AUSTRALIAN Swine Flu vaccines.

[Momtezuma Tuatara]

http://www.theage.com.au/national/national-rollout-as-swine-flu-vaccine-approved-20090918-fuyz.html

National rollout as swine flu vaccine approved
September 18, 2009

A swine flu vaccine has been approved by the Therapeutic Goods Administration, Health Minister Nicola Roxon has confirmed.

The vaccine, developed by pharmaceutical firm CSL, will be available later this month.

Ms Roxon said there was enough vaccination available for all adults.
"I encourage people to now take the opportunity to protect themselves and their families against the pandemic flu by getting vaccinated," she said.

Ms Roxon said issues concerning multi-dose vials and indemnity have both been resolved.

"The Government from day one has been determined to combat this disease in a sensible, clear and direct way," she said.

"The vaccine now is our best defence against the pandemic flu."

She said while the virus has been mild for most people, it has had severe effects on more than 100 children.

She said the flu has been associated with thousands of hospitalisations and 172 deaths in Australia.

Worldwide there have been 3500 deaths associated with the virus.
The vaccine will first be available only to adults, with the TGA awaiting further data from clinical trials before determining whether it is safe for children.

"This registration announcement today marks the commencement of the vaccination program for adults," Ms Roxon said.

"The TGA is awaiting further data from CSL trials of the vaccine for children aged nine and under, and therefore has not yet made a decision on the use of the vaccine in children, but this is expected in the near future."

The Rudd government has already purchased 21 million doses of the vaccine with four million of those stored in CSL warehouses.
Deliveries of the vaccine to immunisation providers will begin from next week.

Ms Roxon said the vaccination program would be the largest in the nation's history with the initial rollout to focus on protecting frontline health workers and those most at risk.

"The priority groups for vaccination are frontline healthcare and community care workers who have direct contact with patients, people with underlying medical conditions such as asthma, cancers, HIV, heart disease, diabetes and chronic kidney failure."

Ms Roxon said people who are obese, indigenous Australians, children in special schools aged over nine, pregnant women and parents and guardians of children aged up to six would also receive priority care.
The vaccination will not be mandatory.

The vaccine will be available from September 30.

Ms Roxon said there would be some delays getting the vaccines to rural and regional areas, adding the sparsely populated state of Western Australia had planned its own distribution program.

"We're in the fortunate position, given advice from CSL, that there is only one dose required for adults, which means we will be able to vaccine anybody in the community who wants to be vaccinated," Ms Roxon.
Adult Australians at risk of contracting swine flu have been urged to get vaccinated, and would be able to access the dose quickly, the minister said.

General practices have on their records "clear information" to enable them to contact patients.

"Some will provide the vaccination as people present. Others will organise actual clinic days to call people in," Ms Roxon said.

Ms Roxon was unable to put a precise figure on the cost of the vaccine.
"There are some confidentiality issues. We have a private contractual agreement with CSL for the priority provision for this vaccine," she said.

"I have made clear on the record before that it is over $100 million. It is not appropriate for us to be itemising the exact cost, given the commercial interests that are also at stake."

Chief medical officer Jim Bishop said trials showed the vaccination would give a high level of protection with one dose for the next flu season "and beyond".

"The evidence that we've got, so far, shows it's extremely good," Prof Bishop told reporters.

"The reason we would say you'd be protected for more than a year, many up to five years, is based on historical seasonal flu vaccine."

But Prof Bishop said it was possible there would be a larger wave of swine flu between now and the next flu season.

"This is a new type of virus, a pandemic virus," he said.

"We would be concerned there would be outbreaks during the year, through the summer.

"We think it's important, in a timely way, for patients to protect themselves now."

[Momtezuma Tuatara]

http://www.silobreaker.com/australia-csl-claim-95-per-cent-success-with-swine-flu-vaccine-5_2262590719585681408

September 10, 2009

Australia: CSL claim 95 per cent success with swine flu vaccine

Via News.com.au: CSL claim 95 per cent success with swine flu vaccine (http://www.news.com.au/story/0,23599,26058191-29277,00.html?from=public_rss). Excerpt:
Results from an Australian trial of a swine flu vaccine have been promising, showing one dose is effective in preventing the virus in adults.
Commonwealth Chief Medical Officer Jim Bishop said 169 people with swine flu have now died in Australia, with 336 currently in hospital. Of these, 65 people were in intensive care.
However, the impact of the pandemic was lessening, with fewer cases now being reported, he said.
Professor Bishop told reporters new information published today in the New England Journal of Medicine (http://content.nejm.org/cgi/content/full/NEJMoa0907413) indicated promising results from the trial of a vaccine by Australian biopharmaceutical company CSL.
A single 15 milligram dose of the vaccine produced antibody levels consistent with preventing infection in 95 per cent of participants. The results from a trial in children were not yet known.
"I think this is very promising. We're very pleased to see it," Prof Bishop said. "There have been no serious adverse effects reported."
The only side effects experienced during the trial of 240 healthy adults aged 18 to 64 were the same as those encountered with the seasonal influenza vaccine. These were a sore arm, muscle ache and pain and a headache for up to a day, occurring in only a minority of participants.
The results of the trial have been provided to the independent medical drug regulator body, the Therapeutic Goods Administration, which will now give advice to the Government.
Prof Bishop would not give a timeframe for when the TGA could be expected to give approval for the vaccine, other than to say the process is usually "timely".

[Momtezuma Tuatara]

http://coto2.wordpress.com/2009/09/18/csl-h1n1-gets-aussie-tga-nod-of-approval/

CSL H1N1 vaccine gets Australia nod of approval (http://coto2.wordpress.com/2009/09/18/csl-h1n1-gets-aussie-tga-nod-of-approval/)

Posted on September 18, 2009 by ozspeaksup
http://coto2.files.wordpress.com/2009/09/vaccine-x-mercola.jpg?w=100&h=150By Aussie Oz

The Australian government has “done a deal” so that CSL is the sole flu vaccine maker to supply us. The press release mentioned Prior Approval in the USA for their “pandemic vaccine.” What they DO NOT actually tell you is the vaccine first registered was a BIRD FLU mix using a NOVEL adjuvant called Iscomatrix.
Trials done in 2004, and in 2007.

WHO has a whole long list of what they and others were trialing back then, quite interesting. NONE were vaccines for H1N1. The H5N1 Baxter- were using Vero then (insect cell).

http://www.who.int/vaccine_research/diseases/influenza/flu_trials_tables/en/index3.html (http://www.who.int/vaccine_research/diseases/influenza/flu_trials_tables/en/index3.html)
Novavax were the ones bragging late last/early this year as it being new and a breakthrough…

Back to CSL, they are using split virion using two California strains, weakened or inactivated. The muliple dose does contain thimerosal (mercury). The single dose 0.5ml, does not.

50 micrograms of mercury per dose, per vial.

On my previous article (http://coto2.wordpress.com/2009/07/28/aussie-vaccine-trials-anomalies-and-oddness/), there is a link to the page from american registry Concerning the approval for Novel Pandemic H5N1 Nowhere!! is this exact virus mentioned, as, it DID NOT exist, until it was created.

Which has me wondering how the US announcements saying it had been approved a few days back…when it only just got the ok here) were based on a NON related viral strain, from the 2008 approval?

It has been SIX WEEKS since trial, yet we’ve heard nothing about follow-ups. Can the government assure us there are ”no nasty side effects” and it is fine to let this go into mass public use?

Our Nicola Roxon immediately starts a media push, and it was approved just today 18 Sept 09.

Dose cost to Taxpayer/govt coffers is a secret?

Well, seeing as they have that EXCLUSIVE SUPPLY DEAL, I guess CSL will be doing VERY WELL out of it, indeed.

Cost to public…unknown!

“Issues of Liability resolved”??? OH? Well, how about saying what they were and just how they have been resolved? If someone has a Serious Adverse Event, the vaccine makers are protected from lawsuits in the US.

How quiet they mean to keep any such events, and who will be paying the damages bill? I suspect not CSL.

NOTE: The patient info PDF specifically warns no data on possible problems with interaction with other vaccines! Yet there is a push to have seasonal and H1N1 fairly close together, within even a month would be a bit soon, as body would be still fairly under pressure from either Virus and adjuvant+mercury whatever.

Trials subjects were chosen for NOT having had Seasonal Jab in the prior year. No asthmatics or anyone on ANY other meds either. Hardly a REAL Population section to be working on!

Panvax H1N1 PI.pdf (application/pdf Object) (http://go2.wordpress.com/?id=725X1342&site=coto2.wordpress.com&url=http%3A%2F%2Fwww.csl.com.au%2Fdocs%2F833%2F508 %2FPanvax%2520H1N1%2520PI.pdf)

Panvax H1N1 Approval for Registration for Use in Aust by TGA.pdf (application/pdf Object) (http://go2.wordpress.com/?id=725X1342&site=coto2.wordpress.com&url=http%3A%2F%2Fwww.csl.com.au%2Fdocs%2F288%2F844 %2FPanvax%2520H1N1%2520Approval%2520for%2520Regist ration%2520for%2520Use%2520in%2520Aust%2520by%2520 TGA.pdf)

http://go2.wordpress.com/?id=725X1342&site=coto2.wordpress.com&url=http%3A%2F%2Fwww.theage.com.au%2Fnational%2Fna tional-rollout-as-swine-flu-vaccine-approved-20090918-fuyz.html (http://go2.wordpress.com/?id=725X1342&site=coto2.wordpress.com&url=http%3A%2F%2Fwww.theage.com.au%2Fnational%2Fna tional-rollout-as-swine-flu-vaccine-approved-20090918-fuyz.html)

[Momtezuma Tuatara]

Here is a training power point on this vaccine. Read this very carefully.

[Momtezuma Tuatara]

This is the NEMJ Panvax study.

Read this carefully.

[TanyaL]

I'm glad someone's got a sense of humor (first powerpoint). The picture of the witches throwing a mouse into their cauldron on slide 16 entitled "What's in Panvax?" before the discussion of ingredients is good. :LMAO:

It's interesting they actually mention problems due to the mercury preservative.

On pag 23, ovalbumin... let me look that up, yeah, it _is_ an egg protein, I wonder why they didn't flag that and ask about allergies? ... ok, it came up on slide 58, but it seems worth mentioning twice.

(I'm ignoring slide 20, too pissed off about that)

I had forgotten, until I read the end of the presentation, that the southern hemisphere is on an opposite timeline for influenza. Not sure how much h1n1 there's been, but it seems harder to sell a vaccine if the flu has been around for a while (presuming it's not noticeably worse than a typical seasonal flu).

[Momtezuma Tuatara]

Well, sometimes truth comes out in Jest, no???

I'm not impressed at the standard of Australian information.

For instance, The children's information sheet (http://www.public.health.wa.gov.au/cproot/2493/2/11483%20Client%20Handout-Children%20PROOF.pdf)talks about the "needle" causes problems, what about the contents in the needle? And it's aimed at the lowest literacy level possible.

If you think that's an abberation, the adults information sheet (http://www.public.health.wa.gov.au/cproot/2494/2/11484%20Client%20Handout-Adults%20PROOF.pdf) is just as bad.

CSL 2008 annual report (http://www.csl.com.au/docs/289/92/FY2008%20results%20presentation%20FINAL%20NN%20v2. pdf)is worth reading.

This pdf below, is about the best I could find in terms of a Panvax data sheet

[TanyaL]

Those information sheets are very short on information. I've not been impressed with the vaccine info sheets in the US, but they were never so deliberately misleading as to talk about the needle vs the vaccine, and they don't say anything like having a hard lump for several weeks is okay (you have to ask your doctor to get that good news). Yikes. I'd hope that having that in writing may make parents stop and think, "Do these people have the same values, the same concept of 'okay' as I do?"

[Momtezuma Tuatara]

I wonder if the people reading this will ask themselves, "Just how dumb do they think we are?" and run a mile.

[MinorityView]

Anybody have a good article about the Australian flu season? Saying how bad it was with the H1N1 flu and the regular flu? Deaths, severe illness, hospitalization, any other stats?

Thanks!

[Japonica]

I just posted a link under the Influenza section (diseases)...but I'll put it here too...

http://www.healthemergency.gov.au/internet/healthemergency/publishing.nsf/Content/ozflu2009.htm/$File/ozflu-no25-2009.pdf

[MinorityView]

Thank you, that is perfect!

[Spy]

http://coto2.wordpress.com/2009/09/18/csl-h1n1-gets-aussie-tga-nod-of-approval/

CSL H1N1 vaccine gets Australia nod of approval (http://coto2.wordpress.com/2009/09/18/csl-h1n1-gets-aussie-tga-nod-of-approval/)

Speaking of, has everyone seen the package insert?
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182401.pdf

Absolutely hilarious...


INDICATIONS AND USAGE
• Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons ages 6 months and older against influenza disease caused by pandemic (H1N1) 2009 virus. (1)
• This indication is based on the immune response elicited by the seasonal trivalent Influenza Virus Vaccine manufactured by CSL (AFLURIA). CSL’s Influenza A (H1N1) 2009 Monovalent Vaccine and AFLURIA are manufactured by the same process. There have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA. (14)

:oops:

Or this one (also based on a seasonal flu vaccine, not H1N1 which we didn't have time to study, too busy selling):


In children, .....The most common systemic adverse reactions observed were irritability, rhinitis, fever, cough, loss of appetite, vomiting/diarrhea, headache, muscle aches and sore throat.

Hmmm... refresh my memory... what is this thing supposed to protect from, again??? :coco:

Or this little gem of doublespeak:


5.2 Altered Immunocompetence

I don't know about the provaccine folks, I would be offended if someone tried to sell me something with this kind of info in package insert... :tease2:

[MinorityView]

package insert? who receives and reads the packet insert?

[Paper Cut]

package insert? who receives and reads the packet insert?

I have a friend with 3 yr old frat twins (born very very prem)... who is.. a "selective vaxer" :droolee: you know the type, 'trusts one vax over others etc' shes extremely defensive over the ones she has used.. but anyway I digress.... She over the years as asked her GP(s) for the pack inserts for these vax's and has been denied every step of the way... which I found odd... this is NZ and all.. you ask you should be given...

Until September 2009 when my husband just about cut his thumb off with a ripping saw at work... now hes a very smart man... he listens to his wife (moi!) When he went off to A&E to have his thumb seen too he was offered the tetanus shot... to which he replied "No Thanks" repeatedly... they proceeded to pretty much steri strip his thumb up and bandage in "as is condition" no cleaning no nothing.. yup bits of wood and grease and saw in the thumb (and 3 fragments of bone)

Anyway I am waffling.. I shall get to the point....

Bandaging had to be done daily at the local clinic here... first app with them.. "did you get the tetanus shot" ... "no thanks" ... "but but you need it" pleaded the nurse... so I said to her can I have the pack insert please (just for fun to test the theory) and I was denied... so yeah long story short... how can most people be informed (even just a little bit) in this country if they are not allowed access to such things as pack inserts!

[Spy]

package insert? who receives and reads the packet insert?

Whoever bothers to google :). Basically, I found it for my husband who asked where he can read up to write an angry letter to his company who markets this vaccine with two doses for adults, claiming that two doses make you 'twice more immune'. He specifically was wondering how did they figure this 'twice' bit. Well, I guesstimated that the thing to read would be the package insert which in H1N1 case probably would not even establish ANY proven immunity whatsoever, once or twice or thrice doesn't matter.

But I guess if people are not curious about package inserts (which can be found in other places then GP office) then the only thing they base their decisions on would be pharmaceutical advertising slogans...

[MinorityView]

so any person with access to a computer, internet access, and some degree of literacy--if they choose to try and find out.

[Spy]

so any person with access to a computer, internet access, and some degree of literacy--if they choose to try and find out.
IF, exactly. So I would start with a basic level of curiosity which appears to be an issue for so many :P

[Momtezuma Tuatara]

Um is this the one that they've asked to extend the use-by date on?