State of the art vaccines for sustainability, profitability and fish welfare - Ben North, PHARMAQ UK
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Making a vaccine: from idea to licensed product Identification - process development – production – validation – documentation - license Slide No. 2
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
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
ISA in Chile – effect on sea launch and production of salmonids Source Kontali Anaysis ,* PHARMAQ estimate Slide No. 6
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
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
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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