GSK planned on using squalene adjuvants in Flu shot from Feb 2009

GSK admits in FEB 2009 that it planned on introducing squalene adjuvant ASO3
into regular season flu shots and aware of autoimmune issues!

Check out pg79-80 of this FDA doc
http://www.fda.gov/downloads/Advisor.../UCM167162.pdf


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 company's 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 don't 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 that's 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.