Vaxxitek HVT+IBD+H5

Opinion

EMA has issued an opinion on this medicine

avian influenza vaccine (live recombinant)

Overview

On 9 October 2025, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion¹, recommending the granting of a marketing authorisation for the veterinary medicinal product Vaxxitek HVT+IBD+H5, concentrate and solvent for suspension for injection, intended for chickens, turkeys and embryonated chicken eggs. The applicant for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.

Vaxxitek HVT+IBD+H5 is an immunological veterinary medicinal product containing ‘Turkey herpesvirus, strain rHVT-IBD-H5 (cell-associated), expressing the VP2 protein gene of Infectious bursal disease virus and haemagglutinin gene of Avian influenza virus subtype H5, live’ (ATCvet code QI01AD) as the active substance. The vaccine induces an active immunity and a serological response against avian influenza in chickens and turkeys.

The benefit of Vaxxitek HVT+IBD+H5 is:

• chickens and embryonated chicken eggs: the active immunisation of one-day-old chicks or 18-day-old embryonated chicken eggs to reduce mortality, clinical signs and virus excretion due to infection with highly pathogenic avian influenza virus (HPAI) virus of the H5 subtype, including the circulating clade 2.3.4.4b.
• turkeys: the active immunisation of one-day-old turkeys to reduce mortality, clinical signs and virus excretion due to infection with HPAI virus of the H5 subtype, including the circulating clade 2.3.4.4b

Vaxxitek HVT+IBD+H5 is generally well tolerated at the recommended dose.

The full indication is:

• Chickens and embryonated chicken eggs:

For active immunisation of one-day-old chicks or 18-day-old embryonated chicken eggs:

To reduce mortality, clinical signs and virus excretion due to infection with highly pathogenic avian influenza virus (HPAI) virus of the H5 subtype, including the circulating clade 2.3.4.4b.

Onset of immunity: 4 weeks

Duration of immunity: 24 weeks

• Turkeys:

For active immunisation of one-day-old turkeys:

To reduce mortality, clinical signs and virus excretion due to infection with HPAI virus of the H5 subtype, including the circulating clade 2.3.4.4b.

Onset of immunity: 50 days

Duration of immunity: 100 days

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

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Vaxxitek HVT+IBD+H5 and therefore recommends the granting of the marketing authorisation under exceptional circumstances².

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¹Applicants 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.

²Marketing authorisation under exceptional circumstances refers to the fact that in exceptional circumstances an authorisation may be granted subject to certain specific obligations, to be reviewed annually.

CVMP summary of positive opinion for Vaxxitek HVT+IBD+H5

Adopted Reference Number: EMA/CVMP/307532/2025

Product details

• Name of medicine:
  Vaxxitek HVT+IBD+H5
• Active substance:
  Turkey herpesvirus, strain rHVT-IBD-H5 (cell-associated), expressing the VP2 protein gene of Infectious bursal disease virus and haemagglutinin gene of Avian influenza virus subtype H5, live
• International non-proprietary name (INN) or common name:
  avian influenza vaccine (live recombinant)
• Species:
  • Chicken
  • Turkeys
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI01AD
• EMA product number:
  EMEA/V/C/006751
• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

• Marketing authorisation applicant:
  Boehringer Ingelheim Vetmedica GmbH
• Opinion adopted:
  09/10/2025
• Opinion status:
  Positive