Spikevax bivalent original/Omicron BA.4-5

Package leaflet: Information for the user

Spikevax bivalent Original/Omicron BA.4-5

(50 micrograms/50 micrograms)/mL dispersion for injectable suspension
Spikevax bivalent Original/Omicron BA.4-5
25 micrograms/25 micrograms dispersion for injectable suspension
Spikevax bivalent Original/Omicron BA.4-5
25 micrograms/25 micrograms injectable dispersion in pre-filled syringe
COVID-19 mRNA vaccine
elasomeran/ davesomeran
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 all of this leaflet carefully before you are given this vaccine because 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 get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

What is in this leaflet

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

1. What is Spikevax bivalent Original/Omicron BA.4-5 and what is it used for

Spikevax bivalent Original/Omicron BA.4-5 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 months and older.
The active substance in Spikevax bivalent Original/Omicron BA.4-5 is mRNA encoding the spike protein of SARS-CoV-2.
The mRNA is encapsulated in lipid nanoparticles (SM-102).
Since Spikevax bivalent Original/Omicron BA.4-5 does not contain the virus itself, it cannot cause COVID-19.
How the vaccine works
Spikevax bivalent Original/Omicron BA.4-5 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.4-5 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 should know before receiving Spikevax bivalent Original/Omicron BA.4-5

Do not receive this vaccine 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.4-5 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 tract infection such as a cold
• you have a serious illness
• you suffer from injection-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 within 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 attention if such symptoms occur.
If you fall under any of the conditions described above (or if you have any doubts), consult your
doctor, pharmacist, or nurse before receiving Spikevax bivalent Original/Omicron BA.4-5.
Recurrence of capillary leak syndrome (CLS)
Cases of recurrence of capillary leak syndrome have been reported following vaccination with
Spikevax (original). This condition causes leakage of fluid from small blood vessels (capillaries),
leading to rapid swelling of the arms and legs, sudden weight gain, feeling faint, and low blood pressure.
If you have previously experienced episodes of CLS, consult your doctor before administration of
Spikevax bivalent Original/Omicron BA.4-5.
Duration of protection
As with any vaccine, the third dose of Spikevax bivalent Original/Omicron BA.4-5 may not fully
protect everyone who receives it, and the duration of protection is not known.
Children
Spikevax bivalent Original/Omicron BA.4-5 is not recommended for children under 6 months of age.
Other medicines and Spikevax bivalent Original/Omicron BA.4-5
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. Spikevax bivalent Original/Omicron BA.4-5 may affect how other medicines work, and
other medicines may affect how Spikevax bivalent Original/Omicron BA.4-5 works.
Immunocompromised individuals
The effectiveness of Spikevax bivalent Original/Omicron BA.4-5 may be reduced in people who are
immunocompromised. In such cases, you should continue to take physical precautions to help
prevent COVID-19. Where appropriate, your close contacts should also be vaccinated. Talk to your
doctor about 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.4-5 during pregnancy
are not yet available. However, extensive data from women vaccinated with Spikevax (original)
during the second and third trimesters of pregnancy have shown no negative effects on pregnancy or
the newborn. Although data on effects during pregnancy or on the newborn following vaccination
during the first trimester are limited, no increased risk of spontaneous abortions has been observed.
Since the differences between the two products concern only the spike protein in the vaccine and no
clinically significant differences exist, Spikevax bivalent Original/Omicron BA.4-5 may be used during
pregnancy.
Data on the use of Spikevax bivalent Original/Omicron BA.4-5 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.4-5 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.4-5 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.4-5 is administered

Table 1. Dosage of Spikevax bivalent Original/Omicron BA.4-5

* Do not use the single-dose vial or the pre-filled syringe to administer a partial volume
of 0.25 mL.
Table 2. Dosage regimen of Spikevax bivalent Original/Omicron BA.4-5 in immunocompromised individuals

* Do not use the single-dose vial or pre-filled syringe to administer a partial volume of 0.25 mL.
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 monitor you for at least 15 minutes to observe for any signs of an allergic reaction.
If you have any doubts about the use of this vaccine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everyone experiences them.
Seek urgent medical advice if you experience any of the following signs and symptoms of an allergic reaction:

• feeling faint or dizzy;
• changes in heart rate;
• 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 any other side effect occurs. 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
• drowsiness (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 lumps (hives) (may appear immediately after injection and up to approximately two weeks after injection)

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

• temporary paralysis on one side of the face (Bell’s palsy)
• facial swelling (facial swelling may occur in individuals who have previously received cosmetic facial injections)
• decreased sense of touch or sensitivity
• unusual skin sensations, 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 causing 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 centre surrounded by lighter red rings (erythema multiforme)
• extensive swelling of the vaccinated limb
• heavy menstrual bleeding (most cases were mild 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 listed 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.4-5

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 date, 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Spikevax bivalent Original/Omicron BA.4-5 contains
Table 3. 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 SARS-CoV-2 (original) viral spike (S) protein.
Davesomeran 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 viral spike (S) protein of SARS-CoV-2 Omicron variants BA.4 and BA.5. The S proteins of SARS-CoV-2 Omicron variants BA.4 and BA.5 are identical.
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 the appearance of Spikevax bivalent Original/Omicron BA.4-5 and contents of the pack
Spikevax bivalent Original/Omicron BA.4-5 (50 micrograms/50 micrograms)/mL dispersion for injectable preparation
Spikevax bivalent Original/Omicron BA.4-5 is a white to off-white dispersion supplied in a multidose glass vial with a rubber stopper and a removable blue plastic cap sealed with an aluminium seal.
Pack size: 10 multidose vials. Each vial contains 2.5 mL.

Spikevax bivalent Original/Omicron BA.4-5 25 micrograms/25 micrograms dispersion for injectable preparation
Spikevax bivalent Original/Omicron BA.4-5 is a white to off-white dispersion supplied in a single-dose glass vial with a rubber stopper and a removable blue plastic cap sealed with an aluminium seal.
Pack size: 10 single-dose vials. Each vial contains 0.5 mL.

Spikevax bivalent Original/Omicron BA.4-5 25 micrograms/25 micrograms injectable dispersion in pre-filled syringe
Spikevax bivalent Original/Omicron BA.4-5 is a white to off-white dispersion supplied in a pre-filled syringe (cyclic olefinic 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 Authorisation 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

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 Authorisation 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 European Medicines Agency website, https://www.ema.europa.eu.
This leaflet is available in all European Union/European Economic Area languages 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 documented.

Spikevax bivalent Original/Omicron BA.4-5 (50 micrograms/50 micrograms)/mL dispersion for injectable suspension (multi-dose vials with blue removable closure cap)

Spikevax bivalent Original/Omicron BA.4-5 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.4-5 is a dispersion that ranges from white to off-white. It may contain white or translucent particles related to the product. Do not administer the vaccine if discoloration or foreign particulate matter is present.

Vials are stored frozen at a temperature between -50 ºC and -15 ºC.
Each multi-dose vial allows withdrawal of five (5) doses (each 0.5 mL) or up to ten (10) doses (each 0.25 mL).

It is recommended to puncture the stopper at a different site each time.

Check that the vial has a blue removable closure cap and that the product name is Spikevax bivalent Original/Omicron BA.4-5. If the vial has a blue removable closure cap and the product name is Spikevax 0.1 mg/mL or Spikevax bivalent Original/Omicron BA.1, please refer to the Summary of Product Characteristics for that formulation.

Thaw each multi-dose vial before use according to the instructions provided below (Table 4).

Table 4. Instructions for thawing multi-dose vials prior to use

Spikevax bivalent Original/Omicron BA.4-5 25 micrograms/25 micrograms dispersion for
injectable preparation (single-dose vial).
Once thawed, the vaccine is ready for use.
Do not shake or dilute. Gently swirl the vial after thawing and before withdrawal.
Check that the vial has a blue removable cap and that the product name is Spikevax bivalent Original/Omicron BA.4-5. If the vial has a blue removable cap and the product name is Spikevax bivalent Original/Omicron BA.1, please refer to the summary of product characteristics for that formulation.
Thaw each single-dose vial before use according to the instructions provided below.
Each single-dose vial or the entire box containing 10 vials may be thawed in a refrigerator or at room temperature (Table 5).
Table 5. Instructions for thawing single-dose vials and boxes before use

Spikevax bivalent Original/Omicron BA.4-5 25 micrograms/25 micrograms injectable dispersion
in a 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.4-5 is supplied in a single-dose pre-filled syringe (without
needle) containing 0.5 mL (25 micrograms of elasomeran and 25 micrograms of davesomeran) of
mRNA and must be thawed before 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 following instructions. The syringes
may be thawed in their blisters (each blister contains 2 pre-filled syringes) or in the carton
itself, in a refrigerator or at room temperature (Table 6).
Table 6. Instructions for thawing pre-filled syringes of Spikevax bivalent
Original/Omicron BA.4-5 and cartons before use

Check that the product name on the prefilled syringe is Spikevax bivalent Original/Omicron
BA.4-5. If the product name is Spikevax 50 micrograms, 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 bivalent Original/Omicron BA.4-5 is a white to off-white dispersion. It may contain white or translucent product-related particles. Do not administer the vaccine if it shows discoloration 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 smaller needles).
• Remove the closure cap vertically by rotating it 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 turning it clockwise until it is securely fixed to the syringe.
• Remove the needle cap when ready for administration.
• Administer the entire dose intramuscularly.
• After thawing, do not refreeze.

Disposal
Any unused medicine and waste material derived from this medicine must be disposed of in accordance with
local applicable regulations.
Dosage and schedule
Table 7. Dosage of Spikevax bivalent Original/Omicron BA.4-5

* Do not use the single-dose vial or the pre-filled syringe to administer a partial volume
of 0.25 mL.
Table 8. Dosage of Spikevax bivalent Original/Omicron BA.4-5 in immunocompromised individuals

* Do not use the single-dose vial or the pre-filled syringe to administer a partial volume of 0.25 mL.
As with all injectable vaccines, medical supervision and appropriate medical treatments must always be readily available in case of an anaphylactic reaction following administration of Spikevax bivalent Original/Omicron BA.4-5.
Vaccinated individuals must be kept under observation 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 should be administered at separate injection sites.
Spikevax bivalent Original/Omicron BA.4-5 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 inject this vaccine intravascularly, subcutaneously, or intradermally.

Multi-dose vials

Pre-filled syringes
Use a sterile needle of appropriate size for intramuscular injection (21 gauge or finer).
Remove the closure cap vertically by rotating it counterclockwise until it detaches. Remove the closure cap with a slow, steady motion. Do not pull on the closure cap while rotating it. Attach the needle by turning it clockwise until it is securely fixed to the syringe. Remove the needle cap when ready for administration. Administer the entire dose intramuscularly. Dispose of the syringe after use. For single use only.