AUTOGENOUS VACCINES

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What is an autogenous vaccine?

Autogenous vaccine: An inactivated immunological veterinary medicinal product that is manufactured from pathogens and antigens obtained from one or more animals in an epidemiological unit and used for the treatment of such animal(s) in the same epidemiological unit or for the treatment of one or more animals in a unit for which an epidemiological link has been confirmed.

It is an autogenous vaccine only if it is a vaccine…

  • Manufactured on demand and under veterinary prescription.
  • Made out of recently isolated pathogens from a specific farm.
  • Destined to a specific farm, or various farms if related epidemiologically.
  • Constantly updated.
  • Inactivated, and therefore very safe.

When are they indicated?

  • When there is no registered vaccine marketed for that animal species and indication.
  • When a commercial vaccine is not available.
  • When existing commercial vaccines do not cover the antigenic variants (serotypes, virulence factors, etc.) present on the farm.
  • When lack of efficacy of the commercial vaccine has been demonstrated.

Autogenous vaccine production process

  1. Presence of sick animals with obvious clinical signs: the veterinarian makes a clinical diagnosis.
  2. Sampling: sending to the laboratory.
  3. Laboratory diagnosis: differential diagnosis, isolation of strains and their characterisation.
  4. Autogenous vaccine design: define which strains, serotypes, etc. are included.
  5. Order: always under veterinary prescription.
  6. Manufacturing: by an authorised laboratory following standardised production protocols.
  7. Quality control: composition, inactivation and sterility of the final injectable product are controlled.
  8. Shipping and application: shipped to farm, owner or veterinarian.

EXOPOL: authorised laboratory (REG No. 235/50/015-AV).

Who is involved

  • Registered veterinarian
  • Diagnostic laboratory
  • Autogenous vaccines producer

Applicable legislation:

  • Real Decreto 666/2023, de 18 de julio, por el que se regula la distribución, prescripción, dispensación y uso de medicamentos veterinarios (Spanish legislation).
  • Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC.