Patient leaflet - Spikevax XFG 50 micrograms Dispersion for injection in Pre-filled syringe
1. What Spikevax XFG is and what it is used for
Spikevax XFG is a vaccine used to prevent COVID-19 caused by SARS-CoV-2. It is given to adults and children aged 6 months and older. The active substance in the vaccine is ribonucleic acid (RNA) encoding the SARS-CoV-2 spike protein. The RNA is embedded in SM-102 lipid nanoparticles.
Spikevax XFG contains messenger ribonucleic acid (mRNA) (mRNA-1273.262) that encodes the spike protein of the XFG strain of the virus.
As Spikevax XFG does not contain the virus, it cannot give you COVID-19.
How the vaccine works
Spikevax XFG stimulates the body’s natural defences (immune system). The vaccine works by causing the body to produce protection (antibodies) against the virus that causes COVID-19. Spikevax XFG uses a substance called messenger ribonucleic acid (mRNA) to carry instructions that cells in the body can use to make the spike protein that is also on the virus. The cells then make antibodies against the spike protein to help fight off the virus. This will help to protect you against COVID-19.
2. What you need to know before you are given Spikevax XFG
The vaccine must not be given if
you are allergic to the active substance or any of the other ingredients of this vaccine (listed in
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Spikevax XFG if: - you have previously had a severe, life-threatening allergic reaction after any other vaccine
injection or after you were given Spikevax in the past
- you have a very weak or compromised immune system
- you have ever fainted following any needle injection.
- you have a bleeding disorder
you have a high fever or severe infection; however, you can have your vaccination if you have a
mild fever or upper airway infection like a cold
- you have any serious illness
- if you have anxiety related to injections
Myocarditis/pericarditis
There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Spikevax (see section 4).
These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often in younger males, and more often after the second dose compared to the first dose.
Most cases of myocarditis and pericarditis recover. Some cases required intensive care support and fatal cases have been seen.
Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Spikevax XFG.
Capillary leak syndrome (CLS) flare-ups
A few cases of capillary leak syndrome flare-ups (causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint, low blood pressure) have been reported following vaccination with Spikevax (original). If you have previously had episodes of CLS, talk to a doctor before you are given Spikevax XFG.
Duration of protection
As with any vaccine, Spikevax XFG may not fully protect all those who receive it and it is not known how long you will be protected.
Children
Spikevax XFG is not recommended for children aged under 12 years.
Other medicines and Spikevax XFG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Spikevax XFG may affect the way other medicines work, and other medicines may affect how Spikevax XFG works.
Immunocompromised individuals
The efficacy of Spikevax XFG may be lower in people who are immunocompromised. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you receive this vaccine. Spikevax can be used during pregnancy. A large amount of information from pregnant women vaccinated with Spikevax has not shown negative effects on the pregnancy or the newborn baby.
Spikevax can be given during breastfeeding.
Driving and using machines
Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines.
Spikevax XFG contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose and, that is to say, essentially ‘sodium-free’.
3. How you will be given Spikevax XFG
Spikevax XFG in pre-filled syringe can only be used for administration to individuals 12 years of age and older.
Table 1. Spikevax XFG pre-filled syringe posology
Age(s) Dose Additional recommendations
Individuals 12 years of age
and older, with or without
prior vaccination
One dose of 0.5 mL, given intramuscularly
Spikevax XFG should be
administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Individuals 65 years of age
and older
One dose of 0.5 mL, given intramuscularly
One additional dose may be
administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Table 2. Spikevax XFG pre-filled syringe posology for immunocompromised individuals
Age(s) Dose Additional recommendations
Immunocompromised
individuals 12 years of age and
older, with or without prior
vaccination
One dose of 0.5 mL, given intramuscularly
Additional doses may be
administered in severely
immunocompromised at least 2 months following the most recent dose of a COVID-19 vaccine at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances.
Your doctor, pharmacist, nurse or healthcare professional will inject the vaccine into a muscle (intramuscular injection) in your upper arm.
During and after each injection of the vaccine, your doctor, pharmacist or nurse will watch over you for at least 15 minutes to monitor for signs of an allergic reaction.
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them. Most side effects go away within a few days of appearing. If side effects such as pain and/or fever are troublesome, they can be treated by medicines for pain and fever such as paracetamol.
Get urgent medical attention if you get any of the following signs and symptoms of an allergic reaction:
- feeling faint or light-headed;
- changes in your heartbeat;
- shortness of breath;
- wheezing;
- swelling of your lips, face, tongue or throat;
- hives or rash;
- nausea or vomiting;
- stomach pain.
Talk to your doctor or nurse if you develop any other side effects. These can include:
Very common (may affect more than 1 in 10 people):
- swelling/tenderness of the underarm glands
- decreased appetite (observed in 6 month to 5 year olds)
- irritability/crying (observed in 6 month to 5 year olds)
- headache
- sleepiness (observed in 6 month to 5 year olds)
- nausea
- vomiting
- muscle ache, joint aches, 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 the
injection)
- feeling very tired
- chills
- fever
Common (may affect up to 1 in 10 people):
- diarrhoea
- rash
rash or hives at the injection site (some of which may occur approximately 9 to 11 days after the
injection)
Uncommon (may affect up to 1 in 100 people):
- itchiness at the injection site
- dizziness
- stomach pain
raised, itchy rash (urticaria) (which may occur from the time of injection and up to approximately
two weeks after the injection)
Rare (may affect up to 1 in 1,000 people)
- severe allergic reactions with breathing difficulties (anaphylaxis)
- temporary one-sided facial drooping (Bell’s palsy)
swelling of the face (swelling of the face may occur in individuals who have had facial cosmetic
injections.)
a skin reaction that causes red spots or patches on the skin that may look like a target or
“bulls-eye” with a dark red centre surrounded by paler red rings (erythema multiforme) - decreased sense of touch or sensation
- unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
Very rare (may affect up to 1 in 10,000 people)
inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart
(pericarditis) which can result in breathlessness, palpitations or chest pain
Frequency not known
- reaction of increased sensitivity or intolerance by the immune system (hypersensitivity) - heavy menstrual bleeding (most cases appeared to be non-serious and temporary in nature) - extensive swelling of the vaccinated limb
rash elicited by external stimulus such as firm stroking, scratching, or pressure to the skin
(mechanical urticaria)
- raised, itchy rash with a duration of more than six weeks (chronic urticaria)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. If you are concerned about a side effect it can be reported directly via the Coronavirus Yellow Card reporting site or search for MHRA Yellow Card in the Google Play or Apple App Store and include the vaccine brand and batch/Lot number if available. By reporting side effects you can help provide more information on the safety of this vaccine.
5. How to store Spikevax XFG
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.
Information about storage, expiry, and use and handling are described in the section intended for healthcare professionals at the end of the package leaflet.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Spikevax XFG contains
This is a pre-filled syringe that contains 1 dose of 0.5 mL.
One dose (0.5 mL) contains 50 micrograms of mRNA-1273.262, a COVID-19 mRNA Vaccine (embedded in SM-102 lipid nanoparticles).
This vaccine contains polyethylene glycol/macrogol (PEG) as part of PEG2000-DMG.
mRNA-1273.262 is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 variant XFG.
The other ingredients 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), trometamol, trometamol hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, water for injections.
What Spikevax XFG looks like and contents of the pack
Pre-filled syringe
Spikevax XFG is a white to off white dispersion supplied in a pre-filled syringe (cyclic olefin polymer) with plunger stopper and a tip cap (without needle).
The pre-filled syringe is packaged in a paperboard carton or in 1 clear blister containing 1 pre-filled syringe or 5 clear blisters containing 2 pre-filled syringes in each blister.
Pack sizes:
1 pre-filled syringe
10 pre-filled syringes
Not all pack sizes may be marketed.
Marketing Authorisation Holder
MODERNA BIOTECH SPAIN, S.L.
C/ Julián Camarillo n ° 31
28037 Madrid
Spain
Manufacturers
Rovi Pharma Industrial Services, S.A.
Paseo de Europa, 50
28703. San Sebastián de los Reyes
Madrid
Spain
Rovi Pharma Industrial Services, S.A.
Calle Julián Camarillo n°35
28037 Madrid Spain
Moderna Biotech Spain S.L.
C/ Julián Camarillo n ° 31
28037 Madrid
Spain
For any information about this medicine, please contact Medical Information telephone on 0800 085 7562.
This leaflet was last revised in September 2026.
Scan the code with a mobile device to get the package leaflet.
Or visit the URL https://www.ModernaCovid19Global.com
The following information is intended for healthcare professionals only:
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Spikevax XFG 50 micrograms dispersion for injection 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. The vaccine comes ready to use once thawed.
One (1) dose of 0.5 mL can be administered from each pre-filled syringe.
Spikevax XFG is supplied in a single-dose, pre-filled syringe (without needle) containing 0.5 mL (50 micrograms of mRNA-1273.262) and must be thawed prior to administration.
During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Thaw each pre-filled syringe before use following the instructions below. Syringes may be thawed in the blister packs (each blister containing 1 or 2 pre-filled syringes, depending on pack size) or in the carton itself, either in the refrigerator or at room temperature (Table 3).
Table 3. Thawing instructions for Spikevax XFG pre-filled syringes and cartons before use
Configuration
Thaw instructions and duration
Thaw
temperature (in a refrigerator)
(°C)
Thaw
duration
(minutes)
Thaw
temperature (at room temperature)
(°C)
Thaw duration
(minutes)
Blister or carton
containing 1 or
2 pre-filled syringes
2 – 8 100 15 – 25 40
Carton containing
10 pre-filled syringes 2 – 8 160 15 – 25 80
Verify that the product name of the pre-filled syringe is Spikevax XFG.
Handling instructions for the pre-filled syringes
- Do not shake.
- Pre-filled syringe should be inspected visually for particulate matter and discolouration prior to administration.
Spikevax XFG is a white to off-white dispersion. It may contain white or translucent product-
related particulates. Do not administer if vaccine is discoloured or contains other particulate matter.
- Needles are not included in the pre-filled syringe cartons.
Use a sterile needle of the appropriate size for intramuscular injection (21-gauge or thinner
needles).
- With tip cap upright, remove tip cap by twisting counter-clockwise until tip cap releases. Remove tip cap in a slow, steady motion. Avoid pulling tip cap while twisting.
Attach the needle by twisting in a clockwise direction until the needle fits securely on the
syringe.
- Uncap the needle when ready for administration.
- Administer the entire dose intramuscularly.
- After thawing, do not refreeze.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Dosing and schedule
Table 4. Spikevax XFG pre-filled syringe dosing
Age(s) Dose Additional recommendations
Individuals 12 years of age and older, with or without prior vaccination
One dose of 0.5 mL, given intramuscularly
Spikevax XFG should be administered at least 3 months after the most recent dose of a COVID-19 vaccine and/or a known SARS-CoV-2 infection.
Individuals 65 years of age and older
One dose of 0.5 mL, given intramuscularly
One additional dose may be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Table 5. Spikevax XFG pre-filled syringe posology for immunocompromised individuals
Age(s) Dose Additional recommendations
Immunocompromised individuals 12 years of age and older, with or without prior vaccination
One dose of 0.5 mL, given intramuscularly
Additional doses may be administered in severely immunocompromised at least 2 months following the most recent dose of a COVID-19 vaccine at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances.
As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in the event of an anaphylactic reaction following the administration of Spikevax XFG.
Individuals should be observed by a healthcare professional for at least 15 minutes after vaccination.
Spikevax (including variant formulations) can be concomitantly administered with influenza vaccines (standard and high-dose) and with herpes zoster (shingles) subunit vaccine.
Different injectable vaccines should be given at different injection sites.
Spikevax XFG must not be mixed with other vaccines or medicinal products in the same syringe.
Administration
The vaccine must be administered intramuscularly. The preferred site is the deltoid muscle of the upper arm.
AIP023120A
AIP023120A
QR
502312001
https://www.modernacovid19global.com DataMatrix Arial
NimbusSanLOT
9 point
9 point
Spikevax XFG EMEA 0.5 mL PI Rovi Alcala AIP023120A
ROVI_AH_INSERT_1PK_SYR_IMA_V3
AIP023120A
Rovi Alcala
975x480mm
Cutter Technical Black
20-May-2026 14:50 GMT+1:00