mRESVIA 50 micrograms dispersion for injection in pre-filled syringe – patient leaflet, side effects, dosage

1. What mRESVIA is and what it is used for

mRESVIA is a vaccine that helps to protect adults aged 60 years and older against a virus called ‘respiratory syncytial virus’ (RSV).

mRESVIA also helps to protect against RSV in adults 18 through 59 years of age at increased risk for RSV disease.

RSV is a common virus that spreads very easily and causes respiratory tract disease in people of all ages. RSV infection can be mild, with cold-like symptoms including blocked nose, cough and/or sore throat. However, the virus can also cause more serious problems, such as lung infections and pneumonia. Older adults are at risk of more serious complications that can lead to hospital admission and even death.

mRESVIA contains an active substance called messenger ribonucleic acid (mRNA) to carry instructions that cells in the body can use to make the same protein that is also present on the virus. This protein stimulates the body’s natural defences (immune system) to produce antibodies which help protect you against lung diseases caused by RSV.

2. What you need to know before you take mRESVIA

Do not take mRESVIA

• if you are allergic to the active substance or any of the ingredients of this vaccine (listed in section 6).
• in children younger than 8 months of age.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given mRESVIA if:

• you have previously had a severe, life-threatening allergic reaction after any other vaccine injection.

  • you have a very weak or compromised immune system.
  • you have ever fainted following any needle injection.
  • you have a bleeding problem or bruise easily.

  • you have a high fever or severe infection. If this happens, the vaccination may be postponed.

    There is no need to delay vaccination for a minor infection like a cold, but talk to your doctor first.

As with all vaccines, mRESVIA may not fully protect all people who are vaccinated.

Children and adolescents

mRESVIA is not indicated for use in children and adolescents below the age of 18 years.

Other medicines and mRESVIA

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

mRESVIA may be given at the same time as a flu vaccine or a COVID-19 vaccine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this vaccine. mRESVIA should not be used during pregnancy or breast-feeding.

Driving and using machines

Some of the effects mentioned below in section 4 “Possible side effects” (e.g. feeling tired) may temporarily affect the ability to drive or use 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.

mRESVIA contains sodium

This vaccine contains less than 1 mmol (23 mg) sodium per dose and, that is to say essentially ‘sodium-free.’

3. How and when mRESVIA is given

mRESVIA is given by a doctor, pharmacist or nurse as a single injection in the muscle at the top of the upper arm (deltoid muscle).

The recommended dose is 0.5 mL.

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.

Side effects that may happen after receiving mRESVIA include:

Very common (may affect more than 1 in 10 people):

• swelling/tenderness in the underarm
• headache
• feeling sick, vomiting
• muscle ache, joint aches
• pain at the injection site
• feeling very tired
• chills

Common (may affect up to 1 in 10 people):

• redness or swelling at the injection site
• fever

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

• raised itchy rash (urticaria)
• swelling of the face (may impact the tissues around the eye, the lip or the tongue)

Very rare (may affect up to 1 in 10 000 people):

• temporary one-sided facial drooping

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store mRESVIA

Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. The following information is intended for healthcare professionals.

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 carton after EXP. The expiry date refers to the last day of that month.

Frozen vaccine

Store in a freezer between -40°C to -15°C.

Keep the pre-filled syringes in the original carton in order to protect from light.

Within the shelf life of 1 year, stability data indicate that the vaccine is stable for 30 days when stored at 2°C to 8°C and protected from light. At the end of 30 days, the vaccine should be used immediately or discarded.

Once thawed, the vaccine should not be refrozen.

Upon moving the vaccine to 2°C to 8°C storage, the outer carton should be marked with the new expiry date at 2°C to 8°C.

If the vaccine is received at 2°C to 8°C, it should be stored at 2°C to 8°C. The expiry date on the outer carton should have been marked with the new expiry date at 2°C to 8°C.

The pre-filled syringes may be stored at 8°C to 25°C for up to 24 hours after removal from the refrigerated conditions. Within this period of time, pre-filled syringes may be handled in ambient light conditions. Do not refrigerate after being stored at 8°C to 25°C. Discard the syringe if not used within this time.

Transportation of thawed pre-filled syringes in the outer carton in liquid state at 2°C to 8°C If transport at -40°C to -15°C is not feasible, available data support transportation of one or more thawed pre-filled syringes in liquid state at 2°C to 8°C (within the 30 days shelf life). Once thawed and transported in liquid state at 2°C to 8°C, pre-filled syringes should not be refrozen and should be stored at 2°C to 8°C until use.

6. Contents of the pack and other information

What mRESVIA contains

One pre-filled syringe of 0.5 mL contains 50 micrograms of a single-stranded 5' capped mRNA (nucleoside modified), an RSV mRNA Vaccine (encapsulated in lipid nanoparticles), produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the prefusion stabilised RSV F glycoprotein, derived from an RSV-A A2 strain.

The other excipients are 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 and water for injections.

What mRESVIA looks like and contents of the pack

mRESVIA is a white to off-white dispersion for injection (pH: 7.0 – 8.0) provided in a pre-filled syringe.

mRESVIA is available in packs containing 1 or 10 pre-filled syringes.

Not all pack sizes may be marketed.

Needles are not provided in the pack.

Marketing Authorisation Holder and Manufacturer

MODERNA BIOTECH SPAIN, S.L.

C/ Julián Camarillo nº 31

28037 Madrid

Spain

For any information about this vaccine, please contact the local representative of the Marketing Authorisation Holder.

For any information about this medicine, please contact Medical Information telephone on 0800 085 7562.

This leaflet was last revised in July 2026.

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The following information is intended for healthcare professionals only:

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

This medicinal product should be administered by a trained healthcare professional using aseptic techniques to ensure sterility.

Handling instructions for mRESVIA before use

The vaccine is ready to use once thawed.

Do not dilute the product.

Do not shake the pre-filled syringe before use.

The pre-filled syringe is for single-use only.

Do not use if the pre-filled syringe has been dropped or damaged or the security seal on the carton has been broken.

mRESVIA is shipped and supplied either as a frozen or thawed pre-filled syringe (see section 6.4). If the vaccine is frozen, it must be completely thawed before use. Thaw each pre-filled syringe before use, either in the refrigerator or at room temperature, following the instructions in Table 1.

Prior to immediate use, single blisters or pre-filled syringes may be removed from a carton of 1 or 10 pre-filled syringes and thawed either in the refrigerator or at room temperature. The remaining blisters or syringes must continue to be stored in their original carton in the freezer or refrigerator.

Table 1. Thawing conditions and times based on presentation and temperature before use

• Remove a pre-filled syringe from the blister or tray.
• The vaccine should be inspected visually for particulate matter and discolouration prior to administration. Do not administer if vaccine is discoloured or contains other particulate matter.
• 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.
• The vaccine should be administered immediately after uncapping.
• Needles are not provided in the pack.
• Use a sterile needle of the appropriate size for intramuscular injection (21-gauge or thinner needles).
• Attach the needle by twisting in a clockwise direction until the needle fits securely on the pre-filled syringe.
• Administer the entire dose intramuscularly.
• Discard the pre-filled syringe after use.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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.