United States Department of Agriculture Animal and Plant Health Inspection Service
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1 United States Department of Agriculture Animal and Plant Health Inspection Service Vaccination Strategy for Swine & Swine Workers: Swine Influenza Virus, pandemic H1N1, & other Flu Viruses 7 th Annual National One Medicine Symposium December 9, 2009 Patricia Foley, DVM, PhD Risk Manager Center for Veterinary Biologics PEL 1920 Dayton Ave. Ames, Iowa USA patricia.l.foley@aphis.usda.gov Safeguarding Animal Health Center for Veterinary Biologics
2 Animal and Plant Health Inspection Service (APHIS) Veterinary Services Deputy Administrator Veterinary Services National Animal Health Policy & Programs Riverdale, MD National Veterinary Services Laboratories Ames, IA Plum Island, NY Center for Veterinary Biologics Ames, IA Riverdale, MD Centers for Epidemiology and Animal Health Fort Collins, CO VS Field Operations Eastern Region Raleigh, NC Western Region Ft. Collins, CO
3 Influenza Virus Subtypes: antigenic drift, shift Random mutations Reassortment Avian flu viruses prefer HA cell receptors with α2-3-linked sialic acid residues; Mammalian flu viruses prefer HA cell receptors with α2-6- linked sialic acid residues Swine have both types of cell receptors for HA: dual infection may allow reassortment and development of new subtypes and new variants of subtypes
4 Animal Flu Vaccines for pigs, poultry, horses, dogs Not or
5 Swine Influenza Virus H1N1 - classical (1930), atypical, variant H3N2 - late 1998 (hu x sw, hu x sw x av) H1N2-2001; hu-h1 viruses H2N (av X sw) H2 not in humans since 1968 = pandemic risk European vs. American strain differences Other strains detected in pigs: H1N7, H3N1, H4N6, H9N2, HPAI H5N1, H3N8, ph1n1
6 Current Flu in N. American Swine ph1n1 (+ ARG,UK,NOR,HK,AUS,IRE,JAP, etc) and other H1N1: respiratory disease in pigs H3N2: abortions, off feed, fever, mortality Most H3N2 isolates are triple reassortants with a similar cassette : Human (HA, NA, PB1) Swine (NS, NP, M) Avian (PB2, PA) swh3n2 similar to huh3n2 (vaccines may protect), swh1n1 not similar to huh1n1(more susceptible) H1N1, H3N2, H1N2, H3N1 strains continue to drift & reassort: need surveillance and vaccine changes
7 Pandemic H1N1 Influenza ph1n1 is a quadruple reassortant also with a cassette but: Eurasian NA & M genes unique Human (PB1) N. American Swine (HA, NP, NS) Eurasian Swine (NA, M) Avian (PB2, PA) Current SIV vaccines may not adequately protect against ph1n1-induced clinical signs + shedding Countries had bans on swine or pork product imports from part or all of the US, now ~7 [Pork is safe!] Goal: prevent spread in the US swine herd, e.g. from exposure to an infected person or animal
8 Vaccination Strategy Vaccinate humans and swine 75,442 US farms w/ swine 30,546 US hog operations Vaccines protect best vs. homologous strains Antigenic drift and shift require changing antigenic content periodically Surveillance, prediction can be very helpful: 40% vs % effective for human flu Mechanism to replace/add strains fast is needed
9 Current Flu Vaccines for Swine Inactivated vaccines: SIV strains alone or with other fractions; no live products Commercial vaccines Variety of H1N1 & H3N2 strains from Master Seed Viruses PRV, E rhu, M hyo, Parvo, Lepto 5- or 6-way Autogenous vaccines firms produce from original herd isolates 9CFR VCP exemption to certain requirements ph1n1 subunit
10 For Standard Full USDA License Supporting Data Must Demonstrate Purity of: Master Seed Master Cell Stock Ingredients Completed Product bacterial/fungal contamination inactivation
11 Supporting Data Must Demonstrate Safety in: Laboratory animals Host animals Master Seed Testing (live) Reversion to virulence Shed and Spread Environmental safety Efficacy studies (limited numbers) Field safety Normal conditions of use, multiple sites Reaction rates Final product (serial release testing)
12 Supporting Potency and Efficacy Data Must Demonstrate: Support of label claims (age, route, etc.) Master Seed immunogenicity (usually host animal vaccination/challenge) Established completed product potency Duration of immunity Stability
13 VS Memo on Viral Strain Changes in Inactivated Equine and Swine Influenza Vaccines To replace/add strains using this method, no substantial production changes Strains can be subtracted or added w/o repeating full-scale efficacy and field safety studies Justification of strain replacement/selection is required No more than 3 strains of a subtype per licensed product H and N subtypes stated Dropping of irrelevant strains encouraged
14 Methods for Using SIV Vaccines Standard license per 9CFR requirements VS Memo for expedited strain changes in already licensed products Conditional license Autogenous license VCP exemption
15 Conditional License Title 9 Code of Federal Regulations (102.6) and VS Memorandum Emergency: emerging disease Limited market or local situation Other special circumstances License expiration Special labeling Live, killed vaccines
16 Conditional License Pros Purity, safety, well known Master Seed tested Reasonable expectation of potency and efficacy Wider distribution Relatively quick Proceed to standard license Cons Time to license Efficacy may be uncertain May lack potency test for each serial Distribution may be limited Limited to domestic products (no permits)
17 Methods for USDA Licensure of Flu Vaccines for Swine Standard full license with all testing completed New or unique strains, new production method Expedited strain change in inactivated vaccine Vaccine is an already-licensed product Production method is the same Conditional license pending efficacy study Where there is reasonable expectation of efficacy Autogenous license for inactivated vaccine VCP, herd of origin, adjacent herd restrictions
18 Autogenous License 9 CFR and VS Memo Inactivated products only Veterinarian (or approved nonvet specialist)- Client-Patient relationship Restricted to herd of origin (adjacent premises under certain conditions) Restricted to domestic agents Licensed facility, approved Outline of Production
19 Autogenous License Pros Basic purity known (freedom from bacteria, fungi) Inactivated Laboratory animal safety known New isolates Quick Cons Not tested for extraneous agents Host animal safety, potency and efficacy not established Limited distribution (primarily herd of origin) No USDA confirmatory testing of seeds Limited to domestic agents
20 CVB is Providing ph1n1 Master Seed Viruses (MSV) to Firms Three tested & approved ph1n1 viruses for use in a conditionally licensed vaccine: A/CA/04/09 A/MX/4108/09 A/reassortant/NYMC X-179A Firms don t each have to develop their own: Saves the firms time: they work on other aspects of licensure Saves CVB time: confirmatory testing done on one set of MSV, not each firm s MSV
21 CA/04, MX/4108 H1N1 MSVs CDC - NADC - CVB 2 passages in Madin Darby Canine Kidney (MDCK) Pig passaged at NADC 5-week-old cross-bred pigs Inoculated intra-tracheally 2 ml of 1 x % TCID50 Euthanized on 5 dpi 50 ml of Lung lavage At CVB passaged in MDCK (1X) DMEM, BSA 0.2%, trypsin (TPCK treated) 2 μg/ml CPE hrs, freeze-thaw, centrifuged, filtered 0.45 μm Not adapted to eggs
22 A/reassortant/NYMC X-179A A/reassortant/NYMC X-179A A/California/07/2009 (H1N1)v NYMC X-157 (H3N2) A/New York/55/2004 (H3N2) A/Puerto Rico/8/1934 (H1N1)
23 Propagation of ph1n1 MSV 4 Master Seed Viruses A/CA/04/09 A/MX/4108/09 X-179A (with CA/07 HA and N) Pig passage (NADC) Yes Yes No No Propagated MDCK MDCK Eggs MDCK MDCK -grown: Egg grown:
24 Extraneous Agent Testing - 1 FA on 6 Cell Lines Bovine virus diarrhea virus 1 and 2 Reovirus Rabies virus Bluetongue virus Bovine adenovirus 1 and 5 Bovine parvovirus Bovine respiratory syncytial virus Canine coronavirus Canine distemper virus Canine parvovirus Porcine adenovirus Porcine parvovirus Transmissible gastroenteritis virus Porcine hemagglutinating encephalitis virus PRRSV
25 Extraneous Agent Testing - 2 Testing for hemadsorbing, cytopathogenic, fluroescent antibody staining viruses Testing for avian lymphoid leukosis Testing for bacteria, fungi, mycoplasma PCR assays for reticuloendotheliosis virus, chicken anemia virus, PCV-2, mycoplasma RT-PCR assays for PRRSV, Pestivirus Pan-human microarray assay Mouse safety testing
26 The One Medicine Perspective
27 Surveillance Present for many years: industry, academia in 2008, a more integrated approach: SIV Pilot Project developed by CDC-USDA With ph1n1, accelerated surveillance for flu in swine Voluntary private vet samples (nasal swabs, lung) from clinically ill animals to the NVSL/NAHLN Samples from clinically ill animals identified at public events or markets Epidemiological follow-ups in swine herds exposed to human patients with ILI
28 Surveillance Goals Detect new influenza strains in swine in a timely manner If present, determine distribution and prevalence of the new strains in swine Determine genetic characteristics of new viruses necessary for vaccine & diagnostics development Develop a National Flu Vaccine Strain Selection System for swine
29 Front row: Sandy Conrad Melisse Schilling Mary Beth Evans Amy Shaffer Pat Foley Joe Hermann Back row: Claude Hovick Deb Narwold Dani Koski Alethea Fry Donna Gatewood Peg Patterson Doug Murtle Questions or comments???
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