Bimervax - opinion on variation to marketing authorisation

Opinion

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

COVID-19 Vaccine (recombinant, adjuvanted) / selvacovatein / damlecovatein

Opinion

On 18 September 2025 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 Bimervax. The marketing authorisation holder for this medicinal product is Hipra Human Health S.L.

The CHMP adopted an extension to the existing indication as follows¹:

Bimervax is indicated as a booster for active immunisation to prevent COVID-19 in individuals 16 12 years of age and older who have previously received a mRNA COVID-19 vaccine (see sections 4.2 and 5.1).

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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¹New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Bimervax (EMAVR0000257408)

Adopted Reference Number: EMADOC-1700519818-2450542

Key facts

• Name of medicine:
  Bimervax
• EMA product number:
  EMEA/H/C/006058
• Active substance:
  SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion dimer produced by recombinant DNA technology
• International non-proprietary name (INN) or common name:
  • COVID-19 Vaccine (recombinant, adjuvanted)
  • selvacovatein
  • damlecovatein
• Therapeutic area (MeSH):
  COVID-19 virus infection
• Anatomical therapeutical chemical (ATC) code:
  J07BN
• 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:
  Hipra Human Health S.L.
• Date of opinion:
  18/09/2025
• Status:
  Positive