If you have an UNDER THREE please read this

[studentmummy]

When the vaccine is available it will not even be OFFERED to UNDER THREE's even though 0-4 year olds are the projected heaviest affected group for MORTALITY. As the mother of a two year old (among other siblings)I resent not having the CHOICE to have my child protected especially if death rates INCREASE. Even the very elderly will take priority over toddlers and babies as they have been allocated vaccine at the very end of the queue.
The government advice is that UNDER THREE'S STAY AT HOME for their own protection instead which is not a realistic option for working or stay at home mothers who will bceome PRISONERS IN THEIR OWN HOMES.
For clarification please read the following :Prof David Salisbury letter to primary care trusts dated 26 June 2009 and goveernment projections for swine flu under NHS choices website. I suggest if you feel as strongly as I do a letter to your MP that under three's are NOT EXPENDABLE but are human beings with full rights as our their mothers!

My son is three and a half months old, and I am also with studentmummy! as the highest projected mortality is in under 5's then I do believe that under fives should be prioritized, alongside the other 'priority' cases. Whilst I appreciate what people are saying, that we do not yet know the safety of this vaccine, I would at least like to be in a position where I could make an informed choice, and depending on what I decided have my baby vaccinated. It is all well and good that they may get around to under 3's by next year; but if the virus mutates and becomes more deadly by the winter.. then that is not much good really!

Can someone please point me in teh direction of the data/speculation from a health agency saying that under 5's have the highest projected mortality?

I believe that they are expected to have (maybe) the highest rate of infection. And I know that is currently true. But I haven't seen anything to say that it is expected that highest mortality is expected to be in that group.

Oh and the incidence of GBS after the 1976 vaccination is debated...and I mean genuinely debated. Many reports do show a statistically significant link. Some do not.

I don't think it was that vaccine per se. In the sense that GBS is something which is looked for in all safety studies concerning vaccinations I believe.

A vaccine is made up of several components. The antigen(s)(ie the thing you want to be immune to), and adjuvent(s) which enhances the immune response to get better immunity and various other salts and stabilisers to preserve the vaccine.

A "mock" vaccine containing everything except the antigen has been thoroughly tested. Most adverse events are linked to the adjuvent (e.g. Aluminium and thimerosal). There was even some suggestion that the GBS was caused by the Tetanus Toxoid which was the adjuvant in the 1976 incident. I don't think this has been proven. But the full mixture won't be tested fully.

The Antigen may have unknown adverse events associated with it. TBH the antigen is ony part of the virus so I am reasonably confident that it shouldn't. The body should respond to the antigen in the same way as it reponds to the virus - from an immunology perspective.

Incidently the seasonal flu vaccine doesn't have vastly more testing that this vaccine. It can't. Although the timescales for the generation of a seasonal flu vaccine are longer than they are talking about for this one. It is only an extra couple of months. The reason for this is that the scientists have to wait and see what strain is going to be the seasonal strain before they can start; the same as they have done with swine flu. It is just that they are under much greater pressure to get an effective vaccine to market because of the cirumstances. Finally, in the UK the vaccine will have to be deemed safe, and ethically sound by 2 regulatory agencies before it will be administered to the first clinical trial patients. And then again before going on general release. There is a system in place for rapid reporting of adverse events, and the regulatory approval can be removed (completely or pending further testing) at any time and within an instant.

However, it is interesting to note - that whatever went on with the 1976 concerns I believe it was an H1N1 "swine" flu....

So to conclude. I have faith in the safety of the vaccine and the systems in place to ensure public safety. However, I am not confident enough to allow my 3yo (and maybe not my 8yo's) to be in the first cohorts.

Hi again

Good to see everyone still talking!
Prefetparfait - some up to date info for you - one to four year olds now most affected group as well as having the highest projected mortality rates.

See HPA weekly National Influenze Report dated 16 July 2009
Page 4 for age groups most affected

Page 7 for disease severity and mortality data per age group.

I do share some of your concerns about an untested vaccine for young children but in common with Lucretiaa am concerned about vaccine shortages if the virus mutates.

Also thinking about this I am a protoscientist of sorts as I am doing a BSc!!

Also interested in the testing of the mock vaccine. Can you post a link to the ingredients and the trial results?
Nope - I am relying on news reports. But it is my understanding that this is the case for all vaccines. I may be able to find something when kids are in bed if you are desperate. I believe that this is the way (to a certain extent) that it is done for all flu vaccines, because the timescales in their very nature are always too short for a full clinical trial. I will try and dig our some info later.

Is it just one general mock vaccine that they have or do they have several different ones tested and ready? Do you know which pharmaceutical company has the mock vaccine or do they all have their own?
They will all have their own. And all mock vaccines which they use will have full safety data on. I think it was the Novatis one I was reading about a couple of weeks ago but can't be sure. As I say it was on the BBC news website or similar rather than a peer reviewed journal.

I know that different vaccines have different ingredients, and there can be different vaccines for the same disease.

I thought that Novartis was leading the vaccine race (but TBH I am not sure why. Just gut instinct which is probably horribly wrong). The Uk government hsa placed orders with GSK and Bayer though so maybe Novartis are not leading hte race.

Student - I am very confident (but not 100% - I am a scientists and scientists will never deal with 100% confidence ) that the vaccine will still be effective ona mutant strain. The Virus would have to undergo thousands of seperate mutations, many of them within the specific Antigen used in teh vaccine. And many vaccines (although i don't know the details of this one(s)) have more than 1 antigen in them so the virus would have to mutate all of the antigens. Finally, I am guessing that as there is more than 1 company producing vaccine they will all use differetn antigens. So if the virus evades teh Novartis vaccine for example the Bayer vaccine should still be effective giving "us" alternatives.

Disclaimer: Much of this relates to my opinions and my general (relatively basic compared to the experts) knowledge about vaccine production etc., and not specifically the flu vaccines currently being prepared.

Haven't heard the vaccinations timescales in detail. Only the conflicting information reported by the BBC (from the BMA I believe) and teh WHO. As regards to teh testing before complete analysis of the trial data. If this is the case the crude output such as reported Adverse events will amost certainily be available. What I suspect will be lacking is the detailed analysis of blood& urine for biomarkers and stuff. Rest assured if the vaccine gives any severe adevrse events this data will be available before dosing to the public.

Sooty - I know. I am checking original sources where I can (but as things are changing so fast I on't check everything.

It is standard protocol to test anything administered to man over a number of years. If there is scope to do that the regulatory authorities would require that. The problem is that teh turn aroudn time required for flu vaccine (of any kind) is too short to allow this. Therefore teh idea of thoroughly testing a mock vaccine is hte compromise which the regulatory agencies have deemed acceptable. many adverse events are either down to the other stuff in teh vaccine. The antigen is usually just something purified from or identical to that found in the disease. Serious adverse events are usually short term and those can be assessed.

Honestly - I don't think that the testing of this vaccine will be massively less than that of a "seasonal" flu vaccine. But that is an educated guess rather than fact.

I haven't read the whole thread but I have a 8mo ds and I am not unduly concerned if he is not eligible for a swine flu vaccination. He would not be routinely eligible for a flu vac in any case and I still consider ordinary influenza (as in been around a while) a substantial risk for a child that age. The vaccinations they receive as babies are pretty comprehensive and include the pcv. As pneumonia is the biggest risk from flu then I am confident he has some protection.

As someone who has worked in the nhs for quite a few years I am not going to take any notice of what the nhs thinks it is going to do when they have the vac. you can guarantee it will have changed by then.

Sooty - you sound very sceptical about the "politics" behind such a vaccination campaign more than the vaccine itself.

I will post 1 more piece of info which you may find intereste to browse through - although it is very technical in places.

This is the guidance from the European regulatory agency. Detailing what is acceptable in terms of generation of mock vaccines and trialling pandemic vaccines and stuff. It is important to note that this document was drawn up BEFORE the pandemic outbreak.

TBH sooty I think we are on the same page. I am supporting the delayed release for under 3's - although your arguments are a little more extreme than mine (which is fine because we are all entitled to our own opinions). I am continuing the discussion not so much for debate as the fact that you seem genuinely interested.

I will copy and paste your post and try and answer what I can (so sorry it will end up being an epic post).

What?s very interesting in the detail of the mock-up vaccine is that this, which I?m assuming has been tested on the public already, could have contained swine flu! I didn?t realise this, for some reason I thought it would have only contained the human flu virus.

Now, I?m not one for conspiracy theories, but it was only last year that one of the big pharmaceutical companies released an annual flu vaccine which was contaminated with avian flu. I think it was intercepted before being injected into the public ? was it? Anyway, it had the potential to cause an avian flu pandemic didn?t it? So, what type of flu virus was used for the mock-up vaccines (pig, human or bird)? Was there more than one type used? Do you know what the results regarding viral shedding were during testing (i.e. the person testing the vaccine being able to spread the disease to others around him)? Do you know when the mock-up vaccine was tested, and in which country? Was it tested on humans? It would have (according to these guidelines) had to be a strain of flu to which; -

?most of all of the population have no detectable immunity?.

I HAVE NO IDEA ABOUT ANY OF THESE WITHOUT LOOKING FOR TH EINFO AND I AM NOT SURE IT IS PUBLICALLY AVAILABLE YET. EACH COMPANY WILL HAVE THEIR OWN MOCK UP. REMEMBER THIS IS GUIDANCE FROM THE REGULATORY AGENCY AS TO WHAT THEY WILL EXPECT AND ACCEPT. TEH PHARMA'S WILL DECIDE FOR THEMSELVES WHAT THEY ACTUALLY DO (BUT IT WILL ONLY BE GRANTED APPROVAL IF THEY ARE WITHIN GUIDELONES)

This document also seems to reiterate that in normal vaccines they have to carry out safety testing but that it?s okay for this vaccine to run the safety tests parallel with the vaccination programme. Does it also say that one batch must be tested on animals (not humans) before being given to the general public, or am I just reading that bit wrong?

I THINK (FROM MEMORY) IT SAYS THAT 3 SEPERATE BATCHES MUST BE TESTED ON ANIMALS. THAT WILL BE TO ENSURE BATCH TO BATCH CONSISTENCY IN HUMANS

I didn?t know that it?s likely the vaccine will contain Mercury (thiomersal). I actually thought that this had been taken out of childhood vaccines in the UK, but then of course this vaccine will not specifically be a childhood one. That mercury is another major concern, given that it looks like people will require at least two doses of the vaccine, perhaps even more. That could add up to quite a lot of mercury (and aluminium?) for a baby?s system ? remember that if you go by weight then the dose a small child will get is massive compared to the does an adult would receive.

BE CAREFUL WHAT YOU READ INTO THAT. THE REGULATORY AGENCY EXPECT THE VACCINES MAY CONTAIN MECURY. IT WILL BE UP TO THE MANUFACTURERS (PROBABLY SUPPORTED BY EFFICACY DATA) WHAT ACTUALLY GOES INTO THE FINAL PRODUCT IS DOWN TO THE PHARMA.

I?m quoting this next bit just to show why I personally think this vaccine will not have had adequate testing for me to feel happy giving it to my children;-

?There will be limited immunogenicity and safety data for the mock-up vaccine and protective efficacy data will not be obtained. Also, the final pandemic vaccine will have to be approved without immunogenicity data?

?the final pandemic vaccine may be approved for use by means of a variation that addresses only the quality issues and without the provision of clinical data?

?Safety data on the final pandemic vaccine will arise from real life use?

It also mentions a (rare) longer term risk of the vaccine is the risk of Guillain-Barré syndrome, which is exactly what happened with the last vaccine (though I believe the government defended their stance when faced with law suits), and because it?s longer term there will be no data showing what this risk is.

IMO (AND I MEAN IN MY OPINION - I AM SPECULATING) THIS IS COULD BE WHY THERE IS A DELAY TO VAILABLILTY TO TODDLERS (AND IS IMPLIED ELSEWHERE IN DOCUMENT).

I totally understand that the timescales involved, i.e. the need to get the vaccine out quickly, somewhat prohibit proper safety testing, but that still wouldn?t make me feel okay about letting my child have it UNLESS, as I said earlier, the risk to my child of becoming very ill (or worse) from swine flu was great.

HTH

pfffft I dont even have the energy to read this whole thread

but,

studentmummy whilst your points may be valid, you are "perpetuating fear"

and treating us like morons by SHOUTING AT US

trots away

Studentmummy. I understand your point. If under 3s are more at risk that 3-16 yr olds then why are they coming lower in the list than them. Why not just do all children (except the more vunerable who will be higher on the list) at the same time. Whether parents trust the vaccine/choose to give their child it etc is another matter entirely.

I have two under 3. The two year old seems to have already had it (drs dx but no blood test) so am completely unsure about how I feel about it all except I undertsand why you dont agree with their logic

Thanks Bronze - Having watched Newsnight this week and listened to some of the scientific postulation on this page, I am now also a little concerned about the safety and applicability of any swine flu vaccine for babies and young infants. On Monday, I learnt that the effectiveness of flu vaccines in general may be compromised in under two's - so that may be one reason why it is not being initially targeted at young infants. However, I still think that the choice should be available for parents of older toddlers, particularly those over eighteen months and beyond for whom the vaccine may be more viable. 0 to 3 years is actually a very large age category as every parent knows - with a very different spectrum of needs! I would be much more protective of what I put into a newborn than a strapping toddler and a toddler generally has a far more active social life!
p.s. aim of debate not to cause alarm but to raise consciousness and inform. I always prefer action over panic!!

Student Mummy - I have just looked back at teh reference to HPA surveillence data.

Just be cautious about your interpretaion of that info.

Firstly - the rate of consultations is undoubtably higher in the pre-school age group. However that is an indirect measure. If you think about it if myself and DD had swine flu I probably woun't ring teh surgery about myself. But I suspect that parents will naturally and quite rightly so be more likely to seek medical advice about their child. What I am saying is that the data may (actually I am saying it WILL IMHO) be skewed by human nature.

Secondly - that rate of hospitalisations is a little more convincing. However, that may also be skewed by GPs acting a little more cautiously with the young and old (although less so than concerned parents IYSWIM).. IT may also reflect the rate of incidence.

I haven't seen any data (and that doesn't mean there isn't any) to say that the illness is more serious in Under 5's, or that the MORTALITY is higher in under 5's. In fact I still think that the mortality hospitalisations rate in 65+'s is more concerning. 0.01% of the 65+ populations is hospitalised - which is the same for teh 16-64 age group. Now given that apparently the rate of infection is lower in this age group that must mean that a higher proportion of those that get it are hospitalised and therefore suffering greater severity and/or complications.

PrefetParfait - I don't want to nit pick, but that link you posted did say that the vaccines are LIKELY to contain mercury, not that they MAY contain mercury.

I KNWO WHAT IT SAYS AND TBH I DON'T KNOW WHY IT SAYS IT. BUT I HAVE NO IDEA WHERE THE SUPPORTING INFO COMES FROM. IT WILL NOT BE THE EMEA OR ANY OTHER REGULATORY AUTHORITY THAT DECIDES TO PUT MERCURY IN -AND I DON'T KNOW HOW THE EMEA CAN POSSIBLY BE SO SURE THAT IT WILL? I MAY BE MISSING SOMETHING THOUGH.

If you do find out any info about the mock vaccines and whether they contained the swine flu virus, I would be really interested. Is it correct so say that the swine flu doing the rounds actually contains swine, avian and human flu? I think that there are a lot of answers required to be honest, but I doubt we will get them.
i HAVE SEEN REPORTS OF 2 DIFFERENT ORIGINS. INITITALLY IT WAS CITED TO BE DERIVED OF 4 DIFFERENT VIRUS SEGMENTS. ONE HUMAN, ONE AVIAN AND 2 SWINE. I HAVE SEEN MORE RECENT REPORTS OF IT BEING JUST 2 SWINE. I HONESTLY DON'T KNOW ABOUT THE MOCK VACCINE - BUT FROM WHAT I CAN TELL THIS IS A NOVEL REASSORTMENT SO UNLIKELY...BUT.....

Anyway, I won't change my mind about not letting my children have the vaccine (nor would I have it myself), but can I just say, PrefetParfait, that we may have differing opinions on this matter but I have thoroughly enjoyed your posts - they are objective and well thought out and highly informative. Very refreshing with all the hysteria flying around about swine flu.
I HONESTLY DON'T THINK WE HAVE GROSSLY DIFFERENT VIEWS (WE ARE BOTH AGAINST EARLY USE OF THE VACCINE IN PEADIACTRICS IN PARTICULAR. YOUR VIEWS ARE JUST SLIGHTLY MORE EXTREME (THINGS ARE NEVER BLACK AND WHITE WE JUST REPRESENT DIFFERETN SHADES OF GREY), AND FUELED BY DIFFERENT BY DIFFERENT CONCERNS...BUT HONESTLY WE ARE FRIENDS

I suspect we could have spent a fantastic afternoon debating over coffee and bouncing ideas/facts off eachother!

If I were asked to make a guess about what might happen from here (and remember the experts also are only guessing) I would say that I think swine flu might just fade away without mutating into something nasty, but if they have managed to vaccinate most of the population by then they will wrongly credit it's demise to their wonderful vaccination programme. Just a guess though - nobody really knows do they?
HERE HERE....MY PERSONAL OPINION IS THAT FLU IS ALREADY FAR MY WIDESPREAD THAN PREDICTED. HOWEVER MOST OF THE POPULATION ACTUALLY HAVE A MUTATED FORM WHICH IS LESS VIRULENT (WHICH WILL HAPPEN...BUT WE WILL ONLY SEE MORE OF THE MORE VIRULENT - SURVIVAL OF THE FTEST AND ALL THAT)...AND AS A RESULT ARE DEVELOPING OUR OWN IMMUNITY WITHOUT EVEN KNOWING WE HAVE THE DISEASE. I FOR ONE AM A BIT ABOUT THE NUMBER OF PEOPLE THAT ARE COUGHING AND SPLUTTEREING (ME INCLUDED) WITHOUT ACTUALLY HAVING THE CONVINCING FLU (ESP HIGH TEMP) SYMPTOMS....BIT FAR FETCHED, BIT WACKY, BIT OFF THE WALL...BUT AS YOU SAY WHO KNOWS!

BTW i MEANT TO MAKE REFERENCE TO THE PIRBRIGHT INCIDENT WITH REFERENCE TO THE POSSIBILITY OF ACCIDENTAL RELEASE FROM A LAB...AS PART OF A "WHO KNOWS" STATEMENT BUT I MUST HAVE DELETED IT.

Shit you have got me there.

Sorry - twas me. I went into teh labs at stole some flu samples, fiddled about with them in my garage a bit to make a novel strain and then stick it on a plane to Mexico.