Vectormune HVT-AIV - opinion on variation to marketing authorisation

Opinion

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

Avian influenza vaccine

Opinion

On 10 September 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Vectormune HVT-AIV. The marketing authorisation holder for this veterinary medicinal product is Ceva Sante Animale.

Vectormune HVT-AIV is currently authorised for active immunisation of one-day-old chickens to reduce mortality, clinical signs, and virus excretion due to infection with highly pathogenic avian influenza (HPAI) virus of the H5 sub-type. 

This group of variations concerns the addition of turkeys as a new target species and the increase of the minimum titre per dose.

As a result of these variations, the full indication has been amended to: 

For active immunisation of one-day-old chickens and one-day-old turkeys to reduce mortality, clinical signs, and virus excretion due to infection with highly pathogenic avian influenza (HPAI) virus of the H5 sub-type. 

Chickens: 

Onset of immunity:                2 weeks of age

Duration of immunity:            100 weeks 

Turkeys: 

Onset of immunity:                7 weeks of age

Duration of immunity: not established 

Detailed conditions for the use of this product are described in the updated summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.

---

Note: Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.

CVMP post-authorisation summary of positive opinion for Vectormune HVT-AIV (VRA0000321340)

Adopted Reference Number: EMADOC-1700519818-3418961

Key facts

• Name of medicine:
  Vectormune HVT-AIV
• EMA product number:
  EMEA/V/C/006288
• Active substance:
  turkey herpesvirus, strain rHVT/AI-H5 (cell-associated), expressing haemagglutinin gene of Avian influenza subtype H5, live
• International non-proprietary name (INN) or common name:
  Avian influenza vaccine
• Date of opinion:
  10/09/2026
• Status:
  Positive