Appendix 3 - Anthrax Vaccinations
While standard
vaccinations[506] are not identified as
having caused any problems, anthrax vaccinations are seen by some as evidence
of a lack of community standards in the provision of health care services, and
a lack of duty of care. The major issue concerning anthrax vaccinations[507] is whether some ADF personnel had an
opportunity to exercise informed consent. Other concerns have also been
expressed, including the quality of some batches of vaccine, the safety and
efficacy of the product, and possible long term effects.[508]
The issue of informed consent for 2nd Gulf War vaccinations
The Defence perception of
consent is that any individual undertaking a standard vaccination program has
in effect consented to its use.
In the administration of routine vaccination to our
people, in accordance with current civilian practice, there is implied consent.
So where a vaccine is made routinely available and is on a routine vaccination
schedule, the fact that a person presents themselves for vaccination is usually
sufficient to imply that they understand the risks and the nature of what they
are receiving.[509]
However, acceptance of
standard vaccinations may be based on the premise that, in spite of some
limited adverse effects, these are generally safe and that consent was
informed in the sense of the individual having enough readily available
information to make a choice and being familiar with the issue of side effects,
often over a period of years:
A wide range of
immunisations are offered to Australia citizens both in childhood and in adult
life that are common, community accepted standards and it is therefore expected
that most people would be familiar with those immunisations and would
understand their benefits and possible consequences. In that sense, we do not
require a signed consent form when people receive routine immunisations.[510]
Unlicensed or unregistered vaccines
Anti-anthrax and some
other vaccines are classed as unlicensed or unregistered, terms which are used
for vaccines which are not registered with the Therapeutic Goods Administration
(TGA) as items of common use. The TGA has no direct administrative
responsibility for use of such items, and delegates this authority: in this
case to the CDF, or to a medically qualified person. The delegation requires
that ADF members are fully informed of benefits and risks.[511]
The Defence submission
states that consent with respect to the use of unregistered vaccines is covered
by ADF policy [which] provides comprehensive guidance on matters of informed
consent[512]
In the case of an unregistered vaccine there is a much greater
responsibility on us to provide people with information, answer any reasonable
questions that they ask of us and ensure that when they receive the vaccine
that it is truly done under the provisions of informed consentthat is, they
know the risks, they know the reasons why it has been given and they have made
the decision freely.[513]
Where
a consent form does not provide full information about other implications, an
individual may or may not be able to make an informed decision about the full
impact of the procedure, regardless of whether consent is given.[514] With respect to the Navy, this wider
issue does not appear to have been considered. It would appear that the
consent form included two optionsone being that consent was given, the other
that it was not - and that certain consequences might follow. Everyone signed
the consent form, and in some cases it is likely that it was the information on
the form or the absence of other information on consequences, which at least
contributed to the decision made not to agree to the vaccination.
This
is apparent from a response to a complaint made by one of the sailors from the Kanimbla, which notes:
You say that your informed consent [ie nonconsent] was
based on the briefing, which advised that there would be no administrative
action taken against [n]onconsenting personnel.[515]
It
has also been stated that the consent form available at the time included the
words may not participate in deployment (if vaccination was refused), rather
than the words will not participate.[516]
The consent form which was given to Kanimbla[517] personnel, dated 29 January 2003, reads: I understand
that I may refuse to accept Anthrax vaccine without prejudicing my medical care
but that I may not be eligible for specific operational deployments.[518] This is true also of the form dated 6th February 2003. Insofar as this
information led individuals to believe that they would remain on the ship, it
was misleading. Later comment that the form was going to be changed and would
make it clear that continuation with a specific deployment was not possible,[519] does not address this concern.
Similarly
the statement that there was in place a policy that those who were not
vaccinated were not deployable[520]
does not effectively counter the statement that the specific briefing on the
ship about this particular vaccination stated that no adverse administrative
action would be taken. It is unlikely that the difference between no administrative
action and the consequences of failing to meet a policy was appreciated in
the circumstances, accounting for some of the confusion experienced when
personnel were removed, having become non-deployable to the MEAO exercise.
It
is also to be noted that long after personnel were removed from ships, the
information available on the defence website[521]
and still there in mid July 2004, did not clarify many issues:
11. What happens if
I dont get vaccinated?
Getting the vaccine is not compulsory and you may refuse
to receive the vaccine at any stage (even if you have already had one or two
injections). You will not be punished or discriminated against because you have
not elected to be vaccinated, however, because of ADF risk management
procedures you may not be allowed to deploy to, or remain in, certain areas
overseas if you have not been vaccinated.
The Defence Health Service recommends all personnel at
risk be vaccinated.
12. Will declining
[the] Anthrax] vaccination affect my individual readiness status?
Although vaccination against Anthrax is voluntary, and can
be declined, members will not be deemed fit to deploy to certain overseas
areas. They can deploy, however, to other areas where Anthrax vaccination is
not required and therefore your individual readiness status will not change.[522]
Any
individual reading this would understand that they would not be able to go to
areas where anthrax was a risk, but it is not clear that if one were already on
the way there, one would be removed. But it is clear, especially in the answer
to Q12, that their readiness to deploy status would not be changed in respect
of all deployments. However, in
response to some queries raised, the Chief of Navy wrote that the revised
policy manual dated June 2003 clarified the issue:
Any uncertainty for similar situations in the future has
been removed with June 2003 issue of ADFP
1.2.2.1Immunisation Procedures which replaced ADFP 702 as outlined [above].[523]
This policy manual[524]
is somewhat different in tone and ruling to the advice that still remains on
the website, and some differences within the manual itself can only continue
the same confusion that previously existed. It states, for example:
-
Failure to undertake a vaccination program can lead to members being deemed nondeployable,
and may lead to a review of their
fitness to continue serving in the ADF.[525]
-
There will be no vaccination waivers[526]
-
Any member [of the ADF] who is not current with
routine and any designated additional vaccinations is not compliant with Individual Readiness and therefore is unfit to deploy.[527]
It would be preferable to clarify the situation, which
seems to have moved from not being able to deploy to areas where a specific
threat exists or was believed to exist (website information) to not being able
to deploy at all (policy manual). On the other hand, the section on anthrax
vaccinations within the policy manual states:
If vaccination is declined, however, that member may not be considered eligible to deploy
to regions or environments where there is a threat of Anthrax exposure.[528]
This contrasts somewhat with the policy manual that
was in place during the deployment period, which states:
Any member who refuses vaccination with Anthrax is not to be deployed to regions or
environments where there is a threat of Anthrax exposure.[529]
From the above, it is still unclear what the
formal position is with regard to deployments. Nonetheless, it was stated by General Cosgrove in February 2003 that
non deployment in MEAO was always going to be the response to those who did not
take the vaccination:
Senator CHRIS EVANSIn terms of the decision about procedure, when
was it determined that those who were unwilling to take the vaccine would not be allowed to stay in the
theatre of operations?
Gen. CosgroveThat was an inprinciple decision when we
decided that was the regime necessary.[530]
If
this was so, it is unfortunate that this was not made obvious to personnel at
the beginning, through being on the consent form.
With
respect to at least one of those members of the ADF who refused the
vaccination, there was a reclassification of status to MEC 207 for a 12 month
period.[531] This did not prevent
deployment per se. For other persons
who were returned to Australia, it was stated that
they would not be subjected to institutionalised retribution, although it is
not clear if their medical status was also changed:
Senator BARTLETTBut what are the implications of not taking it?
Gen. CosgroveThey will not be kept in the environment where those hazards are felt to
be possible.
Senator BARTLETTThat is allthey are just redeployed elsewhere?
Gen. CosgroveYes.
Senator BARTLETTSo you are able to guarantee that there are no
other adverse career or other consequences for people?
Gen. CosgroveI mentioned the personal perceptions amongst
some people who say yes and a very small number who may say no. All I will say
is there will be no institutionalised retribution or anything of that nature[532]
The timing of vaccinations for Navy personnel
According to Defence,
sufficient time was available at least for non-Navy personnel to receive
information on the anthrax vaccine and even to consult other persons about it,[533] allowing informed consent to be
given. Anyone who did not agree to the vaccination did not go on the
deployment.[534] According to Air
Commodore Austin, the ADF generally hopes to have sufficient notice of
deployment to give vaccinations in accordance with the manufacturers
recommendation:
What we do not want to do is to shorten the administration
regimen or increase the number of shots.[535]
With respect to some
Navy personnel (on the Kanimbla), the
main issue is whether personnel should have been told before embarkation from Australia that they would require an anthrax
vaccination.[536] This is distinct from
the issue of whether there was sufficient time for vaccinations to be completed
prior to embarkation.[537]
The in principle decision that antianthrax
vaccine would be required was taken by 10 January 2003.[538]
From evidence provided, it appears that a decision was made not to advise of
the need for this prior to embarkation, whenever embarkation was to occur and
whichever ships would be commissioned.[539]
The main reasons for
this are given as:
-
It was not known which ships and therefore
personnel would be affected;
-
Once this decision was made there was no time to
give the vaccine before embarkation on the basis that staff would be required
to undertake various physical tasks, and the known side effects might interfere
with these.[540]
The first factor is in accordance with the principle that
vaccinations are not given unless required, although this also needs to take
into account the amount of time for vaccinations to become effective. However,
there seems to be no good reason why personnel could not have been informed as
soon as the decision was made about which ships were to be deployed,[541] regardless of when the vaccine was
to be given. On 4 February personnel were advised of the need for anthrax
vaccinations, and these were given on 5 February.[542] Thus there was only one day in which
to obtain other information, and it appears that this was insufficient for the
MO on board the Kanimbla.[543]
If nonnavy personnel
had been given sufficient time to discuss the issues, and were able to consult
with relatives, the issue cannot be one of confidentiality. Had personnel been
advised when ships were still in port, those who chose not to have the vaccine
would have been in no worse position in terms of a removal than those in other
forces who made a similar decision. As far
as adequacy of available information is concerned, when personnel were informed it appears that navy
personnel did not have access to as wide a range of information as those in the
army and air force did.
According
to Air Commodore Austin, a wide range of information was available and there
was time to consult with others.[544]
The same manufacturers material or product information may have been available
to both Navy and nonNavy personnel, but the fact that the ships had embarked
reduced the access of navy personnel to other sources of information and
opportunities for consideration with people outside the system. Although one
example was given of a radio consultation with another doctor, [545] this is not the same as being free
to raise the matter over a longer period of time and seek information from
other sources. Having information on the vaccine on the consent form does not
in itself demonstrate that the information was taken from a range of sources.[546]
According
to one source, the information available to naval personnel was not detailed,
and it was stated in a report on the individuals complaints that even the
manufacturers information (for the UK vaccine) was not as useful as that
provided generally with medicines in Australia.[547]
The leaflet is dated December 2002 and does not identify the
medium or media used to carry the active components of the vaccine or attempt
to identify the chemical composition of any of the nonactive ingredients of
the vaccine.
The leaflet does not indicate whether any of the possible
undesirable effects of the vaccine is related to the active ingredients or
could be related to other chemicals in the vaccine.
The other electronic information made available to him [the
Medical Officer on board the Kanimbla] by [the] Deputy Fleet Medical Officer
(DFMO) would have taken some time to search to see whether it addressed issues
as specific as this one.[548]
Regardless of what is
generally provided with Australian medicines, however, the apparent shortage of
information can hardly be excused. It may be that the Medical Officer was
unaware of the fact that antianthrax vaccinations were to be given, unless the
ships commanding officer had advised other officers:[549]
Vice Adm. RitchieThe
commanding officer of the Kanimbla would definitely have been aware that there was going
to be a requirement. As to whether or not the commanding officer of Kanimbla told his ships company in a
formal manner, we can only ascertain that by asking him.[550]
The vaccine itself had
been provided before Kanimbla left Sydney:[551]
Vice Adm. RitchieIn a nutshell, the vaccine was provided to Kanimbla the day before Kanimbla left Sydney, on 22 January, and
in the period between 22 January and 4 February further information, the
consent form, clearance to use the particular vaccine and education material
was provided to the ship.[552]
However, if the medical
officer was unaware, he/she would not have had much opportunity to go through
the relevant material and see if there were issues which might be raised by
personnel but which were not addressed in any of the documents.[553]
One issue that was raised
was the components of the vaccine and of the media in which these were held,
and it is stated that the MO on board the Kanimbla
did not have the answers to these questions.[554]
Given that some people may have needed to know to clarify the issue of possible
allergies to the agent in which the vaccine is carried or possible severe
reactions to the vaccine itself,[555]
this was information that should have been provided, especially as it may have
affected the level of informed consent. In fact, the consent form dated 29 January
2003, which was the one
used on the Kanimbla, has a section
listing those people who should not receive the vaccine, or should temporarily
defer receipt.[556] These include those
who are immunocompromised, have HIV, or an active infection/illness with
fever. The form dated 6 February also has this information.
While it is not obvious
what other information had been forwarded electronically to the Kanimbla, the data provided by the UK
Ministry of Defence (MoD) on the UK vaccine was extremely detailed,[557] and did include information on the
components of the vaccine and the agent, although this was dated 2000. The UK
MoD link is on the Department of Defence website on this issue.[558]
The process of vaccination
does not seem to have been fully thought through and as a result the
medical/nursing staff were perhaps illequipped to handle some queries. The
responsibility for this is difficult to determine, because confidentiality
appears to have played some part in access to information such as the health
plan:
Vice Adm. Ritchiethere was some degree of classification around
the health plan for Operation Bastille. Therefore, I do not think that it was
appropriate for those sorts of things to be talked about until such time as it
was decided to put that health plan into action The health plan, which comes
down through the theatre, had a classification on it that would not allow it to
be discussed openly on the ship.[559]
Nonetheless, it seems unlikely that the MO at
least would have been unaware of some basic components of the health plan such
as the intention to give anthrax vaccinations. It is obviously important to
ensure that MOs have access to basic technical information which they can
translate into everyday language for the benefit of personnel in general.
This
point has been conceded to some extent:
Nevertheless the experience of these briefings does
suggest that precise questions of this kind can be asked and is better that the
information be available. As ADF personnel become better trained and with more
specialized engineering and scientific skills, the possibility of such
questioning obviously increases. It is desirable, with new vaccinations, that
education programs be planned thoroughly after a focus group of personnel have
been used to draw out the range of possible questions that are likely to arise
for the MO. Accordingly I have made a recommendation to Chief of Staff,
Maritime Headquarters that this should occur in future.[560]
That it was a mistake
not to provide information to naval personnel prior to departure from Australia is now conceded by the ADF.[561] The problems that have occurred for
some personnel in the Navy (having to be taken off ships)[562] did not occur for those in the RAAF
and other naval personnel who did not consent, although this seems to have been
the case only because they were already in the Middle East and were moved back
routinely on aircraft that were operating in and out of the gulf.[563] The issue has therefore become one
of whether some navy personnel were discriminated against through the more
public circumstances of their return, and, to some extent, whether there was
undue pressure on them, while aboard, to be vaccinated.[564]
The quality of vaccines used
A further issue with
respect to anthrax has been the quality of the vaccine used. This issue seems
to have arisen in part at least because of the some of the reported reactions
which were considered excessive, and some queries about the use by date of
the imported vaccine,[565] in respect
both of Afghanistan and 2nd Gulf War deployments.
The ADF has noted that
when reporting of reactions is required, one may have over reporting and a
higher than expected side effect profile.[566]
Those reactions to the anti-anthrax vaccine which have been noted, primarily a
sore arm or an inability to use the arm where the injection was given, or short
term fever, are not in themselves seen as out of the ordinary. They would not
be considered adverse reactions in the sense of being registered,[567] and they would have been expected by
management given that one of the reasons for not advising navy personnel of
anthrax vaccinations in January 2003 was said to be the need to deploy, which
required a certain amount of physical labour:
In preparing a ship
for deployment there is a lot of hard physical labour on the part of the men
and women embarked on the ship and I believe that was a factor that was
considered by the commander of the ship in terms of delaying the administration
of the vaccine, because once a ship is actually embarked and crew go into a normal
workrest cycle there are fewer physical demands upon them and therefore there
will be less operational impact of the vaccine.[568]
Defence witnesses
noted that the problems of assessing the effects of the anthrax vaccine were
both over reporting of what be seen as normal side effects, and the lack of
knowledge of the effects of other factors:
the rates that we saw when
we looked at it in the light of other confounders that may have been present,
such as coadministration of other vaccines or the physical activities that
people were engaged with, made it very difficult for us to determine whether it
was as a direct consequence of a problem with the vaccine or just part of the
normal distribution of what we would have expected to see. [569]
The issue of other vaccine
administration, however, appears to lead to further confusion. It appears from
Defence evidence that mencevax had already been given to the crew of the Kanimbla prior to its departure from Australia, and therefore the confounding of other
vaccinations would have been limited for those personnel.[570] For personnel on other ships, the
mencevax vaccine was not given until later.[571]
Although Defence
believes that there are no difficulties in administering both mencevax and antianthrax
on the same day, at different vaccination sites,[572] other information suggests that this
would not be best practice. Anthrax shots themselves should not be given as
part of a combined vaccination.[573]
The Australian Defence Force Vaccination Handbook itself states that:
Anthrax vaccination
is not to be given concurrently with other vaccines. This will reduce the
incidence of more severe advents from occurring.[574]
Product information on mencevax states that:
No information is available concerning the effects of
drugs, intercurrent illnesses or other vaccines on the response to the
administration of Mencevax.[575]
The NHMRC, in the Australian Immunisation Handbook, is
referred to as stating that it is appropriate to give one of the
anti-meningococcal vaccines in conjunction with other items in the Australian
Standard Vaccination Schedule (ASVS): the
vaccine may be administered simultaneously with other vaccines in the ASVS.[576] However, anthrax is not a
part of the ASVS, and the above statement applies only to the
Meningococcal C conjugate vaccines (MenCCV), while Mencevax is a Meningococcal
polysaccharide (4vMenPV).
It is ironic that the one fact that would have been a sound
medical reason for not giving anthrax shots prior to departurethat there was
to be an interval after the mencevax shotwas not referred to, although this
does not overcome the issue of not providing information on the need for an
anthrax vaccination.
Efficacy and safety of the vaccine
Since anthrax and some
other vaccines have been used rarely, it is inevitable that there will be
concerns about them, well founded or otherwise. Anthrax vaccinations were
formerly used mostly by persons working in industries where there was constant
contact with animal skins.[577] Because
of the limited use, there have been few studies undertaken, and by the time of
the 2nd Gulf War, the two studies that had recently been undertaken
could not provide definitive information on long term effects. Any difference
between exposure from animal skins and militarised anthrax is not mentioned.
The United Kingdom Ministry of Defence website, however, states that:
Independent medical advice from the MoDs Advisory Group
on Medical Countermeasures has confirmed that anthrax immunisation is safe and
effective. Anthrax vaccine has been used routinely to protect those at risk
from anthrax since 1963 and licensed in the UK
since 1979. Many thousands of people, including laboratory workers, veterinary
surgeons, abattoir workers and military personnel, have safely benefited from
the high levels of protection that anthrax immunisation confers.[578]
Nonetheless, any
study of longer term effect and of the interplay of factors such as repeated
vaccination, use of other vaccinations and to exposures to other substances in
a war zone will take some time to complete and any conclusions can only be
described as provisional at this point.
Anthrax vaccinations in the first Gulf War
Some of the concerns
raised about anthrax vaccinations related to the first Gulf War although such
concerns may have gained strength because of the later controversy about their
use in the 2nd Gulf War. According to Defence, no personnel received
anti-anthrax shots in the 1st Gulf War, apart from those who were
working with US or UK forces who would have followed the
vaccination program of those countries.[579]
We were very aware
that a large number of the people who had deployed as a part of the first Gulf
War firmly believed that they had received anthrax vaccine as part of that
deployment. When that was reviewed, we found that almost none of them had in
fact received the anthrax vaccination. There had clearly been a
misunderstanding on their part about the vaccines that they had received as
part of that deployment.[580]
In Gulf War I, I think we administered quantities of anthrax
vaccine to very small groups of people, mainly those that were involved in the
sensitive site examinations. These were specialist teams of personnel whose job
it was to go into Iraq after the first Gulf War and seek out weapons of mass
destruction sitesalso, those who were part of the UN teams that were doing
site surveys.[581]
Afghanistan
deployment
According to Defence,
the anthrax vaccine used for troops deployed to Afghanistan[582] had been obtained from the UK and at one time a batch of this was thought
to have been affected by a breach of storage temperature. Some of this vaccine
had resulted in high levels of adverse reaction amongst personnel deployed to Afghanistan,[583]
and led to the anti-anthrax program for Australian troops in Afghanistan being suspended for two months from November
2001.[584] However, after testing, the
vaccine was deemed to be safe. [585] The vaccine had been manufactured in
January 2001 and the expiry date was January 2003.[586]
Second
Gulf War
The vaccine used for
the 2nd Gulf War deployment came from both the US[587] and the UK. The
date of manufacture of the UK vaccine used for this deployment was
February 2002, with an expiry date of February 2004.Although there were some
problems with the UK vaccine, these seem to relate only to a batch used in the 1st
Gulf War, and, later, the difficulty in obtaining the required product on
schedule. The US vaccine had expiry dates of August 2003, February 2004 and June 2004,[588] which indicates that they were
manufactured in 1999 and 2000 respectively, as the US vaccine has a fouryear life. The US report
on the Safety and Efficacy of the Anthrax vaccine [589] notes that the production of the
vaccine was halted in February 1998 as a result of adverse reactions,[590] and the facility was the subject of
review. [591] This report is somewhat obscure
about the results of the assessment of the production prior to its review:
The newly produced vaccine is expected to have greater
assurance of consistency than the vaccine produced at the time of its original
licensure.[592]
The report concluded
that the method of vaccinationsubcutaneousand also the number of shots
required might account for the adverse reactions, recommending that research
continue to develop options for administering the vaccine and to determine if
fewer doses could be given.[593] The
expiry dates of the U.S. vaccine used in Australia for the 2nd Gulf War indicate
that it was manufactured after the review of the faulty manufacturing process,
and was therefore less likely to be of a variable standard.
Storage issues
There appears to be
some confusion about the effect of vaccines which may not have been maintained
at the correct temperature. In evidence it was stated that if this occurs:
It does not make the vaccine unsafe; it cannot result in
any significant adverse impact on the individual. It simply reduces the
efficacy of the vaccine. [594]
Nonetheless, once the cold chain has been broken, the loss of efficacy
should not be discounted:
The coldchain is
the system of transporting and storing vaccines within the temperature range of
2C to 8C from the place of manufacture to the point of administration. This
temperature range is recommended because outside this range vaccines may (very
quickly) lose their potency. Immunisation service providers should
maintain their vaccine refrigerators as close as possible to 5C, as this gives
a safety margin of + or 3C. Maintenance of the coldchain system requires
that processes are in place to ensure that a potent vaccine reaches recipients.[595]
Although the above
statement on there being no adverse effects may be intended to mean only that
the individual wont have an adverse
reaction, a loss of efficacy could be crucial at any stage and would have an
adverse impact on the individual in that they may not receive a full primary
dose. [596]
There has been little
reference to issues of vaccine storage in the inquiry. However, one submission
did state that vaccination against anthrax was required for some personnel who
had volunteered to work at the Sydney Olympic Games, and that the vaccine
provided for them was out of date[597]
and may have deviated from cold storage standards.[598] The same submission also stated that
second vaccinations had been prepared two weeks earlier in syringes and stored
in a travel fridge,[599] and that no
consent form was provided.[600] The Australian Immunisation Handbook states
that small fridges are those least likely to be able to maintain the stable
temperature of between 28C required for storage of anti-anthrax and many other
vaccines.[601] While larger fridges are
acceptable, special vaccine holding fridges are the best option. Of even more
importance, no vaccination should be given from a syringe that has been
pre-prepared two weeks in advance, when there can be little control over access
to the storage unit, and contamination is possible. Although Defence has noted
that it now has approval to store Anthrax multidose vaccine vials for periods
of up to 28 days once the first dose has been removed, [602] this is distinct from storing
syringes. Out of date vaccines should have been disposed of.
The information in this
submission indicates a very low and in fact unacceptable level of medical
service provision, well below acceptable community standards. If the
information is accurate, any of the ADF personnel who received these
vaccinations and went on to serve in the 2nd Gulf War, could have
been at risk through not receiving an appropriate level of vaccination. It is
also possible that the vaccine, which was from the US, and had an expiry date
of March 2000,[603] was from stock
manufactured under less than acceptable conditions, since it would have been
produced in March 1996.[604]
Did Australian personnel receive an effective measure of vaccination?
Given
that antianthrax was little used it is not surprising that there was limited
awareness of manufacturing and dose details, and the extent of coverage
provided by part of the primary dose. Some of this confusion was obvious in the
early months of 2003, when questions were asked about the amount of time from
the first vaccination before effective cover or protection is provided.[605] There was also uncertainty about the
difference between effective and maximum protection,[606] and the number of shots in a
primary program.[607] Although these
issues were raised after the major publicity on anthrax vaccinations in early
February 2003, senior ADF officials themselves were unclear on some aspects of
the program.[608]
The
US vaccine comprises six
shots for what is called a primary program, and annual boosters thereafter.[609] The six shots are completed 18 months
after the one given at 12 months, so in effect the time for full coverage
is two and a half years. The United Kingdom vaccine comprises 4
shots for a complete primary course, three given over 6 weeks, and the
fourth at six months after the third shot. Annual boosters are then required. While the first three UK vaccinations are given at 0, 3, and 6 weeks,
the US ones are given at 0, 2, and 4 weeks. This
may have been the source of some of the early confusion about the date by which
some level of protection is available.
Both
the US and the UK have argued that their
inoculation programs were commenced prior to any specific conflict in order to
provide maximum protection. Their emphasis therefore is on the time at which
there is 100% protection rather than a level of up to 90%. UK information does not deny that some
protection is available earlier, but emphasises that fully effective
protection is better and the main reason why troops in the UK are vaccinated as
much in advance as possible:
Immunisation against anthrax takes six months to become
fully effective. This is much longer than the warning we might have of a change
in the threat, and longer than the timescales over which our Forces could be
asked to deploy to a highthreat area. Therefore, it makes sense to offer it to
personnel in advance. Previously, we have offered immunisation against anthrax
to personnel deploying on operations to the Gulf and to those in specialist NBC
units. We have always kept the scope of the programme under review, contingent
on new stocks of the vaccine. Now that new supplies are available, and because
we cannot expect to predict exactly where or when a threat might arise, or
which units of our Armed Forces might be called upon to respond, we have
decided to expand the immunisation programme so that all Service personnel,
including reservists and those essential civilians who are likely to deploy on
operations overseas, are routinely offered immunisation against anthrax[610]
The phrase takes six
months to become fully effective may mean six months from the first
vaccination, or six months after the third vaccination. If the latter is meant,
it would be more accurate to say takes 7.5 months.
The US claims that full protection is only
available after the complete first course of the US vaccine:
Immunization for our troops is a prudent action. The
immunization program will consist of a series of six inoculations per Service
member over an 18month period, followed by an annual booster. Although
protection levels increase as shots in the primary series are given; the entire
sixshot series is required for full protection, as determined by the FDA.[611]
How many shots are required for
elementary protection?
The emphasis by the Australian Defence department, however, is more on
acquiring a high, rather than 100%, level of protection. It notes, therefore,
the distinction to be made between the completion of the primary schedule and
the earlier time by which adequate protection is available:
Both vaccines provide some protection after the second
injection and good protection after the third injection (ie after four or six
weeks). If you are exposed to anthrax before you have had your third dose, you
may be given antibiotic treatment.[612]
The Australian Immunisation Handbook states that:
A number of studies suggest greater than 90% production of
protective antibodies after the third dose of anthrax vaccine.[613]
Material provided by
Defence on the level of protection available after three shots does not make
apparent the fact that very few personnel would have received the full primary
dose of even the UK vaccine by the time their deployment to the 2nd Gulf War
was completed. Since a decision was made to cease the anthrax vaccinations in
April 2003,[614] only approximately two
months after commencing them, and there was no exposure to anthrax, testing by
Australia of vaccine efficacy at particular points in time did not occur. With
respect to the number of personnel deployed to the 2nd Gulf War who
were vaccinated on more than one occasion, Defence advised that 353 personnel
received two doses of anthrax vaccine, 2,263 received three doses, and 17 previously
vaccinated (and presumably having received a full primary course) received a
booster.[615] It is assumed that the
2,263 persons who received three doses would have had 90% protection. The alternative
is that they had received one shot for the Afghanistan conflict and then two
shots, although this would have meant some considerable delay between the first
and second shots. The 353 who received two shots may have been deployed later,
with the program ceasing before the third shot was due.
There is no specific
reference in the Defence submission to the post deployment follow up of vaccine
programs, and it is not clear if anyone who received the first three shots
completed the program upon return.[616]
Those who had received the US vaccine were likely to need another three shots,
and those who received the UK vaccine may have needed at least the final one.
Annual boosters would continue the immunity conferred by a full course.
According to Defence, incomplete vaccination courses are generally continued
where they had been left off,[617] so
that a person who had missed the six-month shot of the UK vaccine would be given this, and then
proceed with the booster one year later.
On its website,
Defence states that:
You must complete the primary schedule for your vaccine
type. If a longer interval than that recommended in the schedule has elapsed
since your last dose, you should resume the schedule, extending the times
according to the schedule.[618]
Although this issue
may be one of particular concern for current personnel, it is one which would
also affect reservists since they would need to keep track of their
immunisation status, and are not necessarily aware of whether they received the
US or the UK vaccine.
Accuracy of vaccination records
In its submission, Defence
stated that JHSA was responsible for conducting the majority of inoculations[619] and that a database of nonstandard
vaccinations administered (for example anthrax and smallpox) is held at HQAST.[620] It also states that all vaccines
administered to ADF personnel are recorded in medical documentation and that
DHSB has a responsibility to retain details of ADF personnel who are
administered any vaccine not registered with the Therapeutic Goods Administration,
including batch details.[621]
The requirement is that, if
an ADF member receives a vaccination, that information is to be recorded in the
members international certificate of vaccinationICV. That is an international
document. Whilst it comes out rebadged under an ADF number, it follows
international policy requirements.[622]
There is a second part to
the recording of the information and that is that an entry should be made into
the members medical record onto one of the running sheets in that record. So
there are actually two points of entry of informationwhich should in fact say
exactly the same thing. It should show the nature of the vaccine, the brand
name, the dosage, the date of administration and the batch number. That is the
obligatory information that is recorded.[623]
Other information suggests
that this has not always been the case. The submission referred to above on out
of date vaccines also noted that there was no consent form available,[624] and that this form was said to have
been no longer in use (in 2000). However, this may have been an anomaly, with
the Olympic Games not being seen as a deployment. The situation with respect to
this case, including any lack of accurate recording of information, such as
batch details, is best dealt with through an assessment of the safety and
efficacy of the material used.
Another submission stated
that some vaccinations in the First Gulf War had only been recorded on the WHO
form (the ICV) and not on the personal medical file.[625] However, there seems to be no reason
why such information could not be transferred to the personal file, including
in cases where non-standard vaccines may have been given because the individual
was working under other forces.[626]
A third instance was
stated in the Redress of Grievance document, where it is claimed in respect of Kanimbla personnel, that:
-
10(d) Only
the date of vaccination not the shelf life or batch number were recorded.
-
(e) The
shelf life of the vaccination and the batch number are unable to be provided
because these were not recorded. The vaccines were checked at the time of
inoculation to ensure they were in date and the batch number was recorded on
the packaging or the ampoules which were destroyed after vaccination.
-
(f) The
batch number of vaccinations is sometimes recorded but there is no strict
requirement to do so Rarely will [the batch number] be used in post retail
recall of medications and there has been no recall by the manufacturers of any
batch numbers of Anthrax vaccine used by the ADF.[627]
Strictly speaking, there may
have been no manufacturers recall of the UK vaccine, but there have been instances in which
a check has been initiated by others, including in the United Kingdom with batch No. 348E, during the first Gulf War.[628] However, the statement that there is
no requirement to record the batch number is inaccurate. This statement was
written in January 2004, but it was stated in February 2004 that this
information was incorrect and that the batch numbers had been recorded.[629]
Another concern with
medical records is whether data are available on the need for additional shots
or boosters, and whether there is currently in place a system which produces
such information. It is apparent from the information on HealthKEYS that this
will operate in the future, but in the meantime there is a need for accurate
records for individuals.
Assessment of information overall
The anthrax vaccine
issue highlights some problems, including the ease with which misinformation
can circulate. One of these is that it is important for long term credibility
to make accurate statements about what is and is not known about unusual
vaccinations, as the available information provided by various sources can be
misleading if not seen within context.
Issue of long term safety of the vaccine
Although some work was
undertaken in the 1960s and later on the effect of vaccine on textile mill
workers in limiting anthrax,[630] the
anthrax they may have been exposed to was not a militarised form.[631] In these circumstances, to say that
there are no data demonstrating longterm effects may easily be read as meaning
there are no long term effects.
Even the comment that the literature on safety suggests it is a safe vaccine[632] would have to be read with caution,
bearing in mind the very recent date of the studies on long term outcomes.
Both Defence and the
Repatriation Commission state they are not aware of any research that suggests
there are longterm harmful effects from anthrax vaccinations,[633] but this view must also be seen
within the context of research based on the 1st and 2nd
Gulf Wars. Both are too recent to provide information on effects that may not
occur for some time, and may also be affected by interaction with other
vaccinations and exposure to other substances. The response by the AMA to the
Department of Healths statement was more cautious:
I dont think we have enough data in the medical press,
certainly in the peer reviewed medical journals, that would convince medical
practitioners in Australia of the safety and efficacy of this vaccine. And If
they [the ADF] have that data, [that the vaccine was safe] the medical
profession in Australia would very much like to see it.[634]
The US report on the safety of anthrax vaccinations, though generally
positive, also noted that there was insufficient epidemiological evidence:
The committee found no
evidence that vaccine recipients face an increased risk of experiencing lifethreatening
or permanently disabling adverse events immediately after receiving AVA, when compared with the general population. Nor
did it find any convincing evidence that vaccine recipients face elevated risk
of developing adverse health effects over the longer term, although data are limited in this regard (as they are for all
vaccines).[635]
ATTACHMENT A
Document 1: Copy of consent form dated 29 January 2003
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CONSENT FORM FOR ADMINISTRATION OF
ANTHRAX VACCINE
I,
...............................................................................................
(full name)
hereby consent / do not consent * to the administration of
Anthrax vaccine for myself. (* Strike out
whichever is not applicable)
In addition I confirm that:
-
I
understand that this product is not registered by the Therapeutic Goods Administration
for sale in Australia but it has been approved for importation;
-
I have
read the information provided on pages 24, relating to the use of Anthrax
vaccine and have understood the information presented;
-
I have
discussed the use of the above with the medical officer and been given the
opportunity to ask questions;
-
I
understand that I may refuse to accept Anthrax vaccine without prejudicing my
medical care but that I may not be eligible for operational deployment; and I
have signed this form in the presence of an ADF Health Care professional.
Signed:............................................................................
Date:...........................
I
confirm that I have discussed the relevant products with the above named.
Signed:............................................................................
Date:............................
Printed
Name:.......................................................................................................
Position/Designation:...............................................................................................
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29-Jan-03 Page
1 of 4
ANTHRAX
IMMUNISATION INFORMATION SHEET
WHAT IS
ANTHRAX?
1. Anthrax is a serious illness caused by
the bacterium, Bacillus
anthracis. It is primarily a disease of plant-eating
animals - cattle and sheep being common hosts. Human infection with anthrax can
result in death, even with the best available treatment.
2. It is not a new disease, having been
recorded from around 1500 BC. During the 1930s, extensive research was
conducted in Germany, Russia, and Japan toward the use of anthrax as a biological weapon. During World
War II, several countries produced anthrax, yet Japan was the only country to use it as a biological warfare agent.
Since 1945 several countries have developed anthrax as a biological weapon, including
the former Soviet Union and Iraq.
HOW IS IT
SPREAD?
3. Human infection with anthrax can be
caused by direct contact with products from infected animals (hides, hair or wool),
eating infected meat or inhaling anthrax spores. Natural infection through
direct contact or ingestion is very uncommon due to widespread measures to
control the disease. The greatest threat from anthrax for ADF personnel is
inhalation of aerosol spores produced as a biological warfare agent.
WHAT HAPPENS
TO PEOPLE WHO ARE INFECTED WITH ANTHRAX?
4. There are two main forms of anthrax,
cutaneous (skin) and inhalation, based on route of entry to the body. The
incubation period for anthrax is usually 1 to 7 days, with most cases occurring
within 2 days of exposure. The incubation period for inhalational anthrax has
been recorded up to 60 days. Inhalational anthrax results in death in 90100%
of cases.
5. The first symptoms of inhalation anthrax
are flu-like symptoms such as sore throat, mild fever, chest pain, cough and
muscular pain. Within 2 to 3 days, serious breathing difficulties, collapse and
shock develop. Death occurs within 24 to 36 hours of development of these
serious symptoms.
CAN PEOPLE
WITH INHALATION ANTHRAX BE TREATED?
6. After exposure to anthrax, treatment
with antibiotics may be effective in preventing disease if it is begun before
the onset of any symptoms. To be optimally effective, preventive treatment
should be started within hours of exposure. As aerosol spores are invisible,
tasteless and odourless, personnel may be exposed without their knowledge. Once
symptoms have started, the efficacy of antibiotic treatment is very poor. If not
treated immediately and aggressively in a stateofart hospital centre, once
severe symptoms develop, 45% to 80% of patients will die.
DO INFECTED
PERSONS SPREAD THE DISEASE TO OTHERS?
7. Anthrax is not spread from person to
person.
WHY IS
ANTHRAX AN EFFECTIVE BIOLOGICAL WARFARE AGENT?
8. Anthrax bacteria are capable of forming
spores, which are thick walled inactive forms. Bacterial spores may survive
quite extraordinary extremes of temperature, dehydration or chemical insult.
Spores are easily stored and remain dangerous for a long period.
9. Anthrax spores are well suited for
delivery by missiles or bombs. They can also be dispersed by small devices
using explosives, generators that use either explosives or compressed air, or
spray devices. Anthrax would most likely be dispersed in aerosol form.
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HOW CAN
ANTHRAX INFECTION BE PREVENTED?
10. The single best way to protect against
many lifethreatening diseases is via vaccination. Vaccines work by stimulating
the human bodys natural defences to prevent the development of a disease if
later exposed to it.
IS THERE MORE
THAN ONE TYPE ANTHRAX VACCINE?
11. Two types of anthrax vaccine are
available for ADF personnel, one made in the United States and the other made in the United Kingdom. These vaccines are equally effective in preventing anthrax
infection. Although each vaccine is approved for use in its country of
manufacture, the Therapeutic Goods Administration (TGA) has not registered them
for general use in Australia. TGA has, however, approved the importation and subsequent
administration of these vaccines to ADF personnel and for other persons, such
as veterinary surgeons, considered being atrisk. Vaccination should be
completed with the one type of vaccine, as the vaccines are not
interchangeable.
HOW EFFECTIVE
ARE THE VACCINES?
12. No vaccine provides 100% protection.
However, the available evidence indicates that both types of vaccine provide
equally effective protection against anthrax.
HOW QUICKLY
DO THE VACCINES PROVIDE PROTECTION?
13. Both vaccines provide some protection
after the second injection and good protection after the third injection (ie
after four or six weeks). If you are exposed to anthrax before you have had
your third dose, you may be given antibiotic treatment.
HOW LONG DOES
PROTECTION PROVIDED BY ANTHRAX VACCINES LAST?
14. In order to maintain immunity,
personnel require a booster vaccine dose each year after completion of the
primary schedule. The primary schedules are complete at the 18 month injection.
WHAT HAPPENS
IF I HAVE ALREADY HAD SOME VACCINE DOSES?
15. You must complete the primary schedule
for your vaccine type. If a longer interval than that recommended in the
schedule has elapsed since your last dose, you should resume the schedule,
extending the times according to the schedule. Additional doses to compensate
for any delay are not required.
CAN I GET
ANTHRAX INFECTION FROM VACCINATION?
16. Neither type of anthrax vaccine
contains live bacteria. Therefore, they do not introduce any form of anthrax
infection.
WHAT ARE THE
POSSIBLE ADVERSE EFFECTS OF THE VACCINES?
17. Local
reactions. Reactions at the injection site usually
last from one to three days and go away without treatment. Redness, itching,
and/or swelling, occurs in up to one third of men and up to two thirds of women
following anthrax vaccination. Such reactions are usually only small but in
rare cases may be up to 13 centimetres in diameter. Soreness or local pain
occurs in up to one fifth of persons vaccinated. A lump at the injection site
is common, occurring in up to 90% of people vaccinated. The lump may persist
for a few weeks.
18. Systemic
reactions. Reactions away from the injection site
occur in up to one third of people vaccinated. These reactions may include
muscle aches, joint aches, chills, lowgrade fever, decreased appetite,
headaches, nausea, and swollen glands. They usually go away in a few days.
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19. Acute
allergic reactions. These reactions,
which may be severe, are very rare (about 1 in 100,000) but may occur with
anthrax vaccines, as with any vaccine. There is no evidence that other types of
serious reactions occur with either type of anthrax vaccine.
WHAT DO I DO
IF I EXPERIENCE ADVERSE EFFECTS?
20. You should avoid strenuous exercise for
at least 48 hours following local or systemic reactions. You should report to
your ADF Health Care professional for further advice. Treatment will not
usually be required. It is very unlikely that you will not be able to complete
the schedule.
WHO SHOULD
NOT HAVE ANTHRAX VACCINATION?
21. The following should not have anthrax
vaccine at all:
a. Persons who have had an acute allergic
reaction to a previous dose of anthrax vaccine or to any of the vaccines
components,
b. Persons younger than 18 or older than
65,
c. Persons who are HIV positive.
22. Vaccination should be temporarily
deferred in the following circumstances:
a. Pregnancy, suspected pregnancy,
b. Women who are breast feeding,
c. Active infection/illness with fever,
d. Depressed immune response, including
corticosteroid or other immunosuppressive treatment.
IS THE
VACCINE COMPULSORY? WHAT HAPPENS IF I DONT HAVE IT?
23. Anthrax vaccination is not compulsory.
However, if the Joint Health Support Agency Health Support Plan for a
particular operation indicates that Anthrax vaccination is a requirement,
personnel who decline vaccination may not be considered eligible for deployment
to that operation.
ARE
ANTIBIOTICS AN ALTERNATIVE TO VACCINATION FOR PREVENTION OF ANTHRAX?
24. No. Long-term antibiotic treatment is
not an acceptable alternative to vaccination because it is less effective in
preventing infection and has unacceptable side effects.
ONCE I HAVE
BEEN VACCINATED, DO I NEED TO DO ANYTHING ELSE TO PROTECT MYSELF AFTER EXPOSURE
TO ANTHRAX?
25. Even when fully immunised, antibiotics
may be still indicated after aerosol exposure, to achieve survival as close to
100% survival as possible.
WHERE CAN I
GET FURTHER INFORMATION?
26. Ask your ADF Health Care professional,
as there is a great deal of information available.
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Document
2: ABC Radio interview of Dr
Kerryn Phelps
Navy message to
soldiers
AMFriday,
14 February, 2003, 00:00:00
Reporter: Jo Mazzocchi
LINDA MOTTRAM:
Meanwhile, faced with the dissent within the ranks, the Chief of the Navy, Vice
Admiral Chris Ritchie, has been forced to take the highly unusual step of
delivering a message to all serving Australian Navy personnel that the anthrax
vaccine is safe.
But now, Australia's
peak medical lobby group, the Australian Medical Association, has joined those
taking the opposite view, in a contribution that will only complicate life for
Australian defence personnel caught in the middle of the debate with life and
death issues looming.
Jo Mazzocchi reports that Vice Admiral Ritchie has also publicly rebuked the young sailor
who told the media of his concerns about taking the anthrax vaccine.
JO MAZZOCCHI: The Chief of the Navy rebuked the young
sailor, Able Seaman Simon Bond, who sparked this controversy, by saying that
the types of breaches that have occurred in the last twenty four hours
"create far greater upset for families for our people than they are of any
help to either individuals or your mates".
But judging by the
depth of public confusion over this issue, some might disagree, claiming Able
Seaman Simon Bond has in fact done them a favour.
The Australian Medical
Association says the sailor has acted as a catalyst on the issue.
AMA
President Dr. Kerryn Phelps.
KERRYN PHELPS: Look I think that raising issues and
speaking about the concerns that his colleagues have is not really causing any
harm.
I mean if what this
does is act as a catalyst for the Defence Forces to release the information
that they have about safety and efficacy then I think it would have done a
power of good.
JO MAZZOCCHI: Today in Sydney, there are more farewells for the final
deployment of defence personnel to the Gulf.
It is now believed
vaccinations are being carried out before they leave, but defence sources are
refusing to confirm that.
In his message, the
Vice Admiral also stressed that the anthrax vaccine is safe, saying it has been
very widely used with no greater incidence or side effects or risks of
complications than those associated with any other vaccine.
And that's a view
shared by Australia's Chief Medical Health Officer, Professor Richard Smallwood, who says the vaccine is regarded as safe and effective.
But Kerryn Phelps is not convinced.
KERRYN PHELPS: I don't think we have enough data in the
medical press, certainly in the peer reviewed medical journals, that would
convince medical practitioners in Australia of the safety and efficacy of this vaccine.
The truth is sometimes
difficult and I'm not in the business of propaganda, what I'm about is to
express what I believe is the medical profession's view on this particular
incident.
JO MAZZOCCHI: So there's no clear cut, definitive study
either way?
KERRYN PHELPS: Not that the peer reviewed medical
literature has available to it.
JO MAZZOCCHI: When the Chief of Navy Vice Admiral Chris
Ritchie sends out a message and says the vaccine is safe and effective, what is
your response to that?
KERRYN PHELPS: If they have that data, the medical
profession in Australia would very much like to see it.
LINDA MOTTRAM: AMA President Kerryn Phelps speaking to our reporter Jo Mazzocchi.
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