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 know how it's going to go.

Health committee  Yes, we've been working for many years, right from 2001 or even before that, with the Public Health Agencies and with the provinces. This is not new. The idea that a pandemic was going to come sometime was well known. So there has been preparation all along.

Health committee  On the issue of the virus changing, mutating, changes have been detected recently in the Netherlands, but they're not affecting the antigenicity at the moment. The vaccine is working okay, but I think things are moving in the virus. We don't know where it will take us. Maybe it won't change too much, but they're already detecting some changes in the virus.

Health committee  Not really. When products are licensed in Canada, the data from the manufacturer is usually assessed. It's not an independent assessment. It may involve independent investigators, which is a different issue, but it's all manufacturers' data.

Health committee  Could I add on to that? There were data also from the prototype vaccine in the younger age groups coming in as well.There were half doses there, so we did have an idea coming in for that. The reason we went forward so quickly was that we could see from this first dose that there was sufficient immunity to go on; otherwise, we would have had to wait until November to get the results of the final study.

Health committee  The process is not much different. They went forward in the United States; they decided to go for an unadjuvanted vaccine. I can't speak to the details they have. The manufacturers clearly had provided them with sufficient information for them to make a strain change from their seasonal vaccine into their pandemic vaccine, and so that enabled them to license early.

Health committee  Could I first clarify the point about the timing? I think the idea was—and Dr. Butler-Jones can help me with this one—that we didn't want to say we were going to be able to have a vaccine available in mid-October when we weren't really sure we would be. The conservative approach was to say November.

Health committee  Could I answer that one? I think she was referring to a group trial of 130 in Europe. It's bigger than that; there are two trials there. It's actually double that. I think the figures may have been mixed up somewhere. It's not just 130. There are two studies done in Europe with slightly different concentrations of the adjuvant and the antigen, essentially, so the numbers are not quite correct.

Health committee  With the annual seasonal flu vaccine, which is licensed, all that happens every year is that there's a strain change. There is a small clinical study of the same size that takes place. Some of them are in Europe, some of them are in Canada. Every year, it's the same. It's following the same pattern.

Health committee  The issue with authorizing on data generated in Europe is not quite true. It's a whole package of data, which I tried to express. The data from Europe was really on the efficacy of the H1N1; that was the early data coming in. The safety package was primarily from the H5N1, which has been tested in Europe and the United States and in Canada as well.

Health committee  Thank you very much for this opportunity to speak to the committee. As you've already heard from Dr. Butler-Jones, Health Canada authorized Arepanrix on October 21. This is the adjuvanted vaccine manufactured by GSK, GlaxoSmithKline, for use against the H1N1 flu virus. This authorization was made under an interim order.