Swine Flu Vax to Be Cleared After Only a 5 Day Trial in UK

[ZoeyZoo]

Since a lot of people here on MDC have been following the swine flu vax I thought this would be interesting and to a lot of people here...

http://www.timesonline.co.uk/tol/new...cle6690010.ece

Basically they are talking about fasttracking the vax in the UK so that it could be available in as little as 5 days. People would be getting shots while safety trials are still going on. Also they mentioned they would be "aiming to inoculate about 30 people an hour in a military-style operation."

[Marnica]

Not surprsing at all....From what I remember they licensed Gardasil before the safety trials were finished as well....

I mean those pesky little safety trails are just a formality don't know know

[Sileree]

That's really scary. I'm wondering if this is going to cause a lot of health problems for people.

[newmum35]

First Trials of Swine Flu Vaccine Begin in Australia

First Trials of Swine Flu Vaccine Begin in Australia

http://www.bloomberg.com/apps/news?p...d=aadm7_AYSmKo

Seaton is among the 240 healthy adult volunteers in Australia who CSL Ltd. began injecting today with its experimental vaccine against H1N1 ... CSL is testing the vaccine over the next seven weeks as it prepares to fill orders from Australia, the U.S. and Singapore........
Volunteers are required to keep a diary for six months and record any signs and symptoms, including nausea, increased temperature and swelling around the injection area, Seaton said.

So what's the point in keeping the diary for SIX months when they expect to start mass vaccinations in Sept, Oct, or Nov (varies, depending on which company you ask) - this is pretty much immediately following the 2 month trial period.

Another thing... this is NOT being tested on pregnant women, nor children, nor elderly, nor those with underlying chronic issues (asthma, diabetes, etc, etc, etc)

Guess who its being marketed to: EVERYONE!! If anyone knows about a trial going on with any of these groups (anyone who is not a healthy adult) please do post it.

[TanyaS]

I try really hard not to buy into any conspiracies when it comes to vaccines. But watching it unfold before our eyes makes me want to grab a tinfoil hat.

US trials have been announced:

http://www.cnn.com/2009/HEALTH/07/22...als/index.html

ETA:

http://www.clinicaltrials.gov/ct2/results?term=h1n1

[13Sandals]

I didn't think it was possible with limited time, but they are developing a swine flu nasal spray - remember, the nasal spray uses live vaccine and those who receive it shouldn't be around immunocompromised folks for up to 21 days....

http://www.businessweek.com/ap/finan.../D99JLGOO0.htm

Soon, vaccine from additional manufacturers -- including the only non-shot version, a nasal spray -- will begin separate, company-led studies in several thousand more volunteers.

nasal spray form MedImmune

[limette]

Article: pushing for compensation for H1N1 vaccine

http://www.canada.com/health/Swine+v...716/story.html

Oh how I love this line;

"an incompletely tested vaccine and that a compensation scheme is needed to encourage the public to buy into any mass immunization program."

[SoCaliMommy]

Wow that just proves it's all about $$$

[ss834]

I've been wearing my tinfoil hat for awhile now... but I'm thinking I may actually need it.

Here's a link to the current drugs approved in the US under Emergency Use Authorization (EUA)-- no vaxes up here yet, but it will be good to keep an eye on.

http://www.cdc.gov/h1n1flu/eua/

[amnesiac]

Discussions about vaccine testing are great, just please remember that we no longer wish to host conspiracy theory discussion.

[Mama~Love]

:
Wow, this is just crazy.

regulators said fast-tracking would not be at the expense of patient safety. “The vaccines are authorised with a detailed risk management plan,” the EMEA said. “There is quite a body of evidence regarding safety on the trials of the mock-up, and the actual vaccine could be assessed in five days.”

Yeah, sure, patient safety is always the utmost concern . I'd love to see the UNBIASED, third-party evidence they have that this is perfectly safe after only a 5 day trial. Who the hell are they kidding?!?

[13Sandals]

I have no idea where to post these things now - but here's a nasal spray update:

http://www.google.com/hostednews/ap/...2TZdQD99KD3D02

MedImmune said it will have 14 million swine flu nasal sprays available by October, and 40 million by year's end. But overall it's producing roughly 35 million doses a month, Malchielse said, if only it could turn that bulk product into a form easily administered to people.

that's all we'd need - school kids being sprayed with live swine flu vaccine at school.

[AllyRae]

Originally Posted by TanyaS

I try really hard not to buy into any conspiracies when it comes to vaccines. But watching it unfold before our eyes makes me want to grab a tinfoil hat.

US trials have been announced:

http://www.cnn.com/2009/HEALTH/07/22...als/index.html

ETA:

http://www.clinicaltrials.gov/ct2/results?term=h1n1

They are recruiting babies for those tests. How sad that some parents will willing sign their 6 month old up for that too.

[newmum35]

Originally Posted by 13Sandals

I have no idea where to post these things now - but here's a nasal spray update:

http://www.google.com/hostednews/ap/...2TZdQD99KD3D02



that's all we'd need - school kids being sprayed with live swine flu vaccine at school.

Yeah me too! I'm not sure where to post replies to some of the threads that have been closed, so its like.. end of discussion!


How about this line... they even admit it may not turn out to be any more dangerous than regular seasonal flu (yet they feel 100% of the population should be vaxed for it anyway!)

Even if swine flu is not more dangerous than regular winter flu, "we have a population that's virtually 100 percent susceptible," said committee chairman Dr. John Modlin, a pediatrician at Dartmouth-Hitchcock Medical Center. "This is an entirely appropriate way of proceeding, one that to me seems both necessary and appropriate and prudent."

[newmum35]

Originally Posted by 13Sandals

I have no idea where to post these things now - but here's a nasal spray update:

http://www.google.com/hostednews/ap/...2TZdQD99KD3D02



that's all we'd need - school kids being sprayed with live swine flu vaccine at school.

Oh brother, aren't we all in for a joy ride:

One bright spot: The U.S. has the world's only nasal-spray flu vaccine, and maker announced Thursday that it's producing plenty — so many millions of doses a month that it can't keep up with putting them into the special sprayer required to use it. So Maryland-based MedImmune Inc. is working with the government to see if it can race out a different method for fall, simply dripping its swine flu vaccine into people's noses.

How about this:

The good news: Despite a brisk flu season in the Southern Hemisphere, the new swine flu isn't yet mutating to become more dangerous, said Dr. Nancy Cox of the Centers for Disease Control and Prevention.

Cox said "it's actually quite surprising" that the virus is showing so little genetic variation given its rapid spread. It has sickened more than a million people in the U.S. alone since April and circled the globe in a matter of weeks.

I really wish people would educate themselves about this and JUST SAY NO to a vaccine they don't NEED!! Sometimes I feel like this is just a giant experiment to see how many stupid people are out there and to see just how much they can get away with. Lord only knows if they reap the profits this winter, what is in store for us in the following years. Its funny how I no longer read about "whether or not" we'll need the vaccine this fall, as I used to during the early weeks of swine flu coverage. Back then, it was talk about maybe making a vaccine, and to be used "only" if we needed it. It has NOT mutated, it is NOT a high morbidity disease... yet... we're expected to take their vaccine anyway. Yeah.. right!

[Marnica]

http://www.who.int/csr/disease/swine.../en/index.html



[QUOTE]Specific regulatory procedures have been devised to expedite the approval of pandemic vaccines. In the USA, for example, fewer data are required when the manufacturer already has a licensed influenza vaccine and intends to use the same manufacturing process for its pandemic vaccine.
[QUOTE]

Time constraints mean that clinical data at the time when pandemic vaccines are first administered will inevitably be limited. Further testing of safety and effectiveness will need to take place after administration of the vaccine has begun.

In certain countries, each new influenza vaccine has to be tested in a few people to show that it performs as expected. This requires at least four weeks. In some countries this may not be required as many clinical trials were done with similar annual vaccine preparation, and the assumption is that the new pandemic vaccine will behave similarly.

I'm sorry but your memo which was put out to put the public's fears at ease doesn't

Everything written here defies login IMO. They basically admit that when a pandemic occurs they do what they have to do to get the vaccine out FAST inclusing changing regulatory procedures to suit their needs

Ways were sought to shorten the time between the emergence of a pandemic virus and the availability of safe and effective vaccines.

This is scary!

[Juvysen]

I think the fluMist option freaks me out. I don't want to get something from someone who was vaccinated!

[Sileree]

I read that WHO memo also.

To be fair, I think they made a fairly good case for the swine flu vaccine being as "safe" as a regular flu vaccine - it's made the same way and has the same ingredients so far. It's not a completely new invention.

What I am concerned about is the use of adjuvants, especially new ones that have not been tested adequately, to stretch out the use of the antigens made.

[dinahx]

To be fair, I think they made a fairly good case for the swine flu vaccine being as "safe" as a regular flu vaccine - it's made the same way and has the same ingredients so far. It's not a completely new invention.

The majority of the doses will use an untested adjuvant, which makes it not at all the same.

[Sileree]

Originally Posted by dinahx

The majority of the doses will use an untested adjuvant, which makes it not at all the same.

I have not read that the U.S. has decided it will use a new adjuvant, or even in all vaccines for H1N1.