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

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.

• 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.

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

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

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).

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’.

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.

• 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-α-Tocopherol)
  • Potassium dihydrogen phosphate
  • Potassium chloride
  • Sodium hydroxide (for the adjustment of pH)
  • Hydrochloric acid (for the adjustment of pH)
  • Water for Injections

• 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

10-dose vial

• 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 10 doses of 0.5 mL

Not all pack sizes may be marketed.