More Novel Adjuvants for the Swine Flu stockpile

HHS Purchases Additional H1N1 Vaccine Ingredients--July 13, 2009

(Thanks to Bloomberg News)

Manufacturer	Bulk Vaccine Antigen	Bulk Virus Concentrate/FFF	Bulk Oil and Water Adjuvant
Sanofi Pasteur	$61,425,000	0	0
GSK	$0	0	$71,400,000
Novartis	$346,334,450	0	$343,810,470
CSL	$0	0	0
MedImmune	$0	$61,020,000	0
TOTAL	$407,759,450	$61,020,000	$415,210,470

That means the Department of Health and Human Services has now purchased $698 million dollars' worth of oil-in-water (squalene-containing) adjuvants for the H1N1 Swine Flu pandemic. ($283 million was spent earlier for these adjuvants.) Having expended more than 2/3 of a Billion dollars on these products, it is virtually assured they will be used.

How much do we know about them? At a meeting called by FDA and NIH's NIAID in December 2008 to discuss how to perform studies to determine whether the new adjuvants were safe, there was relatively frank discussion by the speakers. Dr. Pulendran noted:

"if you take stock of the major vaccines that have been made since Edward Jenner's smallpox vaccine in 1798 right through to the first recombinant vaccines to be licensed, say, for example, the Hepatitis B vaccine, what I find very
interesting about this slide is that despite the success of many of these vaccines, we really do not understand the mechanisms by which they stimulate immune responses...(p. 61)

Dr. O'Hagan of Novartis pointed out:

MF59 activates 891 genes... MF59 was the most potent activator and it induced transcription of chemokines, cytokines... (p. 114-115)

According to Dr. van der Laan:

"From a pharmacological point of view, we feel, as the European authorities, that there is a lack of knowledge of mechanism of action. There is a lack of dose response relationships. A lot of studies are done with only one, maybe two dosages, a lack of combination studies with different endpoints.

And most is the focus on immunological effects and there is hardly any idea about cardiovascular or CNS effects. You can imagine that if you have a vaccine leading to the release of cytokines, that there might also be cardiovascular effects... (p. 277)"

What do their remarks mean?

Vaccines, even older ones, work through poorly understood mechanisms. That is why it is very hard to predict their side effects, and effectiveness, in advance. Not until they are given to many thousands or sometimes millions of people are the adverse effects discovered.

Furthermore, MF59 induces a very strong immune response. It activated more genes than any other adjuvant tested. The activated genes are not all immune response genes. In fact, scientists don't know what most of the activated genes really do. That is why scientists cannot predict what effects the adjuvant will have on humans with different genetics and ages.

A powerful immune reaction may be excellent for the elderly, whose immune systems weaken considerably with age. Remember, MF59 has only been licensed overseas for use in flu vaccines for those over 65 years of age. Presumed safety in this age group cannot be extrapolated to the young. There is no evidence of MF59's safety in young adults, and especially in children.

At the FDA-NIH meeting, Dr. van den Bossche characterized scientists' fears about the new adjuvants:

"But what we really want to avoid is that the use of adjuvants would enhance local reactogenicity or even worse, would also enhance systemic reactions. So what we want to avoid is severe reactogenicity. And we are especially, I think, scared of a kind of generalized, unspecific stimulation of innate immune cells breaking tolerance, for example, things that may lead to immune pathology."

From FDA's Dr. Gruber:

"Now safety is always primary but safety is relative. It is not absolute. So in determining whether a vaccine product is safe, one has to look at the indicated target population, the nature of the product, the indication, and the circumstances under which the vaccine will be used...(p. 260)

And because of safety concerns, the law in the Code of Federal Regulations under the IND regulations requires that adequate information about the pharmacological and toxicology studies that have been conducted or that should be conducted for the vaccine or adjuvanted vaccine need to be available... (p. 261) And, again, to remind you, the law also states that an adjuvant shall not be introduced into a product unless there is satisfactory evidence that it does not effect adversely the safety or potency of the product." (p. 262)

The problem with this statement is that by invoking the Public Readiness and Emergency Preparedness Act of 2006 and the Emergency Use Authorization of Bioshield legislation, these laws that protect us have been dispensed with. The law he referred to, tells FDA what evidence of safety is required in order to license a medicinal product.

But the laws we are currently operating under, invoked for the Swine Flu pandemic, authorize use of untested, unlicensed products on the entire population. All in a very compressed period of time.

Thus there will not be enough time to discover any adverse events that take months or years after vaccination to show up, such as autoimmune disorders or excessive allergic responses. The entire population will already have gotten its shots before such side effects appear.

Furthermore, the recent history of vaccines includes a few spectacular failures. A few caused increased susceptibility to the disease they were meant to prevent. Licensed animal vaccines have caused cancer at the injection site in cats, and autoimmune thyroid disease in dogs. Some have contained bacterial or other contaminants.