H1N1 vaccine ready, but you can't have it yet
I've been on a flying visit to Marburg, Germany to look round the cell culture manufacturing plant of Novartis.
Vaccines are important because they are the only way to ensure protection from the H1N1 swine flu virus - short of moving to an uninhabited island.
Two weeks ago Novartis boldly declared that it had produced the first batch of influenza A (H1N1) vaccine, weeks ahead of expectations.
You can see from the photo that I held the jab in my hands. Just one small point - on the label it says "not for human use". So what's happening?
Novartis created the vaccine from the wild type strain of H1N1 - the sort people are catching every day. But it's a slightly modified reassortant seed that flu manufacturers are all using for their pandemic vaccine.
Novartis has demonstrated impressive speed in production, creating the experimental vaccine in just six weeks. It shows the huge advantage of growing flu vaccines in cells rather than eggs, where production takes several months.
But the race to create a vaccine won't surely have been won until the first batch of vaccine is delivered.
Novartis is just a couple of weeks behind with the first doses using the reassortant seed, so they may well still be the first to produce bulk doses. Before that happens, there will have to be clinical trials which will take a couple of months, and the product will have to be licensed.
Novartis has certainly proved itself to be the most media-savvy of the pharmaceutical companies in promoting its pandemic vaccine.
Standing in front of the steel tanks in which the vaccine will be produced, Novartis executives said they hoped to make 500-600 million doses of pandemic vaccine with a price tag of between $10-15 per jab.
In line with other manufacturers, the cost will be less to developing nations. Novartis made it clear that they would not be "giving away" any doses.
This is in contrast to one of its rivals. Two weeks ago the World Health Organization welcomed the planned donation of 100 million doses of H1N1 vaccine from Sanofi-aventis, which is the world's largest flu vaccine manufacturer.
It was impressive to see the CEO of Novartis Vaccines, Dr Andrin Oswald, give interviews in fluent German, English and French. You can watch my interview with him below.
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MARBURG!
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Well it seems our government have preordered sufficient vaccine for everyone, although at an infection rate of 100,000 a day will it be needed-this point was made by a contributor on the previous blog. There now seems to be a better vaccine being developed which will be more able to handle possible mutations which may appear-guess what... It's not the stuff we've got on order! Seems a bit like ordering the latest new gadget as soon as it comes out, only to find a better version is developed weeks later, but you can't change your order! Bit like certain phones!
On a moral note, talk about holding the sick to ransom! Flu vaccine should be free-I think it's a disgrace that any country should have to pay to safeguard it's citizens! There is a vaccination of sorts for Chicken Pox, but it's so expensive, hardly anyone knows about it! Looks like flu vaccinations will be too expensive for some countries to distribute freely, so millions will no doubt take their chances.
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Like a number of aspects about this flu infection, the 'devil is in the detail'.
We still need to understand who will be the 'priority targets' with the vaccine - assuming it passes the 'clinical trials'.
Another issue is that by that point in time, singificant numbers of people may well have already had this flu and be well again, so they presumably won't need the vaccine. I wonder how those will be identified? Or will they be vaccinated irrespective of that? I mean, will everyone who has contracted this flu actually know they did so.
On a similar issue, there still seems no clear, publicly issued, advice as to what those within the vulnerable groups should do. Say you were an asthmatic who thinks you've contracted this flu and are losing your breathing ability as a result.
Should they present to A&E to get their breathing stabilised, or is that a taboo as they might spread swine flu into the hospital?
(Ringing your GP and having Tamiflu sent to a collection point isn't going to stabilise the repiratory distress).
So far, there seems to be lots of advice for the non-vulnerable, but little for the vulnerable.
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There seems to be a tension here - speed vs quality. The drug company wants to be first to market: but not if it compromises testing with the risk of litigation later. The government wants to be first to order: but they risk not getting the best vaccine, which might not be the first.
I will be interested to see the formal announcements on what will be provided to the underclasses in England. Obviously people at high risk of medical complications from the flu should get priority. After that, will there be equitable access? Or will the vaccine be restricted to elites, such as NHS staff, with the rest of us taking pot luck?
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4. At 08:48am on 03 Jul 2009, jon112uk wrote:
"Or will the vaccine be restricted to elites, such as NHS staff.."
There clearly will be some priority targets, but I would suspect those to be vulnerable persons, in clinical terms.
Now clearly, some people with a lot of contact with the public, especially sick people, may be at greater risk of contracting this flu, but that is not the same as to suggest they are more likely to have a more serious episode of flu.
But equally the most vulnerable are served, at least to some degree, by the availability of people to treat them, i.e. doctors and nurses, being protected.
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So Novartis are saying batches ready in August, but clinical trials not complete until late September... have our department of health given any indication of what the logistics will be? Can they distribute stocks and coordinate the triage of doses before the trials are complete? Fergus, would you like to hazard a guess as to when people will actually getting the first injections? The timing is interesting because of weather and the return to school and colleges. Do you think there is any chance schools and Universities will be asked to open a bit late?
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Just a point of information.
Scottish schools return on 19th August - English school obviously not until a few weeks later.
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At 08:48am on 03 Jul 2009, jon112uk wrote:
"Or will the vaccine be restricted to elites, such as NHS staff, with the rest of us taking pot luck".
Talk about rude and inconsiderate!!
This is blatantly unfair to the vast majority of front-line NHS staff who have to work day in and day out and are the most at risk of catching it as they constantly have to deal with high- risk sick patients. They don't have the luxury of just taking time off or avoiding any contact with possible cases like this sneering author of the post, and they don't get paid any extra for knowing that when they catch it they will spread it to their loved ones and small children waiting for them at home.
The NHS is not perfect, but a good many NHS staff try their best in a tough situation, especially now when our GP surgeries and Hospitals are massively overcrowded with fightened people some of whom didn't listen to the advice to stay at home.
They, unlike our MPs, are hardly "elites". Since the Government has ordered 120 million does of vaccine, it is hardly likely they will just be saved for "elites", like this person clearly wishes to be.
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4. At 08:48am on 03 Jul 2009, jon112uk wrote:
"Or will the vaccine be restricted to elites, such as NHS staff.."
Ha! at last, i've become part of the elite!
I work as a senior charge nurse in one of the swine flu hotspots. As part of the nurse led critical care outreach team i have to assess and stabilise the more seriously ill patients throughout the hospital and get them to intensive care quickly if necessary. I get coughed on and get covered in other bodily secretions routinely, this is unavoidable as patients are sick and need help. I'm very angry that the above commenter feels that i don't need to be one of the first to be vaccinated. What do you expect me to do, pull a sickie, change career, get signed of long term sick with stress? (And i KNOW the next few winter months will be very stressful, there will be a MASSIVE strain on itu capacity and patients may not get the care they need because there will not be enough qualified staff to cope)
Yes, i EXPECT to be vaccinated first. I have already had to look after several known swine flu cases and so far my barrier nursing technique seems up to speed.
Oh while i'm here, WASH YOUR HANDS AND/OR USE THE ALCOHOL GEL PROVIDED WHEN YOU VISIT HOSPITAL - i'm fed up with the amount of times i have to tell people to do this!!!!!!!
Now this is an H1N1 pandemic, not the VERY much more serious H5N1 pandemic that everyone is dreading (how does 60% mortality sound to you). In this scenario would i come to work and expose myself to this level of risk for the ungrateful ***** poster above? I'm not sure i would.
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'On a moral note, talk about holding the sick to ransom! Flu vaccine should be free-I think it's a disgrace that any country should have to pay to safeguard it's citizens!'
Who should fund the hundreds of millions of pounds it costs to develop and manufacture if not countries?
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Health workers are being issued with FFP3 filtration masks. Here is a question that I think needs answering.
FFP3 is a particulate arrestment down to 300nano in size and yet the H1N1 virus is between 80/120 nano in size. So is it similar to trying to stop a tennis ball getting through a football goalmouth net? Or does the filter actually trap the virus in someway?
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Fergus - please could you investigate the use of thimerosal - mercury - in flu vaccines? Are Baxter and GSK to add this to the upcoming vaccine?
I am a natural health practitioner and I am constantly aware of the negative effect past flu vaccines have had on my patients.
This may be due not only to the toxicity of the preservative (aluminium is another one), but also the general effect on the immune system.
In our terms, an injection of any vaccine is placed underneath the outer layer of defense (the WEI qi, or layer flowing along the surface) which IS THEN WEAKENED not strengthened, by the vaccine. David Smyth
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Of course all front line health workers, those at risk should be vaccinated first. If we don't have the NHS staff vaccinated then if they get ill, we all up the creek with no one to look after the people at risk.
As for drug companies charging for medicines. They charge for a reason. Someone has to pay for research, studies, staff etc etc. This isn't free and usually very expensive. This is why drugs cost so much.
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Do you really want to be given a vaccine that isn't 'properly' tested? Not sure I want to be a guinea pig.
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