SPIKEVAX, DISPERSIBLE INJECTABLE SUSPENSION

Introduction

Package Leaflet: Information for the User

Spikevax 0.2 mg/ml injectable dispersion

Spikevax 0.1 mg/ml injectable dispersion

Spikevax 50 micrograms injectable dispersion in pre-filled syringe

COVID-19 mRNA Vaccine

Elasomeran

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will include information on 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.

Contents of the pack

1. What is Spikevax and what is it used for
2. What you need to know before you receive Spikevax
3. How Spikevax is administered
4. Possible side effects
5. Storage of Spikevax
6. Contents of the pack and further information

1. What is Spikevax and what is it used for

Spikevax is a vaccine used to prevent COVID-19 caused by the SARS-CoV-2 virus. It is administered to adults and children from 6 months of age and older. The active substance of Spikevax is mRNA that encodes the spike protein of SARS-CoV-2. The mRNA is encapsulated in lipid nanoparticles SM-102.

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

How the vaccine works

Spikevax stimulates the body's natural defenses (immune system). The vaccine works by having the body produce protection (antibodies) against the virus that causes COVID-19.

Spikevax uses a substance called messenger ribonucleic acid (mRNA) to carry instructions that the body's cells can use to produce the spike protein that is also found on the virus. The cells then produce antibodies against the spike protein to help fight the virus. This will help protect you against COVID-19.

2. What you need to know before you receive Spikevax

The vaccine must not be administered ifyou are allergic to the active substance or to any of the other components 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, potentially life-threatening allergic reaction after any other vaccine or after receiving Spikevax in the past.
• you have a very weak or damaged immune system.
• you have ever fainted after any injection with a needle.
• you have a bleeding disorder.
• you have a high fever or severe infection; however, you can be vaccinated if you have a mild fever or an upper respiratory tract infection such as a cold.
• you have any serious illness.
• you have injection-related anxiety.

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

These disorders can occur within a few days of vaccination and have mainly occurred within 14 days. They have been observed more frequently in young males and, more frequently, after the second dose of vaccination than after the first.

Most cases of myocarditis and pericarditis have recovered. Some of the cases required intensive care and fatal cases have been observed.

After vaccination, you should be alert to the signs of myocarditis and pericarditis, such as difficulty breathing, palpitations, and chest pain, and should seek immediate medical attention if they occur.

If you are in any of the above situations (or are unsure), talk to your doctor, pharmacist, or nurse before you are given Spikevax.

Exacerbations of capillary leak syndrome

Some cases of exacerbation of capillary leak syndrome (which causes fluid to leak out of small blood vessels or capillaries, resulting in rapid swelling of the arms and legs, sudden weight gain, and feeling of fainting and low blood pressure) have been reported after vaccination with Spikevax. If you have had previous episodes of capillary leak syndrome, talk to your doctor before you receive Spikevax.

Duration of protection

As with any vaccine, the third dose of Spikevax may not fully protect all people who receive it, and it is not known how long you will be protected.

Children

Spikevax is not recommended for use in children under 6 years of age.

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 how 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. However, the efficacy of Spikevax, even after the third dose, may be lower in immunocompromised individuals. In these cases, you should continue to maintain physical precautions to avoid COVID-19. Additionally, individuals close to you should be vaccinated as appropriate.

Talk to your doctor about individual recommendations.

Pregnancy and breastfeeding

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 on pregnant women vaccinated with Spikevax during the second and third trimesters has not shown negative effects on pregnancy or the newborn. Although information on the effects on pregnancy or the newborn after vaccination during the first trimester is limited, no change in the risk of spontaneous abortion has been observed.

Spikevax can be used during breastfeeding.

Driving and using machines

Do not drive or use machines if you feel unwell after vaccination. Wait until these effects have passed before driving or using machines.

Spikevax contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How Spikevax is administered

Table 1. Spikevax dosing for the initial regimen, third dose in severely immunocompromised individuals, and booster doses.

*Do not use a pre-filled syringe to administer a partial dose of 0.25 ml.

†For the initial regimen for individuals 12 years of age and older, the vial with a concentration of 0.2 mg/ml will be used.

‡For the third dose in severely immunocompromised individuals 12 years of age and older, the vial with a concentration of 0.2 mg/ml will be used.

If you miss your appointment for the 2nd dose of the initial regimen with Spikevax

• If you miss an appointment, schedule 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.

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

Aftereach injection of the vaccine, your doctor, pharmacist, or nurse will observe you for at least 15 minutesto detect 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.

Seek urgentmedical attention if you have any of the following signs and symptoms of an allergic reaction:

• feeling dizzy or faint;
• changes in heart rate;
• shortness of breath;
• wheezing;
• swelling of the lips, face, or throat;
• rash or skin eruption;
• nausea or vomiting;
• stomach pain.

Talk to your doctor or nurse if you experience any other side effect. These may include:

Very common(may affect more than 1 in 10 people):

• swelling/pain on palpation in the armpit
• decreased appetite (observed in children 6 months to 5 years)
• irritability/crying (observed in children 6 months to 5 years)
• headache
• sleepiness (observed in children 6 months to 5 years)
• nausea
• vomiting
• muscle and joint pain 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 injection)
• feeling very tired
• chills
• fever

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

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

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

• itching at the injection site
• dizziness
• stomach pain
• raised and itchy skin rash (hives) (which may appear from the time of injection to approximately two weeks after injection)

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

• temporary one-sided facial drooping (Bell's palsy)
• facial swelling (facial swelling may occur in individuals who have received facial cosmetic injections)
• decreased sensation or pain on palpation of the skin
• unusual sensation in the skin, such as tingling (paresthesia)

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

• inflammation of the heart muscle (myocarditis) or inflammation of the outer lining of the heart (pericarditis) that may lead to difficulty breathing, palpitations, or chest pain.

Frequency not known

• severe allergic reactions with difficulty breathing (anaphylaxis)
• allergic reaction with increased pain on palpation or intolerance of the immune system (hypersensitivity)
• a skin reaction that causes red spots or patches on the skin, which may look like a target or "bull's-eye" with a dark red center surrounded by lighter red rings (erythema multiforme).
• extensive swelling of the vaccinated limb
• heavy menstrual bleeding (most cases were of moderate and temporary nature)
• rash caused by an external stimulus such as strong friction, scratching, or pressure on the skin (mechanical urticaria)
• raised and itchy skin rash lasting more than six weeks (chronic urticaria)

Reporting of side effects

If you experience side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this vaccine.

5. Storage of 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 is the last day of the month shown.

Information on storage, expiry, and handling is described in the section for healthcare professionals at the end of the leaflet.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Spikevax

Table 2. Composition of each container type

Elasomeran is a single-stranded messenger RNA (mRNA) with a 5' cap produced by in vitro transcription from the corresponding DNA templates, which encodes the viral spike (S) protein of SARS-CoV-2 (original).

The other components 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, and water for injectable preparations.

Appearance of the product and container content

Spikevax 0.2 mg/ml injectable suspension

Spikevax is a white to off-white suspension supplied in a 5 ml glass vial with a rubber stopper and a removable plastic cap with a red aluminum seal.

Container size: 10 multidose vials

Spikevax 0.1 mg/ml injectable suspension

Spikevax is a white to off-white suspension supplied in a 2.5 ml glass vial with a rubber stopper and a removable plastic cap with a blue aluminum seal.

Container size: 10 multidose vials

Spikevax 50 micrograms injectable suspension in pre-filled syringe

Spikevax is a white to off-white suspension supplied in a pre-filled syringe (cyclic olefin polymer) with a plunger stopper and a pointed cap (without needle).

The pre-filled syringes are packaged in 5 transparent blisters with 2 pre-filled syringes each.

Container size: 10 pre-filled syringes

Marketing authorization holder

MODERNA BIOTECH SPAIN, S.L.

C/ Julián Camarillo nº 31

28037 Madrid

Spain

Manufacturers

Of the multidose vials

Rovi Pharma Industrial Services, S.A.

Paseo de Europa, 50

1. San Sebastián de los Reyes

Madrid

Spain

Recipharm Monts

18 Rue de Montbazon

Monts, France 37260

Moderna Biotech Spain, S.L.

C/ Julián Camarillo nº 31

28037 Madrid

Spain

Of the pre-filled syringe

Rovi Pharma Industrial Services, S.A.

Calle Julián Camarillo n.° 35

28037 Madrid,

Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

Date of the last revision of this prospectus:

Scan the code with a mobile device to obtain the prospectus in different languages.

Or visit the URL https://www.ModernaCovid19Global.com

Detailed information about this vaccine is available on the European Medicines Agency website: https://www.ema.europa.eu.

The prospectus can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.

This information is intended only for healthcare professionals:

Traceability

In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product must be clearly recorded.

Storage and preparation for administration

Spikevax must be administered by a qualified healthcare professional.

The vaccine is ready to use once thawed.

Do not shake or dilute.

The vaccine must be visually inspected for particles and color changes before administration.

Spikevax is a white to off-white suspension. It may contain white or translucent particles related to the product. Do not administer if the vaccine has changed color or contains other particles.

Store vials and pre-filled syringes in a freezer between -50 °C and -15 °C.

Store the vial and pre-filled syringe in the outer packaging to protect it from light.

Spikevax 0.2 mg/ml injectable suspension (multidose vials with removable red cap)

Up to ten (10) doses (of 0.5 ml each) or a maximum of twenty (20) doses (of 0.25 ml each) can be extracted from each vial.

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

Check that the vial has a removable red cap and that the product name is Spikevax 0.2 mg/ml. If the vial has a removable blue cap and the product name is Spikevax bivalent Original/Omicron BA.1 or Spikevax bivalent Original/Omicron BA.4-5, consult the technical data sheet for that formulation.

Thaw each multidose vial before use by following the instructions below (Table 3).

Table 3. Instructions for thawing multidose vials before use

Spikevax 0.1 mg/ml injectable suspension (multidose vials with removable blue cap)

Up to five (5) doses (of 0.5 ml each) or a maximum of ten (10) doses (of 0.25 ml each) can be extracted from each vial.

Puncture the stopper preferably at a different site each time.

Check that the vial has a removable blue cap and that the product name is Spikevax 0.1 mg/ml. If the vial has a removable blue cap and the product name is Spikevax bivalent Original/Omicron BA.1 or Spikevax bivalent Original/Omicron BA.4-5, consult the technical data sheet for that formulation.

Thaw each multidose vial before use by following the instructions below (Table 4).

Table 4. Instructions for thawing multidose vials before use

Spikevax 50 micrograms injectable suspension in pre-filled syringe

Do not shake or dissolve the contents of the pre-filled syringe.

Each pre-filled syringe is for single use. The vaccine comes ready to use once thawed.

One (1) dose of 0.5 ml can be administered from each pre-filled syringe. Do not use a pre-filled syringe to administer a partial dose of 0.25 ml.

Spikevax is supplied in a pre-filled syringe (without needle) containing 0.5 ml (50 micrograms) of mRNA, which must be thawed before administration.

During storage, minimize exposure to ambient light and avoid direct sunlight and ultraviolet light.

Thaw each pre-filled syringe before use by following the instructions below. The syringes can be thawed in the blisters (each blister contains 2 pre-filled syringes) or in the box, either in the refrigerator or at room temperature (Table 5).

Table 5. Instructions for thawing pre-filled syringes and boxes before use

Check that the product name on the pre-filled syringe is Spikevax bivalent Original/Omicron BA.1. If the product name is Spikevax 50 or Spikevax bivalent Original/Omicron BA.4-5, consult the technical data sheet for that formulation.

Instructions for handling pre-filled syringes

• Do not shake.
• Each pre-filled syringe must be visually inspected for particles and color changes before administration.
• Spikevax bivalent Original/Omicron BA.1 is a white to off-white suspension. It may contain white or translucent particles related to the product. Do not administer if the vaccine has changed color or contains other particles.
• Needles are not included in the pre-filled syringe boxes.
• Use a sterile needle of the appropriate size for intramuscular injection (21-gauge or finer needles).
• To remove the pointed cap, place it in a vertical position and turn it counterclockwise until it comes off. Remove the cap with a slow and continuous motion. Do not pull it while turning.
• Place the needle by turning it clockwise until the needle is firmly attached to the syringe.
• Remove the needle cap when ready for administration.
• Administer the complete dose by intramuscular route.
• Once thawed, do not re-freeze.

Disposal

Disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Dosage and schedule

Table 6. Dosage of Spikevax for the initial regimen, third dose in severely immunocompromised individuals, and booster doses

• Do not use a pre-filled syringe to administer a partial dose of 0.25 ml.

† For the initial regimen for individuals 12 years and older, the vial with a concentration of 0.2 mg/ml will be used.

‡ For the third dose in severely immunocompromised individuals 12 years and older, the vial with a concentration of 0.2 mg/ml will be used.

As with all injectable vaccines, adequate medical treatment and supervision should always be available in case of anaphylactic reaction after administration of Spikevax.

Individuals will remain under observation by a healthcare professional for at least 15 minutes after vaccination.

The high-dose tetravalent flu vaccine can be administered with Spikevax. Spikevax should not be mixed with other vaccines or medications in the same syringe.

Administration

The vaccine must be administered by intramuscular route. The preferred site is the deltoid muscle of the arm or, in infants and young children, the anterolateral aspect of the thigh. Do not administer this vaccine by intravascular, subcutaneous, or intradermal route.

ca.

Multidose vials

Pre-filled syringes

Use a sterile needle of the appropriate size for intramuscular injection (21 gauge or finer). To remove the pointed cap, place it in a vertical position and turn it counterclockwise until it comes off. Remove the cap with a slow and continuous motion. Do not pull it while turning. Place the needle by turning it clockwise until the needle fits firmly into the syringe. Uncover the needle when ready for administration. Administer the complete dose by intramuscular route. Discard the syringe after use. For single use only