Spikevax bivalent original/Omicron BA.1

Package leaflet: Information for the user

Spikevax bivalent Original/Omicron BA.1

(50 micrograms/50 micrograms)/mL dispersion for injectable suspension
Spikevax bivalent Original/Omicron BA.1
25 micrograms/25 micrograms dispersion for injectable suspension
Spikevax bivalent Original/Omicron BA.1
25 micrograms/25 micrograms injectable dispersion in pre-filled syringe
COVID-19 mRNA vaccine
elasomeran/ imelasomeran
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before receiving this vaccine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Spikevax bivalent Original/Omicron BA.1 is and what it is used for
2. What you need to know before receiving Spikevax bivalent Original/Omicron BA.1
3. How Spikevax bivalent Original/Omicron BA.1 is given
4. Possible side effects
5. How to store Spikevax bivalent Original/Omicron BA.1
6. Contents of the pack and other information

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

Spikevax bivalent Original/Omicron BA.1 is a vaccine used to prevent COVID-19, a disease caused by the SARS-CoV-2 coronavirus. It is administered to adults and children aged 6 years and older. The active substance in Spikevax bivalent Original/Omicron BA.1 is mRNA encoding the spike protein of SARS-CoV-2. The mRNA is encapsulated in lipid nanoparticles SM-102.
Spikevax bivalent Original/Omicron BA.1 is intended only for individuals who have previously received at least one primary vaccination cycle against COVID-19.
Since 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 (the immune system). The vaccine prompts 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 deliver instructions that the body's cells can use to produce the spike protein found on the virus. The cells then produce antibodies against the spike protein, helping to fight the virus. This helps protect against COVID-19.

2. What you need to know before receiving Spikevax bivalent Original/Omicron BA.1

The vaccine must not be administered if you 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 receiving Spikevax bivalent
Original/Omicron BA.1 if:

• you have previously had a severe, potentially life-threatening allergic reaction after any other vaccine injection or after administration of Spikevax (original).
• you have a very weak or compromised immune system.
• you have previously fainted after an injection with a needle.
• you have a blood clotting disorder.
• you have a high fever or a serious infection; however, you may receive vaccination if you have a mild fever or a mild respiratory infection such as a cold.
• you have a serious illness.
• you suffer from needle-related anxiety.

After vaccination with Spikevax, there is an increased risk of myocarditis (inflammation of the
heart) and pericarditis (inflammation of the outer lining of the heart) (see section 4).
These conditions may develop a few days after vaccination and have mainly occurred within 14 days.
They have been observed more frequently in young males, and more often after the
second dose than after the first dose.
Most cases of myocarditis and pericarditis resolve. Some cases have required intensive therapy, and fatal cases have been reported.
After vaccination, pay particular attention to signs of myocarditis and pericarditis, such as shortness
of breath, palpitations, and chest pain, and seek immediate medical advice if these symptoms occur.
If you have any of the conditions listed above (or if you have any doubts), consult your doctor,
pharmacist, or nurse before receiving Spikevax bivalent Original/Omicron BA.1.
Recurrence of capillary leak syndrome (CLS)
There have been reports of recurrences of capillary leak syndrome following vaccination with Spikevax (original). This condition causes leakage of fluid from small blood
vessels (capillaries), resulting in rapid swelling of the arms and legs, sudden weight gain, dizziness, and low blood pressure. If you have previously experienced episodes of CLS, consult your doctor before administration of 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 the duration of protection is not yet known.
Children
Spikevax bivalent Original/Omicron BA.1 is not recommended for children under 6 years of age.
Other medicines and Spikevax bivalent Original/Omicron BA.1
Inform 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 effectiveness of Spikevax bivalent Original/Omicron BA.1 may be reduced in
immunocompromised individuals. In such cases, you should continue to take physical precautions to help prevent COVID-19. Where appropriate, your close contacts should also be vaccinated. Discuss with your doctor the recommendations most suitable for you.
Pregnancy and breastfeeding
If you are pregnant or suspect you may be pregnant, inform your doctor, nurse, or
pharmacist before receiving this vaccine. Data on the use of
Spikevax bivalent Original/Omicron BA.1 during pregnancy are not yet available. However, extensive data from women vaccinated with Spikevax (original) during the second and third trimesters
of pregnancy have not shown negative effects on pregnancy or the newborn. Although data on effects during pregnancy or on the newborn after vaccination in the first
trimester are limited, no increased risk of spontaneous abortion has been observed. Since the differences between the two products concern only the spike protein in the vaccine, and there are no significant clinical differences, Spikevax bivalent Original/Omicron BA.1 may be
used during pregnancy.
Data on the use of Spikevax bivalent Original/Omicron BA.1
during breastfeeding are not yet available.
However, effects on breastfed infants are not expected. Data from women who breastfed after vaccination with Spikevax (original) have not
shown a risk of adverse events in breastfed infants. Spikevax bivalent
Original/Omicron BA.1 may be administered during breastfeeding.
Driving and using machines
Avoid driving or operating machinery if you do not feel well after vaccination. Wait until
any vaccine-related effects have disappeared before driving or using machinery.
Spikevax bivalent Original/Omicron BA.1 contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

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

Individuals aged 12 years and older
The dose of Spikevax bivalent Original/Omicron BA.1 is 0.5 mL administered at least 3 months after
the last previous dose of a COVID-19 vaccine.
Children aged between 6 and 11 years
The dose of Spikevax bivalent Original/Omicron BA.1 is 0.25 mL administered at least 3 months after
the last previous dose of a COVID-19 vaccine.
The doctor, pharmacist, or nurse will inject the vaccine into a muscle (intramuscular injection)
in the upper arm.
After each vaccine injection, the doctor, pharmacist, or nurse will observe you for at least 15 minutes
to monitor for any signs of allergic reaction.
If you have any doubts about the use of this vaccine, consult your doctor, pharmacist, or nurse.
Spikevax bivalent Original/Omicron BA.1 is intended exclusively for individuals who have previously received
at least one primary vaccination cycle against COVID-19.
For information on the primary vaccination cycle from the age of 6 years, please refer to the package leaflet
of Spikevax 0.2 mg/mL.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everyone experiences them.
Contact a doctor urgently if you experience any of the following signs and symptoms of an allergic reaction:

• feeling faint or dizzy;
• changes in heartbeat;
• shortness of breath;
• wheezing;
• swelling of the tongue, face or throat;
• hives or skin rash;
• nausea or vomiting;
• stomach pain.

Contact 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/tenderness under the arms
• reduced appetite (observed in children aged between 6 months and 5 years)
• irritability/crying (observed in children aged between 6 months and 5 years)
• headache
• sleepiness (observed in children aged between 6 months and 5 years)
• nausea
• vomiting
• muscle, joint pain and stiffness
• pain or swelling at the injection site
• redness at the injection site (in some cases may occur approximately 9 to 11 days after injection)
• feeling extremely tired
• chills
• fever

Common (may affect up to 1 in 10 people)

• diarrhoea
• skin rash
• skin rash or hives at the injection site (in some cases 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
• itchy skin welts (hives) (which may appear shortly after injection and up to approximately two weeks after injection)

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

• temporary paralysis of one side of the face (Bell's palsy)
• swelling of the face (facial swelling may occur in individuals who have previously received cosmetic facial injections)
• decreased sense of touch or sensitivity
• unusual sensations on the skin, such as tingling or prickling (paraesthesia)

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

• inflammation of the heart (myocarditis) or inflammation of the outer lining of the heart (pericarditis), which may cause shortness of breath, palpitations or chest pain

Frequency not known

• severe allergic reactions with breathing difficulties (anaphylaxis)
• immune system reaction causing increased sensitivity or intolerance (hypersensitivity)
• skin reaction causing 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 non-serious and transient)
• skin irritation triggered by external stimuli such as rubbing, itching or pressure on the skin (mechanical urticaria)
• itchy, raised skin rash lasting longer than six weeks (chronic urticaria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this vaccine.

5. How to store 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 stated on the label after "Exp". The expiry date refers to the last day of that month.
Information on storage, expiry, use, and handling is described in the section for healthcare professionals at the end of this leaflet.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Spikevax bivalent Original/Omicron BA.1 contains
Table 1. Composition by container type

Elasomeran is a single-stranded messenger RNA (mRNA) with 5’ capping, produced by in vitro transcription without the use of cells from the corresponding DNA templates, encoding the spike (S) viral protein of SARS-CoV-2 (original).
Imelasomeran is a single-stranded messenger RNA (mRNA) with 5’ capping, produced by in vitro transcription without the use of cells from the corresponding DNA templates, encoding a full-length, codon-optimized, pre-fusion conformation-stabilized (K983P and V984P) variant of the SARS-CoV-2 spike (S) glycoprotein (Omicron variant, BA.1).
The other components are 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-methoxy-polyethylene glycol-2000 (PEG2000-DMG), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, water for injections.

Description of appearance and contents of Spikevax bivalent Original/Omicron BA.1
Spikevax bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/mL dispersion for injectable preparation
Spikevax bivalent Original/Omicron BA.1 is a dispersion ranging from white to off-white in color, supplied in a 2.5 mL or 5 mL multidose glass vial with a rubber stopper and a removable blue plastic cap sealed with an aluminum seal.
Pack sizes:
10 multidose vials. Each vial contains 2.5 mL.
10 multidose vials. Each vial contains 5 mL.
Not all pack sizes may be marketed.

Spikevax bivalent Original/Omicron BA.1 25 micrograms/25 micrograms dispersion for injectable preparation
Spikevax bivalent Original/Omicron BA.1 is a dispersion ranging from white to off-white in color, supplied in a 0.5 mL single-dose glass vial with a rubber stopper and a removable blue plastic cap sealed with an aluminum seal.
Pack 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 ranging from white to off-white in color, supplied in a pre-filled syringe (cyclic olefin polymer) with a plunger stopper and a cap (without needle).
The pre-filled syringe is packaged in 5 transparent blisters, each containing 2 pre-filled syringes.
Pack 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
28703, 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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder.

België/Belgique/Belgien Lietuva
Tél/Tel: 0800 81 460 Tel: 88 003 1114
България Luxembourg/Luxemburg
Teл: 0800 115 4477 Tél/Tel: 800 85 499
Česká republika Magyarország
Tel: 800 050 719 Tel: 06 809 87488
Danmark Malta
Tlf.: 80 81 06 53 Tel: 8006 5066
Deutschland Nederland
Tel: 0800 100 9632 Tel: 0800 409 0001
Eesti Norge
Tel: 800 0044 702 Tlf: 800 31 401
Ελλάδα Österreich
Τηλ: 008004 4149571 Tel: 0800 909636
España Polska
Tel: 900 031 015 Tel: 800 702 406
France Portugal
Tél: 0805 54 30 16 Tel: 800 210 256
Hrvatska România
Tel: 08009614 Tel: 0800 400 625
Ireland Slovenija
Tel: 1800 800 354 Tel: 080 083082
Ísland Slovenská republika
Sími: 800 4382 Tel: 0800 191 647
Italia Suomi/Finland
Tel: 800 928 007 Puh/Tel: 0800 774198
Κύπρος Sverige
Τηλ: 80091080 Tel: 020 10 92 13
Latvija
Tel: 80 005 898

Scan with a mobile device to obtain the package leaflet in other languages.

Or visit the website https://www.ModernaCovid19Global.com
More detailed information on this vaccine is available on the website of the European Medicines Agency, https://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

The following information is intended exclusively 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.
Spikevax bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/mL dispersion for injectable suspension (multi-dose vials with removable blue cap)
Spikevax bivalent Original/Omicron BA.1 must be administered by a trained healthcare professional.
Once thawed, the vaccine is ready for use.
Do not shake or dilute.
The vaccine should be inspected visually for particulate matter and discoloration prior to administration.
Spikevax bivalent Original/Omicron BA.1 is a dispersion ranging in color from white to off-white. It may contain white or translucent particles related to the product. Do not administer the vaccine if it shows discoloration or contains foreign particulate matter.
Vials are stored frozen at a temperature between -50 ºC and -15 ºC.
From each multi-dose vial, five (5) or ten (10) doses (each 0.5 mL) can be withdrawn, depending on vial size. From each multi-dose vial, ten (10) or twenty (20) doses (each 0.25 mL) can be withdrawn, depending on vial size.
It is recommended to puncture the stopper 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, please refer to the Summary of Product Characteristics for that formulation.
Thaw each multi-dose vial before use according to the instructions below (Table 2).
Table 2. Instructions for thawing multi-dose vials prior to use

Spikevax bivalent Original/Omicron BA.1 25 micrograms/25 micrograms dispersion for
injectable preparation (single-dose vials)
Once thawed, the vaccine is ready for use.
Do not shake or dilute. Gently rotate the vial after thawing and before withdrawal. Thaw each single-dose vial before use according to the instructions provided below. Individual single-dose vials or cartons containing 10 single-dose vials may be thawed in a refrigerator or at room temperature (Table 3).
Table 3. Instructions for thawing single-dose vials and cartons before use

Spikevax bivalent Original/Omicron BA.1 25 micrograms/25 micrograms dispersion for injectable suspension in pre-filled syringe
Do not shake or dilute the contents of the pre-filled syringe.
Each pre-filled syringe is for single use only. Once thawed, the vaccine is ready for use.
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 single-dose pre-filled syringe (without needle) containing 0.5 mL (25 micrograms of elasomeran and 25 micrograms of imelasomeran) of mRNA and must be thawed prior to administration.
During storage, minimize exposure to ambient light and avoid exposure to direct sunlight and ultraviolet light.
Thaw each pre-filled syringe before use according to the instructions provided below. The syringes may be thawed either in their blisters (each blister contains 2 pre-filled syringes) or in the carton, in a refrigerator or at room temperature (Table 4).
Table 4. Instructions for thawing pre-filled syringes of Spikevax bivalent Original/Omicron BA.1 and cartons prior to use

Check that the product name on the prefilled syringe is Spikevax bivalent Original/Omicron
BA.1. If the product name is Spikevax 50 micrograms or Spikevax bivalent Original/Omicron
BA.4-5, please refer to the summary of product characteristics for that formulation.
Instructions for handling prefilled syringes

• Do not shake.
• The prefilled syringe should be inspected visually for particulate matter and discoloration prior to administration.
• Spikevax is a white to off-white dispersion. It may contain product-related white or translucent particles. Do not administer the vaccine if it is discolored or contains foreign particulate matter.
• Needles are not included in the prefilled syringe cartons.
• Use a sterile needle of appropriate size for intramuscular injection (21 gauge or finer needles).
• Remove the closure cap vertically by rotating counterclockwise until it detaches. Remove the closure cap with a slow, even motion. Do not pull on the closure cap while rotating it.
• Attach the needle by screwing it clockwise until firmly secured to the syringe.
• Remove the needle cap immediately before administration.
• Administer the entire dose intramuscularly.
• Do not refreeze after thawing.

Disposal
Unused medicine and waste material derived from this medicine must be disposed of in accordance
with local regulations.
Dosage and schedule
Subjects aged 12 years and older
The dose of Spikevax bivalent Original/Omicron BA.1 is 0.5 mL, administered at least 3 months after
the previous dose of a COVID-19 vaccine.
Children aged between 6 and 11 years
The dose of Spikevax bivalent Original/Omicron BA.1 is 0.25 mL, administered at least 3 months
after the previous dose of a COVID-19 vaccine.
As with all injectable vaccines, appropriate medical supervision and treatments must always be
immediately available in case of an anaphylactic reaction following administration of Spikevax
bivalent Original/Omicron BA.1.
Vaccinated individuals must be observed by a healthcare professional for at least 15 minutes after
vaccination.
Spikevax (all different variants) may be administered concurrently with influenza vaccines (standard and high-dose) and with the subunit herpes zoster vaccine (shingles).
Different injectable vaccines must be administered at different injection sites.
Spikevax bivalent Original/Omicron BA.1 must not be mixed in the same syringe with other
vaccines or medicines.
Administration
The vaccine must be administered intramuscularly. The preferred site is the deltoid region of the
arm. Do not administer this vaccine intravascularly, subcutaneously, or intradermally.
Multi-dose vials

Prefilled syringes
Use a sterile needle of appropriate size for intramuscular injection (21 gauge or finer).
Remove the closure cap vertically by rotating counterclockwise until it detaches. Remove the closure cap with a slow, even motion. Do not pull on the closure cap while rotating it. Attach the needle by screwing it clockwise until firmly secured to the syringe. Remove the needle cap when ready for administration. Administer the entire dose intramuscularly. Discard the syringe after use. For single use only.