Comirnaty - opinion on variation to marketing authorisation

Opinion

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

COVID-19 mRNA vaccine

Opinion

On 23 April 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 Comirnaty. The marketing authorisation holder for this medicinal product is BioNTech Manufacturing GmbH.

The CHMP adopted a change to the existing indication for all Comirnaty 10 micrograms formulations, as follows:

Comirnaty JN.1 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 5 years 6 months of age and older. 

Comirnaty KP.2 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 5 years 6 months of age and older. 

Comirnaty LP.8.1 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 5 years 6 months 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 the 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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Note: New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Comirnaty (VR-0000320534)

Adopted Reference Number: EMADOC-1700519818-3080442

Key facts

• Name of medicine:
  Comirnaty
• EMA product number:
  EMEA/H/C/005735
• Active substance:
  single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2
• International non-proprietary name (INN) or common name:
  COVID-19 mRNA vaccine
• Therapeutic area (MeSH):
  COVID-19 virus infection
• Anatomical therapeutical chemical (ATC) code:
  J07BN01
• 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:
  BioNTech Manufacturing GmbH
• Status:
  Positive