an anti-COVID-19 mRNA vaccine.
The vaccine stimulates the immune system (the body's natural defenses) to produce specific antibodies directed against the virus, thereby providing protection against COVID-19. None of the ingredients in this vaccine can cause COVID-19.

2. What you need to know before receiving BIMERVAX

BIMERVAX 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 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, you may still be vaccinated if you have a mild fever or a minor upper respiratory tract infection such as a cold;
• you have bleeding problems, bruise easily, or are taking a medicine to prevent blood clots (anticoagulants);
• your immune system is not working properly (immunodeficiency), or if you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or anticancer medicines).

If you fall into any of the above categories (or if you are unsure), consult your doctor, pharmacist, or nurse before receiving BIMERVAX.
Like any vaccine, BIMERVAX may not fully protect all individuals who receive it, and it is not known how long protection lasts.
Children and adolescents
BIMERVAX is not recommended for children and adolescents under 16 years of age. Currently, there is no available information on the use of BIMERVAX in children and adolescents under 16 years of age.
Other medicines and BIMERVAX
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, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before receiving this vaccine.
Driving and using machines
Some of the side effects of BIMERVAX listed in section 4 (Possible side effects) may temporarily reduce your ability to drive or operate machinery. Wait until these side effects have passed before driving or using machines.
BIMERVAX 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 mg) 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 is administered

Subjects aged 16 years and older
BIMERVAX will be administered to you as a 0.5 mL injection into a muscle in the upper arm.
It is recommended to receive a single dose of BIMERVAX at least 6 months after a previous vaccination cycle with an mRNA-based anti-COVID-19 vaccine or after a previous booster dose of BIMERVAX.
After the vaccine injection, the 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, consult your doctor, pharmacist, or nurse.

Immunocompromised subjects
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 may cause side effects, although not everybody gets them.
Most side effects occur within 3 days after 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 rash
• nausea or vomiting
• stomach ache

The following side effects may occur with BIMERVAX:
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 soreness 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 crawling sensations (paraesthesia)
• reduced sensation, especially in the skin (hypoesthesia)
• abdominal pain
• pain when swallowing
• allergic reactions such as hives, rash or itching
• bruising at the injection site
• hypersensitivity 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 shortness of breath, palpitations or chest pain

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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

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 medicinal product. The following information on storage, expiry, use, handling, and 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.
After the first puncture of the multidose vial, store at a temperature between 2 °C and 8 °C and use within 6 hours.
Information on handling is described in the section for healthcare professionals at the end of the package leaflet.
Unused medicinal product and waste material arising from this medicinal product must be disposed of in accordance with local regulations.

6. Package contents and other information

What BIMERVAX contains

• Each dose (0.5 mL) contains 40 micrograms of selvacovatein, adjuvanted with SQBA.
• Selvacovatein is a recombinant fusion heterodimer of the spike (S) protein receptor-binding domain (RBD) from the SARS-CoV-2 virus (strains B.1.351 and B.1.1.7), 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 contains potassium, sodium and polysorbate (see section 2).

Description of the appearance of BIMERVAX and package contents
The vaccine is a homogeneous, white, injectable emulsion.
Multidose vial
5 mL of emulsion supplied in a vial with a rubber stopper and a removable plastic cap.
Each multidose vial contains 10 doses of 0.5 mL.
Pack: 10 multidose vials.
Single-dose vial
0.5 mL of emulsion supplied in a vial with a rubber stopper and a removable plastic cap.
Each single-dose vial contains 1 dose of 0.5 mL.
Pack: 5, 10 or 20 single-dose vials.
Not all pack sizes may be marketed.

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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Alternatively, visit the website: www.hipracovidvaccine.com
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

The following information is intended exclusively for healthcare professionals:

Administer BIMERVAX by intramuscular injection only, preferably in the deltoid muscle of the arm.

Traceability
To improve traceability of biological medicinal products, the name and batch number of the administered product must be clearly documented.

Instructions for handling and administration
Do not use this vaccine after the expiry date stated on the label following "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 for use.
• Unopened vaccine must be stored at a temperature between 2 °C and 8 °C and kept within the outer packaging to protect it from light.
• Immediately before use, remove the vaccine vial from the refrigerator packaging.
• After the first puncture of the multidose vial, record the date and time of disposal (6 hours after first puncture) in the designated space on the vial label.

Vial inspection

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

Vaccine administration

• Each vial contains excess volume to ensure that up to ten (10) doses (multidose vial) or one (1) dose (single-dose vial) of 0.5 mL each can be withdrawn. Discard any remaining vaccine in the single-dose vial or multidose vial after withdrawing 10 doses.
• Each 0.5 mL dose should be drawn into a sterile needle and syringe for administration by intramuscular injection, preferably into the deltoid muscle of the arm.
• Once the syringe is filled, the vaccine is stable for up to at least 6 hours under refrigerated conditions or at room temperature (< 25 °C).
• Do not mix the vaccine in the same syringe with other vaccines or medicinal products.
• Do not pool leftover vaccine from multiple vials.

Disposal

• After the first puncture of the multidose vial, store the opened multidose vial at a temperature between 2 °C and 8 °C for a maximum of 6 hours. Discard the vaccine if not used within 6 hours of first puncture of the multidose vial.
• Discard any remaining vaccine in the single-dose vial or multidose vial after withdrawing 10 doses.

Waste disposal

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