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> ordinary flu shots might help protect people from H5N1
> Regular flu vaccine contains the same ‘N’ ingredient as the deadly H5N1
so probably H1N1 vaccine not H3N2
I wonder, why they don’t produce more prepandemic vaccine.
What does it cost ?
Switzerland ordered 8 million doses for its population.
There is some likelyhood that it will help against panflu,
even if the protection is maybe only partial.
That’s a good question. There are however many problems, the biggest one being there isn’t one vaccine with known efficacy and ‘acceptable’ risk. Even a rare adverse reaction may translate into many thousands of lives lost or affected when given to a large population. It is one thing to offer a vaccine against an existing risk, quite another against a ‘hypothetical’ one. Governments are not willing to put their money down for a product that might not work against a pandemic that might not happen, especially a product with a short shelf life. Companies are not willing to sink their millions into developing such products unless they see water-tight commitment from governments. Considerations regarding prepandemic and pandemic vaccines are also discussed on this thread
This is a post from that previous discussion:
pre-pandemic vs pandemic vaccine:
Because of current limited production capacity and the possible need for 2 or 3 dosese, it would be extremely difficult to have enough vaccine (even if all technological and regulatory hurdles are out of the way) and enough people vaccinated in time to affect the outcome of a pandemic. Therefore, consideration is being given to a pre-pandemic vaccine, ie a vaccine to be produced and stockpiled now and given prior to (or as soon as a pandemic starts). It would not provide enough immunity for the above reasons but one would hope that partial immunity may reduce total impact, plus it could be used to ‘prime’ the population so that only 1 dose would be necessary with the actual pandemic strain.
This notion carries its own difficulties. The biggest one is safety. Because you are vaccinating people against a pandemic that has not happened yet, ie a hypothetical risk rather than actual risk, and because you are aiming at a large proportion of the population if not all, and the target is most likely to be young working age people, the most valuable members of society, the safety bar has to be set much higher than normal vaccines.
The next problem is cost or specifically who is going to pay for it? Unless there is definite financial commitment in the form of orders or contracts from governments, vaccine companies are not likely to sink millions or billions of dollars and make large quantities. But even if governments pay for them now, and the product is successfully made, they have a limited shelf-life as with vaccines in general. If a pandemic does not happen and the stockpiles of pre-pandemic vaccines have expired, the money could be wasted. (This is a simplified description, the commercial issues are a lot more complex when you add in companies who want to vaccinate their staff to protect their business.)
Re-examining the efficacy issue: the (relative) efficacy of a pre-pandemic vaccine is determined by how close it is to the ultimate pandemic strain. Make the vaccine too late, we won’t have enough. Make it too soon, the virus might have mutated significantly so that the vaccine is no longer useful.
safety is no issue, since the vaccine would only be stockpiled and only be given, when paflu breaks out. Now, I’d like to know, how much it would cost and how much worth our lifes are for the government resp. how likely they think a pandemic is. Similar question with Tamiflu stockpiles - just a question of money. Compare that money with the amount which we are spending for prepping !
anonymous – at 10:32 safety is no issue
Easy for you to say!
If you stockpile something which will only be used when panflu breaks out, then the expiration issue becomes extremely important. Start stockpiling now, the stuff may expire before there is a pandemic. Plus, when a pandemic is unfolding, you would have run out of time to vaccinate.
There are no easy answers.
Also, tamiflu stockpile is not “just a question of money”. Again this has been discussed numerous times, there is a very limited global production capacity, from one company and now some licensees. It was boosted from 190 million doses a year to 400 million this year. Given that there are 6 billion people on this planet, how long does it take to make enough? At the moment, Roche says it will have fulfilled all back-orders by end of this year, I think. And that’s for orders placed before this year, eg the UK will receive its final batch ordered in 2005 at the end of this year.
It is over-simplistic (also irresponsible from somone who want serious debate IMHO) to think of everything as “just a question of money”. Even if it was, it’s never ‘just’ money, cos any money spent on your pet choice will mean money taken out of something else probably equally worthwhile for someone else. How that is decided and who decides will always be issues of contention.
What we need is rigorous co-operative thinking, not simplistic statements like “safety is no issue” or “its just a question of money”.
anon_22, thank you for your insightful comments on vaccine issues. How close are we to being able to start cell culture vaccines? The egg method takes a long time and does not work well with H5N1. Could safety be tested for a class or family of vaccines, so that final tweaking could be done but additional testing for safety would be minimal? Or does each specific vaccine need extensive safety testing? I imagine that a properly conservative establishment (and they may not be proper!) would/should be slow to experiment on millions of people?
but why is it secret, how much it costs ? They never say this. Also with peramivir.
INFOMASS, see in MustAPanFluDecreaseInLethality Melanie – at 18:14 Use egg-based vaccine cultivation, it will take a year following the emergence of the pandemic strain before sufficient vaccine to be available to confer even a modicum of herd immunity. Cell culture technology is 8–10 years down the road.
The only non-egg based vaccine that is close to ready is the HA recombinant protein vaccine by Protein Sciences. It’s seasonal flu version has passed Phase 3 trials and is fast-tracked for license, probably early 2007. It is IMHO the best option available at the moment, especially for the US. The only problem is that this is a relatively small and new company, and may not have enough lobby voices to make the case, as opposed to the more established manufacturers. This vaccine is discussed in greater detail here
On Yahoo news-health there is a story about Bioshield anthrax vaccines. The program has spent $billions and is beset by delays which, according to a government spokesperson, “are more the rule than the exception” with vaccine development. The contract was let in 2002 and supposed to produce a better anthrax vaccine in 2005. Now, 2008 is the target. My impression is that viral vaccines are harder because you are trying to hit a moving target. Maybe the best we can hope for anytime soon is accelerated cell culture development and some partial protection?
INFOMASS – at 13:34
Each vaccine is different and has different problems. Anthrax vaccines are in a class of their own! Read the MF59 story
INFOMASS – at 12:00
Could safety be tested for a class or family of vaccines, so that final tweaking could be done but additional testing for safety would be minimal? Or does each specific vaccine need extensive safety testing?
I missed this question initially. The European EMEA Mock-Up Dossier Authorization uses this notion, although not for a whole class of vaccines. It’s discussed here and here
anon_22: Thank you for the links to those threads. It sounds like the FDA would take some time to approve a new vaccine, but perhaps the Flublok (?) would be able to substitute different hemaglutin types w/o repeating complete safety testing? Or is that a misreading of that approach or the FDA policy? Sorry to be so naive. I do understand the EU policy is different for seasonal and pandemic vaccines and they might be able to approve a pandemic vaccine sooner.
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