Spikevax LP.8.1

Package leaflet: Information for the user

Spikevax LP.8.1 0.1 mg/mL dispersion for injectable suspension, 50 micrograms injectable dispersion in pre-filled syringe, 25 micrograms injectable dispersion in pre-filled syringe

Anti-COVID-19 mRNA vaccine
This medicine 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 LP.8.1 is and what it is used for
2. What you need to know before receiving Spikevax LP.8.1
3. How Spikevax LP.8.1 is administered
4. Possible side effects
5. How to store Spikevax LP.8.1
6. Contents of the pack and other information

1. What Spikevax LP.8.1 is and what it is used for

Spikevax LP.8.1 is a vaccine used to prevent COVID-19, a disease caused by the coronavirus SARS-CoV-2. It is administered to adults and children aged 6 months and older. The active substance of Spikevax LP.8.1 is mRNA encoding the SARS-CoV-2 spike protein. The mRNA is encapsulated in lipid nanoparticles SM-102.
Since Spikevax LP.8.1 does not contain the virus, it cannot cause COVID-19.
How the vaccine works
Spikevax LP.8.1 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 LP.8.1 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 should know before receiving Spikevax LP.8.1

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 LP.8.1 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 bleeding disorder
• you have a high fever or a serious infection; however, you may still receive the vaccination if you have a mild fever or a mild respiratory 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 occurred mainly 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 these symptoms occur.
If you fall into any of the above categories (or if you have any doubts), consult your doctor, pharmacist, or nurse before receiving Spikevax LP.8.1.

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), resulting in 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 LP.8.1.

Duration of protection
As with any vaccine, the additional dose of Spikevax LP.8.1 may not fully protect all individuals who receive it, and the duration of protection is not yet known.

Children
Spikevax LP.8.1 is not recommended for children under 6 months of age.

Other medicines and Spikevax LP.8.1
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Spikevax LP.8.1 may affect how other medicines work, and other medicines may affect how Spikevax LP.8.1 works.

Immunocompromised individuals
The effectiveness of Spikevax LP.8.1 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. Talk to your doctor about the most suitable recommendations 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 LP.8.1 during pregnancy are not yet available. However, a large amount of data from pregnant women vaccinated with Spikevax (original) during the second and third trimesters have not shown any 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 abortions has been observed. Since the differences between the two products concern only the spike protein in the vaccine and there are no clinically relevant differences, Spikevax LP.8.1 may be used during pregnancy.

Data on the use of Spikevax LP.8.1 during breastfeeding are not yet available. However, adverse effects in 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 LP.8.1 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 side effects of the vaccine have subsided before driving or using machinery.

Spikevax LP.8.1 contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. How Spikevax LP.8.1 is administered

Table 1. Dosage of Spikevax LP.8.1

• Do not use the 0.5 mL pre-filled syringe to administer a partial volume of 0.25 mL.
  Table 2. Dosage of Spikevax LP.8.1 in immunocompromised individuals

* Do not use the 0.5 mL 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 observe you for at least 15 minutes to monitor 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 can cause side effects, although not everybody gets them.
Seek urgent medical advice if you experience any of the following signs or 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 any other side effects occur. These may include:
Very common (may affect more than 1 in 10 people)

• swelling/tenderness under the arms
• reduced appetite (observed in children aged 6 months to 5 years)
• irritability/crying (observed in children aged 6 months to 5 years)
• headache
• drowsiness (observed in children aged 6 months to 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 bumps on the skin (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 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 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 centre surrounded by lighter red rings (erythema multiforme)
• extensive swelling of the vaccinated limb
• heavy menstrual bleeding (most cases were non-severe and transient in nature)
• 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 through 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 LP.8.1

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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Spikevax LP.8.1 contains
Table 3. Composition by container type

SARS-CoV-2 LP.8.1 mRNA 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, which
encodes the SARS-CoV-2 (LP.8.1) viral spike (S) protein.
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-methoxypolyethylene glycol-2000 (PEG2000-DMG), tromethamine, tromethamine
hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, water for injectable preparations.
Description of the appearance of Spikevax LP.8.1 and contents of the pack
Spikevax LP.8.1 0.1 mg/mL dispersion for injectable preparation
Spikevax LP.8.1 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 LP.8.1 50 micrograms injectable dispersion in pre-filled syringe and Spikevax LP.8.1
25 micrograms injectable dispersion in pre-filled syringe
Spikevax LP.8.1 is a white to off-white dispersion supplied in a pre-filled syringe (cyclic olefin copolymer) with a plunger stopper and a closure cap (without needle).
The pre-filled syringe is packed in a paper tray inside a carton or in 1 transparent blister containing 1 pre-filled syringe or in 5 transparent blisters, each containing 2 pre-filled syringes.
Pack sizes:
1 pre-filled syringe
10 pre-filled syringes
Not all pack sizes may be marketed.
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
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
For further information on 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 website of the European Medicines Agency.

The following information is intended exclusively for healthcare professionals:

Traceability
To improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product must be clearly recorded.
Spikevax LP.8.1 must be administered by a trained healthcare professional.
Once thawed, the vaccine is ready for use.
Do not shake or dilute.
The vaccine must be inspected visually for the presence of particles and discoloration prior to administration.
Spikevax LP.8.1 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.

Frozen vaccine
Vials are stored in a freezer at a temperature between -50 ºC and -15 ºC.
Spikevax LP.8.1 0.1 mg/mL dispersion for injectable preparation (multidose vials with removable blue closure cap)
Each multidose vial allows the 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 location each time.
Check that the vial has a removable blue closure cap and that the product name is Spikevax LP.8.1. If the vial has a removable blue closure cap but the product name is Spikevax 0.1 mg/mL, Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5, Spikevax XBB.1.5 or Spikevax JN.1, please refer to the summary of product characteristics for that specific formulation.

Thawed vaccine
The vaccine is transported and delivered either frozen or thawed. If frozen, thaw each multidose vial before use according to the instructions provided below (Table 4).
Table 4. Instructions for thawing multidose vials prior to use

If the vaccine is received at a temperature between 2°C and 8°C, it must be stored at a temperature between 2°C and 8°C.
The new expiry date at 2°C to 8°C must be indicated on the outer packaging.
During this period, transportation for up to 36 hours at a temperature between 2°C and 8°C is permitted.

Spikevax LP.8.1 50 micrograms injectable dispersion in pre-filled syringe and Spikevax LP.8.1
25 micrograms injectable dispersion 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 0.25 mL or 0.5 mL can be administered from each pre-filled syringe, depending on the syringe volume indicated on the label. Do not use the 0.5 mL pre-filled syringe to administer a 0.25 mL dose.
Spikevax LP.8.1 is supplied in a single-dose pre-filled syringe (without needle) containing either 0.25 mL (25 micrograms of SARS-CoV-2 LP.8.1 mRNA) or 0.5 mL (50 micrograms of SARS-CoV-2 LP.8.1 mRNA) and must be thawed before administration.
During storage, minimize exposure to ambient light and avoid exposure to direct sunlight and ultraviolet light.
Thawed vaccine
The vaccine is transported and delivered either frozen or thawed. If frozen, thaw each pre-filled syringe before use according to the following instructions. The syringes may be thawed in their blisters (each blister contains 1 or 2 pre-filled syringes, depending on the pack size) or within the box, in a refrigerator or at room temperature (Table 5).
Table 5. Instructions for thawing Spikevax LP.8.1 pre-filled syringes and boxes prior to use

If the vaccine is received at a temperature between 2°C and 8°C, it must be stored at a temperature between 2°C and 8°C.
The new expiry date at 2°C to 8°C must be indicated on the outer packaging.
The duration of transport for the pre-filled syringes depends on the validated transport time in the appropriate container.
Check that the product name on the pre-filled syringe is Spikevax LP.8.1. If the product name is Spikevax 50 micrograms, Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5, Spikevax XBB.1.5 or Spikevax JN.1, please refer to the Summary of Product Characteristics for that formulation.

Handling instructions for pre-filled syringes

• Do not shake.
• The pre-filled syringe should be inspected visually for particulate matter and discoloration prior to administration.
• Spikevax LP.8.1 is a white to off-white dispersion. It may contain product-related white or translucent particles. Do not administer the vaccine if discoloration or any other particulate matter is present.
• Needles are not included in the pre-filled syringe cartons.
• Use a sterile needle of appropriate size for intramuscular injection (21 gauge or finer needles).
• Remove the closure cap by turning it counterclockwise until it disengages, while holding the syringe vertically. Remove the closure cap with a slow, steady motion. Do not pull on the closure cap while rotating it.
• Attach the needle by screwing it clockwise firmly onto the syringe.
• Remove the needle cap immediately before administration.
• Administer the entire dose intramuscularly.
• Do not refreeze after thawing.

Disposal
Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.
Dosage and schedule
Table 6. Dosage of Spikevax LP.8.1

• Do not use the 0.5 mL pre-filled syringe to administer a partial volume of 0.25 mL.
  Table 7. Dosage of Spikevax LP.8.1 in immunocompromised subjects

* Do not use the 0.5 mL 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 LP.8.1.
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 (shingles) vaccine.
Different injectable vaccines must be administered at separate injection sites.
Spikevax LP.8.1 must not be mixed in the same syringe with other vaccines or medicinal products.

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 turning it counterclockwise until it disengages. 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.