MRESVIA DISPERSION INJECTABLE IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the Patient

mRESVIA injectable dispersion

Vaccine against respiratory syncytial virus (RSV) of messenger RNA (mRNA)

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet contains information on how to report side effects.

Read all of this leaflet carefully before receiving this vaccine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience side effects, ask your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is mRESVIA and what is it used for
2. What you need to know before receiving mRESVIA
3. How and when mRESVIA is administered
4. Possible side effects
5. Storage of mRESVIA
6. Contents of the pack and further information

1. What is mRESVIA and what is it used for

mRESVIA is a vaccine that helps protect adults 60 years of age and older against a virus called respiratory syncytial virus (RSV).

RSV is a common virus that is easily spread and causes respiratory diseases in people of all ages. RSV infection can be mild, with symptoms similar to those of a cold, such as a stuffy nose, cough, or sore throat. However, the virus can also cause more serious problems, such as lung infections and pneumonia. Older adults are at higher risk of developing more serious complications that may require hospitalization.

mRESVIA stimulates the immune system (the body's natural defenses) to protect against lung diseases caused by RSV. The vaccine contains a substance called messenger RNA (mRNA) that contains the instructions for the body to produce the same protein found in RSV. When the immune system encounters this protein, it produces antibodies (substances in the blood that recognize and fight infections) to combat it. If a person comes into contact with RSV, the immune system will recognize and attack the virus to help protect against RSV-related lung diseases.

2. What you need to know before receiving mRESVIA

Do not use mRESVIA

• if you are allergic to the active substance or any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before administering mRESVIA if:

• you have had a severe allergic reaction after any other vaccine in the past.
• you have a bleeding disorder or bruise easily
• you have a weakened immune system that may prevent you from getting the full benefits of mRESVIA
• you are nervous about receiving the vaccine or have fainted after an injection
• you have a high fever infection. In this case, vaccination will be postponed. If the infection is mild, such as a cold, it is not necessary to delay vaccination, but talk to your doctor first.

As with other vaccines, mRESVIA may not protect all vaccinated individuals.

Children and adolescents

The use of mRESVIA is not indicated in children and adolescents under 18 years of age.

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 breastfeeding

The vaccine should not be used in women of childbearing potential, pregnant, or breastfeeding.

Driving and using machines

Some of the effects mentioned below in section 4 "Possible side effects", such as fatigue and dizziness, may temporarily affect your ability to drive or use machines. If you experience these types of side effects, wait until they have disappeared before driving or using machines.

mRESVIA contains sodium

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; i.e., it is essentially "sodium-free".

3. How and when mRESVIA is administered

mRESVIA is administered by a doctor, pharmacist, or nurse, usually as a single injection into the muscle of the upper arm (deltoid muscle).

The recommended dose is 0.5 ml.

If you have any further questions about 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.

The side effects that may occur after receiving mRESVIA are:

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

• axillary swelling/sensitivity (lymphadenopathy)
• headache
• muscle pain (myalgia)
• joint pain (arthralgia)
• pain at the injection site
• feeling tired (fatigue)
• chills

Common(may affect up to 1 in 10 people)

• feeling of dizziness (nausea) / vomiting
• redness (erythema) at the injection site
• swelling/hardening (induration) at the injection site
• fever (pyrexia)

Uncommon(may affect up to 1 in 100 people)

• increased sensitivity or intolerance reaction by the immune system (hypersensitivity)
• dizziness

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

• one-sided facial paralysis (Bell's palsy)
• itchy skin rash (urticaria)
• itching at the injection site (pruritus)

Tell your doctor or nurse if you experience any of the side effects mentioned above. Most of these side effects are mild to moderate and do not last long.

If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this vaccine.

5. Storage of mRESVIA

Your doctor, pharmacist, or nurse is responsible for the proper storage of this vaccine and the disposal of unused product. This 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 label after EXP. The expiry date is the last day of the month shown.

Frozen vaccine

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

Store the pre-filled syringes in the original packaging to protect them from light.

During the 1-year validity period, stability data indicate that the vaccine is stable for 30 days when stored between 2 °C and 8 °C and protected from light. After 30 days, the vaccine should be used immediately or discarded.

Once thawed, the vaccine should not be re-frozen.

When the vaccine is transferred to storage between 2 °C and 8 °C, the new expiry date between 2 °C and 8 °C should be written on the outer carton.

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

The pre-filled syringes can be stored between 8 °C and 25 °C for up to 24 hours after removal from the refrigerator. During this time, the pre-filled syringes can be handled in ambient light conditions. Do not refrigerate again after storage between 8 °C and 25 °C. Discard the syringe if it has not been used within this time.

Transport of thawed pre-filled syringes in the outer carton in a liquid state between 2 °C and 8 °C

If transport between -40 °C and -15 °C is not possible, available data support the transport of one or several thawed pre-filled syringes in a liquid state between 2 °C and 8 °C (within the 30-day shelf-life).

Once thawed and transported in a liquid state between 2 °C and 8 °C, the pre-filled syringes should not be re-frozen and should be stored between 2 °C and 8 °C until use.

6. Contents of the pack and further information

Composition of mRESVIA

A pre-filled syringe of 0.5 ml contains 50 micrograms of mRNA vaccine (modified nucleosides) for respiratory syncytial virus (RSV) encapsulated in lipid nanoparticles.

The active substance is a single-stranded mRNA with a cap at the 5' end that encodes the F glycoprotein of the respiratory syncytial virus stabilized in the pre-fusion conformation.

The other excipients 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, and water for injections.

See section 2 "mRESVIA contains sodium".

Appearance and pack contents

mRESVIA is a white to off-white injectable dispersion (pH: 7.0-8.0)

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

Not all pack sizes may be marketed.

Needles are not included in the pack.

Marketing authorisation holder and manufacturer

MODERNA BIOTECH SPAIN, S.L.

C/ Julián Camarillo nº 31

28037 Madrid

Spain

You can request more information about this vaccine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet

Other sources of information

Scan the QR code with a mobile device to get the leaflet in different languages or visit www.mresvia.eu.

Include the QR code

Detailed information on this vaccine is available on the European Medicines Agency website: https://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

This vaccine 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.

Do not shake the pre-filled syringe before use.

The pre-filled syringe is for single use only.

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

mRESVIA is supplied and shipped as a frozen or thawed pre-filled syringe (see section 6.5). If the vaccine is frozen, it should be thawed completely before use.

Thaw each pre-filled syringe before use, either in a refrigerator or at room temperature, following the instructions in Table 1.

Before immediate use, individual blisters can be removed from a carton of 1 or 10 pre-filled syringes and thawed in the refrigerator or at room temperature. The remaining blisters should continue to be stored in their original packaging in the freezer or refrigerator.

Table 1: Thawing conditions and times based on pack size and temperature before use

• Once thawed, the vaccine should not be re-frozen.
• If the vaccine has been thawed at room temperature (15 °C to 25 °C), the pre-filled syringe is ready for administration.
• The syringes should not be put back in the refrigerator if they have been thawed at room temperature.
• The pre-filled syringes can be stored at a temperature between 8 °C and 25 °C for a total of 14 hours after removal from the refrigerator. During this time, the pre-filled syringes can be handled in ambient light conditions. Discard the syringe if it has not been used within this time.

Administration

• Remove a pre-filled syringe from the blister.
• The vaccine should be inspected visually before administration for particulate matter or color alteration. mRESVIA is a dispersion of white to off-white color. It may contain white or translucent particles related to the product. Do not administer if the vaccine has changed color or contains other types of particles.
• To remove the cap, place it in a vertical position and twist it in the opposite direction of the clock hands until it comes off. Remove the cap with a slow and continuous movement. Do not pull it while twisting.
• The vaccine should be administered immediately after removing the cap.
• Needles are not included in the pack.
• Use a sterile needle of suitable gauge for intramuscular injection (21-gauge or finer).
• Place the needle by twisting it in the opposite direction of the clock hands until it is firmly attached to the pre-filled syringe.
• Administer the full dose by intramuscular route.
• Discard the needle after use.

Disposal

Disposal of unused medicinal products and all materials that have come into contact with them should be done in accordance with local regulations.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.