Spikevax (previously COVID-19 Vaccine Moderna) - patient leaflet, side effects, dosage

1. What Spikevax is and what it is used for

Spikevax is a vaccine used to prevent COVID-19 caused by SARS-CoV-2. It is given to adults and children aged 6 years and older. The active substance in Spikevax is mRNA encoding the SARS-CoV-2 Spike protein. The mRNA is embedded in SM-102 lipid nanoparticles.

As Spikevax does not contain the virus, it cannot give you COVID-19.

How the vaccine works

Spikevax stimulates the body’s natural defences (immune system). The vaccine works by causing the body to produce protection (antibodies) against the virus that causes COVID-19. Spikevax uses a substance called messenger ribonucleic acid (mRNA) to carry instructions that cells in the body can use to make the spike protein that is also on the virus. The cells then make antibodies against the spike protein to help fight off the virus. This will help to protect you against COVID-19.

2. What you need to know before you are given Spikevax

The vaccine must not be given if you are allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Spikevax if:

• – you have previously had a severe, life-threatening allergic reaction after any other vaccine injection or after you were given Spikevax in the past.

• – you have a very weak or compromised immune system

• – you have ever fainted following any needle injection.

• – you have a bleeding disorder

• – you have a high fever or severe infection; however, you can have your vaccination if you have a mild fever or upper airway infection like a cold

• – you have any serious illness

• – if you have anxiety related to injections

There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Spikevax (see section 4).

These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second dose, and more often in younger males.

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 Spikevax.

As with any vaccine, the primary 2-dose vaccination course of Spikevax may not fully protect all those who receive it and it is not known how long you will be protected.

Children

Spikevax is not recommended for children aged under 6 years.

Other medicines and Spikevax

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Spikevax may affect the way other medicines work, and other medicines may affect how Spikevax works.

Immunocompromised individuals

If you are immunocompromised, you may receive a third dose of Spikevax. The efficacy of Spikevax even after a third dose may be lower in people who are immunocompromised. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you receive this vaccine. Spikevax can be used during pregnancy. A large amount of information from pregnant women vaccinated with Spikevax during the second and third trimester have not shown negative effects on the pregnancy or the newborn baby. While information on effects on pregnancy or the newborn baby after vaccination during the first trimester is limited, no change to the risk for miscarriage has been seen.

Spikevax can be given during breastfeeding.

Driving and using machines

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.

Spikevax contains sodium

Spikevax contains less than 1 mmol (23 mg) sodium per dose and, that is to say, essentially ‘sodium-free’.

3. How you will be given Spikevax

Individuals 12 years of age and older

Spikevax will be given to you as two 0.5 mL injections.

Children 6 through 11 years of age

Spikevax will be given to you as two 0.25 mL injections.

It is recommended to get the second dose of the same vaccine 28 days after the first dose to complete the vaccination course.

If you miss an appointment for your primary 2 nddose of Spikevax

• – If you miss an appointment, arrange another visit as soon as possible with your doctor, pharmacist or nurse.

• – If you miss a scheduled injection, you may not be fully protected against COVID-19.

A booster dose (0.25 mL) of Spikevax may be given at least 3 months after the second dose in individuals 18 years of age and older.

If you are immunocompromised, you may receive a third dose (0.5 mL, 100 micrograms for individuals 12 years of age and older; 0.25 mL, 50 micrograms for children 6 through 11 years) of Spikevax at least 1 month after the second dose.

Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection) in your upper arm.

After each injection of the vaccine, your doctor, pharmacist or nurse will watch over you for at least 15 minutes to monitor for signs of an allergic reaction.

If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

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):

• – swelling/tenderness in the underarm

• – headache

• – nausea

• – vomiting

• – muscle ache, joint aches, and stiffness

• – pain or swelling at the injection site

• – redness at the injection site (some of which may occur approximately 9 to 11 days after the injection)

• – feeling very tired

• – chills

• – fever

Common (may affect up to 1 in 10 people):

• – diarrhoea

• – rash

• – rash or hives at the injection site (some of which may occur approximately 9 to 11 days after the injection)

Uncommon (may affect up to 1 in 100 people):

• – itchiness at the injection site

• – dizziness

• – stomach pain

Rare (may affect up to 1 in 1,000 people)

• – temporary one-sided facial drooping (Bell’s palsy)

• – swelling of the face (swelling of the face may occur in patients who have had facial cosmetic injections.)

• – decreased sense of touch or sensation

• – unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)

Very rare (may affect up to 1 in 10,000 people)

• – inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in breathlessness, palpitations or chest pain

Frequency unknown

• – severe allergic reactions with breathing difficulties (anaphylaxis)

• – reaction of increased sensitivity or intolerance by the immune system (hypersensitivity)

• – a skin reaction that causes red spots or patches on the skin that may look like a target or “bulls-eye” with a dark red centre surrounded by paler red rings (erythema multiforme)

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 in Appendix V. By reporting side effects you can help provide more information on the safety of this vaccine.

5. How to store Spikevax

Keep this vaccine out of the sight and reach of children.

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.

Information about storage, expiry, and use and handling are described in the section intended for healthcare professionals at the end of the package leaflet.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Spikevax contains

• – This is a multidose vial that contains 10 doses of 0.5 mL each or a maximum of 20 doses of 0.25 mL each.

• – One dose (0.5 mL) contains 100 micrograms of messenger RNA (mRNA) (embedded in SM-102 lipid nanoparticles).

• – One dose (0.25 mL) contains 50 micrograms of messenger RNA (mRNA) (embedded in SM-102 lipid nanoparticles).

• – Single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.

• – The other ingredients are lipid SM-102 (heptadecan-9-yl 8-{(2-hydroxyethyl)[6-oxo-6-(undecyloxy)he­xyl]amino}octa­noate), cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 1,2-Dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000 DMG), trometamol, trometamol hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, water for injections.

What Spikevax looks like and contents of the pack

Spikevax is a white to off white dispersion supplied in a glass vial with a rubber stopper and aluminium seal.

Pack size: 10 multidose vials

Marketing Authorisation Holder: MODERNA BIOTECH SPAIN, S.L.

Calle Monte Esquinza 30

28010 Madrid

Spain

Manufacturer:

Rovi Pharma Industrial Services, S.A.

Paseo de Europa, 50

28703. San Sebastián de los Reyes

Madrid, Spain

Recipharm Monts 18 Rue de Montbazon

Monts, France 37260

Moderna Biotech Spain S.L.

c/o Grupo Gestiona-T,

Calle Monte Esquinza 30, Madrid

28010 Madrid, Spain

For any information about this medicine, please Authorisation Holder.

België/Belgiqu­e/Belgien

Tél/Tel: 0800 81 46

Btnrapua

Ten: 00800 115 4477

Česká republika

Tel: 800 050 719

Danmark Tlf: 80 81 06 53	Malta Tel: 8006 5066
Deutschland Tel: 0800 100 9632	Nederland Tel: 0800 409 0001
Eesti Tel: 800 0044 702	Norge Tlf: 800 31 401
EUáda TnX: 008004 4149571	Österreich Tel: 0800 909636
España Tel: 900 031 015	Polska Tel: 800 702 406
France Tél: 0805 54 30 16	Portugal Tel: 800 210 256
Hrvatska Tel: 08009614	Romania Tel: 0800 400 625
Ireland Tel: 1800 800 354	Slovenija Tel: 080 083082
Ísland Sími: 800 4382	Slovenská republika Tel: 0800 191 647
Italia Tel: 800 928 007	Suomi/Finland Puh/Tel: 0800 774198
Kúnpo^ TnX:80091080	Sverige Tel: 020 10 92 13
Latvija Tel: 80 005 898	United Kingdom (Northern Ireland) Tel: 0800 085 7562

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

Detailed information on this vaccine 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:

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.

Spikevax should be administered by a trained healthcare professional.

The vaccine comes ready to use once thawed.

Do not shake or dilute.

Spikevax vials are multidose. Ten (10) doses (of 0.5 mL each) or a maximum of twenty (20) doses (of 0.25 mL each) can be withdrawn from each multidose vial.

Pierce the stopper preferably at a different site each time. Do not puncture the vial more than 20 times.

An additional overfill is included in each vial to ensure that 10 doses of 0.5 mL or a maximum of 20 doses of 0.25 mL can be delivered.

Thawed vials and filled syringes can be handled in room light conditions.

For the primary series, Spikevax should be administered as two 0.5 mL (100 microgram) doses for individuals 12 years of age and older. Spikevax should be administered as two 0.25 mL (50 microgram) doses for children 6 through 11 years of age.

It is recommended to administer the second dose 28 days after the first dose.

A third dose may be given at least 1 month after the second dose to individuals 12 years of age and older (0.5 mL, 100 micrograms) and children 6 through 11 years (0.25 mL, 50 micrograms) who are severely immunocompromised.

A booster dose (0.25 mL, 50 micrograms) of Spikevax may be given at least 3 months after a primary series in individuals 18 years of age and older.

As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in the event of an anaphylactic reaction following the administration of Spikevax.

Individuals should be observed by a healthcare professional for at least 15 minutes after vaccination.

There are no data to assess the concomitant administration of Spikevax with other vaccines. Spikevax must not be mixed with other vaccines or medicinal products in the same syringe.

The vaccine must be administered intramuscularly. The preferred site is the deltoid muscle of the upper arm. Do not administer this vaccine intravascularly, subcutaneously or intradermally.

Admin ¡strati en

Swirl vial gently after thawing and before each withdrawal-The vaccine comes ready to use once thawed. Do not shake or dilute.

Prior to injection, inspect each dose to:

Verify syringe volume.

If dosage is incorrect, or discolouration I and other particulate matter is present, do not administer the vaccine.

Confirm ¡quid is while to off-whSe in | colour in both vial and syringe

The vaccine may contain white or translucent product-related particulates.

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