Swine Flu Vaccine In Production

ravjen writes with news that "Swiss pharmaceutical company Novartis AG said they have successfully produced a swine flu vaccine weeks ahead of their expectations. The vaccine was made in cells, rather than grown in eggs as is usually the case with vaccines." This announcement came just a day after the World Health Organization declared H1N1's spread to be a pandemic. The vaccine has not been tested in humans yet, so the first batch is set to be used in clinical trials and pre-clinical testing. If all goes well, the new production method would allow Novartis to get the drug to market in large quantities by this fall. Other drug companies, such as Baxter International, have confirmed that they're in "full-scale production" of H1N1 vaccines as well.

Comments

What's the big deal?

[Jurily]

Can anyone explain why this virus is so different from all the others floating around? Why the panic?

The case fatality rate (CFR) of the pandemic strain is estimated at 0.4% (range 0.3%-1.5%)

We've all had worse diseases than this.

Re:What's the big deal?

[Anonymous Coward]

well, my wife caught it - sickest I have ever seen her. Most of the week in the hospital in isolation.
My son had it as well - he just was home from school for the week sleeping. No energy. For a while I really thought I would lose my wife. If this was the "minor" strain, I am scared at what the "experts" say is the upcoming worse strain in the fall.

Re:What's the big deal?

[Anonymous Coward]

It's a new strain of the virus that caused the Spanish flu. H1N1 is known to be highly unstable. It has a tendency to pick up genes from other viruses.

So far, this new strain is milder than a normal yearly influenza virus. But that was also true about the Spanish flu virus, the first two mutations that went around the globe. The third one was highly lethal and, sadly, 100% lethal to pregnant women.

Look at it this way. Three possibilities:

1. We might get a huge deadly pandemic now, which could be as lethal as a world war.

2. Or we may well get a medium deadly pandemic, which also calls for great measures.

3. Or we may get a mild extra flu, on top of the usual annual flu. If we are so lucky this time, it will have been the best possible exercise for our future defences against the next great deadly pandemic. It's only a matter of time before we are faced with a pandemic with the potential of killing off tens of millions of people worldwide.

Fingers crossed and knock on wood, etc, etc...

Re:What's the big deal?

[Xest]

Funnily enough even that figure is skewed.

I was looking at the details about Swine flu the other day, regarding death tolls and that sort of thing.

Apparently seasonal flu mortality rate is 0.1%, some places said 0.5% but this seems to only be in less trustworthy sources like the general media vs. medical journals and scientific articles etc. which suggest 0.1%.

Now, worldwide the swine flu mortality rate is 0.47% last time I calculated it (I don't have the numbers to hand now) which is to be fair, at least 4 times higher than that of seasonal flu.

However, if you examine the situation in Mexico where as of 5th June 97 of the 117 confirmed deaths had occured you'll notice that it's an anomally. The amount of deaths in Mexico is vastly higher in the rest of the world, despite there now being many more cases outside of Mexico than there are in. Why this is could be any number of reasons - poor healthcare, first place hit so they didn't know how to deal with it, lower quality of life in Mexico city and hence people less healthy - who knows, it could be anything. The point is though, that Mexico IS an anomally.

If you factor Mexico out of the equation (both death rates and infection rates) the mortality rate of Swine flu is drastically lower and really is no worse than that of seasonal flu from a percentage standpoint. In fact, outside of the Americas, despite thousands of cases, no one has died at all.

But of course, mortality rate as a percentage isn't the full story. There seem to be two other factors suggesting Swine flu is a problem, these are:

1) The possibility of it mutating to become worse

2) It's more contagious, so even though the mortality rate as a percentage is lower, more people die because more people get infected

As for point 1) I really am not going to worry about this, I don't like to worry about something that is merely speculation, plan for it and account for the possibility? yes, worry about it? No. Is there even any evidence it's more likely to become worse than a particular strain seasonal flu? Point 2 is the real issue, because although it's no more lethal, more people are going to die because of the contagious nature of it, that said even this might not be the case, I don't know how contagious seasonal flu is in comparison.

With Margaret Chan the director of the WHO coming out with such gems as "After all it really is all of humanity that is under threat during a pandemic." I've lost a lot of respect for them. Swine flu is undoubtedly a problem but I get the impression the WHO is loving this situation because it's a chance for them to get their names in the news but it's not even the first time - look at all the fear mongering over bird flu and apocalyptic scenarios they told us to expect then, how a bird flu pandemic was inevitable etc. within just a few months at the time, remind me, how did that turn out again?

I'm more concerned that we've got a case of the boy who cried wolf, even this time round swine flu reporting seems to be less prominent than the H5N1 bird flu was at the time so I wonder if even media outlets have already decided to treat what the WHO say with a bit more scepticism.

If you want a real apocalyptic scenario then there's the idea that Swine flu both mutates to become worse and is vastly more contagious but personally, I'll file that alongside worrying about global nuclear war and alien invasion. When there's any evidence to suggest we're closer to any of these I'll start worrying or even caring a bit more. Until then, I'll continue living life as always, washing my hands before I eat, after I sneeze and so on as I always have anyway because it's simply good practice if you want to avoid being ill.

Re:What's the big deal?

[rve]

Can anyone explain why this virus is so different from all the others floating around? Why the panic?

The case fatality rate (CFR) of the pandemic strain is estimated at 0.4% (range 0.3%-1.5%)

We've all had worse diseases than this.

It seems to be more infectious that seasonal flu, or people have less resistance to it. In a normal flu epidemic, only a few percent of the population gets infected. Most people either never catch a flu, or have it once every couple of years. The Spanish flu of 1918 had a total infection rate of up to 40%. If 40% of the population gets the Mexican flu, and the death rate remains at about 0.5%, it will be more deadly than the American civil war.

Re:What's the big deal?

[Vellmont]

In general I agree with your sentiment that there's been a lot of over-reaction to this whole thing. A few weeks after the thing first blew up in the news we got more information that this is really "no big deal", but yet there's still remnants in the world of the panic machine going forward. The following, however I don't agree with:

- look at all the fear mongering over bird flu and apocalyptic scenarios they told us to expect then, how a bird flu pandemic was inevitable etc. within just a few months at the time, remind me, how did that turn out again?

What I recall is the idiotic media outlets spreading a lot of fear about bird flu. I recall scientific sources talking about this as a long term problem we need to watch and learn more about because it COULD (but we don't know when, maybe decades) eventually mutate into something that spreads from human to human.

If you want a real apocalyptic scenario then there's the idea that Swine flu both mutates to become worse and is vastly more contagious but personally, I'll file that alongside worrying about global nuclear war and alien invasion.

Why is it people have to turn to some other equally idiotic extreme? Global nuclear was and "alien invasion" have never happened except in movies. Global disease outbreaks including flu that killed millions of people have happened with some regularity for hundreds, if not thousands of years. In all likelihood this whole thing will turn out to be nothing as H1N1 is unlikely to mutate into something more deadly. Putting it in the same category as "alien invasion" is just as stupid as all the fear mongering the media outlets love to do.

When there's any evidence to suggest we're closer to any of these I'll start worrying or even caring a bit more.

If we're close to a deadly flu outbreak, it's really already too late. We need to start developing techniques to get faster vaccines now, not just before it happens. If this HAD been the real-deal, a several month delay to make the vaccine is just too long. You don't need to sit around and cower in fear or start wearing face masks that likely do nothing. You do need to start thinking about how we should be better prepared.

Re:What's the big deal?

[True Grit]

H1N1 is known to be highly unstable. It has a tendency to pick up genes from other viruses.

Is it possible these properties will make for a more "dangerous" vaccine than others?

No, they will instead make for a less effective vaccine, because the virus *might* end up mutating faster than we can produce viable vaccines for it. Or it might just fizzle out and disappear, H1N1 is inheriently undependable in this regard, you can't predict its behavior, which is the problem.

What happened to you can actually happen to anyone after taking any vaccine (though normally its rare). Vaccines are in effect a way to give your body a very *weak* version of the virus so it will recognize it as an enemy if the real virus shows up later. Human variability being what it is though, sometimes a very weak version of the virus manages to gain a foothold despite it being weaker, and sometimes it is still enough to trigger a strong, perhaps overly-strong, immune system response.

Re:What's the big deal?

[Xest]

"Why is it people have to turn to some other equally idiotic extreme? Global nuclear was and "alien invasion" have never happened except in movies. Global disease outbreaks including flu that killed millions of people have happened with some regularity for hundreds, if not thousands of years. In all likelihood this whole thing will turn out to be nothing as H1N1 is unlikely to mutate into something more deadly. Putting it in the same category as "alien invasion" is just as stupid as all the fear mongering the media outlets love to do."

More appropriately, why is it that people have to overreact to what was clearly a non-serious comparison? All you needed to take away from my comment was that swine flu regardless of how likely it is to other major problems is not something I'm going to spend my time worrying about day to day because it's not that big a deal right now. If you take anything more away from it you are simply getting uptight about something that you've strung together yourself. Being equally pedantic though you might want to re-think that argument that nuclear war is unlikely to happen because it's never happened before whilst global pandemics are more likely because they have happened before. The two events are entirely unliked, and the history of nuclear weapons is far too short to start doing a statistical comparison of the two possible events. Nuclear weapons were about 25 years off even being invented when the last serious pandemic occured. FWIW, I do not believe little green men capable of invading our planet even exist.

"If we're close to a deadly flu outbreak, it's really already too late. We need to start developing techniques to get faster vaccines now, not just before it happens. If this HAD been the real-deal, a several month delay to make the vaccine is just too long. You don't need to sit around and cower in fear or start wearing face masks that likely do nothing. You do need to start thinking about how we should be better prepared."

Yes, but there are people whose job it is to do that. There's no point worrying the general public about it when there's nothing they personally can do other than be taught good general hygeine measures and sickness prevention measures in the first place such as not going into work, and working from home if you're ill as well as washing your hands, blowing your nose with something disposable like a tissue etc.

There is absolutely no point me worrying about it, because a) the odds right now are there is nothing to worry about, b) there's nothing I can do other than what I do anyway even if it was worth worrying about.

Re:What's the big deal?

[DJRumpy]

You forgot to mention that they don't even use 'live' virus any more. The vaccines used today for flu are not 'dangerous' unless you have an egg allergy. They basically just prime your immune system so that it can properly recognize a flu infection and respond accordingly. They do not inject you with live flu virus.

Re:What's the big deal?

[Cyberax]

Flu vaccines _do_ _not_ use a weakened viruses. They use _proteins_ from virus envelope, the don't contain viral RNA.

So it's not possible to get a flu infection from a flu vaccine.

Re:What's the big deal?

[True Grit]

look at all the fear mongering over bird flu and apocalyptic scenarios they told us to expect then

Strange, I don't have those same memories. H5N1 is very deadly, but can't transmit human-to-human, and the people I heard talk of it said only if it learns to move directly between humans do we need to get scared. It was the *media* that ended up hyping things, not the WHO.

If you want a real apocalyptic scenario then there's the idea that Swine flu both mutates to become worse

Actually, what the WHO is worried about is the H1N1 strain linking up the existing H5N1 strains in Southeast Asia, combining the H1N1's ease of human transmission, with the H5N1's deadliness. H1N1 is part avian after all, it has a history of mutating and combining with other strains. Is it *likely*? No one really knows.

I'll start worrying or even caring a bit more.

The WHO's doing that for you, so you don't have to. Don't blame them for doing their jobs, blame the media for always hyping everything beyond its actual importance/relevance.

Re:What's the big deal?

[Anonymous Coward]

You forgot to mention that they don't even use 'live' virus any more. The vaccines used today for flu are not 'dangerous' unless you have an egg allergy. They basically just prime your immune system so that it can properly recognize a flu infection and respond accordingly. They do not inject you with live flu virus.

This is not entirely true. MedImmune's Flumist vaccine uses an attenuated, cold-adapted live virus. However, it is not injected. It is sprayed as a mist into the sinuses and causes a VERY MILD infection (typically a runny nose for a couple of days). Unlike the killed virus injections, it causes a full immune response because it is live virus and it is applied at the site where most people are first infected with the flu.

Re:What's the big deal?

[Ozlanthos]

I refuse to have any shots or other treatments until I am actually "sick". If I am a carrier, sorry dude, you might die but I doubt I will. The reason "pandemics" usually occur is due to OVER-POPULATION. Once people start figuring out that having millions and millions of little petrie-dishes concentrated tightly enough for a virus to play mutation-hop-scotch in, the better off we will be. We are biological organisms, and as such the same rules that apply to other populations of biological organisms apply to us!!!

Besides we could probably use a good culling or two. Between pandemic and war, I will choose pandemic 7 days a week and twice on Sunday. Pandemics are indiscriminate and take down rich, poor, black, brown, yellow, red, white, gay, straight, Jew, Gentile, Atheist, young and old. Wars tend to take out those fighting them and some collateral damage.,,,never those rich or privileged enough to escape them.

-Oz

Re:What's the big deal?

[Cyberax]

It's complicated...

First, a special strain of flu virus (A/PR/8/34) is combined with the target virus. The strain A/PR/8/34 is not very pathogenic for humans, but grows readily in eggs.

So there's really not even a trace of a target flu virus in vaccines.

Next, inactivated flu virus is filtered and purified (by centrifugation, chromatography, etc.) to remove nucleic acids, other viral material and all sort of cell debris. So for all practical purposes, flu vaccine does not contain live or even attenuated flu viruses.

In fact, flu vaccine is so non-immunogenic that special adjuvants are needed to boost body's response.

Re:What's the big deal?

[IorDMUX]

Pandemics are indiscriminate and take down rich, poor, black, brown, yellow, red, white, gay, straight, Jew, Gentile, Atheist, young and old.

I invite you to study the sad statistics of one of our current pandemics, AIDS, especially as it affects Africa.

Claiming that a pandemic will equally cull the ranks of rich and poor alike shows a very limited understanding of modern health care issues.

Re:The only problem now is quantum and distributio

[JaredOfEuropa]

As far as I know, vaccines are made in chicken eggs, and takes some time to produce

I know most people here do not bother to read articles before commenting, but you could at least have bothered to read the ./ summary...

Pandemic?

[LordKaT]

It's not a pandemic until Madagascar fucking closes everything.

Scariest

[Smivs]

A Lion, a Polar Bear and a Pig were having a chat, and the conversation came round to how scary they were. The lion said "When I roar, people up to half a mile away run in terror!" The Polar Bear said, "That's nothing, when I growl people on the next island fear for their lives." "Bah!" said the pig, "if I sneeze, half the world shits itself!"

Re:The only problem now is quantum and distributio

[maxume]

At the moment, vaccinating people in the U.S., Canada and Mexico makes the most sense, the prevalence is highest here (3/4 of all infections that the WHO is tracking...).

Countries like India and China can make their own (and have the resources to work in their regions if they want to).

Is the cure worse than the disease?

[Anonymous Coward]

The last time there was a swine flu panic, 1 person in the US died of the flu, 25 died of the vaccine that was rushed out and more than 500 were paralyzed by it. What are the odds it's going to happen again? No thanks, I'll sit this round out.

Why Why Why?!

[XPeter]

People get the flu EVERY SINGLE YEAR, H1N1 is no different. The WHO and the media make a big deal about this because the drug companies asked for their bailout too. It's quite simple; make the world panic (H1N1 being a pandemic is blasphemous) and everyone asks the pharmacudical companies to start pumping out drugs and the cash starts rolling in. I mean, look how much Novartis's stock has gone up http://finance.yahoo.com/q?s=NVS. Don't feed the pig, please.

If you want something to panic about, panic about the millions of people each year who die from easily treatable illnesses such as Malaria.

Re:Why Why Why?!

[that IT girl]

Because the pharmaceutical industry can scare everybody into paying them billions of dollars. Yes, billions.
God, it's so nice to find someone else who doesn't buy into the bullshit.

Re:Why Why Why?!

[True Grit]

People get the flu EVERY SINGLE YEAR,

Folks get a *different* strain of influenza every year.

H1N1 is no different.

Yes, it is. It is a different strain of H1N1 that we haven't seen before, a combination of parts of four other strains of influenza A.

The WHO and the media make a big deal about this

The WHO is making a big deal about it only because it is a new strain that hasn't been seen before, and its spreading rapidly, thus fewer people will have any built-in resistance to it. And this particular category of influenza A has a nasty history of mutating quickly.

The media make a big deal about it because its news, but inevitably they end up over-hyping it since they're trying to fill 24/7 with 'interesting' news, and there just isn't enough to do that.

(H1N1 being a pandemic is blasphemous)

No. You just don't know what the meaning of the word 'pandemic' actually is. Hint: the number of casualties to the disease has *nothing* to do with its pandemic status. Look it up, it doesn't mean what you think it does.

millions of people each year who die from easily treatable illnesses such as Malaria.

Please define what you mean by "easily treatable". Malaria has no silver bullet, and the only available treatments which work consistently are really just preventative measures and are relatively expensive. And since the parasites behind Malaria are evolving resistance to the usual antimalarial drugs, for the most part, once you get it, you're cooked.

Malaria is a highly *intractable* problem that occurs in the poorest parts of the world, which makes dealing with it nearly impossible. That's why its a chronic problem, its not something that would just go away if the whole world threw some money at it. Nobody knows *how* to get rid of it.

Re:Why Why Why?!

[areusche]

The drug you are referring to is Lariam, the trade name for Mefloquine http://en.wikipedia.org/wiki/Lariam. There are many many more drugs available to combat against malaria then this that do not have this type of dangerous side effect.

I don't need a damn vaccine!

[Doug52392]

I live in Madagascar, you insensitive clod!

Re:The only problem now is quantum and distributio

[philpalm]

The prevailing main argument is who has the money to pay for the vaccine. If India or China can pay for it then let them have some. The highest bidder usually wins, despite your bias to send it to only certain countries.

Re:The only problem now is quantum and distributio

[maxume]

How do you know what my bias is?

Role of Vaccines vs Anti-Flu Drugs

[betasam]

Using the new In-Cell growing technique many companies seem to be coming up with vaccines in a shorter period than earlier. Medicinenet has an informative article on Flu Vaccines and immunization candidates, and goes on to say why they are required. This is a good read to understand why vaccination is being given importance here. The 1918 "Spanish" Flu epidemic Virus which is very similar to the recent outbreak was re-created in a laboratory in 2005 by Dr. Jeffery Taubenberger and colleagues at AFIP. Comparison with Avian flu strains led to the conclusion that Human Flu Virus strains are derived from Avian flu virii.

Among young people and children Flu vaccines claim to be 70%-90% effective, while this drops down to 30%-40% in people aged over 65 who may have other secondary complications. Hence the scale of vaccination required for the present outbreak (which has been repeatedly noted for not being as lethal as the 1918 Flu strain) may be entirely different covering only those in a risk category. More stress is on drugs that help in combating the Virus in an infected individual. These are usually amino-acid chain suppressors like Tamiflu. There has already been mobilization and distribution of the drugs to combat such an outbreak. The WHO has done a recent donation of drugs to Nigeria. This is however related to continued support of a H5N1 outbreak since 2006.

The role and importance of the Vaccines that would be available is not yet certain. It seems that the stress is more on treatment. Insofar stress on prevention without the involvement of Primary Medical care personnel. Only those who suspect infection have been requested to visit quarantine or medical facilities for treatment. The W.H.O's present stand with the Flu Virus has been a direct result of criticism during the second widespread Avian flu H5N1 attack incidents in 2006. Attention is being given to Avian Influenza as a pandemic because it leads to complications and secondaries making it difficult to fight other diseases with stronger morbidity. -- No Greater Friend, No Greater Enemy! (Lucius Cornelius Sulla)

Re:Quite frankly

[rve]

with all the hype surrounding this, one might be tempted to start considering the possibility that some big pharma in search of the next blockbuster could have designed the virus, the vaccine, the initial test release in a remote village and subsequent dispersal in airports, and the fud campaign together.

Not feasible. Although it has been a popular theme in both Sci-fi and conspiracy theories, technology is still not advanced enough to design a virus. It is unthinkable that a laboratory would have advanced this far ahead of the rest of the scientific community in complete isolation and without ever publishing or filing for patents.

It will almost certainly be possible one day, but not any time soon.

Re:Swiss...

[Goldberg's Pants]

Twitter was insane when H1N1 first broke. Now it's pandemic... Crickets.

Just wait a couple of months and the scaremongering bandwagon will set off again. Just in time for the companies to sell millions of vaccines for a flu that, thus far, has presented with symptoms equal to or lesser than the regular flu we see every year.

252 cases where I am. 2 required hospitalization. No deaths.

And WOW! The companies have a whole lot of time to test the safety and efficacy of these vaccines don't they! If this were, say, a heart drug or whatever being rushed to market (and heart disease still kills more people every year than flu ever will*) they would never be allowed to rush it to market this quickly and would need to spend at least six more months faking the tests, I mean doing the tests.

Yet most will happily line up and be beta testers for this vaccine.

The best thing we can do to prevent the flu is COUGH AND SNEEZE INTO OUR ARMS! Seriously, do not cover your mouth with your hands. You cough or sneeze into the crook of your elbow. You don't touch anyone with that, and it contains the germs.

(* - Do not come back with the Spanish Flu pandemic. Medical science, hygiene etc... have ALL comes on in leaps and bounds since then.)

Whatever. Glad to see someone has used the "money" tag on this story. The shareholders of the companies working on the vaccine must be damn near pissing themselves with excitement at the dividend they're going to receive.

Re:The only problem now is quantum and distributio

[Goldberg's Pants]

Given flu traditionally excels in cold weather, I'm not sure swine flu, particularly with the other issues in Africa, are an especially big concern.

And saying North America has a functioning healthcare system.... BWAHAHA! Canada, yes. The US? HAHAHA! You should try telling that to the American's I'm friends with who have medical problems.

One friend the other day pointed out that if she injures herself, she's better off getting into her car and deliberately crashing it as her deductible is half that of her HMO.

As I said above, there's sure going to be a lot of testing of the safety and efficacy of this vaccine isn't there! I mean it's probably 2-3 months before CNN and friends begin the hype machine to sell vaccines. 3 months.

Russian Roulette in needle form.