Oil-Based Adjuvants and Mechanisms for Increased Risk of Anaphylaxis

by: SusanC

Tue Dec 01, 2009 at 23:01:56 PM EST

As far as I can tell, there has been no new reports of anaphylaxis from Canada.  It is hard to interpret such absence of reports, since vaccination rates are going down (see Vaccination clinics in Ontario start to close their doors).  Plus everything depends on the accuracy and promptness of reporting by local health authorities, and the speed with which the Public Health Agency of Canada (PHAC) shares that information.  PHAC has a Weekly Vaccine Surveillance Report page, which has finally been updated, to include information up to Nov 14.  They are now confirming 24 cases of anaphylaxis.  6 of these were from the batch of vaccine that was recalled.  Of the 172,000 doses, all but 15,000 were used up, which gives us an incidence of around 3.8 per 100,000 doses distributed for that particular batch.  The one fatal case, in Quebec, did not receive a dose from that batch.

Will Adjuvants be Protective or Detrimental? - Influenza in the Immune-Stimulated Host - part 1

by: SusanC

Sun Nov 08, 2009 at 19:40:44 PM EST

This is a diary that I had wished I would never have to write - if I could have convinced myself the scenario described here can't possibly happen.  It addresses a hypothetical scenario that may or may not happen, but if these concerns turn out to be valid, they have the potential to cause severe or even life-threatening consequences to some unknown proportion of people. I am going to state very clearly right up front, that this is highly speculative, and to ask that anyone who has the slightest inclination to take (or change) any action as a result of reading this, to please read my disclaimers, for your own safety as well as my sanity!  Thank you!

So here's the problem.  Influenza activity due to the 2009 H1N1 is widespread in many places.  To get a sense of how quickly it sweeps through communities, take a look at this animated map for BC (British Columbia) in Canada.  At the same time, mass vaccinations are under way, in many cities.  Scenes like these are being repeated in Canada and many other countries.  

Adjuvants and Cytokines II - The Meaning of 'Reactogenicity'

by: SusanC

Fri Oct 23, 2009 at 20:28:32 PM EDT

"We typically see, for effective adjuvants, increased reactogenicity, an FDA term for feverishness, sore arm at the site, which we typically see with non-adjuvanted vaccines but often see more in the presence of an adjuvant.

"I want to point out it is very unclear whether these ever correlate with more severe adverse events.  You know occasionally they do.  But we have not found, to date -- (unclear) but the flip side is it would be difficult to find, for example, that increased local reactogenicity or feverishness down the road increases the commonality of some of the more severe adverse events that we might be concerned about such as neurologic events.  

"There just aren't those data."

Jesse Goodman, Chief Scientist, FDA, Dec 2008
Workshop on Adjuvants and Adjuvanted Preventive
and Therapeutic Vaccines for Infectious Disease Indications

Part 1 is here http://www.newfluwiki2.com/dia...

Adjuvants and Cytokines I - the Curious Case of IL-6

by: SusanC

Tue Oct 20, 2009 at 00:03:35 AM EDT

We have studied serum cytokine profiles in BALB/c mice after immunization with influenza vaccine...The MF59-based adjuvants significantly increased the IL-5 and IL-6 levels,  Valensi (Chiron/Novartis) 1994

IL-6 is a pleiotropic* cytokine that is involved in the physiology of virtually every organ system. Aberrant expression of this cytokine has been implicated in diverse human illnesses, most notably inflammatory and autoimmune disorders, coronary artery and neurologic disease, gestational problems, and neoplasms. (Hong 2007)

*pleiotropic = multi-functional

UPDATE: Part 2 of this series is here The Meaning of 'Reactogenicity'

I'm Angry (or, The Shortest Version on What's Wrong with some Swine Flu Vaccines)

by: SusanC

Fri Oct 09, 2009 at 19:52:29 PM EDT

UPDATE (Oct 10, 2009) The rant warnings still apply LOL, but I'm working on adding links, references, and further explanations of the issues that triggered this outburst, which in essence describes some core issues that bother me, a whole lot...  So, if you are not a FW regular, feel free to visit after a couple more days and you'll probably find this place chock full of information. Thank you for your patience. ;-D

Adjuvants and Pathogenesis of Autoimmune Disease II - Inflammation and Immune Regulation

by: SusanC

Fri Oct 02, 2009 at 01:52:11 AM EDT

1. pathogen recognition: the presence of an infection must be detected.  
   
2. effector functions: cells of the immune system respond to contain the infection and if possible eliminate it completely.
   
3. immune regulation: the immune response must be kept under control so that it does not itself do damage to the body.  
   
4. immunological memory: when the initial immune response is over, the immune system stores the 'memory', in order that subsequent encounters will result in stronger, more efficient response.  

Adjuvants and Pathogenesis of Autoimmune Disease I - Overview

by: SusanC

Sat Sep 26, 2009 at 23:10:39 PM EDT

I think all the manufacturers have presented data that shows that the effects of the adjuvants are limited in time, limited to the space where it is injected and in the draining lymph nodes. They don't have widespread activation of the immune response, and there isn't plausibility that they would activate autoimmunity in organs separate from the muscle where they are injected.

Is he right?  There are 2 (non-exclusive) ways to find out.  One is to go through the meeting transcripts and see if they did present such data (I did, and they didn't).  The other is to take a look at the science.  

Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic VI - Squalene Antibodies Revisited

by: SusanC

Mon Jun 29, 2009 at 20:05:25 PM EDT

• part I - First Questions
• part II - Reasons for Concern
• part III - The Story of Fluad
• part IV - Safety of MF59
• Part V - Insights from Immunology
• part VI - Squalene Antibodies Revisited

A newly published study appears to refute the connection between the presence of anti-squalene antibodies and Gulf War Syndrome, but is it convincing?

Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic V - Insights from Immunology

by: SusanC

Wed Feb 18, 2009 at 21:29:49 PM EST

• part I - First Questions
• part II - Reasons for Concern
• part III - The Story of Fluad
• part IV - Safety of MF59
• Part V - Insights from Immunology
• part VI - Squalene Antibodies Revisited

Today and tomorrow, there's a meeting of the Vaccines and Related Biological Products Advisory Committee at the FDA.   Day 2 of the meeting deals with Clinical Studies With Pandemic Influenza Candidate Vaccines in the Pediatric Population in the Absence of an Influenza Pandemic.  Briefing information is available here.  

Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic IV - Safety of MF59

by: SusanC

Wed Oct 17, 2007 at 22:07:21 PM EDT

UPDATE: Novartis has finally confirmed what we suspected.  A review published by the company Safety of MF59™ adjuvant (Schultze 2008) states:

the results of Novartis' GLP toxicology studies performed to fulfil global health authority requirements for clinical testing or product approvals have not been published, to date.

Click on the links for

• part I - First Questions
• part II - Reasons for Concern
• part III - The Story of Fluad
• part IV - Safety of MF59
• Part V - Insights from Immunology
• part VI - Squalene Antibodies Revisited

Exploring the safety data on MF59 and MF59-adjuvanted vaccines.

Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic III - The Story of Fluad

by: SusanC

Wed Oct 17, 2007 at 12:47:02 PM EDT

• part I - First Questions
• part II - Reasons for Concern
• part III - The Story of Fluad
• part IV - Safety of MF59
• Part V - Insights from Immunology
• part VI - Squalene Antibodies Revisited

Reading the fine print, on the safety profile of adjuvanted flu vaccines.

The equivalent of "read the fine print" for a scientific paper is "read the data".  The interpretation of the data can be skewed by an author to support a larger agenda  Or an author can make mistakes.

Gary Matsumoto, Vaccine A, published by Basic Books 2004, p 134.

Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic II - Reasons for Concern

by: SusanC

Sun Oct 14, 2007 at 01:26:28 AM EDT

• part I - First Questions
• part II - Reasons for Concern
• part III - The Story of Fluad
• part IV - Safety of MF59
• Part V - Insights from Immunology
• part VI - Squalene Antibodies Revisited

The debate on the safety of oil-in-water adjuvants has received renewed attention on flublogia after the revelation and concern that tptb might be considering adding adjuvants such as MF59 to prepandemic vaccines.  There appears to be a fair amount of misunderstanding or confusion on this subject, and concerns whether all of this is nothing more than internet conspiracy rumor, so I thought this might be a good time to re-visit the issue.

Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic I - First Questions

by: SusanC

Wed Aug 08, 2007 at 23:26:27 PM EDT

• part I - First Questions
• part II - Reasons for Concern
• part III - The Story of Fluad
• part IV - Safety of MF59
• Part V - Insights from Immunology
• part VI - Squalene Antibodies Revisited

The world of science is a strange place.  You would have thought that different people working on the same substance, one group set on figuring out how to use it, the other trying to find out how it harms people, will at least have heard of each other and hopefully talked to each other from time to time.  Apparently, that doesn't happen, not in ways that you can take for granted anyhow.