Overview

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

If you need more information about how this product may be used, you should consult your national veterinary authority. If you want more information on the basis of the CVMP's recommendations, read the scientific discussion (also part of the EPAR).

Nobilis Influenza H5N2 is a vaccine containing an inactivated avian influenza virus H5N2 (inactivated means that the virus has been killed so that it cannot cause the disease any more).

Nobilis Influenza H5N2 is a vaccine used in chickens to protect against avian influenza. The vaccine reduces the signs of flu and the excretion (shedding) of the virus by the infected birds. The vaccine is injected intramuscularly (into a muscle) or subcutaneously (under the skin).

The vaccine will only be used as part of an approved national disease control programme. This is because control of avian influenza is the responsibility of national veterinary authorities in consultation with the European Commission.

Nobilis Influenza H5N2 is a vaccine. When it is given to chickens, the birds’ immune system (their natural defence mechanism) learns how to make antibodies (a special type of protein) to fight the disease. In the future, if the birds are exposed to the avian flu virus, the immune system will be able to make those antibodies quicker and this will help them fight the disease.

The virus used for the vaccine carries the H5 (haemagglutinin 5) and N2 (neuramidase 2) antigens. This means that vaccinated birds make antibodies against these two antigens. This strain has been chosen because it protects birds against virulent H5N1 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds. Vaccinated birds can be differentiated from infected birds by a diagnostic test for antibodies against the N2 component. This differentiation is important for disease surveillance and control.

The company carried out laboratory safety studies using a vaccine very similar to Nobilis Influenza H5N2. This vaccine has some of the same ingredients but different antigens (viruses), two of which are produced using the same process to that used for the avian influenza antigen of Nobilis Influenza. It also tested the safety of three standard production batches of Nobilis Influenza H5N2.

Studies were carried out in one-day-old and two- to four-week-old chickens free of any infection. The data on the effectiveness of the vaccine was based on published scientific papers and internal company reports. They included studies in other avian species (ducks, turkeys, pheasants), and studies using either the subcutaneous or intramuscular routes.

The vaccine was assessed in the context of an emergency situation, which means that further studies with Nobilis H5N2 are still ongoing and will be assessed.

The results of the safety studies indicated that the product is safe for chickens. When compared, the subcutaneous and intramuscular routes were shown to produce the same responses.

  • The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens.
  • The vaccine is able to induce antibodies in a wide range of birds.
  • If the circulating avian influenza field virus has a different N component to the N2 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect neuraminidase antibodies.

In common with many adjuvanted vaccines swelling may occur at the vaccination site which may last for about 14 days.

The vaccine contains a mineral oil. The person who gives the vaccine should be careful to avoid accidental self-injection.

Zero days.

The vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated birds.

The Committee for Medicinal Products for Veterinary Use concluded that the vaccine has been shown to be effective in preventing clinical disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection. Because of the current epidemiological situation of avian influenza and the consequent threat to both human and animal health, the Committee recommended the granting of a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Nobilis Influenza H5N2 has been authorised under 'exceptional circumstances'. This means that it has yet not been possible to obtain complete information about the product. The European Medicines Agency will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary.

The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis Influenza H5N2 to Intervet International BV on 1 September 2006.

Nobilis Influenza H5N2 : EPAR - Summary for the public

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Product information

Nobilis Influenza H5N2 : EPAR - Product Information

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Latest procedure affecting product information: IG/1348

18/03/2021

Nobilis Influenza H5N2 : EPAR - All Authorised presentations

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Product details

Name of medicine
Nobilis Influenza H5N2
Active substance
inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86)
International non-proprietary name (INN) or common name
adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5
Species
Chicken
Anatomical therapeutic chemical veterinary (ATCvet) code
QI01AA23

Pharmacotherapeutic group

Immunologicals for aves

Therapeutic indication

For active immunisation of chickens against avian influenza type A, subtype H5.

Efficacy has been evaluated on the basis of preliminary results in chickens. Reduction of clinical signs, mortality and excretion of virus after challenge were shown by three weeks after vaccination.

Serum antibodies could be expected to persist for at least 12 months after administration of two doses of vaccine.

Authorisation details

EMA product number
EMEA/V/C/000118

Accelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Marketing authorisation holder
Intervet International BV

Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Marketing authorisation issued
01/09/2006
Revision
8

Assessment history

Nobilis Influenza H5N2 : EPAR - Procedural steps taken and scientific information after authorisation

Nobilis Influenza H5N2 : EPAR - Scientific Discussion

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