Nuvaxovid XBB.1.5

Package leaflet: Information for the user

Nuvaxovid XBB.1.5 dispersion for injectable preparation

COVID-19 vaccine (recombinant, adjuvanted)
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 taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of 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 get any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Nuvaxovid XBB.1.5 is and what it is used for
2. What you need to know before receiving Nuvaxovid XBB.1.5
3. How Nuvaxovid XBB.1.5 is given
4. Possible side effects
5. How to store Nuvaxovid XBB.1.5
6. Contents of the pack and other information

1. What Nuvaxovid XBB.1.5 is and what it is used for

Nuvaxovid XBB.1.5 is a vaccine used to prevent COVID-19, a disease caused by the
SARS-CoV-2 virus.
Nuvaxovid XBB.1.5 is administered to individuals aged 12 years and older.
The vaccine prompts the immune system (the body's natural defenses) to produce antibodies and
specialized white blood cells to fight the virus, thereby providing protection against COVID-19.
None of the components of this vaccine can cause COVID-19.

2. What you need to know before receiving Nuvaxovid XBB.1.5

Nuvaxovid XBB.1.5 must not be given to you

• 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 Nuvaxovid XBB.1.5:

• if you have previously had a severe or life-threatening allergic reaction after receiving any injectable vaccine or after being given Nuvaxovid or Nuvaxovid XBB.1.5 in the past;
• if you have fainted after any needle injection;
• if you have a high fever (over 38 °C) or a serious infection. However, if you have a mild fever or a respiratory tract infection similar to a cold, you may still receive the vaccination;
• if you have bleeding disorders, are prone to bruising easily, or are taking a medicine to prevent blood clots;
• if 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).

After vaccination with Nuvaxovid, there is an increased risk of myocarditis (inflammation
of the heart muscle) and pericarditis (inflammation of the outer lining of the heart), see
section 4.
These conditions may occur within a few days of vaccination and have mainly occurred
within 14 days.
After vaccination, you should be alert for signs of myocarditis and pericarditis, such as
shortness of breath, palpitations, and chest pain, and if these occur, you must seek
immediate medical attention.
If you have any of the conditions listed above (or are unsure about them), consult your
doctor, pharmacist, or nurse before receiving Nuvaxovid XBB.1.5.
As with any vaccine, a single dose of Nuvaxovid XBB.1.5 may not fully protect
everyone who receives it, and the duration of protection is not known.
Children
Nuvaxovid XBB.1.5 is not recommended for children and adolescents under 12 years of age.
Currently, there is no information available on the use of Nuvaxovid XBB.1.5 in children and
adolescents under 12 years of age.
Other medicines and Nuvaxovid XBB.1.5
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 to become pregnant, or are breastfeeding,
please consult your doctor, pharmacist, or nurse before receiving this vaccine.
Driving and using machines
Some of the side effects of Nuvaxovid XBB.1.5 listed in section 4 (Possible side
effects) might temporarily reduce your ability to drive vehicles or operate machinery
(for example, feeling faint or dizzy, or feeling extremely tired).
Avoid driving or operating machinery if you do not feel well after vaccination. Before driving
or using machinery, wait until any vaccine-related effects have passed.
Nuvaxovid XBB.1.5 contains sodium and potassium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
This medicine contains less than 1 mmol of potassium (39 milligrams) per dose, i.e.
essentially “potassium-free”.

3. How Nuvaxovid XBB.1.5 is administered

Individuals aged 12 years and older
Nuvaxovid XBB.1.5 will be administered as a single 0.5 mL injection.
If you have previously received a COVID-19 vaccine, Nuvaxovid XBB.1.5 should be
administered at least 3 months after the most recent dose of a COVID-19 vaccine.
The doctor, pharmacist, or nurse will inject the vaccine into a muscle, usually in the upper arm.
During and after each vaccine injection, the doctor, pharmacist, or nurse will observe you for approximately 15 minutes to monitor for any signs of an allergic reaction.
Additional doses (0.5 mL) of Nuvaxovid XBB.1.5 may be administered at the physician's discretion, taking into account the clinical condition and in accordance with national recommendations.

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

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them. Most of the side effects disappear within a few days of onset. If symptoms persist, consult your doctor, pharmacist or nurse.
As with other vaccines, you may experience pain or discomfort at the injection site or notice redness and swelling in that area. However, these reactions usually disappear within a few days.
Seek urgent medical advice if you experience any of the following signs and symptoms of an allergic reaction:

• feeling faint or dizzy
• changes in heartbeat
• difficulty breathing
• wheezing
• swelling of the lips, face or throat
• hives or skin rash
• nausea or vomiting
• stomach pain

Consult your doctor or nurse if any other side effect occurs. These may include:
Very common (may affect more than 1 in 10 people):
headache
nausea or vomiting
muscle pain
joint pain
pain or tenderness at the injection site
feeling very tired (fatigue)
general feeling of being unwell

Common (may affect up to 1 in 10 people):
redness at the injection site
swelling at the injection site
fever (>38 °C)
pain or discomfort in the arm, hand, leg and/or foot (limb pain)

Uncommon (may affect up to 1 in 100 people):
enlarged lymph nodes
high blood pressure
itching, skin rash or hives
skin redness
itching at the injection site
chills

Rare (may affect up to 1 in 1,000 people):
warmth at the injection site

Not known (frequency cannot be estimated from the available data):

• severe allergic reaction
• unusual skin sensations, such as tingling or pricking (paraesthesia)
• reduced sensation, especially of the skin (hypoesthesia)
• inflammation of the heart muscle (myocarditis) or 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, consult your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to 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 Nuvaxovid XBB.1.5

Keep this medicine 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 any unused product.
Information on storage, expiry, use, and handling is provided in the section for healthcare professionals at the end of this leaflet.

6. Package contents and other information

What Nuvaxovid XBB.1.5 contains
One dose (0.5 mL) of Nuvaxovid XBB.1.5 contains 5 micrograms of the SARS-CoV-2 (Omicron XBB.1.5) \textit{spike} protein* with Matrix-M adjuvant.
*Produced using recombinant DNA technology with a baculovirus expression system in an insect cell line derived from Sf9 cells of the species \textit{Spodoptera frugiperda}

• Matrix-M is included in this vaccine as an adjuvant. Adjuvants are substances contained in some vaccines to accelerate, enhance, and/or prolong the protective effects of the vaccine. The Matrix-M adjuvant contains fraction A (42.5 micrograms) and fraction C (7.5 micrograms) of \textit{Quillaja saponaria} Molina extract per 0.5 mL dose.
• The other components (excipients) contained in Nuvaxovid XBB.1.5 are:
  disodium hydrogen phosphate heptahydrate
  sodium dihydrogen phosphate monohydrate
  disodium hydrogen phosphate dihydrate
  sodium chloride
  polysorbate 80
  cholesterol
  phosphatidylcholine (including all-rac-α-tocopherol)
  potassium dihydrogen phosphate
  potassium chloride
  sodium hydroxide (for pH adjustment)
  hydrochloric acid (for pH adjustment)
  water for injections

Description of the appearance of Nuvaxovid XBB.1.5 and contents of the pack

• Dispersion ranging from colourless to slightly yellow, from clear to slightly opalescent (pH 7.2).

Single-dose vial (1 dose)

• 0.5 mL of dispersion for injectable preparation in a vial with rubber stopper and blue plastic flip-off cap.
• Pack: 1 single-dose vial or 10 single-dose vials. Each vial contains one 0.5 mL dose.

Multi-dose vial (5 doses)

• 2.5 mL of dispersion for injectable preparation in a vial with rubber stopper and blue plastic flip-off cap.
• Pack: 2 multi-dose vials or 10 multi-dose vials. Each vial contains 5 doses of 0.5 mL each.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturer
Novavax CZ a.s.
Líbalova 2348/1, Chodov
149 00 Praha 4
Czech Republic

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Sanofi Belgium
tel: +32 2 710.54.00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 9140

България
Swixx Biopharma EOOD
Teл.: +359 2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
tel.: +32 2 710.54.00

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt
Tel: +36 1 505 0055

Danmark
Sanofi A/S
Tel: +45 4516 7000

Malta
Sanofi S.r.l.
Tel: +39 02 39394 275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 54 54 010
Tel. aus dem Ausland: +49 69 305 21 130

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge
Sanofi-aventis Norge AS
Tel: +47 67 10 71 00

Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Τηλ: +30.210.8009111

Österreich
Sanofi-Aventis GmbH
Tel: +43 (1) 80185-0

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi – Produtos Farmacêuticos, Lda.
Tel: +351 21 3589 400

Hrvatska
Swixx Biopharma d.o.o
Tel: +385 1 2078 500

România
Sanofi Romania SRL
Tel: +40 21 317 31 36

Ireland
sanofi-aventis Ireland T/A SANOFI
Tel: +353 (0) 1 4035 600

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 2355 100

Ísland
Vistor
Tel: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 20833 600

Italia
Sanofi S.r.l.
Tel: 800536389

Suomi/Finland
Sanofi Oy
Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ.: +357 22 741741

Sverige
Sanofi AB
Tel: +46 8-634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 6164 750

Scan the code with a mobile device to access the package leaflet in different languages.

Or visit the website: https://www.NovavaxCovidVaccine.com

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.
This leaflet is available in all European Union/European Economic Area languages on the European Medicines Agency website.

The following information is intended exclusively for healthcare professionals:

Administer Nuvaxovid XBB.1.5 by intramuscular injection, preferably into the
deltoid muscle of the arm, as a single dose.
In individuals previously vaccinated with a COVID-19 vaccine, Nuvaxovid
XBB.1.5 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Additional doses may be administered to severely immunocompromised individuals in
accordance with national recommendations.

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

Instructions for handling and administration
Do not use this vaccine after the expiry date stated on the label and carton following
Exp/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
the sterility of each dose.

Preparation for use

• The vaccine is supplied ready for use.
• The closed vial must be stored refrigerated (2 °C – 8 °C) and kept in the outer packaging to protect it from light.
• Immediately before use, remove the vaccine vial from the carton stored in the refrigerator.
• Single-dose vial
• Discard the vial and any remaining volume after withdrawal and administration of one dose.
• Multi-dose vial
• Use within 12 hours if stored at 2 °C – 8 °C or within 6 hours if stored at room temperature (up to 25 °C) after first puncture with a needle. Record the date and time of disposal on the vial label.

Inspection of the vial

• Gently rotate the vial before withdrawing the dose. Do not shake. Gently rotate the multi-dose vial before withdrawing each additional dose.
• Each vial contains a dispersion ranging from colourless to slightly yellow, from clear to slightly opalescent.
• Before administration, visually inspect the vial contents for the presence of visible particulate matter and/or discolouration. If either condition is present, do not administer the vaccine.

Administration of the vaccine

• Each vial contains an overage to ensure withdrawal of one 0.5 mL dose from the single-dose vial or up to five 0.5 mL doses from the multi-dose vial (2.5 mL vial).
• Each 0.5 mL dose is drawn into a sterile syringe through a sterile needle for administration via intramuscular injection, preferably into the deltoid muscle of the arm.
• The vaccine must not be mixed in the same syringe with other vaccines or medicinal products.
• Do not pool excess vaccine from multiple vials.

Storage after first needle puncture of multi-dose vial

• Store the opened multi-dose vial at 2 °C – 8 °C for up to 12 hours or at room temperature (up to 25 °C) for up to 6 hours after first puncture.

Disposal

• Single-dose vial
• Discard the vial and any remaining volume after withdrawal and administration of one dose.
• Multi-dose vial
• Discard the vaccine if not used within 12 hours when stored at 2 °C – 8 °C or within 6 hours when stored at room temperature after first puncture of the vial.

Waste disposal

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