mResvia - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

Respiratory syncytial virus mRNA vaccine (nucleoside modified)

Opinion

On 26 March 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product mResvia. The marketing authorisation holder for this medicinal product is Moderna Biotech Spain S.L.

The CHMP adopted changes to the existing indication, as follows:

mRESVIA is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in:

• adults 60 18 years of age and older.;
• adults 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

The use of this vaccine should be in accordance with official recommendations.

For information, the full indication for mResvia will now be:

mRESVIA is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in adults 18 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Notes:

New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for mResvia (VR0000312911)

Adopted Reference Number: EMADOC-1700519818-3003233

Key facts

• Name of medicine:
  mResvia
• EMA product number:
  EMEA/H/C/006278
• Active substance:
  Respiratory syncytial virus mRNA vaccine (nucleoside modified)
• International non-proprietary name (INN) or common name:
  Respiratory syncytial virus mRNA vaccine (nucleoside modified)
• Therapeutic area (MeSH):
  Respiratory Syncytial Virus Infections
• Anatomical therapeutical chemical (ATC) code:
  J07BX05
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Marketing authorisation holder:
  Moderna Biotech Spain, S.L.
• Date of opinion:
  26/03/2026
• Status:
  Positive