OK. Limited research on Squalene....my interpretation.
Link 1
Concludes that squalene is a natural product. We eat it daily. We make it daily (in quite large amounts as it is a precursor to cholesterol and a number of steroids and hormones essential for us to function). It also says that many members of the public have low levels of anti-squalene ABs even if they have never been exposed to squalene in an adjuvant. Therefore Squalene is inherantly safe for the body. The question is therefore does shoving it up your but with an antigen do anything different.
In this same paper there is a look at the so caled anti-squalene antibodies which were attributed to gulf war syndrome mentioned earlier. I know that the research is carried out by Novartis, but it is in a peer reviewed journal - meaning that the data has been scrutinised by INDEPENDANT experts. The data they present looks rigerous in concluding that the MF59 (which is v v similar to AS03 according to one of Lama's links) does not induce an immune response to teh adjuvant. There is also a paragraph at the beginning offering citations concluding that the Gulf War links to squalene have been rejected.
link 2 originally posted by Llama
This link is published by teh WHO. It concludes that the evidence presented satisfies safety requirements, at least in an adult population, and the limited data available in children appears to be similar to that seen in adults. Link 1 says that vaccines containing MF59 have been given to children as young as 1 day with no safety concerns raised - although there are no numbers and I can't access the original citation.
link 3 (again originally posted by Llama)
This is the clinical data which supports the GSK vaccine which will be receiving (or at least the mock vaccine which is considered comparable to the one "we" will recieve).
In this link there is a table. The important numbers on this table are SPR - which is an indication of how many people are now considered immune. Without the adjuvant 18% are immune. With the adjuvant 95% are immune. That is WHY the adjuvant is there.
link 4 this is an interesting read too. It has more data from teh Prepandrix trials (which is the mock vaccine). In this paper they give more data from the Prepandrix trials. As has been pointed out an adjuvant is a mechanism to use lower doses of vaccine and make stocks go further (although IMO it has biological value too). At the highest dose of vaccine without AS03 the maximum rate of protection was 43% in the Vietmanese group. At the LOWEST dose of vaccine with adjuvant they managed to acheive 84% protection. Agains demonstrating the value of AS03.
this is the most important bit for those that want to skip to teh chase
Anyway I must go and entertain small people. My conclusions and opinions....having spent an hour or so researching squalene and AS03, it is my honest opinion that this is something that sceptics have whipped up to have something to talk about. Vaccines containing AS03 are officially considered safe, and have been approved by the regulatory agents. The data presented looks rigerous to me. The data supporting their benefit is very rigerous. TBH emulsions have a long history of use as an adjuvant. Many people will never have heard of an adjuvant or squalene 6 months ago and would never have given it a second thought. However, the research that I have done does have gaps. I have seen no original data from peadiactric groups (although I can see that there is some, I just can't see teh data or how thorough it is). I also haven't seen any data for longer term effects (beyond 51 days), however, squalene containing vaccines have been on hte market since 1997 with (I believe) no long term adverse events reported - again mostly administered to older age-groups as it is one of the seasonal flu vaccines. So I may be cautious about it's use in peadiactrics, given that on the whole Swine flu is relatively mild ATM. But I am not making a decision yet.
link 5 looks like a pretty good impartial, easy reading summary about squalene.