|At least the group that is trying to find out about the harmful effects of oil adjuvants did quote the other group, those promoting their use, in their references, but I suppose it would be too much to expect the latter to volunteer to their readers the existence of the former!
The thing is, if you were looking for possible side-effects of oil-adjuvants like MF59 in vaccine journals or in vaccine conferences, you would not come across the findings (eg induction of autoimmune antibodies) of those researchers who have been doing animal studies on precisely the same substance that would likely have disqualified it from even getting into human trials in the first place!
Let me backtrack a little, and give everybody a bit of background.
We have all heard how our vaccine production capacity is nowhere near enough to produce pandemic vaccines to make a difference to the outcome of a pandemic (at least that is MY definition of what spending all these billions to produce a pandemic vaccine should be about), whether we look at this from the national or global perspective. Among many ways of trying to make the small amounts we can produce go further ie dose-sparing techniques, the hottest game in town is adjuvants, substances which when added to a vaccine can make it so much more effective that you only need very small doses, thus instantly creating more with less! Sounds good, right?
Another bit of background: Under 'normal' circumstances, for any pharmaceutical product or vaccine to get licensed, they have to go through many stages of testing. The first one is always animal tests, cos unless you have very unusual attachments to animal rights, you don't really want to test something new on humans first thing, do you? Regulatory agencies such as the FDA have specific requirements that need to be fulfilled before you can even begin human clinical trials, which consist of several phases designed to test efficacy, safety, dosage, etc, everything that they need to know before they can license a product for market.
Now, the case of MF59 is a rather unusual one. Some of you may remember me writing about it in the old forum, based on the book Vaccine A, by Gary Matsumoto, a NY Times journalist also writing for Vanity Fair, as part of the controversy around Gulf War Syndrome and allegations that the DOD was/is using experimental vaccines including those with MF59 on service personnel without informing them (No consent is needed, apparently, if you are in the military - you gotta take whatever they give you.) Anyway, I still haven't been able to make heads or tails out of that story, cos I haven't come across definitive evidence one way or the other, so I'm going to leave that well alone for now, and go somewhere else instead.
I'm going to go specifically to Italy in 1992, when the first clinical trials using MF59 adjuvanted influenza vaccines started. The rationale was that the elderly tend to have poor immune responses to flu vaccines, and they suffer most complications and deaths from flu, so it would make sense to find some ways of enhancing their immune response. Animal studies then showed that certain oil emulsion compounds had the ability to stimulate and produce enhanced immune responses when given in conjunction with vaccines. At least that is what we are given to understand from reading the (like I said) writings of vaccine scientists, although even then those working on the harmful effects of oil adjuvants had published studies just as prodigiously showing, well, harmful effects.
Be that as it may, the clinical trials went ahead in Italy, with groups of elderly (65 or older) people recruited from the community and duly given the vaccines for three consecutive years, and the results showing enhanced response were duly published.
Let me digress here a little and tell you what I discovered about vaccine safety, or specifically what kind of data from clinical trials would satisfy the requirements and the product be deemed 'safe' for licensing. Now, this is only what I figured out from the various vaccine papers that I've read; I'm not privy to the exact technical specifications that regulatory agencies require. It would appear that in most instances clinical trial subjects are monitored for 20-30 minutes at the clinic, then given a list of specified or 'solicited' symptoms that they are supposed to record for the next 7 days. Sometimes, but not always, they also record 'unsolicited' symptoms, although whether the staff actively 'solicits' such 'unsolicited' symptoms is never quite apparent.
This is all well and good, if we can assume two things to be universally true:
- that we know ALL the possible or likely symptoms or reactions that may arise, enough to include them on the list of 'solicited' symptoms, and
- that adverse vaccine reactions are bound to start only within 7 days of vaccination and not beyond
(UPDATE I have since learned that the follow-up period is normally longer, 28 days or even more, but the method of follow-up remains the same.)
Well, in the case of swelling and pain of injection sites, for example, that might very well be true. And if we are testing vaccines that are not too different, conceptually, from the many vaccines that have been in use for many years, such that we pretty much know what to expect (eg we don't expect your hair to turn green), then it would probably work well enough, I guess.
But what if, as in the case of MF59, we are talking about a whole new class of substances for which we had at the time very little data in human subjects, the mechanism of which was specifically designed to elicit enhanced immune responses in the first place, wouldn't it be prudent to ask ourselves how the heck would we know if the immune responses were to become TOO enhanced as to be harmful? And what if the problem that we worry about is a chronic disease that may take weeks or months to manifest instead of days? After all, if our immune system is supposed to be activated by the vaccine to be able to mount responses against viruses months after vaccination, surely we should also expect abnormal immune responses to persist well beyond the 7 days?
The thing is, excessive response to the degree that is damaging instead of beneficial, specifically the induction of autoimmune reactions, is a lot less common in the elderly than the rest of the population. In other words, one way to NOT have a particular adverse consequence be pegged with your product is to AVOID the kind of people who are most likely to have such adverse consequences in the first place. Pick the group that is most unlikely to have problems, particularly since in this instance they are elderly and have all sorts of other health challenges such that it would be easy to say "there were no reports of vaccine-related serious adverse events after the first, second, or third immunization", to quote that first study by Minutello et al 1999. Make sense?
To cut a long story short, the vaccine Fluad, an inactivated subunit influenza vaccine adjuvanted with MF59, was duly licensed in Italy, and by the quirks of EU regulations, in the EU, for use in the elderly. And it has been used by now for
thousands millions of people with apparently good safety profile. It has even been used, I'm told, from time to time off-label in younger people when they ran short of the regular seasonal flu vaccine.
You might say, so what's the problem? The problem is, in the meantime, scientists are finding stacks of evidence in animals that such kinds of oil adjuvants including squalene or MF59 were causing distinctive patterns of autoimmune responses and induction of lupus autoantibodies - antibodies that target the hosts' own cells, believing them to be foreign, thus causing inflammation, tissue destruction, and disease - antibodies that are involved in a host of autoimmune diseases, the most important one being systemic lupus erythematosis or SLE, a very nasty, often fatal, disease which typically appears in young females, black more commonly than Caucasians, and hardly ever happen to men except very occasionally in elderly ones.
NOW let's go back and re-visit the book Vaccine A, that I wrote about in the old forum, on what happened to Gulf war veterans. Specifically, the very unusual finding of large numbers of autoimmune conditions including lupus in previously healthy young men. As I said, I can't find evidence to prove anything one way or the other, but I did find one study that is particularly intriguing.
I came across this while trying to find information on lupus cos one FW mother on the old forum, the only one that I know of who participated in a clinical trial of adjuvanted H5N1 vaccines, developed symptoms shortly thereafter and was subsequently (as I understand it) diagnosed to be suffering from lupus. In the process of looking up the literature, I found this review of 5 cases of post-vaccination lupus by Older et al, 1999 which I wrote about here in the old forum. Two pieces of information jumped out at me in this review
- all five were military personnel who had received vaccinations as part of a required protocol, and
- 2 out of these 5 patients, all young, were males. The normal ratio of female to male cases is 10 to 1, falling to 3 to 1 in the elderly. Simard et al 2007
Now I know purists would call these cases 'anecdotal', and they would be right, technically. But my point is, if we are talking about potentially vaccinating the entire population, or at least a large proportion of the young, surely we need to have a higher degree of certainty that we DO have, in our regulatory processes, the ability to discover such severe adverse consequences, even if they occur but rarely? I once asked this question of a senior scientist/executive of a vaccine company, whether there are processes in the regulatory pathway that allow us to pick up chronic and delayed adverse reactions, and his response took the form of shrugging of his shoulders, more-or-less saying "if the government cannot come up with ways of discovering problems, who am I to help find them, eh?"
Does that keep you awake nights? It should. Particularly if you are TPTB.
The rest of this series can be found via links here part II, part III, part IV, and part V