Spikevax (ex COVID-19 Vaccine Moderna)

Package leaflet: Information for the user

Spikevax 0.2 mg/mL dispersion for injectable suspension

Spikevax 0.1 mg/mL dispersion for injectable suspension
Spikevax 50 micrograms injectable suspension in pre-filled syringe
mRNA COVID-19 vaccine
elasomeran
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any suspected adverse reactions you experience while receiving this medicine. See the end of section 4 for information on how to report adverse reactions.
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 experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Spikevax is and what it is used for
2. What you need to know before receiving Spikevax
3. How Spikevax is administered
4. Possible adverse reactions
5. How to store Spikevax
6. Contents of the pack and other information

1. What Spikevax is and what it is used for

Spikevax 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 of Spikevax is mRNA encoding the spike protein of SARS-CoV-2. The mRNA is encapsulated within lipid nanoparticles SM-102.

Since Spikevax does not contain the virus, it cannot cause COVID-19.
How the vaccine works
Spikevax 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
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

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 if:

• you have previously had a severe, potentially life-threatening allergic reaction after any other vaccine injection or after administration of Spikevax.
• 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 be vaccinated if you have a mild fever or a mild respiratory infection such as a cold.
• you suffer from a serious illness.
• you have anxiety related to injections.

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 fall into any of the above conditions (or if you have any doubts), consult your doctor, pharmacist, or nurse before receiving Spikevax.
Recurrence of capillary leak syndrome (CLS)
Cases of recurrence of capillary leak syndrome have been reported following vaccination with Spikevax. 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 receiving Spikevax.
Duration of protection
As with any vaccine, the primary vaccination course of 2 doses of Spikevax may not fully protect all individuals who receive it, and the duration of protection is not known.
Children
Spikevax is not recommended for children under 6 months of age.
Other medicines and Spikevax
Inform 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. The effectiveness of Spikevax, even after a third dose, may be reduced in immunocompromised individuals.
In this case, 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. Spikevax may be used during pregnancy. A large number of data from pregnant women vaccinated with Spikevax 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.
Spikevax 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 disappeared before driving or using machinery.
Spikevax contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. How Spikevax is administered

Table 1. Dosage of Spikevax for primary series, third dose in severely immunocompromised individuals, and booster doses

* Do not use the pre-filled syringe to administer a partial volume of 0.25 mL.
† For the primary vaccination series in individuals aged 12 years and older, the vial with the 0.2 mg/mL dosage strength must be used.
‡ For the third dose in severely immunocompromised individuals aged 12 years and older, the vial with the 0.2 mg/mL dosage strength must be used.
If you miss your appointment for the 2 nd dose of the primary vaccination series with Spikevax

• If you miss your appointment, schedule a new appointment with your doctor, pharmacist, or nurse as soon as possible.
• If you miss the scheduled injection, protection against COVID-19 may be incomplete.

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 questions 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 everyone gets 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 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 effects. 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 very 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, raised lumps on the skin (hives) (which may appear shortly after injection and up to about 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 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-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, tell 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

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 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 package leaflet.
Do not dispose of medicines 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 contains
Table 2. 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).
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 the appearance of Spikevax and contents of the pack
Spikevax 0.2 mg/mL dispersion for injectable suspension
Spikevax is a white to off-white dispersion, supplied in a 5 mL glass vial with a rubber stopper and a removable red plastic cap secured with an aluminum seal.
Pack: 10 multidose vials
Spikevax 0.1 mg/mL dispersion for injectable suspension
Spikevax is a white to off-white dispersion, supplied in a 2.5 mL glass vial with a rubber stopper and a removable blue plastic cap secured with an aluminum seal.
Pack size: 10 multidose vials.
Spikevax 50 micrograms injectable dispersion in pre-filled syringe
Spikevax is a white to off-white dispersion, supplied in a pre-filled syringe (cyclic olefin polymer) with a plunger stopper and a closure cap (without needle).
The pre-filled syringe is packed 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
For multidose vials
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

For pre-filled syringes
Rovi Pharma Industrial Services, S.A.
Calle Julián Camarillo n°35
28037 Madrid
Spain

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 website of the European Medicines Agency.

The following information is intended for healthcare professionals only:

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

Storage and preparation for administration
Spikevax 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 is a white to off-white dispersion. It may contain product-related white or translucent particles. Do not administer the vaccine if discoloration is observed or if it contains any foreign particulate matter.

Store vials and pre-filled syringes in a freezer at a temperature between -50 °C and -15 °C.
Keep the vial and pre-filled syringe in their outer packaging to protect the medicinal product from light.

Spikevax 0.2 mg/mL dispersion for injectable preparation (multi-dose vials with red removable closure cap)
Each multi-dose vial allows for the withdrawal of up to ten (10) doses (each 0.5 mL) or up to twenty (20) doses (each 0.25 mL).
It is recommended to puncture the stopper at a different site each time. Do not puncture the multi-dose vial with red removable closure cap more than 20 times.
Ensure that the vial has a red removable closure cap and that the product name is Spikevax 0.2 mg/mL. If the vial has a blue removable closure cap and the product name is Spikevax bivalent Original/Omicron BA.1 or Spikevax bivalent Original/Omicron BA.4-5, please refer to the Summary of Product Characteristics for that formulation.

Thaw each multi-dose vial prior to use according to the instructions provided below (Table 3).
Table 3. Instructions for thawing multi-dose vials prior to use

Spikevax 0.1 mg/mL dispersion for injection (multi-dose vials with removable blue closure cap)
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 pierce the stopper at a different point each time.
Ensure that the vial has a removable blue closure cap and that the product name is Spikevax 0.1 mg/mL. If the vial has a removable blue closure cap and the product name is Spikevax bivalent Original/Omicron BA.1 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 provided below (Table 4).
Table 4. Instructions for thawing multi-dose vials prior to use

Spikevax 50 micrograms dispersion for injection in a prefilled syringe
Do not shake or dilute the contents of the prefilled syringe.
Each prefilled 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 prefilled syringe. Do not use the prefilled syringe to deliver a partial volume of 0.25 mL.
Spikevax is supplied in a single-dose prefilled syringe (without needle) containing 0.5 mL (50 micrograms) 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 prefilled syringe before use according to the instructions below. The syringes may be thawed in their blisters (each blister contains 2 prefilled syringes) or in the carton, either in a refrigerator or at room temperature (Table 5).
Table 5. Instructions for thawing prefilled syringes and cartons before use

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

• Do not shake.
• The pre-filled syringe should be inspected visually for the presence of particles and discoloration before administration.
• Spikevax is a dispersion that ranges from white to off-white in color. It may contain white or translucent particles related to the product. Do not administer the vaccine if it shows discoloration or contains any foreign particulate matter.
• Needles are not included in the boxes of pre-filled syringes.
• Use a sterile needle of appropriate size for intramuscular injection (21 gauge or finer needles).
• 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 screwing it clockwise until firmly secured to the syringe.
• Remove the needle cap when ready for administration.
• Administer the entire dose intramuscularly.
• Do not re-freeze after thawing.

Disposal
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.
Dosage and schedule
Table 6. Dosage of Spikevax for primary series, third dose in severely immunocompromised individuals, and booster doses
Vaccination Spikevax 0.2 mg/mL Spikevax 0.1 mg/mL
dispersion for injectable dispersion for injectable
preparation preparation and Spikevax
50 micrograms dispersion
for injectable preparation
in pre-filled syringe*
Primary series Individuals aged 12 years and older Not applicable†
To complete the vaccination two injections of 0.5 mL
series, it is recommended to
receive the second dose of the
same vaccine 28 days after the
first dose.
Children aged 6 to 11 years Children aged 6 to 11 years
two injections of 0.25 mL two injections of 0.5 mL
Not applicable Children aged 6 months to 5 years
two injections of 0.25 mL*
Third dose in severely
immunocompromised
individuals
at least 1 month after the second
dose
Individuals aged 12 years and older Not applicable‡
0.5 mL
Children aged 6 to 11 years Children aged 6 to 11 years
0.25 mL 0.5 mL

* Do not use the pre-filled syringe to administer a partial volume of 0.25 mL.
† For the primary series in individuals aged 12 years and older, the vial with the 0.2 mg/mL dosage strength must be used.
For the third dose in severely immunocompromised individuals aged 12 years and older, the vial with the 0.2 mg/mL dosage strength must be used.
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.
Vaccinated individuals must remain under observation by a healthcare provider 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 should be administered at separate injection sites.
Spikevax must not be mixed in the same syringe with other vaccines or medicinal products.

Administration
The vaccine must be administered by intramuscular injection. The preferred site is the deltoid region of the arm or, in young children, the anterolateral thigh. 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 screwing it on clockwise until firmly secured to the syringe. Remove the needle cap when ready to administer. Administer the entire dose intramuscularly. Dispose of the syringe after use. For single use only.