Overview

Vaxxitek HVT+IBD is a veterinary vaccine used to protect chickens against infectious bursal disease (IBD, also known as Gumboro disease) and Marek’s disease.

Vaxxitek HVT+IBD is used to prevent the deaths of chickens and to reduce clinical signs and effects of IBD, a disease which damages the immune system of chickens. Vaxxitek HVT+IBD is also used to reduce mortality, clinical signs and effects of Marek's disease, a herpes virus infection of chickens.

Vaxxitek HVT+IBD is available as a frozen suspension to be reconstituted with diluent and injected into chickens and into eggs where chicks are developing. It can only be obtained with a prescription.

For more information about using Vaxxitek HVT+IBD, see the package leaflet or contact your veterinarian or pharmacist.

Vaxxitek HVT + IBD is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. It contains vaccine strains which induce an active immunity and a serological response (detected antibodies) against the two diseases. The product appears to show no interference with antibodies derived from the mother bird and can be safely administered to day-old chickens and chicks in the egg without presenting any apparent safety problem or inducing an immunosuppressive effect.

The safety of the product has been demonstrated in several laboratory and field trials in specific pathogen-free and other chickens. The studies were performed according to the requirements of the appropriate European Pharmacopoeia monographs. Whilst the vaccine is unlikely to affect male fertility, a warning has nevertheless been included in the product information.

The safety for non-susceptible bird species (pheasants, ducks, partridges, quails and pigeons) and for mammalian species (mice and guinea-pigs) was also demonstrated. As for any turkey Herpesvirus (HVT) live vaccine, the product is excreted from vaccinated birds and may spread to turkeys. Studies have shown that the strain appears safe for turkeys, however precautionary measures should be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.

The studies demonstrated that Vaxxitek HVT+IBD is effective in the active immunisation of chickens and chicks in the egg against Infectious Bursal disease. The onset of protection is from 2 weeks onwards and the protection extends to 9 weeks. The vaccine is also effective against Marek’s disease. The onset of protection is from 4 days onwards. A single vaccination is sufficient to provide protection during the risk period.

Only healthy birds should be vaccinated and the product should not be used in birds in lay and breeding birds. No information is available on the safety and efficacy from the concurrent use with any other vaccine, except Merial attenuated vaccines against Marek’s disease, Newcastle disease and Infectious bronchitis. It is therefore recommended that no other vaccine than these should be administered within 14 days after vaccination with the product. In the absence of specific studies, no other vaccine should be administered at the same time when the product is injected into eggs.

For the full list of side effects of Vaxxitek HVT+IBD, see the package leaflet.

Safety information has been included in the summary of product characteristics and the package leaflet for Vaxxitek HVT+IBD, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.

As the product is stored in a tank under liquid nitrogen, particular instructions for reconstitution of the vaccine are provided in the product information.

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption. It is also the time required after administration of a medicine before eggs may be used for human consumption.

The withdrawal period for meat and eggs from chickens treated with Vaxxitek HVT+IBD is zero days.

The European Medicines Agency decided that Vaxxitek HVT+IBD’s benefits are greater than its risks and it can be authorised for use in the EU.

Vaxxitek HVT+IBD received a marketing authorisation valid throughout the EU on 9 August 2002.

Vaxxitek HVT+IBD : EPAR - Medicine overview

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Product information

Vaxxitek HVT+IBD : EPAR - Product information

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Latest procedure affecting product information: IG/1450

20/12/2021

Vaxxitek HVT+IBD : EPAR - All Authorised presentations

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Product details

Name of medicine
Vaxxitek HVT+IBD
Active substance
Recombinant turkey herpesvirus, strain vhvt013-69, live
International non-proprietary name (INN) or common name
Infectious bursal disease and Marek's disease vaccine (live recombinant)
Species
  • Embryonated eggs
  • Chicken
Anatomical therapeutic chemical veterinary (ATCvet) code
QI01AD15

Pharmacotherapeutic group

  • Immunologicals for aves
  • Domestic fowl
  • Immunologicals

Therapeutic indication

For active immunisation of chickens:

  • To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.
  • To reduce mortality, clinical signs and lesions of Marek's disease.

Authorisation details

EMA product number
EMEA/V/C/000065
Marketing authorisation holder
Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein
Germany

Opinion adopted
17/04/2002
Marketing authorisation issued
09/08/2002
Revision
17

Assessment history

Vaxxitek HVT+IBD : EPAR - Procedural steps taken and scientific information after authorisation

Vaxxitek HVT+IBD : EPAR - Scientific Discussion

Vaxxitek HVT+IBD : EPAR - Procedural steps taken before authorisation

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