Patient leaflet - Nuvaxovid XBB.1.5 Dispersion for injection
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 caused by the SARS-CoV-2 virus.
Nuvaxovid XBB.1.5 is given to individuals 12 years of age and older.
The vaccine causes the immune system (the body’s natural defences) to produce antibodies and specialised white blood cells that work against the virus, to give protection against COVID-19. None of the ingredients in this vaccine can cause COVID-19.
2. What you need to know before you receive Nuvaxovid XBB.1.5
Nuvaxovid XBB.1.5 should not be given
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Nuvaxovid XBB.1.5 if:
- you have ever had a severe or life-threatening allergic reaction after receiving any other vaccine injection or after you were given Nuvaxovid or Nuvaxovid XBB.1.5 in the past,
- you have ever fainted following any needle injection,
- you have a high fever (over 38°C) or severe infection. However, you can have your vaccination if you have a mild fever or upper airway infection like a cold,
- you have bleeding problems, you bruise easily or you use a medicine to prevent blood clots,
- your immune system does not work properly (immunodeficiency) or you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or cancer medicines).
There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Nuvaxovid, see section 4.
These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days.
Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before you are given Nuvaxovid XBB.1.5.
As with any vaccine, a single dose of Nuvaxovid XBB.1.5 may not fully protect all those who receive it and it is not known how long you will be protected.
Children
Nuvaxovid XBB.1.5 is not recommended for children aged below 12 years. Currently, there is no information available on the use of Nuvaxovid XBB.1.5 in children younger than 12 years of age.
Other medicines and Nuvaxovid XBB.1.5
Tell 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 or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before you receive this vaccine.
Driving and using machines
Some of the side effects of Nuvaxovid XBB.1.5 listed in section 4 (Possible side effects) may temporarily reduce your ability to drive and use machines (for example, feeling faint or lightheaded or feeling very tired).
Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines.
Nuvaxovid XBB.1.5 contains sodium and potassium
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
This vaccine contains less than 1 mmol potassium (39 milligrams) per dose, that is to say, essentially ‘potassium-free’.
3. How Nuvaxovid XBB.1.5 is given
Individuals 12 years of age and older
Nuvaxovid XBB.1.5 will be given to you as a single dose 0.5 mL injection.
If you were 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.
Your doctor, pharmacist, or nurse will inject the vaccine into a muscle, usually in your upper arm.
During and after each injection of the vaccine, your doctor, pharmacist, or nurse will watch over you for around 15 minutes to monitor for signs of an allergic reaction.
Additional doses (0.5 mL) of Nuvaxovid XBB.1.5 may be administered at the discretion of your physician, taking into consideration your clinical conditions in line with national recommendations.
Immunocompromised individuals
If your immune system does not work properly additional doses may be administered in line with national recommendations.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them. Most side effects go away within a few days of appearing. If symptoms persist, contact your doctor, pharmacist or nurse.
As with other vaccines, you may feel pain or discomfort at the injection site, or you may see some redness and swelling at this site. However, these reactions usually clear up within a few days.
Get urgent medical attention if you get any of the following signs and symptoms of an allergic reaction:
- feeling faint or light-headed
- changes in your heartbeat
- shortness of breath
- wheezing
- swelling of your lips, face, or throat
- hives or rash
- nausea or vomiting
- stomach pain
Talk to your doctor or nurse if you develop any other side effects. These can include:
Very common (may affect more than 1 in 10 people):
- headache
- feeling sick (nausea) or getting sick (vomiting)
- muscle ache
- joint pain
- tenderness or pain where the injection is given
- feeling very tired (fatigue)
- generally feeling unwell
Common (may affect up to 1 in 10 people):
- redness where the injection is given
- swelling where the injection is given
- fever (>38°C)
- pain or discomfort in the arm, hand, leg and/or foot (pain in the extremity)
Uncommon (may affect up to 1 in 100 people):
- enlarged lymph nodes
- high blood pressure
- itchy skin, rash or hives
- redness of the skin
- itchy skin where the injection is given
- chills
Rare (may affect up to 1 in 1000 people):
- warmth where the injection is given
Not known (cannot be estimated from available data):
- severe allergic reaction
- unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
- decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
- inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis), which can result in breathlessness, palpitations or chest pain
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card reporting site www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Nuvaxovid XBB.1.5
Keep this medicine out of the sight and reach of children.
Your doctor, pharmacist, or nurse is responsible for storing this vaccine and disposing of any unused product correctly.
Information about storage, expiry, use and handling are described in the section intended for healthcare professionals at the end of the package leaflet.
6. Contents of the pack and other information
What Nuvaxovid XBB.1.5 contains
One dose (0.5 mL) Nuvaxovid XBB.1.5 contains 5 micrograms of SARS-CoV-2 (Omicron XBB.1.5) spike protein* and is adjuvanted with Matrix-M.
*produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the Spodoptera frugiperda species.
- Matrix-M is included in this vaccine as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, improve, and/or prolong the protective effects of the vaccine. Matrix-M adjuvant contains Fraction-A (42.5 micrograms) and Fraction-C (7.5 micrograms) of Quillaja saponaria Molina extract per 0.5 mL dose.
The other ingredients (excipients) included 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 the adjustment of pH)
- Hydrochloric acid (for the adjustment of pH)
- Water for injections
What Nuvaxovid XBB.1.5 looks like and contents of the pack
- The dispersion is colourless to slightly yellow, clear to mildly opalescent (pH 7.2).
Single dose vial of 1 dose
- 0.5 mL of dispersion for injection in a vial with a rubber stopper and a blue flip-off top.
- Pack size: 10 single dose vials. Each vial contains 1 dose of 0.5 mL.
Multidose vial of 5-doses
- 2.5 mL of dispersion for injection in a vial with a rubber stopper and a blue flip-off top.
- Pack size: 2 multidose vials or 10 multidose vials. Each vial contains 5 doses of 0.5 mL.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi
410 Thames Valley Park Drive
Reading
Berkshire
RG6 1PT
UK
Tel: 0800 035 2525
Manufacturer
Novavax CZ a.s.
Líbalova 2348/1, Chodov
149 00 Praha 4
Czechia
This leaflet was last revised in 11/2025.
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The following information is intended for healthcare professionals only:
Administer Nuvaxovid XBB.1.5 intramuscularly, preferably into the deltoid muscle of the upper arm, as a single dose.
For individuals who have previously been 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 individuals who are severely immunocompromised in accordance with national recommendations.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Handling instructions and administration
Do not use this vaccine after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.
This vaccine should be handled by a healthcare professional using aseptic techniques to ensure the sterility of each dose.
Preparation for use
- The vaccine comes ready to use.
- Unopened vaccine should be stored in a refrigerator (2°C - 8°C) and kept within the outer carton to protect from light.
- Immediately prior to use, remove the vaccine vial from the carton in the refrigerator.
Single dose vial
- Discard the vial and any excess volume after one dose withdrawal and administration.
Multidose vial
- Use within 12 hours at 2°C to 8°C or 6 hours at room temperature (maximum 25°C) after first needle puncture. Record the date and time of discard on the vial label.
Inspect the vial
- Gently swirl the vial before the dose withdrawal. Do not shake. Gently swirl the multidose vial before each additional dose withdrawal.
- Each vial contains a colourless to slightly yellow, clear to mildly opalescent dispersion.
- Visually inspect the contents of the vial for visible particulate matter and/or discolouration prior to administration. Do not administer the vaccine if either are present.
Administer the vaccine
- An overfill is included per vial to ensure that one dose of 0.5 mL from the single dose vial or a maximum of 5 doses of 0.5 mL from the multidose vial (vial of 2.5 mL) can be extracted.
Each 0.5 mL dose is withdrawn into a sterile needle and sterile syringe to be administered by intramuscular injection, preferably in the deltoid muscle of the upper arm.
- Do not mix the vaccine in the same syringe with any other vaccines or medicinal products.
- Do not pool excess vaccine from multiple vials.
Storage after first needle puncture of multidose vial
- Store the opened vial between 2°C to 8°C for up to 12 hours or at room temperature (maximum 25°C) for up to 6 hours after first puncture.
Discard
Single dose vial
- Discard the vial and any excess volume after one dose withdrawal and administration.
Multidose vial
- Discard this vaccine if not used within 12 hours when stored between 2°C to 8°C or 6 hours when stored at room temperature after first needle puncture of the vial, see section 6.3.
Disposal
- Any unused medicinal product or waste material should be disposed of in accordance with local requirements.