Fight for swine flu vaccine could get ugly

July 16, 2009 By MARIA CHENG , AP Medical Writer

(AP) -- An ugly scramble is brewing over the swine flu vaccine - and when it becomes available, Britain, the United States and other nations could find that the contracts they signed with pharmaceutical companies are easily broken.

Experts warn that during a global epidemic, which the world is in now, governments may be under tremendous pressure to protect their own citizens first before allowing companies to ship doses of out of the country.

That does not bode well for many nations, including the United States, which makes only 20 percent of the regular vaccines it uses, or Britain, where all of its flu vaccines are produced abroad.

"This isn't rocket science," said Michael Osterholm, director of the Center for Research and Policy at the University of Minnesota. "If there is severe disease, countries will want to hang onto the vaccine for their own citizens."

Experts say politicians would not be able to withstand the pressure.

"The consequences of shipping vaccine to another country when your own people don't have it would be devastating," added David Fedson, a retired vaccine industry executive.

About 70 percent of the world's existing flu vaccines are made in Europe, and only a handful of countries are self-sufficient in vaccines. The U.S. has limited flu vaccine facilities, and because factories can't be built overnight, there is no quick fix to boost vaccine supplies.

Earlier this week, the U.S. Department of Health and Human Services announced it was spending $884 million to buy extra supplies of two key ingredients for a vaccine. The U.S. has contracts to get swine flu vaccines from Sanofi Pasteur, MedImmune, GlaxoSmithKline and Novartis. Sanofi Pasteur and MedImmune both have vaccine plants in the U.S., while GlaxoSmithKline and Novartis have plants in Europe.

Even if the U.S. held onto all the swine flu vaccine produced domestically, it would still not be enough for all Americans.

About 80 million Americans are vaccinated against the seasonal flu every year. In 2004, when problems with the U.S.' flu vaccine supply at a British factory hit, there were less than 54 million shots available. Flu vaccines were saved for those in high-risk groups like the elderly and pregnant women, and officials asked other people to simply forgo their usual flu shot.

If there are limited swine flu shots during a pandemic that turns more serious, experts are not sure people will be as willing to skip getting a vaccine.

Last week, the World Health Organization reported nearly 95,000 cases of swine flu, including 429 deaths worldwide. If swine flu turns deadlier in the winter, the main flu season in the Northern Hemisphere, countries will likely be clamoring for any available vaccines.

"Pandemic vaccine will be a valuable and scarce resource, like oil or food during a famine," said David Fidler, a professor of law at Indiana University who has consulted for WHO. "We've seen how countries behave in those situations, and it's not encouraging."

Britain claims it will start vaccinating people in August, Italy says it will begin by the end of the year, and many other countries have similar strategies. Those mass vaccination plans could be derailed by problems making the vaccine and by other countries' refusal to ship it abroad.

If the virus remains mild, this could all be moot. Experts estimate swine flu to be about as dangerous as seasonal flu, and there usually isn't a high demand for those vaccines. Still, regular flu kills up to 500,000 people a year.

In past pandemics, or global epidemics, vaccines were never exported before the country that produced them got enough for its own population first.

Unlike the last two pandemics in 1957 and 1968, however, many more countries this time around have struck deals with companies which they say guarantee them first access to vaccine. Yet in a global health emergency, those contracts may ultimately be meaningless.

Countries with flu vaccine plants might decide to seize all vaccines and ban their export, thus breaking the pharmaceutical contracts promising other countries vaccine supplies. These private contracts are not binding international law between two countries, according to Fidler.

He said most vaccine contracts include a clause allowing them to be broken under extraordinary circumstances, such as a health emergency. That would leave the countries who had brokered such deals not only without vaccine, but without legal recourse.

"There's nothing in international law that helps you resolve this, it's just a political nightmare happening in the midst of an epidemiological nightmare," Fidler said.

Britain has ordered 60 million doses, enough to cover its entire population. But those doses are being manufactured by PLC and Baxter International Inc., whose production plants are in Germany, Austria and the Czech Republic. Neither Britain's department of health or the vaccine manufacturers would comment on delivery plans.

On Thursday, Britain's chief medical officer estimated that as many as 75,000 Britons could eventually be killed by the swine flu pandemic, if 1 in 3 people are infected.

Osterholm said about 80 percent of the United States' pandemic vaccine supply will be coming from abroad and he is very concerned about when it might arrive. Timing could be everything to avoid a vaccine spat.

"It's easy to move vaccine around if the disease is relatively mild. But if it is more severe, countries may not be willing to let it go," he said.

So far, swine flu remains a relatively mild disease, and most people don't need medical treatment to get better. But experts fear the virus could mutate into a more dangerous form. And during the flu season, when the virus spreads more easily, more people will probably fall sick and die.

Public health officials are aware that so-called "vaccine wars" might break out if the swine flu outbreak worsens, but are loathe to even discuss the topic.

The European Centre for Disease Prevention and Control, an agency of the European Union, said it had no mandate to advise countries in such circumstances. WHO said it was not aware of any nations planning to block the shipment of vaccines and said it would work to ensure all countries get enough doses to protect their health workers.

Questions also remain about when a swine flu vaccine will even be available, as WHO reported this week that a fully licensed vaccine might not be ready until the end of the year.

With little or no safety data about a swine flu vaccine, governments that are planning to roll out mass campaigns are taking a gamble, since any rare side effects won't show up until millions of people start getting the shots.

Experts say government promises about when vaccines will arrive should be taken with a huge grain of salt.

"Many pieces of the puzzle are missing," Osterholm said. "Anyone who pretends to have a well-defined schedule of vaccine delivery is obviously very poorly informed."

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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4 / 5 (4) Jul 16, 2009
I suspect that vaccines are not produced to a great degree in the U. S. due to our love of lawsuits and the powerful lawyers lobby.
5 / 5 (1) Jul 16, 2009
either way, if this happens, its gonna be WW3, which is then going to further spread the virus across the world and cause bulk infections, thereby killing hundreds of thousands of soldiers that way (assuming that most involved in war get infwected), then the citizens they came in contact with, then the governments get weak and start dropping the big bombs, then its game over for a few thousand years while the earth recovers from our fall out.


I could see that happening though, at least portions of it :)

But I tell ya, if that does happen, and that coincides with december 21, 2012, wouldnt we all feel just a tad stupid before we died? :D
not rated yet Jul 22, 2009
I suspect no matter what degree they are produced at, they all contain the same lethal concoction of chemicals. If idiots want to fight over something that's riskier than the flu itself, let them. That's one way to cut down the population...

I'm still uncertain about 2012, true the stars seem a tad brighter but I won't be convinced til I can see planet X headin this way. Which should be visable next year if it's really gonna happen...
not rated yet Jul 24, 2009

on the subject of the vaccine: that is already being tested by some countries on volunteers to check effectiveness. im not a big fan of doctors or pills or things like that either (in fact, I have not been to a doctor since my forced visit when I was discharging from the army back in 1/2000), but a vaccine for something with the potential eventual mutation into an extremely lethal form is very important. Chemical concoction or not, I guarantee you will thank them when they get the vaccine right and you dont die from the strain that *could* be in the future with a fatality rate of 40% or higher because you got the vaccine. Truthfully, I don't plan on getting it, but my kids and wife most certainly will...

on the 2012 thing:

well thats only one concept...planet x would just be a planetoid though :) but yea, id shit myself i wont lie.....probably repetitively....

i do find it interesting that, from the research stuff ive read on the subject, that 2012 really does coincide with us passing through the orbital plane of the center of the galaxy (our supermassive black hole(s)) or what have you. If that is indeed true though, I highly doubt it would be a large enough tug to move an entire planetoid (say the size of pluto) out of its orbit and into an erratic one. Most likely, we would have seen something of that size already anyways, and if we just havent yet, were still looking :) (not that anything could stop it anyways)

My thought is that it could be a clear enough path to allow more of the gravitational effect to come through than normal, and possibly budge many decent sized chunks of asteroids around, creating an inner solar system "way fkn late heavy bombardment" of sorts across all 4 or 5 inner planets.

however if you really think about it, common sense says our galaxy rotates around this supermassive black hole, or whatever it is, therefore, our orbital distance really should not vary much, if at all, as our solar system orbits it...relatively same speed and same distance at all in my thinking, in order for it to even be considered "passing in front of the orbital plane of the sm blackhole" or whatever, then it would mean something has to be different than the rest of the time we orbit about it...possibly a clear spot where very little matter (less than normal) is in front of our solar system or something like that...

my point being, i would feel fkn stupid as all hell if the mayans were right, but, common sense and logical thinking tell me its most likely not so...I'll have to plead the ahkems razor on this one....

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