Select Committee on Science and Technology Minutes of Evidence

Examination of Witnesses (Questions 580-599)



  580. Who should be responding to the media? The media campaigns are anti everything really, are they not?
  (Dr Miller) It depends really what the question is. I have to front quite a lot of media issues but that relates to the evidence upon which a vaccine's safety has been endorsed. If it is a question of policy, why the Department of Health is not providing vaccines separately rather than together, very much a policy issue, I see that down to the Department of Health. The manufacturers have a difficult role to play here because even individuals might get accused of having conflicts of interest. They have been involved in the introduction of the vaccine and are now conspiring to keep its dangers away from the public. That is very much more so with the vaccine manufacturers, but they can provide an important role in ensuring that professional groups have access to information. It is quite difficult to have all the information at your fingertips and having well researched sets of data available not only for an individual like myself, because I am aware of the data, but other professional groups who can be brought together and spokesmen identified. For instance, a group has been brought together on MMR where there is a particular issue. There are lead individuals who will make themselves available to the press with a paediatric or general practice background and they having access to readily available information is something which is very important but has actually arisen out of the MMR controversy.

  581. We heard about DEFRA suddenly coming into the frame. I have to say that came as a surprise for me and may have come as a surprise to some others. Do you feel they have any role or should this actually be watched much more firmly in the DOH?
  (Dr Chatfield) My personal view is that it should be lodged more firmly in the DOH. There are clearly environmental issues potentially about releasing genetically modified organisms. At the moment it sits with the Department of the Environment to make that assessment. The issue comes with having a very clear remit about what they are doing because at the moment we have different groups reviewing different issues. It appears that another group is now involved looking at the safety aspects in the human subjects as well and that has become something we have had to respond on in questions to DEFRA. We just need to have firm remits for what each of these groups is doing in terms of their place in the review process.


  582. Do you think this might be a commitment that the HPA would take on board?
  (Dr Chatfield) Potentially.
  (Dr Miller) A commitment in relation to evaluating the environmental impact of live vaccine?

  583. Yes.
  (Dr Miller) Clearly there would be expertise available within the Health Protection Agency and the ability possibly to set up some surveillance studies. I do not see it taking the lead in establishing the regulatory framework. That has to come from the Medicines Control Agency and if there are bodies outside the Medicines Control Agency who are being required to look at safety issues in human subjects, there is the potential there for confusion. It needs to be concentrated within the regulatory agency, which could tap into appropriate expertise as it exists with very clearly defined remits and terms of reference.

Lord Rea

  584. What are your views on establishing a no-fault compensation scheme for the fortunately small number of individuals who suffer from side-effects as a result of vaccination? What are the advantages and disadvantages in your view?
  (Dr Miller) Is this over and above what exists in relation to the existing vaccine damage payments scheme and the availability individuals have through the law courts to claim for compensation under consumer law, which does not require negligence on the part of a manufacturer? Another scheme in addition to those two.

  585. The current one does imply fault.
  (Dr Miller) In relation to the consumer protection law under which, for instance, the MMR litigation is being brought, no question of fault is necessarily implied there. That does require you to go through the legal process. Under the vaccine damage payment scheme which exists already, whereby individuals who are deemed to have suffered side-effects as a result of vaccination are eligible to receive compensation, the sum is a maximum of £100,000. That has been in place for some years. The amount has increased. Clearly the requirement there is to establish causality. Are you thinking of a wider system whereby anybody who suffers an adverse event after vaccination would be liable to have compensation, whether or not fault had been or actual causality had been established.

  586. One would have to establish causality.
  (Dr Miller) You could argue that the scheme we have does not pay enough and maybe the criteria could be revisited in relation to how much is paid to individuals who suffer side-effects. However, there is that scheme in existence.

Lord Turnberg

  587. Who funds that? Is that government?
  (Dr Miller) Yes. The decision about whether or not a particular child is suffering an adverse event is made by medical assessors who have no relationship to the Joint Committee on Vaccination, licensing authority or the Department of Health. It is run independently.
  (Mr Kingston) The current scheme is funded by the Department for Works and Pensions, which we think actually probably has some merit to it; to have a scheme not funded either by the Department of Health who are buying the vaccines and setting the policy or possibly also by the manufacturers. The advantages of the current scheme are that it does provide financial compensation up to a ceiling which some would say is relatively low. It provides it very quickly without imposing a terrific burden of proof on people who allegedly are suffering as a result of having a vaccine. You have somebody in trouble and they get some relatively easy assistance. At the other end of the scale, if somebody felt they had been damaged by a vaccine which was incorrectly or negligently produced, then of course they have all the liberties to take a case against a manufacturer. We in UVIG think those two possibilities for compensation do quite a good job at covering all the various needs people might legitimately expect if we are asking them to participate in a public health scheme where, sure, they get individual benefits from taking the vaccine, but we also need to bear in mind that society as a whole benefits when we do get vaccine coverage up above the so-called herd immunity rate.

Baroness Walmsley

  588. You all clearly seem to think that the current system is absolutely fine. Do you have any suggestions? Is it possible to improve it or is it absolutely perfect? How could it be improved?
  (Dr Miller) The issue of whether the amount is adequate. If you are looking at compensation for lifetime loss of function, as may happen after polio vaccine, one can question whether that is enough. The amount has been raised. I am not sure why it was put at £100,000 as opposed to something higher. Perhaps that could be revisited, but in principle that is the right way to do it, together with the recourse to litigation for those who believe they have been suffering from effects but perhaps would not be eligible for compensation under this scheme.


  589. Do you think that the burden of proof for causality is about right as it is at present or is it too onerous for the current compensation scheme?
  (Dr Miller) The information about who has been compensated and what the evidence was of causal association is not widely available. Certainly I have not seen detailed descriptions of cases which have been awarded compensation. It is not put in the public domain, certainly it is not data which are regularly reviewed, for instance by the Joint Committee on Vaccination and Immunisation. I believe it is very much down to the views of individual medical assessors and a small panel. I cannot answer that one.

Lord Turnberg

  590. Are there any cases? Presumably there are people who have been compensated.
  (Dr Miller) Yes. Many more apply that receive compensation that I am aware of.

Lord Rea: Yes, I know of numbers who have applied and been turned down and feel rejected and rather aggrieved. They feel sure themselves that there was a connection, but in fact the evidence does not bear up.

Lord Oxburgh

  591. Flu pandemics. These tend to originate in South East Asia and sweep across the world. We have heard quite a lot of evidence to suggest that really these things arise so rapidly and then spread so rapidly that there is little chance of both developing an appropriate vaccine and producing it and getting it to populations in time for it to have much effect. Would you agree that this is currently the case and is there anything we can do about it?
  (Mr Kingston) UVIG would agree this is currently the case. The most practical thing to be done about it would be to increase the recurring medical demand for vaccine in a non-pandemic year in our view. The recurring medical demand for vaccines in the UK at the moment under current policy is 12 million doses per annum. Clearly if you suddenly want 60 million doses, that is quite a magnitude of change. Most practically, there are groups at the European level and in the States where they have probably gone a little further, where policy has shifted to say rather than 65 years and above, let us look at 50 years and above. There are health economics data to suggest that even in a non-pandemic year going to 50 years and above catches so many of your at risk groups for the flu vaccine—asthmatics, coronary heart disease patients, diabetics—that it is not an unreasonable medical intervention to make anyway and it would simultaneously have the effect of at least doubling the regular supply of vaccines in the UK.

  592. That doubles your production facilities but it does not do anything about the development time taken for a new vaccine for a new strain.
  (Mr Kingston) Correct; yes.

  593. Is that a timetable which is feasible?
  (Mr Kingston) Once the actual viral component of the vaccine is identified, we are then in the timetable I alluded to earlier on, which tends to be: start growing the virus in April ending up with finished vaccine ready for administration at the earliest in August. From the UVIG companies' point of view, we see no way of accelerating that process significantly.
  (Dr Chatfield) To some extent that depends on the virus itself. There are issues each year in terms of manufacturing yields, in terms of length of time it may take to culture the virus, etcetera. One of the things which could be considered is to look at new technologies for pandemic type vaccines because it is clear that, considering we are talking about the A strains, there are some new technologies emerging. There are groups now who are working on vaccines which are not based on surface antigen, (on which current vaccines are based) which are based on the nuclear protein or the matrix protein where you get broad protection across strains. It is by a different mechanism of immunity, but the really important thing about it is that you could produce them as a conventional protein peptide type vaccine and you could actually start to stockpile these types of vaccines because you are then not reliant on producing a new vaccine each time a new A strain comes along. I think from this perspective that there should be a focus on this type of technology as well, given the issues we have heard about with the current vaccines.

Lord Oxburgh: That is very interesting; thank you.

Lord Turnberg

  594. Is anyone doing that work?
  (Dr Chatfield) A couple of US companies are looking at that sort of work in terms of looking at presenting the M protein in a virus-like particle, but it is a virus-like particle which does not rely on eggs to grow in or mammalian cells; you can grow it in bacteria which makes a much simpler production process.

  595. Is this something the government might think about funding? It sounds as though it would bring benefits here.
  (Dr Chatfield) There are now blossoming technologies where it is right to start the funding process.


  596. Is there sufficient collaboration with China in view of the fact that the majority of flu strains do come out of that part of the world? Is there sufficient collaboration with the Chinese as to what is happening within China in the pig, chicken, duck, human population?
  (Dr Miller) The surveillance side is very good: WHO, collaborating laboratories, rapidly identify. That side is okay. The problems are very much the capacity, turning up the volume suddenly and being able to have technologies which allow you to have heterologous protection rather than strain specific protection.

  597. One of the big problems about flu is that you can prepare all your vaccines and then it never happens.
  (Dr Miller) Yes. We have quite a good flu surveillance system in the UK, actively looking for isolates in individuals presenting with flu-like illness. Active surveillance is going on so new strains are picked up very quickly in the UK. Internationally the surveillance is good.

  598. My last question is on communicable disease as a global phenomenon, of which flu is one, I suppose, and the control mechanisms. Possibly one should have a global outlook here. Does the vaccine industry and the United Kingdom Government have a sufficiently global outlook in relation to vaccine research and development? If not, how should this be achieved?
  (Dr Chatfield) I certainly think that the UK vaccine industry has a global outlook. As a company we have to develop vaccines for the global market. We could not justify developing these vaccines for the UK market alone, so for that reason, the UK vaccine industry has to be a global industry.

  599. What are the problems that vaccine developers have in meeting the demands of the various countries, in registering vaccines and vaccine schedules and the rest? Is this a major problem for getting vaccines into countries which need them?
  (Mr Kingston) It becomes a problem in designing the clinical trials. This particularly applies to infant schedule vaccines, which in one country may be administered at two, three, four months of age and in another country it might be two, four six; there are several different schedules, all with their own arguments for and against. Clearly if you are going to test all those in your clinical trial programme that adds to time, complexity and expense. Beyond that, certainly within Europe, different stances are taken by the different medical agencies, which are not new to the pharmaceutical industry, so we know what we are dealing with there, but unless you come up with a very new vaccine and you get it licensed through the EMEA, you do have a period of negotiation and dealing with different questions and sometimes opposing perspectives through the Member States.
  (Dr Chatfield) It comes back to some of the comments I made earlier. In the US it is much easier because you are going through one system and you are dealing with one regulatory authority. The difficulties you have just alluded to in Europe are real in terms of how those vaccines may end up being used despite the centralised procedure, the additional work which you have to do to make sure you can get those vaccines into the national vaccination schedules or bought into in terms of some of the agencies that will eventually provide these vaccines.

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