Licensing Requirements for vaccines: US perspective Larry R. - - PowerPoint PPT Presentation

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Licensing Requirements for vaccines: US perspective Larry R. - - PowerPoint PPT Presentation

Apr 09, 2024 389 likes •603 views

Animal and Plant Health Inspection Service Licensing Requirements for vaccines: US perspective Larry R. Ludemann, M.S., D.V.M. Center for Veterinary Biologics 1920 Dayton Avenue Ames, Iowa USA 50010 Email: larry.r.ludemann@usda.gov CVB

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SLIDE 1

Licensing Requirements for vaccines: US perspective

Larry R. Ludemann, M.S., D.V.M. Center for Veterinary Biologics 1920 Dayton Avenue Ames, Iowa USA 50010 Email: larry.r.ludemann@usda.gov

Animal and Plant Health Inspection Service

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CVB Mission

The Veterinary Biologics Program implements the provisions of the Virus-Serum-Toxin Act to ensure the veterinary biologics available for the diagnosis, prevention and treatment of animal diseases are pure, safe, potent, and effective.

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Primary Missions (linked to VSTA)

  • Licensing/Permitting Veterinary Biological Products
  • Evaluating product dossiers
  • Evaluating (testing) products and product critical components
  • Program documentation (notices, memorandum, regulations,

licensing considerations)

  • Facility inspections
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SLIDE 4

Product Types

  • Vaccine
  • Bacterin and Bacterial Extract
  • Toxoid
  • Bacterin-Toxoid
  • Antitoxin
  • Antiserum and Antibody
  • Diagnostic Test Kits
  • Immunomodulator and Immunostimulant
  • Allergenic Extracts
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SLIDE 5

Testing Activities

  • Confirmatory and Investigatory Testing (pre- and post-

license)

  • Seeds and cells
  • Final Product (check and surveillance)
  • Test development and standardization
  • Reference/reagent production and distribution
  • Technical harmonization
  • Quality Assurance
  • Training and scientific advice
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SLIDE 6

Confirmatory and Investigative Testing

  • Pre-license
  • Seeds
  • Cells
  • First Serials
  • Post-license
  • Random selection of samples prior to release
  • Problem, surveillance, stability, dating extension,

reprocess

  • First serials after change
  • Investigation of field reports
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SLIDE 7

Confirmatory and Investigative Testing

  • Efficacy (Pre-license)
  • Host Vaccination-Challenge
  • Minimum antigenic dose, highest

passage

  • Route, Age, etc.
  • Duration of Immunity
  • Field performance (Post-license)
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SLIDE 8

Confirmatory and Investigative Testing

  • Potency - correlated to Efficacy
  • Live
  • Enumeration
  • Killed
  • Vaccination-challenge/Vaccination-

serology

  • Host Animal
  • Laboratory Animal
  • In Vitro
  • Validated with in vivo testing
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SLIDE 9

Confirmatory and Investigative Testing

  • Safety
  • Pre-license
  • Controlled animal studies
  • Backpassage
  • Field trials
  • Post-license
  • Laboratory animals
  • Target animals
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SLIDE 10

Licensing Exemptions

  • Official USDA Program, emergency disease situation,
  • r USDA experimental use
  • Veterinarian-client-patient relationship
  • Animal owners
  • Products under State license
  • Currently, no active state programs
  • FDA Export Reform and Enhancement Act of 1996
  • No U.S. Establishment # on the label
  • Not approved for distribution in the U.S.
  • Claims not allowed in the U.S.
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SLIDE 11

Types of Product Licenses

Standard

  • Autogenous
  • Conventional
  • Breakout or fall-out
  • Genetic modified

Conditional

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SLIDE 12

Autogenous Product

Requirements:

  • Outline of Production
  • If killed viral Autogenous Vaccine
  • CVB confirmatory testing and approval of

Master Cell Stock (MCS)

  • Labels

Risks:

  • Unknown efficacy
  • Unknown potency
  • Minimal safety
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SLIDE 13

Conventional Products

Requirements (VS Memorandum 800.50):

  • Outline of Production
  • CVB confirmatory testing Master Seed(s)
  • If modified-live: reversion-to-virulence and

shed-spread studies

  • If viral vaccine
  • CVB confirmatory testing of MCS
  • Efficacy studies
  • Establish minimum dose
  • Duration of immunity studies
  • Immunological interference studies
  • Studies in maternal antibody-positive

animals

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SLIDE 14

Conventional Products

Requirements (continued):

  • Safety studies
  • Field Safety
  • If Killed vaccine:
  • Inactivation kinetics
  • establishment of slaughter withholding period

for adjuvant

  • Potency test validation data
  • Reference qualification & stability monitoring
  • Sensitivity/specificity
  • CVB confirmatory testing prelicense batches
  • Labels
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SLIDE 15

Conventional Products

Risks:

  • Minimal
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SLIDE 16

Breakout of Conventional Products

Requirements:

  • Combination products may be blended into

smaller fraction products following same manufacturing procedures and release criteria

  • Outline of Production
  • Labels

Risks:

  • Safety-excess antigen concentrations
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SLIDE 17

Genetic Modified Products

Same requirements as conventional products plus:

  • Summary Information Formats (SIF). For Master

Seeds produced by recombinant DNA technology, additional safety and identity data

  • Publication of an environmental release risk

assessment before conducting Field Safety

  • CVB confirmation of recombinant seed

Risks: Safety-Recombination of Live Vectored products

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SLIDE 18

Conditional Licensed Products

Requirements:

  • All are mono-fraction majority Killed Products
  • Outline of Production
  • CVB confirmatory testing Master Seed(s)
  • If viral vaccine
  • CVB confirmatory testing of MCS
  • Reasonable expectation of efficacy study
  • Serology
  • Small host animal vaccination/challenge
  • Safety studies
  • Field Safety
  • Inactivation kinetics
  • establishment of slaughter withholding period

for adjuvant

  • Labels
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SLIDE 19

Conditional Licensed Products

Risks:

  • Unknown efficacy
  • Potency not correlated to efficacy
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SLIDE 20