[back] Squalene Flu shots
GSK admits in FEB 2009 that it planned on introducing
squalene adjuvant ASO3 into regular season flu shots and aware of autoimmune
Check out pg79-80 of this FDA doc
DR. GELLIN: We spent most of yesterday talking about how to make better vaccines to provide better cross-protection for seasonal flu. Given what you have here with your adjuvant, can you comment about the companyís plans to use an adjuvant for seasonal flu? I guess you have already told us that this is the body of information in children, but you might want to tell us some more about these plans if they are to introduce that product and what the development plans would be, particularly to bring a product like that down to younger children.
DR. VAUGHN: Yes, the company does have plans to utilize the ASO3 adjuvant with seasonal antigens. There is a trial under way now in 43,000 elderly to look at that age group, and also plans to look at children, where the adjuvant may provide benefit or children donít respond so well to antigen alone.
DR. MODLIN: Melinda?
DR. WHARTON: Given that there is a more robust body of experience with the ASO3 adjuvanted vaccines in adult, could you share with us a little more information about the safety experience, particularly addressing the issue of some autoimmune conditions, which I think is the thing that raises at least a theoretical concern?
DR. VAUGHN: GSK is sensitive to the issue, the concern about autoimmune with new adjuvant systems, such as this one. We have come to agreement with CBER on a list of adverse events of special interest, many of which are presumed to be immune-mediated. Some are not, but many are. We are actively looking for those types of cases, not only in the Q-Pan program, but the D-Pan program and other programs that are using ASO3, such as the efficacy study in the elderly thatís under that I just mentioned.
Not surprisingly, we are finding some cases on this list. To date, they are
not above expected background rates. We continue to monitor that.
I think on an earlier slide I mentioned that as part of our submission packet, we will be putting together an integrated summary of safety that will look across D-Pan and Q-Pan programs to assess that risk.