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PotentialPotential HumanHuman BirdBird FluFluOutbreakOutbreak in in thethe CzechCzech
RepublicRepublic
KaKarelrel LehmertLehmertStateState Office Office forfor NuclearNuclear SafetySafety
Department Department ofof BiologicalBiological WeaponsWeapons ProhibitonProhibiton
StateState Office Office forfor NuclearNuclear SafetySafety
Radiological• Radiological Protection• Emergency Prepareness
Chemical• The Chemical Weapons Convention
Nuclear•Nuclear Safety
•The Non-proliferation Treaty• The Comprehensive Test Ban Treaty
Biological• Bacteriological (Biological) and Toxin
Weapons Convention
LegislationThe Act on Prohibition of Biological WeaponsNo. 281/2002 Coll.The Act No. 594/2004 Coll. on Export Control ofDual-use Goods and Technology (Council Regulation No. 1334/2000)
The Act No. 186/2004 Coll., Customs Act
The Penal Act No. 140/1961 Coll.
Decree No. 474/2002 Coll.
Act No. 281/2002 Coll.Governmental administration authority
Establishment of governmental record keeping
Handling of biological agents and toxins
Handling control and supervision
Defines competencies of inspectors and createslegal frame for international inspections
Penalties and other sanctions
Decree No. 474/2002 Coll.
Highly hazardous biological agents and toxins
Hazardous biological agents and toxins
Determining qualification for handling
Keeping of records and UN declaration data
DisclosureFebruary 17, 2009Regular monitoring of newspapers disclosedseveral news mentioning outbreak of bird fluin Biotest Co.When verified, SONS inspection team waspromptly designated.
HistorySubmitter of test was Austrian company Avir GreenHills Biotechnology AG. Research was done under EU Framework Programm7, project FLUVACC. Task was development of liveattenuated replication-defective influenza vaccine.
Partners:Avir Green Hills (AT) Biotest (CZ)GPC Biotech AG (DE) Med. Univ. Wien (AT)BIA Separations (SL) Weikom & Network (AT) Robert Koch Institute (DE) Institute of Influenza (RU) Shemyakin Institute of Bioorganic Chemistry (RU) Vichem Chemie Research LTD (HU)
VaccinesAvir as contractor of Baxter InnovationsGmbH developed in 2008 nasal dual vaccinedeltaFLU (live attenuated vaccine withdelNS1 against H3N2 and H5N1).Baxter has certified CELVAPAN (H5N1 inj. vaccine based on A/H5N1/Viet/1204/2004) by EMEA on 18/12/2008 with perspective ofnasal form in II.Q/2009.Biotest was under hard pressure of AVIR to break national legislative and speed uptests of vaccine in January 2009
TestTolerance test of two nasal H3N2-ΔNS1vaccines allowed by commision of Ministry ofIndustry and Trade.Both vaccines prepared in Baxter AG plant inOrth a.d.D., delivered by GNN Groupmessenger on Jan 30, 2009.Each vaccine applied to group of 5 ferretsShort time after application occured atypicreaction with rapid progress.
Infection Outbreak I.February 6, 2009Morning observation shows premortal conditionof 60% ferrets in single group. On middayBiotest contacts Avir; devitalization withoutautopsy is ordered (3 ferrets dissect).Avir stops test for possible contamination in evening. After another 2 hours Avir declarescontamination with H5N1 virus and ordersimmediate action including Tamiflu prophylaxis.
Infection Outbreak II.By order of Avir safety manager of Baxter CZ distributes Tamiflu to 13 Biotest lab workerswithout medical prescription. All isolated inremote cottage in nearby woods.No warning or advicesend anywhere.
Sweeping of EvidenceFebruary 7 - 8, 2009Remaining ferrets devitalized, decontamined(70% ethanol) and frozen in rendering cool box.Lab animal boxes cleaned, vaccine vialsautoclaved.Biotest, Avir and Baxter AG confirming highpossibility of H5N1 vaccine contamination.Medicated personnel work continualy; onebitten by infected ferret asks for medicaltreatment.No warning or advice still send anywhere.
CompromisingFebruary 9, 2009SVA contacted by Biotest announcing possibleoutbreak of H5N1. Four ferret cadaverssecured and sent to Bird Flu Nat. Lab. of SVIby local state veterinary inspector.Safety manager of Baxter CZ asks for isolationand treatment in hospital for 8 persons; bittenone taken to hospital. Baxter CZ hazard team takes control overBiotest.Chief Hygienist of CR informed by hospital.
FinishFebruary 10, 2009Remaining Biotest lab personnel taken to hospital by Baxter CZ minibus for examiniation.February 11, 2009Same symptoms manifested by other ferret indifferent lab room. Avir orders devitalizationand strict decontamination of lab building.February 12, 2009Tamiflu therapy continues with 2nd cycle.Cadavers disposed according to legislative.
InvestigationVarious governmental executive bodies takepart in investigation according to ownresponsibilities given by various acts:
State Veterinary Administration – animalwelfareState Office for Nuclear Safety – bio agentCzech Inspection of Environment - GMOCriminal Police/CBRN sec. State Institute for Drugs Control – GLP
State Veterinary Administration
First agency informedTissue samples secured and promptly sent to laboratory for rapid test – H5N1 confirmedVeterinary isolation ordered and checkedAccording to own procedures kept onlyveterinary line of investigationLesson learned – memorandum of cooperationsigned with SONS
Czech Inspection ofEnvironment
Announcement received from SONS via Ministry of Environment when GMO discoveredClose cooperation with SONS inspection teamOwn investigation finished with accusation ofillegal handling with GMOFine of 1.000.000 CZK grantedLesson learned – cooperation with SONS started in information exchange and combined inspections
Criminal Police Specialized CBRN unit called by SONSInvestigation coordinated with SONSFocused on evidence of criminal handlingand spread of transmision disease accordingto Criminal ActDelict not proven, passed on SONS to administrative procedureLesson learned – formulations of CriminalAct and related regulation are too old fornew types of criminality
State Institute for DrugControl
Investigative agency of Ministry of HealthInspection focused on Biotest facility and study conductingStudy declared as non-GLPAustrian Agency for Health and FoodSafety (AGES) asked for sharinginformationLesson learned: lack of cross bordercooperation
State Office for NuclearSafety
Leading executive body in investigationInspection team sent on scene next day afterdiscoverFirst inspection visit found Biotest and BaxterCZ employees unpreparedRelated documents securedAfter month second visit done – Biotest and Baxter CZ employees instructed
Information GatheringClose cooperation with Criminal PoliceCommunication records of BiotestDocumentation of testsBasic laboratory documentation – GMO handling procedures, emergency plansPersonal allegations of involved personsDocuments voluntary given by Biotest directorOpen information sources
State Veterinaty Institute Experts´ Statement
Original tissue samples stored in SVI BirdFlu National Reference LaboratoryComplete DNA scan of both positive samplesConfirmed 100%/99,5% matching withreference strains A/Vietnam/1203/2004No evidence of H3N2 virus or any geneticmodification found
SONS Inspection finishedBiotest found to break several paragraphs ofBiological Weapons Prohibition Act
Illegal handling with GMO according to evidence freely given to inspectors (GMO declarations for Ministry of Environment)Violation of duty obligation
Biotest appealed mentioning their bravery incrisis solution and defending itself withimpossibility of knowledge of all acts.Appeal denied by chairperson of SONS.
Administrative ProceduresCIE
Fine granted for illegal handling with GMO.Biotest uses all legislative procedures to win.Probable outcome is action in court withuncertain finale.
SONSInspection closed with record documentingoffence against Bacteriological WeaponsProhibition Act. Proposal for procedure ofinfliction is expertised by legal division.
Baxter Standpoint
Baxter was contrated to manufacture and deliver of samples of experimentalattenuated vitus materialAvir reported to Baxter lab incident on Feb 6 indicating potential contamination with H5N1 – contradiction with realityIncident announced to Ministry of Health, EMEA, ECDC, WHO - contradiction withrealityBaxter CZ was not involved in materialshipped to Biotest
Foreign ConjunctionsOn Feb 11 Austrian press mentionedexposition of 15/18 of Baxter contractors to H5N1 virus in Otto-Wagner-Spital, Wien. Alltreated with Tamiflu. Case descripted as Phase 1 of clinical tests of H5N1 nasalvaccine.Slovenian news mentioned lab accident in Avir´s contractor laboratory and infection ofHPAI H5N1 from Baxter vaccines.Other incidents mentioned in Germany and Russia without further details.
ConclusionOfficialy nothing serious happenedChain of regrettable blunders occuredNo international infromation exchangesystem exists (only vertical fluewaysystem)Private sector has always rightCooperation of all national agencies iscrucialLive test of legislative found major gaps
