Conclusions and recommendations
A vaccine for cattle
1. During the last
18 months the debate on the availability of a cattle vaccine for
bovine TB has been characterised by a lack of clarity and public
misunderstanding. Although it is by no means solely responsible,
the Government must accept a great deal of the blame for this.
The quality and accuracy of the information that Defra has put
in the public domain has been insufficient and inadequate. It
is unfortunate that this has led to debate over the timetable
for use of the vaccine overshadowing scientific breakthroughs
in the development of both the vaccine and DIVA test that should
be applauded. (Paragraph 16)
2. We await publication
of the TB eradication strategy with interest and expect it to
include not only information on those methods that are available
for the eradication of bovine TB but progress on those in development.
The launch of the strategy must be accompanied by a public information
campaign to make the position clear in the public's mind and dispel
misunderstanding. (Paragraph 17)
3. It is perplexing
that the Government has maintained that field trials were prohibited
under EU law when, as recent events have shown, this is not the
case. We accept that field trials might be permitted only if certain
criteria are met, the development of the DIVA test being one of
them, but to have stated that legislative change is required is
misleading. It would be unfortunate if the Government's interpretation
of the legislation had delayed progress in delivering a vaccine.
(Paragraph 25)
4. We are not convinced
that the Government had to wait until all the 'factors were in
place' before approaching the Commission. However, while we believe
negotiations could and should have begun earlier, we welcome the
efforts of the Government and the Commission in coming to an agreement
that field trials might take place in the UK. To be able to study
the efficacy of the vaccine and DIVA test in UK field conditions
is a big step forward and we congratulate the Government on securing
this position. (Paragraph 26)
5. It is difficult
to envisage Defra designing field trials of the scope and size
requested by the Commission without using the commercial herd.
In doing so, the Government must take steps to reassure the public
that such field trials will not pose a public health risk. The
Government must also make sure that farmers volunteering their
herds for these trials are not left financially disadvantaged.
We look forward to seeing details of the programme for field trials
once it is agreed. (Paragraph 28)
6. We welcome the
ongoing dialogue between the UK, EU and OIE. A good working relationship
is vital to ensuring early success in the development and deployment
of a vaccine to help combat bovine TB. The indicative 10-year
timetable set down by the Commission is precisely that, indicative.
The UK Government should do all it can to condense the timetable
without compromising the collection of the robust field data necessary
to satisfy the VMD and European and international communities.
Once the programme for field trials is agreed we look forward
to the Government publishing its own indicative timetable for
the use of a cattle vaccine. We accept that such a timetable may
be subject to change but any changes must be clearly explained.
(Paragraph 31)
7. We invite Defra
to indicate in its response to this Report, the timetable proposed
for the new Animal Health legislation. (Paragraph 33)
8. A vaccine that
is 65% effective will not immediately solve the problems of bovine
TB within the cattle industry. Over the short term, its use will
be an additional financial cost and may lead to an increase in
the administrative and testing burdens farmers already face. While
it will be a useful tool to have, the circumstances in which it
might be used, the precise objectives of applying it and levels
of protection that would be needed to make vaccination worthwhile
need careful consideration. Before deployment the Government must
undertake and publish a robust cost-benefit analysis. The analysis
must also consider the extent to which EU financial support would
be available for such a programme. (Paragraph 35)
9. Even if the cattle
BCG vaccine becomes available to use the Government must not stop
there. The considerable cost of the DIVA test and cattle BCG mean
that research into a vaccine that does not desensitise animals
to the skin test must remain an objective. There is also considerable
merit in focusing research on improving the immunity offered by
the existing BCG vaccine. (Paragraph 37)
An injectable vaccine for badgers
10. In order for vaccination
to be considered part of a strategy to eradicate bovine TB we
first need to establish what level of efficacy can be expected.
The research undertaken by Chambers et al was vital in gathering
the data required to get a badger vaccine licensed and available
to use and we congratulate those involved in achieving this aim.
To have another tool to use against bovine TB is valuable. However,
what is also apparent is that substantial data clearly showing
the effect of the vaccine in the field are lacking. Now that a
vaccine is available the Government should consider addressing
this evidence gap by researching the efficacy of the BadgerBCG
vaccine in the field. (Paragraph 45)
11. Although they
were not originally planned to test the effectiveness of the vaccine
or the impact of its deployment on the incidence of TB in cattle,
the cancellation of five of the six Badger Vaccine Deployment
Projects represents a missed opportunity to collect valuable data
on the effect of the badger vaccine. (Paragraph 47)
12. The absence of
empirical evidence of the impact of badger vaccination on the
incidence of TB in cattle is not on its own a reason not to pursue
a vaccination strategy. A vaccine that reduces the excretion of
M. Bovis bacteria is a powerful tool. An effective programme of
badger vaccination in areas where badgers are the suspected source
of TB in cattle would be expected to reduce transmission of the
disease between the species (Paragraph 48)
13. Although the extent
of infection transmitted between badgers and cattle is subject
to debate, we believe there is merit in gathering information
on potential transmission pathways and we welcome FERA's research
project on badger farm visits. Developing and implementing effective
badger exclusion methods may prove more cost effective than other
measures aimed at addressing the impact of infected badgers on
cattle. (Paragraph 51)
14. Herd immunity
is a sought after outcome of any vaccination programme. It means
transmission of disease is reduced and non-vaccinated animals
are given a measure of protection reducing the need for further
deployment of the vaccine. The identification of the indirect
effect of badger vaccination on unvaccinated cubs is an important
step forward in research on the effectiveness of the BadgerBCG
vaccine. For herd immunity to occur, a significant proportion
of the uninfected badger population must be trapped and vaccinated.
The precise numbers depend not only on local factors such as badger
population, density and environmental factors but, as importantly,
on the efficacy of the vaccine. While herd immunity may mean that
not every badger has to be vaccinated every year, we need to be
confident, without testing each badger, that herd immunity has
developed. Further research on the indirect effect of vaccination
is therefore necessary and must be included as part of future
evidence-gathering on the efficacy of the vaccine in the field.
(Paragraph 54)
15. Although vaccination
is costly, scope exists for economies of scale but this will need
a more coordinated national approach to badger vaccination to
enable equipment and information to be shared more effectively.
There is great enthusiasm among voluntary organisations for deploying
the badger vaccine. The Government should not miss the opportunity
to use them both to gather evidence and as a resource to carry
out vaccination. A first step should be to set up an advisory
service to help NGOs plan and deploy a programme of vaccination
and to advise what data it would be useful to obtain. (Paragraph
56)
16. PCR testing of
badger faeces has the potential to identify those setts which
harbour infected badgers. Doing so will not only enable a vaccination
programme to be better targeted and therefore more cost-effective
but may also be able to show whether the vaccination has been
successful in creating herd immunity in particular social groups.
We recommend that the Government provide funding to explore how
this research might be applied practically in the field. (Paragraph
59)
17. Farmers are not
entitled to funding to complete the lay vaccinator training course
despite it being their land on which access is required to undertake
the vaccination. This is perverse. The Government should amend
eligibility for the course to include farmers. (Paragraph 60)
18. The Government
should increase the number of places on its lay vaccinator training
course. It would be disappointing if a lack of qualified vaccinators
became the limiting factor in a programme aimed at reducing TB
in badgers. (Paragraph 61)
19. The Government
needs to undertake further research in order to have confidence
in the level of efficacy to be expected from the vaccine when
deployed in the field. (Paragraph 63)
20. The development
of a vaccine that reduced the level of infection in badgers would
be a valuable tool in the battle against bovine TB but, despite
10 years of research and £11million spent in development,
it is one that Defra lack a strategy for using. A number of voluntary
organisations are deploying the vaccine and, while we commend
their actions, in the absence of a clear nationally coordinated
strategy this work can only have a limited impact on the wider
problem of bovine TB. We are particularly concerned that Defra
may miss the opportunity to make use of the enthusiasm that exists
in the voluntary sector for badger vaccination. (Paragraph 64)
21. Badger vaccination
is expensive and no magic bullet. We agree with the Wildlife Trusts
that if it is going to make a difference, it needs to be deployed
strategically in areas where it is likely to have the biggest
impact. The vaccine has been available for use for more than three
years. Having developed the vaccine, Defra must now produce a
clear strategy for its use. (Paragraph 65)
An oral vaccine for badgers
22. We welcome the
Government's continued commitment toward the development of an
oral baited vaccine for badgers. An oral vaccine that is cost
effective and easy to deploy is arguably the best means of creating
a healthy badger population. It is important that sufficient resources
are available in order to accelerate the necessary research required
to make an oral vaccine available for use. The Government must
also continue to work closely with other countries with similar
problems of infected wildlife such as Ireland, New Zealand and
Spain. (Paragraph 70)
23. Progress towards
an oral vaccine for badgers is evident but one will not be available
in the near future. Further scientific information is required
before a candidate vaccine might be taken forward to be licensed.
The most cost-effective means of deploying the vaccine which will
maximise uptake among the target badger population and minimise
consumption by other species also remains to be fully identified.
(Paragraph 71)
24. Even if an oral
vaccine becomes available it is unlikely to be an immediate or
complete solution in combating bovine TB in badgers. If herd immunity
could be achieved it would take many years and considerable effort
and expense. That is not to say that it should not be considered;
it is the most likely means of creating a healthy badger population,
but it is important that these caveats are understood by all those
interested in this subject. (Paragraph 73)
25. Defra has a clear
responsibility to keep the public informed of scientific progress
toward developing an effective oral vaccine. It has so far failed
to do so adequately. Reticence about publishing indicative timescales
is understandable but there is scope for Defra to improve information
available. Basic details of trials, such as their purpose and
length, and updates on progress should be available and easily
accessible to the public. (Paragraph 74)
Other issues
26. The testing regime
is central to the control and eradication of bovine TB in this
country. It is frustrating to hear government officials acknowledge
that the current testing regime misses infectious cattle when
they have a test at their disposal with a greater sensitivity.
We accept that the gamma interferon test is expensive but the
Government must explore whether it is possible to use the test
more widely than is the case at present. Doing so may help the
Government to get ahead of the spread of infection and begin to
bear down on the disease. (Paragraph 79)
27. Now that the gamma
interferon test is out of patent it seems to us timely for the
Government to explore whether it is possible to improve the performance
of the test and reduce its cost. (Paragraph 80)
28. The Government
should explore the possibility of integrating local vets into
strategies for improving farm biosecurity and disease control.
The local vet is well placed to know what is going on in a particular
herd and will be familiar with the area and trusted by the farmer.
We are mindful that this may lead to extra costs for farmers and
this must be included in any consideration of such a strategy.
(Paragraph 82)
29. The Government
should explore the possibility of integrating local vets into
strategies for improving farm biosecurity and disease control.
The local vet is well placed to know what is going on in a particular
herd and will be familiar with the area and trusted by the farmer.
We are mindful that this may lead to extra costs for farmers and
this must be included in any consideration of such a strategy.
(Paragraph 82)
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