I just watched a little bit of C-span, and congress is speaking with the presidents of H1N1 vaccine makers about wether the FDA should approve their adjuvants.
They hope to have MF59 approved by the FDA based on the studies done under european oversight, rather than spend the money to have it tested in accordance with FDA regulations. This sounds perfectly fine to me, but the details make me skeptical.
The first reason, is that it is said that in various European countries, the adjuvant has been used for so many years, but had only been approved and used on people 65 and over.
Now the problem with this is that at age 65, your health generally begins to or is already degrading. I would like to know yet can't find the information, which countries have been participating in this, and what the average life expectancy is in each of these countries.
Now the adjuvant boosts the immune response because the oil injected into the bloodstream is attacked by the immune system aggressively, and because it is mixed with the vaccine, the anti-gen is subject to the same immune response. The concern most people who are against the adjuvant argue is that because squalene ( the active ingredient in the adjuvant) is present naturally in the body, injecting it into the blood stream and forcing the immune system to attack it, may cause the immune system to begin to attack the squalene which is naturally present in your body leading to an auto immune disorder.
For those who don't know much about these types of auto immune disorders, here is a brief
explanation from google health about Lupus,
"
Causes
SLE (lupus) is an autoimmune disease. This means there is a problem with the body's normal immune system response. Normally, the immune system helps protect the body from harmful substances. But in patients with an autoimmune disease, the immune system can't tell the difference between harmful substances and healthy ones. The result is an overactive immune response that attacks otherwise healthy cells and tissue. This leads to chronic (long-term) inflammation.
The underlying cause of autoimmune diseases is not fully known. Some researchers think autoimmune diseases occur after infection with an organism that looks like certain proteins in the body. The proteins are later mistaken for the organism and wrongly targeted for attack by the body's immune system."
https://health.google.com/health/ref/Systemic+lupus+erythematosus
Lupus interestingly is also one of the very rare side effects of regular flu vaccines, and is an incurable auto-immune disorder.
Now unlike an allergic reaction, this type of reaction wouldn't necessarily show signs beyond the normal range of side effects, and would only become evident over time. For people over 65, you very well may die, or suffer other non related diseases before there is enough time for this to become evident, and many of the symptoms are similar to that which a person this age would already be experiencing due to old age. Like another example, how many people out of 100 thousand had a heart attack after the vaccine, and how many would have had one out of 100 thousand anyways, how many people over 65 would have died anyways and how many did after the vaccine? The first problem with this is that depending which country your in, your life expectancy may already be achieved at 65 leaving any data on the safety of the adjuvant limited, and hard to differentiate.
So I have a hard time with this. The fact that it was only used in vaccines on this age range and without mention of life expectancy in these countries, which is now being used as an argument that it is safe in general seams kind of shady to me.
Do you think the adjuvant should be approved and added to this years or next years batches of vaccine, or should it be subject to normal FDA testing regulations and go through the normal process. Advantages of this would be cheaper vaccines, and more supply. Disadvantages would be the undermining of regulations put in place to protect the health of the public.