State of the art vaccines for sustainability, profitability and fish welfare - Ben North, PHARMAQ UK

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State of the art vaccines for sustainability, profitability and fish welfare - Ben North, PHARMAQ UK
State of the art vaccines for sustainability,
profitability and fish welfare

Ben North, PHARMAQ UK
State of the art vaccines for sustainability, profitability and fish welfare - Ben North, PHARMAQ UK
Making a vaccine: from idea to
      licensed product

Identification - process development – production – validation – documentation - license

                                     Slide No. 2
State of the art vaccines for sustainability, profitability and fish welfare - Ben North, PHARMAQ UK
Vaccination for sustainability

            Slide No. 3
State of the art vaccines for sustainability, profitability and fish welfare - Ben North, PHARMAQ UK
Vaccination and sustainability
                                        60           Antibiotic usage in Norwegian salmon farming                                              700
                                                     Fish production (’000 tonnes)

                                                                                                                                                     1000 metric tonens of salmonids produced
                                                                                   *                                                           600
 No. kgs of antibiotics (in thousand)

                                        50
                                                                                                                                               500
                                        40                                               *
                                                                                                                                               400
                                        30
                                                                                               *
                                                                                                                                               300
                                        20
                                                                                                                                               200
                                        10                                                                                                     100
                                                                                                           *
                                                                                                               *
                                        0    74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05
                                                                                                                                               0

                                                                                       Slide No. 4
State of the art vaccines for sustainability, profitability and fish welfare - Ben North, PHARMAQ UK
Geographical distribution of Positve Farm sites in X                              Voigue (CMCH)
                                                                                    Diciembre

Region. Updated July 31, 2008                                                     Chelín Sur (MH)
                                                                                   20 Diciembre
                                                                                 Planchada (MH)
                                                                                  20 Diciembre
     Puchilco (MH)
        25 Julio                                       Buill (S. Humboldt)       Punta Cuem (MH)
                                                               Mayo
                                                                  y                12 Diciembre
    Aldachildo (MH)
        26 Julio                                          Putique (MH)            Aguantao (MH)
                                                              Mayo
                                                                 y                 28 Diciembre
    Cahueldao (AC)
       26 Julio                                        Chelín Norte (MUL)          Puyao (MH)
                                                              Mayo
                                                                y                   21 Enero
   Curaco de Lin-Lin
    ((MH)) 06 Agosto
               g                                         Matao (C.PAC)            Chulchuy (MH)
                                                             Mayo
                                                                y                   21 Enero
     Cheñiao (MH)
           g
      13 Agosto                                          Quenac (S.ANT)           Tanecuhe (MH)
                                                             Junio                   23 Enero
  S. Juan de Chadmo
   ((MAI)) 20 Agosto
               g                                       Guamblad (P.STAR)        Guamblad (AQCH)
                                                             Junio                 04 Febrero
    Chalihué (INV)
           g
      28 Agosto                                           Auchac (INV)            Llicaldad (MH)
                                                             Junio                  04 Febrero
     Apabon (MH)
         p
    24 Septiembre                                        Cahuach (MH)              Lin-Lin (MH)
                                                          18 Febrero                06 Febrero
     Lincay (MH)
         p
    26 Septiembre                                      San Pedro (P.STAR)      Conchas Blancas (MH)
                                                             Junio                  07 Febrero
     Teliupta (MH)
      11 Octubre                                        Isla Guar (S.MAU)       Pta. Aguantao (MAI)
                                                               Junio                  Febrero
    Chalihué (MH)
     11 Octubre                                            Ichuac (AC)            Alao Sur (MH)
                                                              Junio                18 Febrero
   Chelín Bajo (MH)
     19 Octubre                                           Meulin (INV)           Alman (P.STAR)
                                                            Junio                    Marzo
      Terao (MH)
      24 Octubre                                          Chauco (MAI)             Teupa (MAI)
                                                             Julio                   Marzo
     Huenao (MH)
      31 Octubre                                          Traigen (INV)           Pta. Llancacheo
                                                              Julio                (CMCH)Abril
                                                                                   (       )
    Quinchao (MH)
     30 Octubre                                           Yelcho (CAM)           Cachihué(CMCH)
                                                              Julio                    Abril
     Imelev (MAI)
       Octubre                                          Fiordo Largo (FB)          Ahoní (CAM)
                                                              Julio                   Abril
   Quellón V (AQCH)
    05 Noviembre                                       Bahía Edwards (FB)         Pitihorno (MUL)
                                                              Julio                     Abril
     Yaotal (MH)
      Noviembre                                          Leutepu (GMT)             Apiao (MUL)
                                                              Julio                    Abril
    Peldehue (MH)
    06 Noviembre                                         Isla Tac (CMCH)           Quilen (MAI)
                                                               Julio                   Abril
     Huelmo (MH)
     12 Diciembre                                      Faro Mauchil (AQCH)        B. Corcovado
                                                              Julio               (P.STAR)
                                                                                  (       ) Abril
    Huar Sur (MH)
      Diciembre                                            Chilco (FB)            Tenaun (H&T)
                                                              Julio                  Mayo
                                                                                        y
   Huar Norte (MH)
    20 Diciembre
                                                                    Outbreak      Suspicious
State of the art vaccines for sustainability, profitability and fish welfare - Ben North, PHARMAQ UK
ISA in Chile – effect on sea launch and production
                         of salmonids

Source Kontali Anaysis ,* PHARMAQ estimate

                                             Slide No. 6
State of the art vaccines for sustainability, profitability and fish welfare - Ben North, PHARMAQ UK
Developing our ISAV vaccine; an R&D
               success story
•   Choice of ISAV strain
•   Developing a reproduceable challenge model
•   Optimisation of culture process for a cost-effective vaccine
•   R&D investment ISA projects cost more than 7 mill USD

•   ALPHA JECT micro1 ISA , mono-valent ISA vaccine licensed March
    2010
•   ALPHA JECT 5-1a penta-valent vaccine; licensed May 2010
•   AJ micro 1 ILA June 2010 (accepted for sale in Norwegian ISA zone)

                               Slide No. 7
State of the art vaccines for sustainability, profitability and fish welfare - Ben North, PHARMAQ UK
Vaccination for improved profitability

                 Slide No. 8
State of the art vaccines for sustainability, profitability and fish welfare - Ben North, PHARMAQ UK
Introducing ALPHA JECT Panga 1
• ALPHA JECT Panga 1: Monovalent Edwardisella ictaluri
• Granted an observational licence in 2011; first
  commercial scale vaccination now underway
• Benefits demonstrated in the Panga 1 field trial:
  –   Increase survival and yield
  –   More uniform size (fewer under/over sized fish
      rejected from filet factory)
  –   Reduced likelihood of infection from other pathogens
  –   Reduced antibiotic usage
  –   Reduced production cost
  –   Reduced risk for farm owner

                         Slide No. 9
State of the art vaccines for sustainability, profitability and fish welfare - Ben North, PHARMAQ UK
Vaccination for profitability

              Slide No. 10      10
SRS field trail: cumulative mortality
  and growth

Fewer antibiotic interventions required in fish vaccinated with PHARMAQ vaccines
(4 compared with 7 treatments in the mixed and competitor vaccinated fish)

                                 Slide No. 11
Vaccination for improved
fish welfare

                     12
Minimising side-effects: ILAB
  extended safety testing
        Every batch of vaccine is tested for efficacy and
        vaccine safety at external accredited laboratories
        before approval for release;
        • VESO Vikan (efficacy)
        • Norwegian Institute of Fisheries and Aquaculture
          Research, Kårvika (safety 6 wks. post-vaccination
          with double dose)

        Additional testing is carried out in-house by PHARMAQ:
        • ILAB, Bergen (6 & 12 wks @ 17oC i.e. worst case
          scenario)
        • Consensus meetings
        • This is over and above any regulatory requirements
          and provides additional assurances to the safety of
          PHARMAQ vaccines

                  Slide No. 13
PHARMAQ-SalmoBreed-NOFIMA
                                 Vaksinering: 4 mars 2008
                                 Merkemetode: PIT                                                150 families
                                 Evaluering: 6mpv(nov-2008) (blindet)                            Vaccine: AJ6-2 vs. AJ Micro 6

                                      Mean adhesion score per family (n=15/family)
                      4
                                                                                                   AJ 6-2 adh = 2.3
                     3,5
                                                                                                   AJ Micro 6 adh = 1.7
ALPHA JECT Micro 6

                      3

                     2,5                                                                           After 12 months, groups
                                                                                                   of fish injected with
                      2
                                                                                                   ALPHA JECT Micro 6
                     1,5                                                                           revealed an 8 % average
                      1
                                                                                                   higher weight compared
                                                                                                   to fish injected with an
                     0,5
                           0,5        1      1,5       2      2,5          3           3,5   4
                                                                                                   ordinary 0.1 ml dose of AJ
                                                     ALPHA JECT 6-2                                6-2.

                                                                        Slide No. 14
Current challenges and future
developments in fish vaccination

              Slide No. 15
Challenges to be overcome
•   Protecting fish throughout the entire production cycle:
     – FW diseases affecting fish too small for I.P. Vaccination
     – Diseases affecting fish towards the end of the production cycle; challenge
       could be >1 year after vaccination
•   IP barriers:
     – Compatibility with other supplier’s vaccines
     – Necessity for two separate vaccination operations (↑stress ↑cost)
•   Limitations on space in the vaccine i.e. how many components can fit
    into one jab?
•   Consumer perception and regulatory barriers to different vaccination
    technologies e.g. recombinant, live, DNA etc.
•   Translating the success seen in high value species like salmon to low
    value high volume markets.

                                    Slide No. 16
Concluding remarks
• Vaccination is now an integral part of commercial
  aquaculture of high value species e.g. salmon, bass
  bream.
• Now need to translate the success seen in high value
  species like salmon to low value high volume markets.
• Vaccination can:
   – prevent most bacterial diseases
   – reduce mortality caused by viral diseases
• Efficacious vaccines has been one of the main drivers
  behind the global success of salmon farming.
• Successful vaccination outcomes rely on correct
  administration of products to healthy fish.

                            Slide no. 17
Thank you for your attention
PHARMAQ/SalmoBreed
                  Average weights of fish vaccinated with AJ 6-2 or AJ Micro 6 in 150 families, 6
                                         months after seawater transfer
   1600

   1400

   1200

   1000
Vekt (g)

           800

           600

           400                       Fulldose
                                     Redusert dose
           200

            0
                                 All families plotted as a function of increased weight in AJ Micro 6 vaccinated fish - 0.05 ml dose

                 Groups of fish injected with ALPHA JECT Micro 6 revealed an 8 % average higher weight compared to
                 fish injected with an ordinary 0.1 ml dose of AJ 6-2.

                 Average weight for AJ Micro 6 vaccinated fish was 1080 gram.
                 Average weight for AJ 6-2 vaccinated fish was 1002 gram.

                                                                        Slide No. 15
Vaccination in the poultry industry
• Widespread use of live and recombinant vaccine
• Vaccination of day old chicks
• Delivery: in-ovo, spray/inhalation, oral, injection
• 43 day production cycle for broilers
• Not unusual for >20 vaccines to be administered
• DIVA vaccine control strategies e.g. AI

Images courtesy of Worldpoultry.net

                                       Slide No. 17
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