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Patient Information Leaflet for Spikevax

Updated 20 August 2021

Package leaflet: Information for the user

Spikevax dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)

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 Spikevax is and what it is used for
2. What you need to know before you are given Spikevax
3. How Spikevax is given
4. Possible side effects
5. How to store Spikevax
6. Contents of the pack and other information

1. What Spikevax is and what it is used for

What is Spikevax

Spikevax is a vaccine used to prevent COVID-19 caused by SARS-CoV-2. It is given to adults and children aged 12 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
• have a very weak or compromised immune system
• have ever fainted following any needle injection.
• have a bleeding disorder
• 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
• have any serious illness
• have anxiety related to injections

Very rare cases of inflammation of the heart (myocarditis or pericarditis) have been reported following vaccination with Spikevax. These have happened most often in younger men and shortly after the second dose of the vaccine. Most of these cases were mild and people recovered soon after with simple treatment and rest.

It is important that you urgently seek medical attention if you experience new onset of symptoms such as chest pain, shortness of breath or feelings of having a fast-beating, fluttering, or pounding heart.

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 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 12 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..

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell your doctor, pharmacist or nurse before being vaccinated.

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

Spikevax will be given to you as two 0.5 mL injections. It is recommended to administer the second dose 28 days after the first dose to complete the vaccination course..

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

If you miss an appointment for your 2nd dose of Spikevax

• If you miss an appointment, arrange another visit as soon as possible with your doctor, nurse, or pharmacist.
• If you miss a scheduled injection, you may not be fully protected against COVID-19.

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. Most side effects go away within a few days of appearing. If side effects such as pain and/or fever are troublesome, they can be treated by medicines for pain and fever such as paracetamol.

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, tongue 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 of the underarm glands on the same side as the injection site
• Headache
• Nausea
• Vomiting
• Muscle ache, joint aches, and stiffness
• Pain or swelling at the injection site
• Feeling very tired
• Chills
• Fever

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

• Rash
• Rash, redness, or hives at the injection site (some of which may occur some time after the injection)

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

• Itchiness at the injection site

Rare (may affect up to 1 in 1000 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.)
• Dizziness
• Decreased sense of touch or sensation

Frequency unknown

• Severe allergic reactions with breathing difficulties (anaphylaxis)
• Reaction of increased sensitivity or intolerance by the immune system (hypersensitivity)
• 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. If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card reporting site 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 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 vaccine contains polyethylene glycol/macrogol (PEG) as part of PEG2000-DMG.

This is a multidose vial which contains 10 doses of 0.5 mL.

One dose (0.5 mL) contains 100 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 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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

This leaflet was last revised on 18/08/2021.

This vaccine has been given ‘conditional approval’. This means that there is more evidence to come about this vaccine.

Scan the code in the PDF of this document with a mobile device to get the package leaflet in different languages. Or visit Moderna COVID-19 Global.

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.

$A 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 can be withdrawn from each multidose vial. Pierce the stopper preferably at a different site each time.

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

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

Spikevax should be administered as two 0.5 mL doses. It is recommended to administer the second dose 28 days after the first dose.

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.

The rest of this document, including information about storage and handling, can be found in the PDF.