Risk analysis for veterinary vaccines in Australia

Risk analysis for veterinary vaccines in Australia Sam Hamilton Office of the Chief Veterinary Officer Australian Department of Agriculture, Fisheries and Forestry

Overview Australia s animal health system Market for veterinary vaccines in Australia Use of a GMO vaccine for equine influenza in 2007 Roles of regulatory bodies in Australia Additional risk analysis for GMO vaccines in Australia, using example of EI vaccine Examples of feedback mechanisms to regulators: control of distribution Monitoring safety

Organisation of animal health in Australia Australian government responsible for quarantine, international animal health issues, national coordination State and Territory governments responsible for disease control and eradication Animal Health Australia facilitate, manage, evaluate national programs and liaison with industry bodies

Veterinary vaccines in Australia We are a small international market: 9 domestic producers of veterinary vaccines 11 companies distribute veterinary pharmaceuticals Over 70% of registered products are for foodproducing species (pigs, ruminants & poultry).

Australia s equine influenza epidemic in 2007 25 August 2007 EI confirmed in NSW 76,000 horses on 10,651 premises infected in NSW and Queensland Provisional freedom declared on 14 March 2008 Declared freedom 30 June 2008

Vaccination for equine influenza in Australia in 2007 Vaccination not initially used to control infection National agreement to use vaccine occurred 3 weeks after EI confirmed Buffer vaccination was used with biosecurity, movement controls, zoning and quarantine to control infection Proteqflu and Proteqflu TE (Merial), canarypox vectored vaccine was the vaccine of choice 5 inactivated products also considered Also used to reduce disease in infected areas and protect vulnerable industries Over 320,000 doses administered

Stakeholder consultation on permits for EI vaccine Australian CVO Regulators Gene Technology Ministerial Council Australian Pesticides and Veterinary Medicines Authority Environment Dept State government Australian Chief Medical Officer

Regulation of vaccines for emergency use Office of the Gene Technology Regulator / Minister for Gene Technology AQIS / Biosecurity Australia Emergency Dealing Determination Import permit Australian Pesticides and Veterinary Medicines Authority Emergency use permit

Office of the Gene Technology Regulator (OGTR) Part of the Department of Health and Ageing Regulates research, manufacture, production, transport, disposal and import of all GMOs (crops, human and vet products) Conducts risk analysis into the impacts on the health and safety of people and the environment GMO vaccines come under three types of licenses: Dealings not involving intentional release Dealings involving intentional release Emergency dealing determinations

Risk communication Monitor and review OGTR risk analysis framework Licence application Risk context Risk assessment Risk management plan Issue a licence? Yes Licence No licence Monitor for compliance

OGTR risk assessment process EVIDENCE What could go wrong? How could harm occur? Risk identification (Risk scenarios) How serious could the harm be? Consequence assessment How likely is harm to occur? Likelihood assessment UNCERTAINTY What is the level of risk? Risk estimation

OGTR likelihood assessment Category Highly likely Likely Unlikely Highly unlikely Description Is expected to occur in most circumstances Could occur in many circumstances Could occur in some circumstances May occur only in very rare circumstances

OGTR consequence assessment Category Major Intermediate Minor Marginal Description The negative impact is severe The negative impact is substantial There is some negative impact There is minimal or no negative impact

LIKELIHOOD ASSESSMENT OGTR risk matrix RISK ESTIMATE Highly likely Low Moderate High High Likely Low Low Moderate High Unlikely Negligible Low Moderate Moderate Highly unlikely Negligible Negligible Low Moderate Marginal Minor Intermediate Major CONSEQUENCE ASSESSMENT

OGTR Application to use EI vaccine Australian CVO applied for an emergency dealing determination from OGTR to use GMO vaccine Specified that vaccination would be conducted by registered veterinarians Tactical use would be under state CVO control, after plan endorsed by national emergency management committees

OGTR risk management for EI vaccine Emergency Dealing Determination issued for 6 months Requirements: Inform the Regulator if any new risk suspected Inform others using the GMO of their obligations Regulator must be able to access, audit and monitor premises where GMO imported, held, used or disposed Record keeping of supply and movement of product Approved containers must be used Imported into a quarantine approved premises, and only moved under direction of the Chief Veterinary Officer or delegate of the state or territory All contaminated waste collected and incinerated

Australian Quarantine and Inspection Service / Biosecurity Australia AQIS responsible for assessing and issuing import permits for imported vaccines, based on animal products used in manufacture and treatments Concerned about animal biosecurity risk of contamination Biosecurity Australia responsible for providing policy advice to AQIS on the animal health risks with imported vaccines AQIS assessed the risks associated with the animal materials used in the manufacture of Proteqflu according to existing policies and issued an import permit

Australian Pesticides and Veterinary Medicines Authority (APVMA) Evaluation, registration and review of agricultural and veterinary chemicals Issuing of registration/permits: Full registration Minor use, emergency, trial and research permits Assess GMP and supply of chemical products Ensure and enforce compliance with regulations Control of use is conducted by state/territory authorities

APVMA assessment process for EI vaccine Chemistry and manufacture Environmental safety Target species efficacy and safety No local data, so used data from EU dossier Must be manufactured according to Australian or equivalent Good Manufacturing Practice OGTR and AQIS import permits are mandatory

APVMA import permit for EI vaccine Emergency permits issued to Australian CVO to allow the emergency supply and use of the unregistered product The permit required that: the product may be supplied to state/territory Department of Primary Industries (or equivalent) disease control centres on the written order of the Chief Veterinary Officer (CVO) or Deputy CVO of the relevant state or territory and subsequently to persons as ordered, directed or authorised by the CVO or Deputy CVO to use the product. Persons ordered, directed and authorised by CVO or DCVO are directed to read the permit

Agencies responsible for control of distribution and use A private company managed the storage, distribution, cold chain and documentation of vaccine movements Vaccination conducted by registered veterinarians authorised by the state CVO/DCVO after completing online training All vaccinated horses were identified permanently by microchip or harness racing brand Database used to manage applications for use of vaccine, approvals, manage release and return of vials, and record vaccination certificates OGTR conducted audits on the use and control of vaccine in Queensland, Victoria, NSW and ACT, all were found compliant

Monitoring safety - adverse experience reporting APVMA runs the national adverse experience reporting program (AERP) Vaccination teams advised owners on potential vaccine reactions and were provided with forms to report adverse experiences Data were collated by states and reported to APVMA Classified by AERP, according to an algorithm, as probable, possible, unlikely or unknown Results: Few formal reports of minor adverse events 43 horses in NSW and 5 in QLD had adverse events reported The number of adverse reactions were negligible compared with the number of horses vaccinated.

Discussion The OGTR s role to regulate all GMO use is a One Health approach For EI, a candidate vaccine selected and necessary permits arranged for import and use within 3 weeks Process was quicker because of the registration and manufacturing data from the EU Obtaining necessary permits and developing policies before outbreaks would reduce time to deployment AUSVETPLAN outlines the potential use of emergency vaccination in emergencies

Further information OGTR: www.ogtr.gov.au APVMA: www.apvma.gov.au AQIS: www.aqis.gov.au Biosecurity Australia: www.daff.gov.au/ba Office of the Chief Veterinary Officer: www.daff.gov.au/animal-plant-health/animal Animal Health Australia: www.animalhealthaustralia.com.au

Thank you