SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.1 (50 micrograms/50 micrograms) per mL Injectable Dispersion

Introduction

Package Leaflet: Information for the User

Spikevax Bivalent Original/Omicron BA.1

(50 micrograms/50 micrograms)/ml dispersion for injection

Spikevax Bivalent Original/Omicron BA.1

25 micrograms/25 micrograms dispersion for injection

Spikevax Bivalent Original/Omicron BA.1

25 micrograms/25 micrograms dispersion for injection in a pre-filled syringe

COVID-19 mRNA vaccine

elasomeran/imelasomeran

This medicine is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you 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 Spikevax Bivalent Original/Omicron BA.1 is and what it is used for
2. What you need to know before you receive Spikevax Bivalent Original/Omicron BA.1
3. How Spikevax Bivalent Original/Omicron BA.1 is administered
4. Possible side effects
5. Storage of Spikevax Bivalent Original/Omicron BA.1
6. Contents of the pack and other information

1. What Spikevax Bivalent Original/Omicron BA.1 is and what it is used for

Spikevax Bivalent Original/Omicron BA.1 is a vaccine used to prevent COVID-19 caused by the SARS-CoV-2 virus. It is administered to adults and children from 6 years of age and older. The active substance of Spikevax Bivalent Original/Omicron BA.1 is mRNA that encodes the spike protein of the SARS-CoV-2 virus. The mRNA is encapsulated in lipid nanoparticles SM-102.

Spikevax Bivalent Original/Omicron BA.1 can only be administered to individuals who have previously received at least the primary vaccination against COVID-19.

Because Spikevax Bivalent Original/Omicron BA.1 does not contain the virus, it cannot cause COVID-19.

How the vaccine works

Spikevax Bivalent Original/Omicron BA.1 stimulates the body's natural defenses (immune system). The vaccine works by causing the body to produce protection (antibodies) against the virus that causes COVID-19. Spikevax Bivalent Original/Omicron BA.1 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 on the virus. Then, the cells produce antibodies against the spike protein to help fight the virus. This will help protect against COVID-19.

2. What you need to know before you receive Spikevax Bivalent Original/Omicron BA.1

The vaccine must not be administered ifyou are allergic to the active substance or any of the other components of this vaccine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you receive Spikevax Bivalent Original/Omicron BA.1 if:

• you have previously had a severe, potentially life-threatening allergic reaction after any other vaccine or after receiving Spikevax (original) in the past.
• you have a very weak or damaged immune system.
• you have 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 a few days after 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 recover. 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 receive Spikevax Bivalent Original/Omicron BA.1.

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 a feeling of fainting and low blood pressure) have been reported after vaccination with Spikevax (original). If you have had previous episodes of capillary leak syndrome, talk to your doctor before you receive Spikevax Bivalent Original/Omicron BA.1.

Duration of protection

As with any vaccine, the third dose of Spikevax Bivalent Original/Omicron BA.1 may not fully protect all individuals who receive it, and it is not known how long you will be protected.

Children

Spikevax Bivalent Original/Omicron BA.1 is not recommended for use in children under 6 years of age.

Other medicines and Spikevax Bivalent Original/Omicron BA.1

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Spikevax Bivalent Original/Omicron BA.1 may affect how other medicines work, and other medicines may affect how Spikevax Bivalent Original/Omicron BA.1 works.

Immunocompromised individuals

The efficacy of Spikevax Bivalent Original/Omicron BA.1 may be lower in immunocompromised individuals. In these cases, you should continue to maintain physical precautions to avoid COVID-19. Moreover, individuals closest to you should be vaccinated as appropriate.

Consult your doctor for 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. There is currently no data available on the use of Spikevax Bivalent Original/Omicron BA.1 during pregnancy. However, a large amount of observational data on pregnant women vaccinated with Spikevax (original) during the second and third trimesters has not shown any negative effects on pregnancy or the newborn. Although data on pregnancy outcomes after vaccination during the first trimester are currently limited, no increased risk of spontaneous abortion has been observed. Since the differences between the two products are limited to the sequence of the spike protein in the vaccine and there are no clinically relevant differences, Spikevax Bivalent Original/Omicron BA.1 can be used during pregnancy.

There is currently no data available on the use of Spikevax Bivalent Original/Omicron BA.1 during breastfeeding.

However, no effects on breastfed infants/children are expected. Data from women who were breastfeeding after vaccination with Spikevax (original) have not shown any risk of adverse effects in breastfed infants/children. Spikevax Bivalent Original/Omicron BA.1 can be administered 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 Bivalent Original/Omicron BA.1 contains sodium

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

3. How Spikevax Bivalent Original/Omicron BA.1 is administered

Individuals 12 years of age and older

The dose of Spikevax Bivalent Original/Omicron BA.1 is 0.5 ml, administered at least 3 months after the last dose received of the COVID-19 vaccine.

Children 6 to 11 years of age

The dose of Spikevax Bivalent Original/Omicron BA.1 is 0.25 ml, administered at least 3 months after the last dose received of the COVID-19 vaccine.

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

Spikevax Bivalent Original/Omicron BA.1 can only be administered to individuals who have previously received at least the primary vaccination against COVID-19.

See more information on the primary vaccination schedule for individuals 6 years and older in the package leaflet of Spikevax 0.2 mg/ml.

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 heartbeats;
• 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 axilla
• 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
• elevated 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 aesthetic injections)
• decreased sense of touch or pain on palpation of the skin
• unusual sensation in the skin, such as a tingling sensation (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 can 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)
• elevated 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 listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this vaccine.

5. Storage of Spikevax Bivalent Original/Omicron BA.1

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 use and handling is described in the section for healthcare professionals at the end of the package leaflet.

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

6. Container Contents and Additional Information

What Spikevax Bivalent Original/Omicron BA.1 Contains

Table 1. Composition of Each Container Type

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

Imelasomeran is a single-stranded messenger RNA (mRNA) with a cap at the 5' end, manufactured by in vitro transcription from the corresponding DNA templates, and which encodes for a pre-fusion stabilized complete variant (K983P and V984P) of the spike (S) protein of SARS-CoV-2 (Omicron variant, BA.1)

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, water for injectable preparations.

Appearance of Spikevax Bivalent Original/Omicron BA.1 and Container Contents

Spikevax Bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/ml injectable dispersion

Spikevax Bivalent Original/Omicron BA.1 is a dispersion of white to off-white color that is supplied in a multidose glass vial of 2.5 ml or 5 ml with a rubber stopper and a removable plastic cap of blue color with an aluminum seal.

Container size:

10 multidose vials. Each vial contains 2.5 ml.

10 multidose vials. Each vial contains 5 ml.

Only some container sizes may be marketed.

Spikevax Bivalent Original/Omicron BA.1 25 micrograms/25 micrograms injectable dispersion

Spikevax Bivalent Original/Omicron BA.1 is a dispersion of white to off-white color that is supplied in a single-dose glass vial of 0.5 ml with a rubber stopper and a removable plastic cap of blue color with an aluminum seal.

Container size: 10 single-dose vials

Spikevax Bivalent Original/Omicron BA.1 25 micrograms/25 micrograms injectable dispersion in pre-filled syringe

Spikevax Bivalent Original/Omicron BA.1 is a dispersion of white to off-white color that is 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

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

Rovi Pharma Industrial Services, S.A.

Calle Julián Camarillo n.° 35

28037 Madrid,

Spain

Patheon Italia S.p.a.

Viale G.B. Stucchi, 110

20900 Monza

Italy

Patheon Italia S.p.A.

2 Trav. SX Via Morolense 5

03013 Ferentino (FR)

Italy

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

Date of Last Revision of this Leaflet: {DD month YYYY}.

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

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

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

The leaflet 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 should be clearly recorded.

Spikevax Bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/ml injectable dispersion (multidose vials with removable blue cap)

Spikevax Bivalent Original/Omicron BA.1 should be administered by a qualified healthcare professional.

The vaccine is ready to use once thawed.

Do not shake or dilute.

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

Spikevax Bivalent Original/Omicron BA.1 is a dispersion of white to off-white color. It may contain white or translucent particles related to the product. Do not administer if the vaccine has changed color or contains other particles.

The vials should be stored in a freezer between -50 °C and -15 °C.

Five (5) or ten (10) doses (of 0.5 ml each) can be extracted from each multidose vial, depending on the vial size. Ten (10) or twenty (20) doses (of 0.25 ml each) can be extracted from each multidose vial, depending on the vial size

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

Thaw each multidose vial before use by following the instructions below (Table 2).

Table 2. Instructions for Thawing Multidose Vials Before Use

Spikevax Bivalent Original/Omicron BA.1 25 micrograms/25 micrograms injectable dispersion (single-dose vials)

The vaccine is ready to use once thawed.

Do not shake or dilute. Gently rotate the vial after thawing and before each extraction. Thaw each single-dose vial before use by following the instructions below. Each single-dose vial can be thawed separately or in the box of 10 units, either in the refrigerator or at room temperature (Table 3).

Table 3. Instructions for Thawing Single-Dose Vials and Boxes Before Use

Spikevax Bivalent Original/Omicron BA.1 25 micrograms/25 micrograms injectable dispersion 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 is ready to use once thawed.

One (1) dose of 0.5 ml can be administered from each pre-filled syringe.

Spikevax Bivalent Original/Omicron BA.1 is supplied in a pre-filled syringe (without needle) that contains 0.5 ml (25 micrograms of elasomeran and 25 micrograms of imelasomeran) of mRNA and that 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 4).

Table 4. Instructions for Thawing Pre-filled Syringes Spikevax Bivalent Original/Omicron BA.1 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 datasheet for that formulation.

Handling Instructions for Pre-filled Syringes

• Do not shake.
• Each pre-filled syringe should be inspected visually for particles and color changes before administration.
• Spikevax Bivalent Original/Omicron BA.1 is a dispersion of white to off-white color. 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 boxes of pre-filled syringes.
• Use a sterile needle of suitable size for intramuscular injection (needles of 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 movement. Do not pull it while turning it.
• Place the needle by turning it clockwise until it fits firmly into the syringe.
• Uncover the needle when ready for administration.
• Administer the complete dose by intramuscular route.
• Once thawed, do not re-freeze.

Disposal

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

Dosage and Schedule

Persons 12 years of age and older

The dose of Spikevax Bivalent Original/Omicron BA.1 is 0.5 ml, administered at least 3 months after the last dose received of the COVID-19 vaccine.

Children from 6 to 11 years of age

The dose of Spikevax Bivalent Original/Omicron BA.1 is 0.25 ml, administered at least 3 months after the last dose received of the COVID-19 vaccine.

As with all injectable vaccines, adequate medical treatment and supervision should always be available in case of anaphylactic reaction following the administration of Spikevax Bivalent Original/Omicron BA.1.

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

There are no data to evaluate the concomitant administration of Spikevax Bivalent Original/Omicron BA.1 with other vaccines. Spikevax Bivalent Original/Omicron BA.1 should not be mixed with other vaccines or medicinal products in the same syringe.

Administration

The vaccine should be administered by intramuscular route. The preferred site is the deltoid muscle of the arm. Do not administer this vaccine by intravascular, subcutaneous, or intradermal route.

Multidose Vials

Pre-filled Syringes

Use a sterile needle of suitable size for intramuscular injection (needles of 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 movement. Do not pull it while turning it. Place the needle by turning it clockwise until it fits firmly into the syringe. Uncover the needle when ready for administration. Administer the complete dose by intramuscular route. Dispose of the syringe after use. For single use.