AUSTRALIAN PEACEKEEPER & PEACEMAKER VETERANS’ ASSOCIATION P.O. BOX 5444 HEIDELBERG WEST, VIC, 3081 (INCORPORATED IN VICTORIA) ABN 59 558 194 094 Patron Major General John Pearn AM, KStJ, RFD (Ret’d) Telephone: (03) 9496 2327 Fax (03) 9496 2285 Mobile: 0409 650016 Email: Graham.Castles@austin.org.au Website: www.peacekeepers.asn.au Listed Ex-Service Organisation with the Department of Veterans’ Affairs ESO Directory Commemorating 60 Years of The establishment of the United Nations Command – Korea. The Korean War – “The Forgotten War” AUSTRALIAN DEFENCE FORCE VACCINATIONS POTENCIAL HEALTH EFFECTS INTRODUCTION 1. This paper is written on behalf of the Australian Peacekeepers and Peacemakers Veterans Association (APPVA).Its intent is to detail potential adverse effects associated with the vaccines administrated by the Australian defence forces (ADF) during both routine vaccination programme and those that are more specific to operational deployments. This paper will also address the potential adverse effects associated with the use of various forms of anti malarial prophylaxis and treatment. 2. while it is acknowledged that the vaccination of ADF troops is a necessary requirement to fulfil the ADF’s duty of care responsibility to its personnel, it is also recognised that some individuals with potentially experience short term adverse events, of grater significant, however is that a percentage of this population may experience long sequelae which can impact both their ADF service retention and future and social well being. 3. In the context of the potential for long term health impacts resulting from ADF directed vaccinations, it is prudent for the Australian repatriation authorities to include medium to long term adverse outcomes as compensable under the military compensation and rehabilitation Act. Recognition of linkage between number of operationally required vaccinations and the ongoing health and well-being of the veteran community is of major concern to many in veteran community , these concerns have been well documented by the Australian media1 ,particularly with regard to the vaccination of Australian troops with anthrax, and therefore demand careful consideration regarding there validity in claim. ROUTINE ADF VACCINATION 4. In line with , and in many respects exceeding, accepted community vaccination protocols and standards the ADF routinely vaccinated s its personnel with following vaccines:2,3 a. Adult Diphtheria and Tetanus vaccine (ADT) b. Sabin Oral Polio vaccine / Inactivated Poliovirus(IPV) c. Meningococcal vaccine (Meningococcal Quadrivalent vaccine) Meningococcal C-Type d. Typhoid vaccine (Thyphim VI) e. Hepatitis A and B vaccines Rubella vaccines (either enegirix B Havrix 1440 or Twinrix combined Vaccine) f. Measles mumps and rubella vaccine (MMR 11) g. Vericella Vaccine (Varilix) 1 legal breakthrough for gulf war syndrome vet Http://www.abv.net.au/news/newsitems/s847662.htm 2 the Australian Immunisation Hand book 8th edition, NHRMC 2003 3 ADFP1.2.2.1 Immunisation procedure, commonwealth of Australia 2003 OPERATIONAL SPECIFIC AND MISCELLANEOUS VACCINES 5. Additional operational specific vaccination schedules are initiated at the direction of the operational mounting authority for particular ADF operation. This direction is made in response to specific health thread identified as endemic to the area of operations or according to real or potential threat such as biological welfare agents. These additional vaccines are :4 a. b. c. d. e. f. g. h. Anthrax Vaccine (UK or US variant) Botulism Vaccine (Clostridum Botulinum Toxoid) Cholera Vaccine (oral Cholera) Japanese Encephalitis vaccine Plague Vaccine Rabies vaccine Smallpox Vaccine Yellow Fever Vaccine GENERAL VACCINATION REACTION 6. Adverse reaction may occur with the administration of any vaccine and vary in severity localised, to systemic (whole body reaction), or allergic reaction. Allergic reactions are the most severe and are potentially life threatening, Usually occurring rapidly following vaccination. Most reactions are, however of the localised type, causing minor discomfort for a limited period of time. 7. The Australian immunisation hand book5 states the following in relation to adverse reactions: “An adverse event is a serious, uncommon or unexpected event following immunisation …. Any serious or unexpected adverse event should be reported (Page 22)6 8 The immunisations handbook7 continues by stating the following regarding serious adverse reactions: ‘The following adverse events should be reported …..no time limit has been set, as some adverse reaction related to vaccination could occur many years later…… Abscess Acute flaccid paralysis Allergic reaction Anaphylactoid reaction (Acute hypersensitivity reaction) Anaphylaxis Arthralgia Arthritis 4 ADFP 1.2.2.1 Immunation Procetures, common wealth of Australia 2003 5 The Australian Immunisation Hand Book 8th Edition ,NHRMC 2003 6 The Australian Immunisation Hand Book 8th Edition ,NHRMC 2003 7 The Australian Immunisation Hand Book 8th Edition ,NHRMC 2003 Brachial neuritis Death Disseminated BCG Encephalopathy Encephalitis Fever over40.5C Guillain – barre Syndrome()GBS Hypotensive-hypotensive episode (Shock,collaps) Local reaction (severe Lymphadenitis(include supporative Lymphadenitis) Meningitis- diagnosis must be made by a physician Orchitis Osteitis Ostomyelitis Parotitis Rash (severe or unusual) Screaming (persistent) Seizure Sepsis Subacute sclerosing penancephalitis Thrombocytopenia Toxic – chock syndrome Vaccine associated paralytic poliomyelitis Other severe or unusual events(pages22-23)’8 9. While every effort made to minimise possible adverse reaction they cannot be entirely eliminated. good screening of individual undergoing vaccination should identify a percentage of ADF personnel who may be susceptible to adverse reactions. Screening will identify previously known reactions, immunosuppression, sickle cell anaemia’s asplenia, concurrent medication or a family history of reaction to a particular vaccine: however it will not eliminate potential adverse events entirely. 10. Another potential causative factor in adverse reaction is the administration of multiple vaccines at single vaccination session. While ADF and NHRMC guidelines 9,10 suggest that the administration of multiple vaccines is not associated with any increase in adverse reaction ,anecdotal evidence from Australia and international gulf war veterans disputes this finding.11 this anecdotal evidence ,however has been called into question by the minister for veterans affair following the release of study of Australian gulf war veteran’s12 which indicate that the vaccinations of Australian troops and rates of negative health outcomes within this population are not liked. Evidence from UK study published in the lancet 13 belies this finding and strongly suggests that a casual link between multiple vaccinations and the ‘so called’ gulf war syndrome does exist(this finding has also been supported ________________________________________________ 8 9 The Australian Immunisation Handbook 8th Edition .NHRMC 2003 ADFP 1.2.2.1 Immunisation Procedures, common wealth of Australia 2003 10 The Australian Immunisation Handbook 8th Edition .NHRMC 2003 11 Legal breakthrough for gulf war syndrome vet http:www.abc.net.au/news/newsitesitems/s847662.htm 12 Australian gulf war veterans ‘health study, Monash, university 2003 13 Health of UK servicemen who served in the Persian gulf war, the lancet, volume 1999 353, no9148, 16jan by the British courts).14another study conducted for the Canadian department of national defence 15 also concluded that a casual link may exit with the chronic fatigue syndrome , but included other potential casual factors such as proximity to uranium depleted munitions and the use of prophylactic chemical welfare agents such as pyridostigmine bromide as potential causes of adverse health outcomes in its veteran community. 11. The information detail above, while acknowledging inconsistencies between the Australian and International research literature, strongly suggest that there is a link between vaccination and adverse reaction in susceptible individuals. Further, it support s an increased potential for adverse reaction and long term sequelae in ADF personnel who undergo multiple vaccinations in preparation for operational deployments. Therefore ,as vaccination is a mandatory requirement of ADF service then it is imperative for the Australian community ,through government ,to recognise adverse reactions as compensable where the balance of probabilities ‘ would suggest the long term consequence of these reactions ()whether presenting as “gulf war syndrome” ,”chronic fatigue syndrome” or in another form of disability) are directly or indirectly attributable to service in the ADF. SPECIFIC ADF VACCINATIONS AND THEIR POTENTIAL REACTION 12 Anthrax: The international debate on the use and the safety of the anthrax vaccine continues. the evidence to direct link this vaccine to “gulf war syndrome”, however .remains tenuous. The US variant of the vaccine has been used in meat and ternary workers in the US since approximately 1957 though there is little research on the long term effects of the UK vaccine. Currently there is no statistical evidence that indicates the development of any such syndromes among these workers. multiple vaccination with multiple agents have been demonstrated to cause serum syndromes some individuals16 and this has been suggested as a cause of “multi symptom syndrome” and may also be associated with the development of some level of autoimmune disease.17 anthrax vaccine is not TGA approved for use in Australia potential adverse effects of anthrax vaccination include;18 a. Localised reaction that are usually limited to 3 days-indurations erythimia. Oedema, pruritis, and tenderness. b. Larger reaction close to the site of injection that may persist for weeks – oedema extending from the vaccination site to the elbow or forearm and small painless nodules c. Mild systemic reactions lasting around 2 days- myalgia, headache and mild to moderate malaise Note: anthrax in its inhalation form is uniformly fatal with out vaccination and adequate treatment post exposure. 14 Legal Breakthrough for gulf for syndrome vet http;/www.abc.net.au/news/newsitems/s847662.htm 15 Canadian department of national defence hrrp;/www.dnd.gov/reform/na/hearings/testimony 16 health of UK servicemen who served in the Persian gulf war, lancet vol 353 no 9148 16Jan1999 17 Vaccination and auto immune disease;what is the evidence ? the lancet, volume 362 no 9396,15 nov 2003 18 The Australian Immunisation Handbook 8th Edition .NHRMC 2003 13. Botulinum : this is the most poisonous bio weapon substance known, potential adverse effects are:19 A localised reaction that are usually limited to 1-2-days –erythema,oedema and /or indurations at the site of injection B larger localised reactions are rare but the incident of reaction increases with subsequent doses Systematic reactions- fever, malaise, headache and myalgia Incapacitating localised and systematic reactions are uncommon 14. Cholera : Japanese encephalitis: no series adverse events have been reported with the use of this vaccine20 15. Japanese encephalitis: This vaccine is administered to all ADF troops deploying to the land area of operations in south East Asia and to all land based troops on 28 days notice to movie. Potential adverse effects can be vary from mild to very severe and include:21 a. commonly mild local and systemic adverse effects- tenderness, redness, swelling, headache, fever, malaise rash, chills, dizziness, myalgia b. , nausea vomiting and abdominal pain. generalised reaction – urticaria ,angiodema,with respiratory with disress and collapse associated with hypotensiton ,erythema multiforme and erythema,nodusum,joint swelling. c. severe long term reaction (rare )- guillian-barriesyndrome,hepatitisand respiratory failure,respiratory and renal failure sudeen death,neaurologic events(enchephalits etc) –causation unclear Reaction may be delayed by as much as 17days following immunisation 16 . Plague : Local and general adverse effects are noted as both mild and infrequent but may cause neurological disturbances, speech disorders.22,23 17 . Rabies : Administrated as both pre exposure prophylaxix and as a postexposure treatments following potential exposure to rabies. a. minor localised and systematic reaction-sore arm, headache, malaise, nausea b. anaphylactoid reaction are noted as rare c. number of cases of central nervous system disease similar to guillainbarre syndrome have been noted24 19 ADFP 1.2.2.1 Immunisation Procedures, common wealth of Australia 2003 20 The Australian Immunisation Handbook 8th Edition .NHRMC 2003 21 Japanese Encephalitis Virus Vaccine Inactivated ,consumer medicine information ,Aventis pasteur 1998 22 The Australian Immunisation Handbook 8th Edition .NHRMC 2003 23 MIMS issue no 5 October /November 2003 24 The Australian Immunisation Handbook 8th Edition .NHRMC 2003 18. Smallpox This vaccine is not TGA approved in Australia. Reactions include but are not limited to the following; a. mild reaction – sore arm, erythema, enlarge and painful axillary glands, headache, fever, mild rash, myalgia, pains and chills b. moderate reactions-high faver, behavioural changes, systematic rash c. severe reactions – anaphylatoid reactions 25 19. Yellow fever: Adverse reaction are generally mild with headaches, myalgia, low grade fever and other minor symptoms with hypersensitivity reaction occurring (asthma, uriticaria and rash) infrequently largely due to sensitivity to eggs. Some cases of encephalitis have been noted. 26 Summary of ADF vaccinations 20. The mains point in to note in the adverse reaction information detailed above are that many vaccination used by the ADF have very similar reaction profiles, which while generally minor in manifestation are likely to be amplified in the use of multiple vaccination agents, further ,a number of vaccination are not TGA approved for use in Australia calling into direct question the ADF’s duty of the care with regard to its personnel and adverse health outcomes resulting from vaccination. 21. There is sufficient evidence in the international literature to suggest that while vaccination is a necessary form of preventative treatment for ADF personnel there are inherent risks and long term sequelae that may manifest in many different forms. it is acknowledged that the correlation between vaccination and long term adverse health outcomes is difficult to quantify directly ,however to ignore that a connection exists in short term will leave the government open to the potential for substantial financial loss through class actions initiated by ADF ex- Servicemen in the future. ADF MALARIAL PROPHYLAXIS,TREATMENT AND ERADICATION 22. ADF personnel are very frequently deployed to areas of the world that carry substantial risk of disease of parasites. One of the largest risk to the health of ADF personnel is from the variant forms of malaria ; plasmodium folciparum, plasmodium vivax ,plasmodium ovale and plasmodium malaria. Of these, plasmodium falciparum is the most dangerous form. 27 23. The ADF ,through the army malarial institute ,has tested and used a number of agent for both malarial suppression and for the eradication of the malarial parasites in the liver .it is recognised that the programs used have minimized the direct health risks to the ADF personnel from malaria, however the treatments do not come without their own inherent risks, particularly when used for long periods of time ,more so as ADF experience in this field of research has develop treatment regimes for malarial suppression have also altered. 25 ADFP 1.2.2.1 Immunisation Procedures, common wealth of Australia 2003 26 The Australian Immunisation Handbook 8th Edition .NHRMC 2003 27 Rang,HP Dale,MM()1987,pharmacology,Chapter 33 Antiprotozoal Drugs, Churchhill, Living stone 24. The mainstay of ADF malarial treatment remains doxycyline for malarial suspension with mefloquine being used as the alternative for those individuals that don’t tolerate tetracyclines well,and also for those individuals who are likely to remain in malarious area for longer than six months terfenaquine has also been trialled (initially in east Timor) as a suppressive agent. 25. The use of chloroquine and primoquine is still accepted as the primary method of eradication of the malarial parasite from the liver in personnel returning to Australia from operations following is an outline of possible adverse health effects resulting from the use of the different malarial treatment agents used by the ADF. 26. Doxycycline: This tetracycline antibiotic has been used by the ADF for a considerable number of years ,however the dosage used has gradually decreased from 200mg per day in 1995, to 100mg per day in 1999 and in currently used at 50mg per day . the change in dosing reflects the good malarial suppressive effects at lower dosing and recognition that long term higher doses are more likely to be associated with long term adverse health effects. 27. Adverse reaction includes : diarrhoea ,anorexia, nausea ,glossitis, dysphagia, enterocolitis, maculopapular and erythematous rashes, exfoliative,dermatitis,photosensitivity,renal toxicity, anaphylaxis, urticaria, perocarditis ,exacerbation of systemic lupus erythematosus,haemolytic anaemia, thrombocytopenia neutropenia and eosinophilia.notable common reactions are the occurrence of gastro-oesophageal reflux and hyper sensitive to sunlight which may lead in the long term to gastric ulceration in the former and increased potential for skin cancers in the latter.28,29 28. Mefloquine : This schizonticidal quinolone-methanol compound has some advantages over the use of doxycycline due its better tolerance and it long plasma half life (over 30 days) which means compliance is usually better. Adverse effects include ; psychiatric disturbances, dizziness, disturbed balance ,GI upset and sleep disorders. 30 29. Chloroquine : a potent anti malarial drug , however resistance of plasmodium falciparum to this drug has limited its use. It’s generally well tolerated but may cause; pruitus, anaxia, abdominal discomfort and temporary difficulty in the visual accommodation. 31,32 28 Rang,HP Dale,MM()1987,pharmacology,Chapter 33 Antiprotozoal Drugs, Churchill, Living stone 29 MIMs Annual 2003,IMS Publishing 30 MIMs Annual 2003,IMS Publishing 31 32 30. MIMs Annual 2003,IMS Publishing Rang,HP Dale,MM()1987,pharmacology,Chapter 33 Antiprotozoal Drugs, Churchill, Living stone Primoquine: This is an 8-aminoquinolone that is used to eradicate the malarial parasite from the liver and is generally used in combination with chloroquine. This drug should not given to people who are deficient in glucose-6-phosphate dehydrongenase as this may cause a metabolic distrabance of the red blood celll(the ADF routinely determines the G6PD status of its members period to prescribing this drug). Other adverse effects include ; gastrointestinal symptoms and possibly methamoglobinaemia with cyanosis and other blood dyscrasias.33 SUMMARY OF ANTIMALARIAL TREATMENTS 31. the use and benefit of anti malarial; treatments in the ADF population is well established. Of note, however is that these treatments do have their adverse effects and may lead to long adverse health outcomes in some ADF members. A correlation could easily be established between long-term doxycycline use and the development of the skin cancer in the ADF personnel Further ,gastrointerstinal disorders may also be either exacerbated or initiated by the use of these drugs. Conclusions 32. The ADF has well established practice to minimise the long term health impacts to its members being deployed to operations. This include the administration of the schedule of routine vacci nations, the provision of operation specific vaccinations and the administration of antimalarial drugs in response to identified health risks . these vaccines and drugs are given under direction to ADF members to satisfy the ADF’ duty of care to its personnel. 33. In directing its members to undergo these prophylactic treatments the ADF also takes on the responsibility for adverse health outcomes may result from the use of these agents. To that end the Australian government , through the repatriation health authorities ,must establish in policy, mechanism to both recognise and compensate ADF members for adverse effects experienced as a direct result(on the balance of probabilities) of their ADF service requirements. 33“Rang,Hp Dale,MM(1987) Pharmacology,chapter 33 Antiprozoal drugs, Churchhill Livingstone. This paper was prepared by A.Ormsby RN,BN,MNsg South Australian Chairman of the Australian Peacekeepers and Peacemakers veterans Association March 2004