1. Adjuvant

A vaccine substance administered with an antigen that enhances the immunological response of the animal.

2. Antigen

The active substance of a vaccine that stimulates an immune reaction in an animal and binds to an antibody or immune cell.

3. Attenuated vaccine

A vaccine that contains a live microorganism with reduced virulence for the species of animal to be vaccinated.  The microorganism is attenuated using a number of techniques that enable the vaccine to stimulate a protective immune response in the animal without causing overt signs of disease.

4. Blue eye

An immune-mediated reaction in the eye of dogs that may occur following infection with CAV-1 (ICH), rarely with vaccination with CAV-1 and extremely rarely following administration of CAV-2 vaccines.  Antibody induced by the vaccine combines with antigen from the vaccine or disease organism to form immune complexes.  The immune complexes in the eye cause inflammation and swelling which result in a blue discolouration.

5. Challenge study

A laboratory study in which vaccinated animals and control animals are infected with the virulent disease organism to demonstrate the level of protection afforded by the immune response induced by the vaccine.  Vaccinated animals may be protected from infection, clinical signs or death, whilst the control animals should show signs of disease.

6. Endemic (enzootic) disease

A disease that is continuously present in a particular population.  Endemic is often used with reference to human disease and is a more commonly used term than enzootic that refers to disease in animal populations.

7. Epizootic (epidemic)

A disease spreading rapidly and extensively in an unusually high number of animals (epizootic) or humans (epidemic) in a particular geographical area or region.

8. European Medicines Agency (EMA)

The European Medicines Agency is a decentralised body of the European Union with headquarters in the Netherlands.  Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.  The Agency is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure).   Under the centralised procedure, companies submit a single marketing authorisation application to the Agency.  Once granted by the European Commission, a centralised (or Community) marketing authorisation is valid in all European Union (EU) and EEA-EFTA states (Iceland, Liechtenstein and Norway). EMA website.

9. European Public Assessment Report (EPAR)

This reflects the scientific conclusion reached by the Committee for Medicinal Products for Veterinary Use (CVMP) at the end of the centralised evaluation process.  The legal basis for its creation and availability is contained in Article 38(3) of Regulation (EC) No 726/2004.  It is made available by the EMA for information to the public after deletion of commercially confidential information.  The EPAR provides a summary of the grounds for the CVMP opinion in favour of granting a marketing authorisation for a specific medicinal product.  It results from the Committee’s review of the documentation submitted by the applicant and from subsequent discussions held during CVMP meetings.  The EPAR is updated throughout the authorisation period as changes to the original terms and conditions of the authorisation, such as, variations, pharmacovigilance issues, specific obligations, are made.  EPARs also contain a summary written in a manner that is understandable to the public.

10. Immunogenicity

The ability of a vaccine to stimulate an immune response in an animal.  Immunogenicity studies demonstrate the ability of a vaccine to protect an animal against challenge with the virulent disease microorganism. 

Inactivated or killed vaccine is a live pathogenic vaccine organism or toxin treated with physical or chemical agents so that it is no longer infectious or toxic to the vaccinated animal.  Inactivated vaccine organisms cannot replicate in the animal.  Many inactivated vaccines contain an adjuvant, an agent to enhance the immune response, in order to achieve an acceptable level of immunity.

11. Marketing Authorisation (MA)

The UK Veterinary Medicines Regulations require that any person who places a veterinary medicinal product on the UK market does so in accordance with a Marketing Authorisation granted by the Secretary of State or by the European Medicines Agency, subject to certain specific exemptions.

Further guidance.

For a Marketing Authorisation to be granted, an applicant must submit a scientific data package containing quality, safety and efficacy information and studies in accordance with the requirements of the legislation.  An authorised product will have an authorisation number, preceded by ‘ Vm’ on its product literature, for examples, labels; this offers users a clear guarantee that the medicine has been assessed and approved in accordance with the instructions on the product literature.  Please note, products authorised via the centralised route will not have a Vm number on their product literature.

12. Modified Live Virus (MLV) vaccine

A live vaccine prepared from attenuated (reduced virulence for producing clinical signs in the vaccinated animal) pathogenic strains to protect against challenge with the fully virulent wild-type organism.

13. Mucosal immunity

Immunity provided at the surface membranes that provides protection from infection with virulent microorganisms.

14. Multivalent vaccine

A combination of several vaccine organisms or antigens in a single formulation.  The advantage of multivalent vaccine is a single administration to the animal which will lead to protection against a number of diseases.

15. Peracute

A very rapid and severe form of a disease.

16. Potency

A quality measurement of the immunological activity of a batch of vaccine to protect vaccinated animals against challenge with the disease organism or induce an immune response.

17. Recombinant vaccine

A vaccine antigen or active part of the vaccine that is expressed in another microorganism such as a bacteria, virus or yeast cell. Some recent recombinant vaccines include antigens incorporated into harmless virus vectors. Recombinant vaccines may be live or killed vaccines and contain only a small part of the infectious agent, therefore eliminating the risk or the vaccine reverting to virulence.  Live recombinant vaccines can stimulate both antibody and cell mediated immunity.

18. Reversion to virulence

A process in which a live vaccine microorganism regains its virulence in an animal.  This may occur after several passages in the species of vaccinated animal.

19. Serovar

A group of closely related microorganisms distinguished by a characteristic set of antigens.

20. Sub-unit vaccine

A type of vaccine consisting of specific protein units of the pathogen rather than the whole organism, for example, specific proteins from a virus or bacteria.

21. Summary of Product Characteristics (SPC)

The SPC contains information about a product that is supported by the scientific data submitted during the application for a marketing authorisation.

For example:

• the name, potency/antigen content and pharmaceutical form of the product
• the name and potency/antigen content of each active substance
• the animal species it can be administered to
• the level of protection against infection, clinical signs or mortality
• the shelf life

It also gives safety warnings, which may include:

• warnings about the product’s use, for both the person administering the product and for the animal(s) the product is being administered to.  Mineral Oil adjuvanted vaccines are a particular risk if a self-injection injury is inflicted on the person administering the vaccine.
• warnings about the product’s use in various categories of animals such as pregnant animals or in very young animals.
• information about the safe disposal of the product and its packaging, to ensure safety to protect the environment.

The SPC forms part of a product’s MA and it cannot be changed without prior approval from the VMD.  Some products also have datasheets, which are different to the SPC.   The VMD does not assess or approve datasheets because they are not a requirement under legislation, however, the information in the datasheet should be the same as the information contained in the approved SPC.

SPCs are available on the VMD product information database.

22. UK Public Assessment Report (UKPAR)

All products authorised after 30 October 2005 have an UKPAR in accordance with legislation, which can be found on the VMD product information database

An UKPAR is split into three parts:

1.         Summary of Product Characteristics.

2.         Scientific Discussion: a summary of the assessment report drafted during the application procedure covering quality, safety, environmental safety and efficacy.

3.         Post Authorisation Assessments: this sets out any changes that have been made to the MA since it was first authorised, such as any variations or renewals conducted on an MA.

23. Veterinary Products Committee (VPC)

An independent scientific committee formed under the Veterinary Medicines Regulations to give scientific advice on any aspect of veterinary medicinal products asked for by the Secretary of State.

24. The Veterinary Medicines Regulations 2009 (legislation.gov.uk)

25. Virulence

The ability of a microorganism to produce disease in the affected animal.

26. X–CICADA-Live

Computer-based Investigation into Companion Animal Disease Awareness.  The research data was collected in the six months to May 2009 by Intervet/Schering Plough Animal Health.  The response compiled from 95 veterinary practices and representing 332 vets across Britain and includes suspected and confirmed incidents of disease.

27. Zoonosis

A disease of animals that is transmissible to man.