Is anyone else worried about Celvapan as it hasn't been tested?

[Bodenbabe]

I'm due to have a Celvapan jab tomorrow but now I'm reading how it hasn't been tested properly. FFS, I thought it was Pandremix we were all worried about but now Celvapan is feeling like a risk too. I think they've done preliminary trials which indicate that it's safe but there is no official data that has tested it thoroughly, is that right? If so, WTF?!

i am in a quandry myself as i have been called up to have the vaccine as i have asthma.

but i don't know anyone who has had swine flu AT ALL - i think the hype is disproportionate, there are always seasonal flu deaths and i've managed this far.

i have my doubts as to the the whole arrrrrrrrrgh swine flu quick make a vaccine - oooh look heres a vaccine ( that was quick)

i don't know it's all a bit suspect

A really tough decision for you and so much contradictory information that doesn't help at all.

I have read a lot and feel no wiser - just more doubtful which makes me hesitate. I want to feel sure before allowing medicine into myself or my loved ones.

There are many voices in the medical profession/government who are uncertain about this too: www.youtube.com/watch?v=RhZesZe33cw www.youtube.com/watch?v=A0JqQyl09zQ news.xinhuanet.com/english/2009-02/18/content_10838633.htm

The medical establishment is NOT always right and as I have said elsewhere, the official vaccine insert even states that safety has NOT been established and trials are ongoing.

I do hope you find the right solution for you

It's a flu vaccine, similar to the flu vaccines that get tweaked every year to take into account the latest circulating versions of flu virus (in this case, they've recently changed from H5N1 inactivated virus to H1N1 inactivated virus). They've been producing flu vaccines for years including preparing for a pandemic strain.

It's passed all the safety trials that are required for any medicine to be authorised. However ALL medicines are then part of further ongoing trials to double-check what happens when given to 1000s of patients, in case the original small samples led to any side-effects being missed. That's what's happening now.

My 14mo got the GSK swine flu vaccine yesterday and is now part of the clinical trial of around 9000 patients to follow up reactions, so I'm completing a diary for a week and then will get contacted after I think 1 month and 3,6 and 12 months to discuss any medical problems he's had since (many of which obviously could be totally unrelated but will end up being considered as ptential side effects)

Am I concerned that we don't know that much about this drug on large groups of people? Of course. But I'm also worried about H1N1 flu (and do know many people who've been ill with it, some off work for over a month, and know that unlike normal flu young people get it disproportionately badly). So I had to decide which risk to take - there is no risk-free option!

I wouldn't argue with anyone who came to the opposite conclusion (people more expert than me might), as long as they aren't the same people who complain when they aren't offered a 'new miracle drug' - by definition a new drug is one that is still undergoing testing! For example, Herceptin - huge complaints that people couldn't get it (even those without HER2-expressing cancers in which case it would do diddly), but no media recognition of the fact that there were concerns about its effect on the heart and indeed HER2 is vital in heart valves so taking an antibody to it isn't a miracle solution...

More info on Celvapan here:
www.emea.europa.eu/humandocs/PDFs/EPAR/celvapan/Celvapan-H-982-PU-02-AR.pdf

Notcitrux:
I just want to respond to what you said about how this vaccine is made in the same way as previous flu vaccines - I understand that and in fact the vaccine insert even says that the information about safety and effectivenss are based on the regular flu vaccine... but I have to wonder how it can be considered 'as safe' when it has different ingredients?

One cake is not the same as another because it is baked using the same methods - it is the ingredients that count surely?

I am having C not P because I specifically requested it and my PCT were sympathetic.

Notcitrus makes a good point.

There is no risk free option here.

What you have to weigh up is whether the risk of infection is greater than the risk of potential side effects.

FWIW, I do believe that the drug companies are hyping the need for the vaccine. They stand to make a great deal of money from this and, because WHO have labelled H1N1 a pandemic, the drug companies have much greater protection from being held accountable should anything go wrong.

So it's a no brainer for them.

TinalouiseUK - Basically, data has been extrapolated from forumations and chemicals that HAVE been tested.

Harimosmummy:
But I don't understand how if it is a new disease strain and this is a new vaccine created specifically for it - how that part of the vaccine can be a formulation or chemical that has been tested? Sincere query

It works like this:

The biologists look at what active ingredients are required. They do this, in very simple terms, by mimicking the actual virus.

Once that has been sorted, the chemists have to work out how that active ingredient can be made up into a usuable vaccination dose....

So, it will depend on whether the 'active' is water soluble, miscible, it's reactivty etc...

The end formation needs to be stable under normal atmospheric conditions, have a rasonable shrlf life etc., and that's why all the non active ingredients are required.

Can you tell i'm a formulation chemist

Sorry for my ignorance Harimosmummy - but there must be a new ingredient as this is a novel strain and surely that new ingredient can't have previously been tested?

Bodenbabe- I have just received the Celvapan shot on Friday, as I requested it like you did, I'm 32wks pregnant and can tell that I feel fine, no red or sore arm as women have stated about the Pandemrix.

The new active ingredient is almost certainly new. it will have been formulated specifically to tackle this strain of flu.

but, it's likely to be extremely similar to the other chemicals used. Chemicals are pretty logical things... it's reasonably easy to predict how a chemical will react based on it's chemical structure (it's one reason nomenclature works so well in chemistry and is so important)... So, I suppose the best analogy is times tables... If 22=4 and 32=6, then it follows that 4*2=8.. That's basically what the chemists are doing when looking at the chemicals... Do you see what I mean?

The non active ingredients are slightly different. they WILL have been tested and used before and will carry licences and approvals for use. The chemists just select which ones work best to carry the active ingredient.

So, for example, if the active is water soluble, then water can be used as the base. but, if it's not, then a solvent of some sort will be required and if there are any separation issues, then an emulsifier will be required.. Stabilizers and preservatives may also be required. Blah, blah...

So, no... the chemicals won't have been tested in this formulation but again, there will be a wealth of information about their effectiveness.

All that said, of course... there are always some anomolies... and that's the risk.. what IF there is a side effect which wasn't expected....

Thanks for the excellent explanation Hariomsmummy... although I do wonder (taking your analogy to make another)if the fact that 4, 2 & 8 appear together for the first time, might make an unforseen difference if you get what I mean?

Really appreciate the sharing of your knowledge

Yes... absolutely... that's the risk.

It's pretty much a given that the bulk properties of a chemical can be predicted but what cannot be predicted with 100% certainty is whether there will be any particular side effects.

Possibly the best known (and worse tragedy) is Thalidomide. There are two enantiomers (these are optical isomers of the same chemical - they are mirror images of each other) but one form does not cause teratogenicity and the other does.

It was this fact that lead to the tragedy.

Now, that's not really a great example and I'm NOT saying that is a risk with new vaccines, but, yes, occasionally, there is a side effect that wasn't expected.

That reminded me of a management training exercise that demonstrates that 1 + 1 = 3. You get one person with an idea and another with an idea and together they become not just the 2 ideas but another as well, as there is the 'one' that is the sum of the two... hope that made sense??

Thanks again for the informed insights

Harimosmoney, squalene worries me because it is not permitted for use in the SF vaccines in the States, and because in animal studies it has been shown to cause arthritis. The whole gulf war link is very confusing, so I am setting that aside, but still, I have concerns [having had severe arthritis in the past]

Harimosmummy i mean!

hey, I don't mind being Harimosmoney!!!!

I didn't know about squalene being banned in the Us... I will have a look into that one.

Squalene is produced in the body - I think at higher concentrations than in the vaccine but not sure. It's just never been authorised in the US, which is rather different to being 'banned'.

Re the active ingredient - influenza viruses tend to be very similar in their RNA sequences except the H and N genes - there's about 16 major variants of each. The 1918 pandemic flu virus was H1N1 and so has been studied intensely; more recently we've had the various H5N1 strains so the new forms of N1 are pretty well known too. It's the growing all the virus needed for bulk lots of vaccine that takes the main time before new flu vaccines are available, rather than the safety tests. Apparently a general 'influenza A' vaccine has just passed its first safety tests so maybe in a few years the annual rounds of trying to make sufficient vaccine available before it mutates again will be over - and there will only be one vaccine for people to reassure themselves about.

re thalidomide - the enantiomers interconvert in the body so the fact that one is 'safe' doesn't really help. It was the fact that no-one thought drugs could cross the placenta at the time that meant no-one looked at the fetuses of animals it was tested on, which do show the typical defects (I know it's off-topic but it's a common myth that animal testing led to the thalidomide tragedy)

well it is not licensed for a reason. And yes squalene is found in the body, and in olive oil and shark liver oil, but animal studies suggest when injected, rather than introduced orally, it can cause arthritis in susceptible rats. I mean it is introduced in the vaccine to provoke an immune response, so you can see the logic behind the idea that it can trigger an auto immune response in susceptible individuals.

Hi, had Pandemrix on Friday afternoon (because of swine flu outbreak at my child's school). Had a very marginally sore arm, really nothing to mention, I could even sleep on that side and it felt fine. Other than that absolutely nothing, and I was so very worried about it.

baby is moving fine and I feel relieved that I am building up antibodies as sf seems to be increasing in our area.

xx

Just reading an article out today about the PCT's being told to make both vaccines (with and without adjuvant) available to pregnant women in the UK. On Sky News at ow.ly/163OE0

Article says: "Ian Dalton, national director of flu resilience at the DoH, has now written to NHS chief executives instructing them to make Celvapan available."

Pofacedandproud - there is a WORLD of difference between something not being licenced / authorised and it being banned. HUGE difference.

it's like likening a child whose been expelled from a great school to a child who has never attended the school because the parents couldn't afford the fees. Honestly, it is.

Squalene has not been banned. Just to make that clear.

Notcitrus - Sorry, yes, it was a bad example... I was aware of that, I was just trying to make the point that very similar chemicals can, at times, have extremely different effects - it's uncommon but it happens. I agree, it was not the most useful example.

To be honest, I've done quite a bit of research into this now and I'm coming around more to the conclusion that if my kids (two under two) are offered it, I'll probably take it.

yes of course there is harimosmummy But apparently it has not been licensed because of the public's perception of safety and fears of reluctance to get the jab if it contained squalene. Perhaps the gulf war association [proven or not] is fresher in people's minds in the states, I don't know. But they have bought up a load of squalene adjuvant in the States and some are questioning why they are not being used, as it would make their vaccines go much further [they currently have a shortage] but so far they are holding off using it [it seems the y could license it quite quickly if they wanted to] So hard to know.

I was going to take Celvapan as soon as I could get hold of it (which would have been this week), but, after further web-seaches, I feel there are significant risks with Celvapan. It hasn't been tested thoroughly and the reason it has been released to the public is only because we are in a 'pandemic' situation - the report about Celvapan states this quite clearly. It's manufactured in a completely different way than all other flu viruses, which is a risk in itself. It's a big unknown. Baxter, the manufacturing company, appears to have been linked to two very series slip-ups, so my confidence in the manufacturer went out the window after reading that.

I've also recently read more information to put me off Pandemrix. Two pregnant nurses have told me off-the-record (of information they'd read/been told about) that they wouldn't touch either vaccine because of the varying mercury levels in each vaccine, in different batches - you'd never know which batch you got. A friend of mine's mother works in a hospital with young children and every doctor she's asked wouldn't give Pandemrix to their own kids - one of her grandkids has asthma, hence her queries. I was forwarded this info re: Pandemrix (dated Sept 09) too:
"Glaxo SmithKline is the main supplier to the UK government, having been contracted to provide 60 million doses, with the first batches set to arrive next month. It has been reported that the GSK swine flu vaccine contains thimerosol ? that's mercury to you and me. GSK is not the only company said to be adding thimerosol to its swine flu vaccine. Worse still, GSK's vaccine will also contain squalene, and it isn't alone in that, either.
Squalene is an adjuvant (a substance added to exaggerate the immune system's response to the viral material in a vaccine) of extremely dubious track record. Another way to describe an exaggerated immune response is "autoimmune disease" and squalene has already been implicated in causing just that. It is believed to be the main culprit behind Gulf War Syndrome (which shows up as arthritis, chronic fatigue, multiple sclerosis and/or many other debilitating autoimmune conditions and symptoms), after it was included in experimental anthrax vaccines given to soldiers in the early 1990s. Even the pro-vaccination mainstream media is reporting that this new vaccine sounds like an insanely dangerous experiment. "
For now, my decision is to hang-fire and keep my fingers crossed I won't get SF. I'm going to keep my ear to the ground and if SF appears to get much worse in the UK then I may have to go for Pandemrix, with huge reservations. I respect anyone's decision to take Pandemrix, or indeed Celvapan, but right-now, I just can't. I have a 4-year son so am not taking this decision lightly. Anyone know of what's good to boost your immune system?