Patient leaflet - Mresvia 50 micrograms Dispersion for injection
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).
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).
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.
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
- muscle ache, joint aches
- pain at the injection site
- feeling very tired
- chills
Common (may affect up to 1 in 10 people):
- feeling sick, vomiting
- 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.
Information about storage, expiry, and use and handling are described in the section intended for healthcare professionals at the end of the package leaflet.
6. Contents of the pack and other information
What mRESVIA contains
This is a single-dose vial that contains 1 dose of 0.5 mL.
One dose (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: 7.1 – 7.8) provided in a glass vial with a rubber stopper and a purple flip-off plastic cap with aluminium seal.
mRESVIA is available in packs containing 10 single-dose vials. Each vial contains 0.5 mL.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
MODERNA BIOTECH SPAIN, S.L.
C/ Julián Camarillo nº 31
28037 Madrid
Spain
Moderna Technology Centre
Harwell (MTC-H)
Perimeter Road
Harwell Oxford
Didcot
OX11 0GN
United Kingdom
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 May 2026.
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
Store vials in a freezer between -40°C to -15°C.
The vaccine is ready to use once thawed.
Do not shake or dilute the product. Swirl the vial gently after thawing and before withdrawal.
The single-dose vial is for single-use only.
Do not use if the vial has been dropped or damaged or the security seal on the carton has been broken.
mRESVIA is shipped and supplied as a frozen single-dose vial that must be completely thawed before use. Thaw each vial, either in the refrigerator or at room temperature, following the instructions in Table 1. The remaining vials 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
Pack size
Thaw instructions and durations
Thaw
temperature
(in refrigerator)
(°C)
Thaw duration
(minutes)
or
Thaw temperature (at room temperature)
(°C)
Thaw duration
(minutes)
Carton of 10
vials 2 - 8 105 15 - 25 45
1 vial
(removed
from carton)
2 - 8 45 15 - 25 15
- After thawing, the vaccine cannot be refrozen.
- If mRESVIA is thawed at room temperature (15°C to 25°C), the vial is ready to administer. Vials should not be returned to the refrigerator after being thawed at room temperature.
The vial may be stored at 8°C to 25°C for a total of 24 hours after after removal from refrigerated conditions.
Within this period of time, vials may be handled in ambient light conditions. Discard the vial if not used within this time.
Administration
- Remove a vial from the carton.
The vaccine should be inspected visually for particulate matter and discolouration prior to administration.
mRESVIA 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.
- Administer the entire dose intramuscularly.
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.
DFT02276-3
DFT02276-3
XXXXX DataMatrix NimbusSanLOT OCRB
SJG
22-10-2025 19:37:32
980 x 475mm
TF Swindon
9 point
9 point
DFT02276-3
TFS_INSERT_LINE B_10R_10CT_UK_V 3 mRESVIA OUS 0.5 mL PI TF Swindon DFT02276-3
Cutter Technical
Black P 1795 C