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Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted) {equilateral_black_triangle}

Active Ingredient:
SARS-CoV-2 recombinant spike protein
Company:  
Novavax, Inc See contact details
ATC code: 
J07BN04
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 16 Jul 2024

{equilateral_black_triangle} This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PLGB 54180/0003.

{printer} Print patient leaflet as text only

Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted)

Package leaflet: Information for the user

Nuvaxovid XBB.1.5 dispersion for injection

COVID-19 Vaccine (recombinant, adjuvanted)

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Nuvaxovid XBB.1.5 is and what it is used for
2. What you need to know before you receive 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 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 Coronavirus Yellow Card reporting site https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store, and include the vaccine brand and batch/lot 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.

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).

5-dose vial

  • 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
Novavax CZ a.s.
Líbalova 2348/1
Chodov
149 00 Praha 4
Czechia

Manufacturer
Novavax CZ a.s.
Bohumil 138
Jevany
28163
Czechia

This leaflet was last revised in June 2024.

Scan the code with a mobile device to access an electronic copy of the package leaflet for Great Britain.

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

To listen to or request a copy of this leaflet in Braille, large print, or audio, please call 0800 198 5000 (free of charge).

Please be ready to give the following information when you call:

Product name: Nuvaxovid XBB.1.5 dispersion for injection

Reference number: PLGB 54180/0003

This is a service provided by the Royal National Institute of Blind people.

Novavax, Inc
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Address
21 Firstfield Road, Gaithersburg, Maryland, 20878, USA
Telephone
+1 240-268-2000
Fax
+1 240-268-2100
Medical Information Direct Line
+44 020 3514 1838
Medical Information Website
novavaxmedinfo.com
Customer Care direct line
+44 020 3514 1838
WWW
www.Novavax.com
WWW
www.novavaxcovidvaccine.com