Patient leaflet - Nuvaxovid
1. What Nuvaxovid is and what it is used for
Nuvaxovid is a vaccine used to prevent COVID-19 caused by the SARS-CoV-2 virus.
Nuvaxovid is given to adults 18 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
Nuvaxovid 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 if:
- you have ever had a severe or life-threatening allergic reaction after receiving any other vaccine injection or after you were given Nuvaxovid 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).
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.
As with any vaccine, the 2-dose vaccination course of Nuvaxovid may not fully protect all those who receive it and it is not known how long you will be protected.
Children and adolescents
Nuvaxovid is not recommended for children aged below 18 years. Currently, there is no information available on the use of Nuvaxovid in children younger than 18 years of age.
Other medicines and Nuvaxovid
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 listed in section 4 (Possible side effects) may temporarily reduce your ability to drive and use machines (for example, feeing 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 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 0.5 mL dose, that is to say, essentially ‘potassium-free’.
-
3. How Nuvaxovid is given
Nuvaxovid will be given to you as two separate 0.5 mL injections.
Your doctor, pharmacist, or nurse will inject the vaccine into a muscle, usually in your upper arm.
It is recommended that you receive the second dose of Nuvaxovid 3 weeks after your first dose to receive the full course of this vaccine.
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.
If you miss an appointment for your second injection of Nuvaxovid ask your doctor or nurse for advice. If you miss a scheduled injection, you may not be fully protected against COVID-19.
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)
- chills
- 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
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 national reporting system listed inand include 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
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 contains
- One dose (0.5 mL) Nuvaxovid contains 5 micrograms of SARS-CoV-2 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 are:
- Disodium hydrogen phosphate heptahydrate
- Sodium dihydrogen phosphate monohydrate
- Disodium hydrogen phosphate dihydrate
- Sodium chloride
- Polysorbate 80
- Cholesterol
- Phosphatidylcholine (including all-rac-a-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 looks like and contents of the pack
- The dispersion is colourless to slightly yellow, clear to mildly opalescent (pH 7.2).
- 5 mL of dispersion in a vial with a rubber stopper and a blue flip-off top.
- Each vial contains 10 doses of 0.5 mL
- Pack size: 10 multidose vials.
Marketing Authorisation Holder
Novavax CZ a.s.
Bohumil 138
Jevany, 28163
Czechia
Manufacturer
Novavax CZ a.s.
Bohumil 138
Jevany, 28163
Czechia
This leaflet was last revised in {DD month YYYY}.
This vaccine has been given ‘conditional approval’. This means that there is more evidence to come about this vaccine.
The European Medicines Agency will review new information on this vaccine at least every year and this leaflet will be updated as necessary.
Scan the code with a mobile device to get the package leaflet in different languages.
Or visit the URL:
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
The following information is intended for healthcare professionals only:
Administer Nuvaxovid intramuscularly, preferably into the deltoid muscle of the upper arm, as two doses, 3 weeks apart.
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 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 at 2°C to 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.
- Record the date and time of discard on the vial label. Use within 6 hours after first puncture.
Inspect the vial :
- Gently swirl the multidose vial before and in between each dose withdrawal. Do not shake.
- Each multidose 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 a maximum of ten (10) doses of 0.5 mL each 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:
- Nuvaxovid does not contain a preservative. Store the opened vial between 2°C to 25°C for up to 6 hours after first puncture.
Discard:
- Discard this vaccine if not used within 6 hours after first 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.
ANNEX IV
CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Conclusions presented by the European Medicines Agency on:
- Conditional marketing authorisation
The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.
31