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Vaccine titres - efficacy, safety and regulatory
Transcript of Vaccine titres - efficacy, safety and regulatory
MaxRT Minimum Release Titre MED / MPD / EOSLT Increasing titre
Maximum Release Titre Minimum Effective Dose Increasing titre Animal-defined titres Product-defined titres An enthusiast's guide to vaccine titres Robert Pottie International requirements Titre: A form of defining concentration by means of titration - the amount of organism in a quantity of vaccine (MED, or Minimum Protective Dose, MPD) How do we define effective? e.g. Pasteurella vaccine monograph: Control group: Vaccinated group: Does MED = EOSLT (End of Shelf Life Titre?) Depends on jurisdiction The maximum dose safe for the animal How do we define safe? Regulatory requirements include:
Repeat 1xMaxRT doses
Specific monograph thresholds (MaxRT) Target titre (MinRT) Defined primarily by the stability of the product The MinRT is set to ensure the product stays above EOSLT until at least the expiry date Not required by any regulator
The basis of productions calculations
Accounts for variation inherent in production and assay variation
Balances MinRT with wastage Therefore, tightly linked to EOSLT and shelf life (Animal-defined) (Product-defined) Australia (APVMA)
EU (EMA): EOSLT (=MED)
MaxRT US (CVB): MED defines EOSLT Japan: Minimum titre (MED) ~MaxRT >70% affected >70% unaffected *