ADF Vaccinations Potential Health Effects

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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
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