This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 54180/0002.
Nuvaxovid dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted)
Nuvaxovid 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.
1. What Nuvaxovid is and what it is used for
2. What you need to know before you receive Nuvaxovid
3. How Nuvaxovid is given
4. Possible side effects
5. How to store Nuvaxovid
6. Contents of the pack and other information
Nuvaxovid is a vaccine used to prevent COVID-19 caused by the SARS-CoV-2 virus.
Nuvaxovid 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.
Talk to your doctor, pharmacist, or nurse before you are given Nuvaxovid if:
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.
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.
Nuvaxovid is not recommended for children aged below 12 years. Currently, there is no information available on the use of Nuvaxovid in children younger than 12 years of age.
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines or vaccines.
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.
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, 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.
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’.
Individuals 12 years of age and older
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.
A booster dose of Nuvaxovid may be given approximately 6 months after the second dose in individuals 18 years of age and older.
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.
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:
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):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Not known (cannot be estimated from available data):
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.
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.
Not all pack sizes may be marketed.
This leaflet was last revised in June 2023 .
This vaccine has been given ‘conditional approval’. This means that there is more evidence to come about this vaccine. New information on this vaccine will be reviewed at least every year and this leaf-let will be updated as necessary.
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 dispersion for injection
Reference number: PLGB 54180/0002
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