Zoonotic Influenza Vaccine Seqirus - opinion on variation to marketing authorisation

Opinion

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

Zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted)

Opinion

On 25 April 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 Zoonotic Influenza Vaccine Seqirus. The marketing authorisation holder for this medicinal product is Seqirus S.r.l.

The CHMP adopted an extension to the existing indication to include active immunisation of children from 6 months of age. For information, the full indication will be as follows:¹

Zoonotic Influenza Vaccine Seqirus H5N8 is indicated for active immunisation against H5 subtype influenza A viruses in individuals 6 months of age and abovein adults 18 years of age and above (see sections 4.4 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 Zoonotic Influenza Vaccine Seqirus (VR0000249071)

AdoptedReference Number: EMADOC-1700519818-2059670

Key facts

• Name of medicine:
  Zoonotic Influenza Vaccine Seqirus
• EMA product number:
  EMEA/H/C/006375
• Active substance:
  A/Astrakhan/3212/2020 (H5N8)-like strain (CBER-RG8A) (clade 2.3.4.4b)
• International non-proprietary name (INN) or common name:
  Zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted)
• Therapeutic area (MeSH):
  Influenza A Virus, H5N8 Subtype
• Anatomical therapeutical chemical (ATC) code:
  J07BB02
• Marketing authorisation holder:
  Seqirus S.r.l.
• Date of opinion:
  25/04/2025
• Status:
  Positive