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Safety Questions Over Swine Flu Jab

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http://www.independent.co.uk/life-style/he...ab-1751547.html

The first doses of swine flu vaccine will be given to the public before full data on its safety and effectiveness become available, doctors confirmed yesterday.

The aim is to provide maximum protection against the pandemic in the shortest possible time.

But, unlike seasonal flu vaccine, the pandemic version will be spread over two doses in a higher quantity, and one brand is expected to contain a chemical additive to make it go further, potentially increasing the risk of side-effects.

Children, who are most vulnerable to swine flu and are likely to be among those first in line for the jab, may get the vaccine more than a month before trial results are received.

Adam Finn, professor of paediatrics at the University of Bristol and an expert on vaccination who will be testing the pandemic vaccine, said: "There will be a period where a risk judgement will have to be made. It will depend if there is an increase in the number of cases and deaths. Children are potent spreaders [of the virus] – they are now seen as the engine of the epidemic. We are dealing with information as it comes in – we could be dealing with a far worse epidemic, and we need to act sooner rather than later."

Yesterday it emerged that a baby aged under six months died at the Royal Free Hospital, London, last week and a 39-year-old mother who was reported to have given birth died at Whipps Cross Hospital, east London, on Monday. The Department for Children, Schools and Families said 1,000 schools had been affected by swine flu and some could be forced to stay shut after the summer holiday if the number of cases escalates.

The pressure to protect the population from the growing pandemic, and the short time available for production and testing of the vaccine since the H1N1 virus was identified in May, mean the licensing process is to be accelerated.

A previous vaccine against swine flu turned out to be worse than the disease. An outbreak in the US in 1976 infected 200 soldiers at a military camp in New Jersey, of whom 12 were hospitalised and one died. But before it was over 40 million people had been vaccinated, 25 of whom died and 500 of whom developed Guillain-Barre syndrome, an inflammation of the nervous system which can cause paralysis and be fatal.

Doctors said yesterday that today's vaccines are purer and cause fewer side-effects. Though the virus is mostly mild in its effects, it has claimed 29 lives in the UK and hospitalised 652 people in England. The NHS was ordered this week to plan for a worst-case scenario in which swine flu might cause 65,000 deaths over the coming winter, including several thousand deaths among children.

Discussions are still going on between the manufacturers, the European Medicines Evaluation Agency (EMEA), and the Department of Health over how much data will be required.

The Government has placed advance orders for up to 132 million doses of vaccine with two manufacturers, GlaxoSmithKline and Baxter. The manufacturers have tested and licensed in advance three "core" vaccines in preparation for a pandemic. These are vehicles into which the H1N1 pandemic strain of the virus is inserted.

A spokesman for the EMEA said the first samples of the fully functional pandemic vaccine were expected by the end of July and a decision on whether to approve them would be taken within five days. Trials involving 200 to 400 patients would be conducted, but the vaccine would be made available for use by the NHS before the results came in.

"What the manufacturers will be submitting will not have any clinical trial data. We expect the interim adult data from September and the first paediatric data from October onwards," he said.

Last night a spokesperson from the Department of Health defended the EMEA, saying : "The UK has one of the most successful immunisation programmes in the world.

"Appropriate trials to assess safety and the immune responses have been carried out on vaccines very similar to the swine flu vaccine. The vaccines have been shown to have a good safety profile. More than 40,000 doses of the vaccines which the swine flu vaccines are based on have been given without any safety concerns."

For those without children the good news is it appears that children will be the guinea pigs for this vaccine, although for those of us with children this is rather unnerving that the govt is prepared to use a untested vaccine on our kids before they know if it's safe or not.

How many of you with kids will be willing to risk your children over this, especially if they are amongst the first to get it?

We definitely appear to be in a police state will those of us who refuse to immunise our kids be charged with child abuse?

I can see this ending in disaster with the drug companies getting sued.

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Will this 'vaccine' contain Thimerosal?

Thimerosal:

http://www.melisa.org/thimerosal.php

Thimerosal, also known as "thiomersal", is 50 per cent ethyl mercury by weight. Since the 1930s, it has been used as a preservative in child vaccines -- predating the rigorous vetting procedures now in place. To this day, its use in medicine has never been approved from the FDA.

It does not take a scientist to understand the risk. Mercury is the second-most toxic element on earth (next to plutonium). It is a proven neurotoxin. Pregnant women are advised to restrict their fish intake due to mercury pollution. Yet we are injecting it into babies from the age of eight months. Why? The answer -- the only answer -- is that mercury makes vaccines cheaper.

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Ambivalent about this thread.

On the one hand, distributing the vaccine without adequate data would be a bad thing.

On the other hand, the media and various pressure groups have previously attempted to discredit vaccines (most recently MMR) in spite of hundreds of thousands of patient-years* of safety data showing no link to the conditions they cite.

To any anti-vaccinators out there, I demand consistency:

Either safety data is irrelevant, in which case we may as well distribute a swine flu vaccine without safety data.

Or safety data is paramount (my own view), in which case we must acknowledge that the MMR/autism scare was evidently groundless from the beginning.

(*1 patient-year = 1 patient followed up for a year)

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It does not take a scientist to understand the risk. Mercury is the second-most toxic element on earth (next to plutonium). It is a proven neurotoxin. Pregnant women are advised to restrict their fish intake due to mercury pollution. Yet we are injecting it into babies from the age of eight months. Why? The answer -- the only answer -- is that mercury makes vaccines cheaper.

How about this for a shocker:

It does not take a scientist to understand the risk. Sodium is a highly flammable, toxic metal. Chlorine is the second-most toxic gas on earth, and used as a chemical weapon. Yet astonishingly these two elements are deliberately added to ready-meals aimed specifically at children, simply because they make the food taste better. Won't somebody think of the children?

Just because the elements are both fatal in ingestion, doesn't mean that the compound (sodium chloride or table salt) is. So you can't assume that because elemental mercury is toxic, so is thiomersal.

Maybe it is, maybe it isn't, the only way to know is to carry out sufficiently large, properly designed epidemiological studies.

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snip in spite of hundreds of thousands of patient-years* of safety data showing no link to the conditions they cite.

snip

yeah but, its never been tested by scientists, thats the point. It MUST have a certificate.

thats why I refuse to eat carrots...never seen a safety cert.

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Ten years of hysteria

The Millennium Bug

The War on Terror

SARS

Bird Flu

Swine Flu

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Guest DissipatedYouthIsValuable
http://www.independent.co.uk/life-style/he...ab-1751547.html

For those without children the good news is it appears that children will be the guinea pigs for this vaccine, although for those of us with children this is rather unnerving that the govt is prepared to use a untested vaccine on our kids before they know if it's safe or not.

How many of you with kids will be willing to risk your children over this, especially if they are amongst the first to get it?

We definitely appear to be in a police state will those of us who refuse to immunise our kids be charged with child abuse?

I can see this ending in disaster with the drug companies getting sued.

It's pretty tricky isn't it?

Being at the frontline, having to make decisions based on very fuzzy datasets.

I'm intrigued to know what the 'additive to make it go further' is.

Presumably something other than viral antigen proteins?

Something which induces greater potentiation of antibody response?

Not seen any details yet.

It's also quite difficult to make decisions on who to give antivirals, because mainly the reliance is on symptom set clusters which can be quite spectral rather than definitive.

I've given out Tamiflu to around 10 people this week.

Here's the datasheet. (For Tamiflu, NOT the vaccine)

OseltamivirDataSheet.pdf

I'm looking for some literature on the vaccine now.

OseltamivirDataSheet.pdf

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How about this for a shocker:

It does not take a scientist to understand the risk. Sodium is a highly flammable, toxic metal. Chlorine is the second-most toxic gas on earth, and used as a chemical weapon. Yet astonishingly these two elements are deliberately added to ready-meals aimed specifically at children, simply because they make the food taste better. Won't somebody think of the children?

Just because the elements are both fatal in ingestion, doesn't mean that the compound (sodium chloride or table salt) is. So you can't assume that because elemental mercury is toxic, so is thiomersal.

Maybe it is, maybe it isn't, the only way to know is to carry out sufficiently large, properly designed epidemiological studies.

Hooray for Selling Up.

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Ten years of hysteria

The Millennium Bug

The War on Terror

SARS

Bird Flu

Swine Flu

John Terry going to City

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Guest DissipatedYouthIsValuable

Looks like www.replikins.com are producing the vaccine, and looking at the infectivity and lethality of current infections.

Link

Pretty sparse information so far, no sign of a datasheet that I can find.

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I have swine flu. Feel lousy but in all honesty the flu I had last year was a lot worse than this!

However because of the publicity I am certainly on the ball at the moment in case I take a turn for the worse, but it just seems to have been blown out of proportion. I haven't even got Tamiflu! Not that I'd take that either.

If I had kids, I certainly would not be drugging them up with this Swine Flu Jab.

You can go a long way just by looking after your kids properly! Like feeding them well and teaching them good hygiene.

Kids should catch Swine Flu. Obviously no-one wants to get it badly, but you need to catch these things to build up your future immunity. It makes you and future generations stronger in the long run!

It's better to get it now than when you are elderly and things break down so easily!

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A swine flu article from the Times:

http://www.timesonline.co.uk/tol/life_and_...icle6718690.ece

"All of Britain’s flu vaccine is produced abroad. About 60 million doses of the vaccine — enough to cover half the population — are due for delivery by the end of December, with the rest following next year. The first batches are expected next month. However, there is expected to be some delay between when Baxter and GlaxoSmithKline, which is producing batches in Germany, deliver the supplies and people receive their first vaccinations. "

"All of Britain’s flu vaccine is produced abroad."

No shock there then. :ph34r:

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SNIP

Kids should catch Swine Flu. Obviously no-one wants to get it badly, but you need to catch these things to build up your future immunity. It makes you and future generations stronger in the long run!

SNIP

Yes- weed out the weak!!!11!1!

"Should catch swine flu". Genius.

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Guest DissipatedYouthIsValuable

I suppose the difficulty with this is that it is evolving in real time.

Seemingly there are some gene sequences which are associated with lethality and some with virulence.

These are looking at correlation over populations rather than individuals, and I suppose you could ask the question of gene sequence changes and their effect on protein transcription, and how this affects the stereochemistry. For instance, if you get a point mutation in a gene, it might not make any difference to the protein that is produced, but put the point mutation somewhere else in the gene and it can make a big difference to the shape of the transcribed protein, vastly changing its biological effects, as occurs with sickle cell anaemia.

There's also the rate of mutation. In the case of flu you also have cross-species transmission, with mutation rates probably having some degree of species specificity.

Lots and lots of uncertainty.

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Guest DissipatedYouthIsValuable

I suppose the question people are asking is at what point do you trust a relatively sparsely tested vaccine?

What sort of mortality statistics affect your decision making process?

Would you trust a bloke called Jenner who said, "I've got an idea which involves injecting you with pus from cowpox blisters from a milkmaid, I reckon it might prevent you dying from smallpox" ?

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I suppose the question people are asking is at what point do you trust a relatively sparsely tested vaccine?

What sort of mortality statistics affect your decision making process?

Would you trust a bloke called Jenner who said, "I've got an idea which involves injecting you with pus from cowpox blisters from a milkmaid, I reckon it might prevent you dying from smallpox" ?

Gonna be emotional, isn't it?

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Guest DissipatedYouthIsValuable
Gonna be emotional, isn't it?

Of course, and quite rightly people will be asking themselves whether they want to conduct the trial on their kids.

Kids generally being the life's work and expression of love.

The thing about kids is that they are great little vectors of viral disease, from the amount of virus expressed, to proximity with other humans, and size of social networks.

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I suppose the difficulty with this is that it is evolving in real time.

Seemingly there are some gene sequences which are associated with lethality and some with virulence.

These are looking at correlation over populations rather than individuals, and I suppose you could ask the question of gene sequence changes and their effect on protein transcription, and how this affects the stereochemistry. For instance, if you get a point mutation in a gene, it might not make any difference to the protein that is produced, but put the point mutation somewhere else in the gene and it can make a big difference to the shape of the transcribed protein, vastly changing its biological effects, as occurs with sickle cell anaemia.

There's also the rate of mutation. In the case of flu you also have cross-species transmission, with mutation rates probably having some degree of species specificity.

Lots and lots of uncertainty.

You have me worried if promoter sequences are affecting stereochemistry.

Please tell me we're not heading into dexter-world.

Edited for typo.

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It's pretty tricky isn't it?

Being at the frontline, having to make decisions based on very fuzzy datasets.

I'm intrigued to know what the 'additive to make it go further' is.

Presumably something other than viral antigen proteins?

Something which induces greater potentiation of antibody response?

Not seen any details yet.

It's also quite difficult to make decisions on who to give antivirals, because mainly the reliance is on symptom set clusters which can be quite spectral rather than definitive.

I've given out Tamiflu to around 10 people this week.

Here's the datasheet. (For Tamiflu, NOT the vaccine)

OseltamivirDataSheet.pdf

I'm looking for some literature on the vaccine now.

Ethically a tricky one!

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Ambivalent about this thread.

On the one hand, distributing the vaccine without adequate data would be a bad thing.

On the other hand, the media and various pressure groups have previously attempted to discredit vaccines (most recently MMR) in spite of hundreds of thousands of patient-years* of safety data showing no link to the conditions they cite.

To any anti-vaccinators out there, I demand consistency:

Either safety data is irrelevant, in which case we may as well distribute a swine flu vaccine without safety data.

Or safety data is paramount (my own view), in which case we must acknowledge that the MMR/autism scare was evidently groundless from the beginning.

(*1 patient-year = 1 patient followed up for a year)

The question is this: would you trust the government given its record of lying and being in the pocket of big business (RBS, Lloyds et al)? Who stands to gain from massive quantities of vaccine and antiviral drugs being liberally injected into the population?

There is a clear link between mercury containing preservatives used in vaccines (thimerosal), elemental mercury and neurological damage. Elemental mercury itself is a powerful neurotoxin.

Even if the flu vaccine doesn't contain thimerosal, should we be using it on civilians without properly testing it? The new EU laws relating to vitamin and mineral supplements are seemingly more stringent than the testing requirements for vaccines.

The so called "gulf war syndrome" was attributed to vaccinations against biological warfare. Are we about to see the same thing repeat itself in the general population?

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Yes- weed out the weak!!!11!1!

"Should catch swine flu". Genius.

Ignorance. Yet it's hardly surprising when so many people just follow the herd!

Did you know Measles is a lot more dangerous now than it used to be because of the MMR jab?

Now we have two problems. The controversy that still remains over having the MMR jab in the first place and the fact Measles is now, far more dangerous if caught.

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You have me worried if promoter sequences are affecting stereochemistry.

Please tell me we're not heading into dexter-world.

Edited for typo.

A promoter sequence affecting stereochemistry wouldn't make it a promoter sequence as defined by phenomenological concept.

If you're a flu virus with a lot of well-binding haemagluttinin on your coat you might be sticking to more cells to infect them. So promoter sequences are obviously important.

I am using the term stereochemistry with this definition: the branch of chemistry concerned with the three-dimensional arrangement of atoms and molecules and the effect of this on chemical reactions.

Chirality is one of many elements of stereochemistry.

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Guest DissipatedYouthIsValuable
Ethically a tricky one!

"First, do no harm"

Possibly Hippocratic in its orgins.

Of course, the World was much more simple and granular then.

There have been a few million prescriptions of tamiflu in the US, and as far as I can tell from the literature it doesn't seem to be bumping people off at any noticeable rate.

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