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Oil-Based Adjuvants and Mechanisms for Increased Risk of Anaphylaxis

by: SusanC

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

This diary is a continuation of the previous discussion Risk of Anaphylaxis Associated with AS03-Adjuvanted H1N1 Vaccines.

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.

There's More... :: (14 Comments, 2640 words in story)

Fetal Malformations and Neurodevelopmental Delays Associated with the AS03-Adjuvanted H1N1 Vaccine

by: SusanC

Fri Nov 27, 2009 at 19:28:08 PM EST

I have said before, and clearly stated in my disclaimers, that I do not give medical advice.  That rule, I will not break, but I will break another one, the one that says I don't have an opinion as to what you as an individual should do, especially in decisions that affect your health.  I'm going to break this rule because I have a very strong opinion about something that I think you should do, if you are considering getting vaccinated with one of the adjuvanted H1N1 vaccines.  

Before you decide, I think you should take the time to read through all of the pages of any and all product information you can get your hands on, and not skip sections that look like they are filled with technical jargon that you think you probably don't need to read, since it is stated somewhere ealier in the document, that there are no safety concerns.  The most important thing is, check their findings, not their conclusions.  Don't take anyone's word for it, mine included.  Also make sure you read all the way to the last page; companies do not like to air dirty laundry, and they pay big dollars to hire the smartest and craftiest, to make sure the information in such documents is always laid out to their best advantage.  Not yours.  

There's More... :: (17 Comments, 2777 words in story)

Risk of Anaphylaxis Associated with AS03-Adjuvanted H1N1 Vaccines

by: SusanC

Mon Nov 23, 2009 at 11:02:11 AM EST

UPDATE Dec 1, 2009: Follow-up on anaphylaxis in this diary, Oil-Based Adjuvants and Mechanisms for Increased Risk of Anaphylaxis

Old FW hands may remember me saying I was an accidental blogger.  It all started with me trying to explain something to someone, thinking I was just going to post a couple of comments, to clarify a few things, and that would be it.  Of course, you know it didn't quite work out that way ;-D.  I think the most rewarding - also the most addictive - part of writing on this forum is the sheer amount of knowledge you gain, either learning from others, or trying to answer a question, to share something that you know.  Or at least you think you know.  Until you start to double check, just to be sure, and you find yourself chasing one interesting lead after another, going deeper and deeper, and, before you know it, you've disappeared down a gigantic warren of rabbit runs (with Hat-Tip to beehiver!)...

Which was what happened to me the other day.  ;-p  Someone sent me a link and a question ("is this normal?").  I clicked on that link, and, thinking I ought to check my numbers before I replied, decided to invoke the powers of google.  And then I was just gone.  Of course, not being a rabbit, by the time I found my way out and finally saw daylight again, I discovered 3 days had gone by, but I'd learned so many things that now my new problem is trying to condense it all down to something sensible and which actually answers the question that was asked!!

There's More... :: (8 Comments, 1466 words in story)

Are We DONE Here??

by: SusanC

Sat Nov 14, 2009 at 00:02:48 AM EST

Has the pandemic in the UK gone past its peak?  There are signs that the worst may be over... Or, I must be dreaming...
There's More... :: (62 Comments, 1201 words in story)

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

UPDATE - see new post and reference concerning similarity of symptoms and risk of delayed treatment, in this comment

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.  

There's More... :: (56 Comments, 2770 words in story)

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...

There's More... :: (9 Comments, 2276 words in story)

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'

There's More... :: (21 Comments, 4941 words in story)

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

Serious RANT warning: I may decide to delete (or alter) this diary at some point in the future (or not), not least because I can't guarantee that all the information I give are 100% accurate, (they probably are 99.99% accurate), when I'm so mad I can't see straight.  Just so you're aware if you are going to post comments.  And, there ain't gonna be any links, to anything, for ditto reasons (not yet, for now)..  If you want to know the source for anything, ask me some other time, like tomorrow.....

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

There's More... :: (115 Comments, 1165 words in story)

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

by: SusanC

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

OK, carry on with the science.  As I said in part 1, our immune system is a result of evolution.  The primary evolutionary need is/was to defend against invasion by infectious disease agents or pathogens, but the same basic immune response is used when other antigens, including vaccines and self-antigens, are detected.  To protect the host effectively, the immune system has to do 4 things:  
  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.  
There's More... :: (5 Comments, 2476 words in story)

Adjuvants and Pathogenesis of Autoimmune Disease I - Overview

by: SusanC

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

At a recent FDA advisory committee meeting to discuss their approach to swine flu vaccines, the GSK representative, guy called Bruce Innis, said:

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.  

There's More... :: (27 Comments, 1763 words in story)

BBC Panorama Programme Misleads the Public on Swine Flu Vaccine

by: SusanC

Wed Sep 16, 2009 at 17:39:27 PM EDT

I have just finished watching the BBC Panorama programme on swine flu http://news.bbc.co.uk/panorama...  I wrote the following as comment on the Panorama website - it is self-explanatory.
UPDATE: information on safety of UK's swine flu vaccine in pregnancy is here.  The vaccine, made by GSK, contains the novel squalene-based adjuvant AS03.
There's More... :: (58 Comments, 278 words in story)

Mass Vaccination against Swine Flu H1N1 in the US

by: SusanC

Thu Aug 06, 2009 at 20:21:50 PM EDT

"The President wants the vaccination effort done safely and quickly." source

Seeing as some of you are signed up to go to the CDC vaccination public engagement meetings, I thought it might be useful to put together in one place, a summary of the situation with regards to vaccine development, current understandings and gaps in science, policy issues, decision-making process etc.  The most important thing to remember is planning for this vaccination campaign is a work in progress, with many issues still outstanding, and a lot of changes can happen between now and the moment when the needle hits your arm, including changes as a result of public attitudes and input!!
There's More... :: (39 Comments, 3394 words in story)

Guillain-Barre Syndrome after Influenza Vaccination - More Lessons from 1976

by: SusanC

Mon Jul 27, 2009 at 19:45:18 PM EDT

A follow-up to Swine Flu 1976 - Old Vaccines, New Lessons?
There's More... :: (45 Comments, 772 words in story)

Swine Flu Vaccine in 5 Days?

by: SusanC

Wed Jul 15, 2009 at 03:26:09 AM EDT

They say "there's no smoke without fire".  

There's been recent reports that a swine flu vaccine will be fast-tracked for use in Britain within five days after it's made.  Since this appears to come from official sources, I believe we'd be remiss not to check out what this is about.

There's More... :: (42 Comments, 1617 words in story)

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

by: SusanC

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

Click on the links for

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

There's More... :: (45 Comments, 1718 words in story)

Swine Flu 1976 - Old Vaccines, New Lessons

by: SusanC

Tue Mar 31, 2009 at 20:15:08 PM EDT

A follow-up to this diary has been posted here Guillain-Barre Syndrome after Influenza Vaccination - More Lessons from 1976

Anti-Ganglioside Antibody Induction by Swine (A/NJ/1976/H1N1) and Other Influenza Vaccines: Insights into Vaccine-Associated Guillain-Barré Syndrome

The US army suffered heavy losses during the 1918 pandemic - more men died from flu than from fighting in the War.  When an outbreak of swine flu occurred in 1976 among army recruits in a camp, the US government ordered millions of doses of vaccines against the virus, in anticipation of another pandemic.  But a pandemic didn't happen.  Instead, the massive vaccination campaign resulted in reports of Guillaine-Barre syndrome (or GBS) in some vaccine recipients, eventually causing the vaccination program to be halted.  

Now, decades later, researchers sought to discover how this happened. A paper published last year (link) gives some unexpected and disturbing findings.  

There's More... :: (13 Comments, 736 words in story)

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

by: SusanC

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

Click on the links for

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.  

There's More... :: (19 Comments, 1773 words in story)

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

by: SusanC

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

( - promoted by SusanC)

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

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

There's More... :: (69 Comments, 2588 words in story)

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

( - promoted by SusanC)

Click on the links for

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.

There's More... :: (24 Comments, 1693 words in story)

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

by: SusanC

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

( - promoted by SusanC)

Click on the links for

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.

There's More... :: (57 Comments, 1723 words in story)
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