Spikevax JN.1 50 micrograms dispersion for injection in pre-filled syringe – patient leaflet, side effects, dosage

1. What Spikevax JN.1 is and what it is used for

Spikevax JN.1 contains messenger ribonucleic acid (mRNA) (mRNA-1273.167) that encodes the spike protein of the JN.1 strain of the virus.

As Spikevax JN.1 does not contain the virus, it cannot give you COVID-19.

How the vaccine works

Spikevax JN.1 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 JN.1 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 JN.1

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 section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Spikevax JN.1 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 JN.1.

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 JN.1.

Duration of protection

As with any vaccine, Spikevax JN.1 may not fully protect all those who receive it and it is not known how long you will be protected.

Children

Spikevax JN.1 is not recommended for children aged under 12 years.

Other medicines and Spikevax JN.1

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Spikevax JN.1 may affect the way other medicines work, and other medicines may affect how Spikevax JN.1 works.

Immunocompromised individuals

The efficacy of Spikevax JN.1 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 JN.1 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 JN.1

Spikevax JN.1 in pre-filled syringe can only be used for administration to individuals 12 years of age and older.

Table 1. Spikevax JN.1 pre-filled syringe posology

Table 2. Spikevax JN.1 pre-filled syringe posology for immunocompromised individuals

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 JN.1

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 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 JN.1 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-1273.167, a COVID-19 mRNA Vaccine (embedded in SM-102 lipid nanoparticles).

This vaccine contains polyethylene glycol/macrogol (PEG) as part of PEG2000-DMG.

mRNA-1273.167 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 JN.1.

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 JN.1 looks like and contents of the pack

Pre-filled syringe

Spikevax JN.1 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 February 2026.

Scan the code with a mobile device to get the package leaflet.

Or visit the URL https://emclink.uk/MdnCv

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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 JN.1 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 JN.1 is supplied in a single-dose, pre-filled syringe (without needle) containing 0.5 mL (50 micrograms of mRNA-1273.167) 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 JN.1 pre-filled syringes and cartons before use

Verify that the product name of the pre-filled syringe is Spikevax JN.1. If the product name is Spikevax 50 micrograms, Spikevax bivalent Original/Omicron BA.1, Spikevax bivalent Original/Omicron BA.4-5 or Spikevax XBB.1.5, please make reference to the Summary of Product Characteristics for that formulation.

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 JN.1 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 JN.1 pre-filled syringe dosing

Table 5. Spikevax JN.1 pre-filled syringe posology for immunocompromised individuals

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 JN.1.

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 JN.1 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.