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Health committee  I think Dr. Butler-Jones should be speaking to this.

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  The recommendation is to use the adjuvanted vaccine because they usually respond very poorly. But those data are not available yet. We are moving forward here, but there are still these special groups that we need to study. Do we need one or two doses of the vaccine? It's an ongo

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  Oh sorry, the H1N1. Yes, it was fairly mild, but that was their first wave. They expect the second wave in spring for us--our spring, essentially.

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  There's a lot in there, but very briefly on autoimmune disease--Guillain-BarrĂ© syndrome, for example, could be an autoimmune disease--these are so rare you'd really have to look at the big picture here. You would not see these until you actually roll out into millions. As Dr. B

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  Could I add a point there? I think you have to remember we're not making Aspirin or Coca-Cola, or something, when you're making vaccine. When you make a vaccine, there are biologics that are very difficult to make. You can have policy based on the best science that's available, b

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  Not on the purchasing side. That's the Public Health Agency. We regulate whatever vaccine comes to us, let's say. But it's a Public Health Agency issue. It's the supply part.

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  Both will be available; that's right. On this issue of the mutations, as you know, seasonal flu is mutating all the time. This particular virus is fairly stable, strangely enough. It hasn't mutated very much. As I mentioned earlier on, changes have now been detected in the Nethe

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  Yes, the seasonal flu is changing every year. That is changing. That is why you have to have a new vaccine every year. So this meeting that takes place for the northern hemisphere takes place in Geneva. The southern hemisphere does the same. It takes place in September. They deci

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  I'll deal with the pregnant women, to start with. This vaccine isn't contraindicated for pregnancy. We're not saying it should not be used in pregnant women. The regulators are saying that we don't.... No clinical trials were carried out in pregnant women, so therefore we cannot

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  That's right. Everybody is pooling their data from all the different countries, and that has never happened before on the regulatory side. It has always been confidentiality and this sort of thing. So we are all sharing. So you can imagine that from a safety point of view you hav

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  Dr. Butler-Jones should answer that one.

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  I think this has been the big issue. Trials have been done so far in an age group from the middle group, if you like. There's a top end, where we're not really sure what the dose should be. Yes, these have to be tracked. They've got to be going off with one dose, but they will be

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  On the safety aspect, this adjuvant type of vaccine has been used in up to 40,000 people without any significant effect. With a vaccine like Prevnar, which is the pneumococcal vaccine, virtually all the trials were done in the United States and Africa. In the United States trial

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  There are no data to say that you shouldn't have it. The idea would be that if you're going to have it at the same time, have it on different arms. There's no real data to say that you shouldn't have it at the same time.

October 26th, 2009Committee meeting

Elwyn Griffiths

Health committee  I think there's no question of the benefits of immunization here in relation to the risks. Regarding the risks of a pandemic influenza, we don't know how it's going to develop. At the moment it's been fairly quiet in the first round. The second round could be much worse. We don't

October 26th, 2009Committee meeting

Elwyn Griffiths