Nuvaxovid

Package leaflet: Information for the user

Nuvaxovid dispersion for injectable suspension

Anti-COVID-19 vaccine (recombinant, adjuvanted)
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while receiving 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 experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Nuvaxovid is and what it is used for

Nuvaxovid is a vaccine used to prevent COVID-19, a disease caused by the
SARS-CoV-2 virus.
Nuvaxovid 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 should know before receiving Nuvaxovid

Do not receive Nuvaxovid

• 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:

• if you have previously had a severe or life-threatening allergic reaction after receiving any other injectable vaccine or after being administered Nuvaxovid 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 resembling 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 functioning properly (immunodeficiency) or if you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or anticancer drugs).

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 develop within a few days after 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 fall into any of the above conditions (or have any doubts about them), consult your doctor, pharmacist, or nurse before receiving Nuvaxovid.
As with any vaccine, the two-dose vaccination course with Nuvaxovid may not fully protect all individuals who receive it, and the duration of protection is not known.

Children
Nuvaxovid is not recommended for children and adolescents under 12 years of age. Currently, there is no information available on the use of Nuvaxovid in children and adolescents under 12 years of age.

Other medicines and Nuvaxovid
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, consult your doctor, pharmacist, or nurse before receiving this vaccine.

Driving and using machines
Some of the side effects of Nuvaxovid listed in section 4 (Possible side effects) could temporarily reduce your ability to drive vehicles or operate machinery (for example, feeling faint, dizzy, or extremely tired).
Avoid driving or operating machinery if you do not feel well after vaccination. Before driving or using machinery, wait until any effects from the vaccine have passed.

Nuvaxovid 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 is administered

Individuals aged 12 years and older
Nuvaxovid will be administered as two separate 0.5 mL injections.
The doctor, pharmacist, or nurse will inject the vaccine into a muscle, usually in the upper arm.
To complete the vaccination course, it is recommended to receive the second dose of Nuvaxovid
3 weeks after the first dose.
In individuals aged 12 years and older, a booster dose of Nuvaxovid may be administered approximately
3 months after the second dose.
During and after each vaccine injection, the doctor, pharmacist, or nurse will observe you for about
15 minutes to monitor for any signs of an allergic reaction.
If you miss your appointment for the second Nuvaxovid injection, consult your doctor or nurse.
If you skip the scheduled injection, protection against COVID-19 may be incomplete.

4. Possible side effects

Like all medicines, this vaccine may 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 at the site. 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 heart rate
• shortness of breath
• 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 extremely tired (fatigue)
general malaise

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):
swollen lymph nodes
hypertension
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 sensations on the skin, such as tingling or pricking (paresthesia)
• decreased 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 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 Nuvaxovid

Keep this medicinal product out of the sight and reach of children.
The doctor, pharmacist or nurse is responsible for storing this vaccine and for the proper disposal of any unused product.
Information on storage, expiry date, 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 contains
One dose (0.5 mL) of Nuvaxovid contains 5 micrograms of SARS-CoV-2 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 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 extract from Quillaja saponaria Molina per 0.5 mL dose.
• The other components (excipients) contained in Nuvaxovid are:
  disodium hydrogen phosphate heptahydrate
  sodium dihydrogen phosphate monohydrate
  disodium hydrogen phosphate dihydrate
  sodium chloride
  polysorbate 80
  cholesterol
  phosphatidylcholine (including all-racemic 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 and contents of the pack

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

5-dose vial

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

10-dose vial

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

Not all pack sizes may be marketed.

Marketing Authorization 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 on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Sanofi Belgium Swixx Biopharma UAB
tel: +32 2 710.54.00 Tel: +370 5 236 9140

България Luxembourg/Luxemburg
Swixx Biopharma EOOD Sanofi Belgium
Teл.: +359 2 4942 480 tel.: +32 2 710.54.00

Česká republika Magyarország
Sanofi s.r.o. SANOFI-AVENTIS Zrt
Tel: +420 233 086 111 Tel: +36 1 505 0055

Danmark Malta
Sanofi A/S Sanofi S.r.l.
Tel: +45 4516 7000 Tel: +39 02 39394 275

Deutschland Nederland
Sanofi-Aventis Deutschland GmbH Sanofi B.V.
Tel: 0800 54 54 010 Tel: +31 20 245 4000
International tel: +49 69 305 21 130

Eesti Norge
Swixx Biopharma OÜ Sanofi-aventis Norge AS
Tel: +372 640 10 30 Tel: +47 67 10 71 00

Ελλάδα Österreich
ΒΙΑΝΕΞ Α.Ε. Sanofi-Aventis GmbH
Τηλ: +30.210.8009111 Tel: +43 (1) 80185-0

España Polska
sanofi-aventis, S.A. Sanofi Sp. z o.o.
Tel: +34 93 485 94 00 Tel: +48 22 280 00 00

France Portugal
Sanofi Winthrop Industrie Sanofi – Produtos Farmacêuticos, Lda.
Tél: 0 800 222 555 Tel: +351 21 35 89 400
From abroad: +33 1 57 63 23 23

Hrvatska România
Swixx Biopharma d.o.o Sanofi Romania SRL
Tel: +385 1 2078 500 Tel: +40 21 317 31 36

Ireland Slovenija
sanofi-aventis Ireland T/A SANOFI Swixx Biopharma d.o.o.
Tel: +353 (0) 1 4035 600 Tel: +386 1 2355 100

Ísland Slovenská republika
Vistor Swixx Biopharma s.r.o.
Tel: +354 535 7000 Tel: +421 2 20833 600

Italia Suomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800536389 Tel: +358 (0) 201 200 300

Κύπρος Sverige
C.A. Papaellinas Ltd. Sanofi AB
Τηλ.: +357 22 741741 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 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 Nuvaxovid by intramuscular injection, preferably into the deltoid muscle of the arm, as
two doses given 3 weeks apart.
In individuals aged 12 years and older, a Nuvaxovid booster dose may be administered approximately 3 months after the second dose.
Traceability
To improve 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 after Scad/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 supplied ready to use.
• The closed vial must be stored refrigerated (2 °C to 8 °C) and kept in the outer packaging to protect from light.
• Immediately before use, remove the vaccine vial from the refrigerator and take it out of its packaging.
• Record the disposal date and time on the vial label. Use within 12 hours when stored at 2 °C to 8 °C or within 6 hours at room temperature (up to 25 °C) after first puncture.

Vial inspection

• Gently rotate the multidose vial before withdrawing a dose and between withdrawals. Do not shake.
• Each multidose vial contains a dispersion ranging from colourless to slightly yellow, from clear to slightly opalescent.
• Before administration, visually inspect the vial contents for visible particulate matter and/or discolouration. Do not administer the vaccine if either of these conditions is present.

Vaccine administration

• Each vial contains an overfill to ensure withdrawal of up to 5 doses (2.5 mL vial) or 10 doses (5 mL vial) of 0.5 mL each.
• Each 0.5 mL dose should be drawn into a sterile syringe using a sterile needle for 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

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

Disposal

• Discard the vaccine if not used within 12 hours when stored at 2 °C to 8 °C or within 6 hours when stored at room temperature after first vial puncture.

Waste disposal

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