tick tock...

[Cat]

Quote:

"The viruses are one to two mutations away from sustained human-to-human transmission."

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MarketWatchWEEKEND EDITION

Time is flying by - Will U.S. finish preparing for flu pandemic before clock runs out?

By Ruth Mantell, MarketWatch
Last Update: 5:00 PM ET Mar 16, 2007

WASHINGTON (MarketWatch) -- U.S. medical, scientific and pharmaceutical personnel are racing against nature to protect Americans from what some say is the imminent threat of a worldwide outbreak of deadly influenza, specifically the danger posed by an avian-flu virus that could mutate to a more-lethal form.

Although preparations have been underway for some time, the nation's capacity to produce vaccines and antiviral drugs is strained and a federal goal of creating a stockpile of avian-flu vaccine for 20 million critical workers such as police officers and firefighters has yet to be met.

"The problem is that this virus already has the ability to infect humans, so it's one step closer than anything we've seen before," said Robin Robinson, acting associate director for pandemic influenza medical countermeasures with the Department of Health and Human Services. "The viruses are one to two mutations away from sustained human-to-human transmission."

A world outbreak, or pandemic, could occur when a new flu virus emerges for which people have little or no immunity, and spreads easily from person to person, according to PandemicFlu.gov, a Web site managed by the U.S. government. In that event, it would take months to produce an effective vaccine and for manufacturers to gear up.

The first doses of a well-matched flu vaccine could be available in the United States 20 weeks after the onset of a pandemic, according to Robinson. Stockpiles of antiviral drugs could treat about 34 million people; by 2008 that figure could reach 81 million.

Health professionals are concerned about the H5N1 avian-flu virus because it is especially virulent and may be transmitted directly from infected birds to humans. A vaccine created from the current strain of H5N1 probably would not be potent enough to fully protect consumers from a stronger pandemic strain, but scientists say it could do some good. (See Avian flu FAQ.)

"As the virus continues to evolve genetically and acquires by mutation the ability for sustained human-to-human transmission, then an H5N1 pandemic may emerge," Robinson said. "When will this event occur is not known, but the virus does continue to evolve and does represent a significant pandemic threat."

So far, the number of confirmed human cases of avian influenza has reached 279, with 169 deaths, according to the World Health Organization.

Vaccine manufacturers and the government have been working to increase capacity as well as boost the efficiency of the vaccines they do create. U.S.-licensed flu vaccine manufacturers include Sanofi-Aventis SA, GlaxoSmithKline PLC, Novartis AG and MedImmune Inc. -- all of which are also under contract with HHS for advanced development of flu vaccine for pandemics.

"The U.S. is better prepared than it was in 2004 due to the huge efforts by federal, state and local governments, combined with industrial sectors," Robinson said. "In 2004, we were just starting to evaluate vaccine in clinical trials. Today, we are very close to licensing the first of the H5N1 vaccines."

Vaccine advances

Earlier this month, said its vaccine under development provided a "substantial level" of protection in trials against different strains of H5N1. The candidate uses a proprietary "adjuvant" system. Adjuvants are molecules that boost the strength of vaccines, allowing for a reduction in the amount of vaccine needed to immunize people against a pandemic virus.

"This means that proactive administration of our prepandemic vaccine before or just after the start of the pandemic could help to substantially slow down the spread of disease," said Jean Stephenne, president of GlaxoSmithKline Biologicals, in a statement.

Glaxo is in discussions with the Food and Drug Administration about protocols for U.S. clinical trials of the vaccine that should start in 2007, according to a company spokesman. However, he added: "it's too early to say when a submission to the agency could be accomplished," and production, which is difficult to predict, generally takes several months for the first vials of a new strain.

Sanofi-Aventis SA's Pasteur unit has also made recent gains. Late last month, an advisory committee to the FDA backed a Sanofi avian-influenza vaccine that could become the first approved by regulators.

Sanofi has already been producing bulk concentrated vaccine for the U.S. stockpile. The first doses from the stockpile could be available in about eight weeks, according to Len Lavenda, a company spokesman.

To increase vaccine production flexibility, companies are also looking to cell-based technology, which uses laboratory-grown mammalian cells rather than chicken eggs. Cell-based vaccine production could more easily meet "surge capacity needs" because cells can be frozen and stored before an epidemic, or developed rapidly, according to the government. Also, people allergic to eggs could be immunized with a cell-based vaccine.

By 2011, domestic manufacturers producing pandemic-flu vaccine with cell-based technology could provide 470 million doses within six months of a pandemic, according to Robinson.

Baxter International Inc. said in October that preliminary results for the first clinical evaluation of a cell-based H5N1 pandemic vaccine, which was conducted outside the U.S, showed promise.

"These preliminary data, which must be confirmed in a larger study, suggest that the vaccine may provide wider protection for a larger number of people before and during a pandemic," said Dr. Hartmut Ehrlich, vice president of global research and development for Baxter BioScience, in a statement.

In the U.S., Baxter is working with HHS in partnership with DVC L.L.C. to further develop cell-based pandemic and seasonal flu candidate vaccines. The company is also pursuing continued development and research outside of the U.S.

Capacity challenges

The government's primary goal is for domestic makers to be able to produce enough vaccine for the entire U.S. population within six months of the recognition of a human flu virus with pandemic potential. Since December 2005, Congress has appropriated $5.6 billion for pandemic-flu preparedness, and response activities and products, according to Robinson.

Building capacity remains a high priority to deal with the pandemic threat. However, Sanofi's Lavenda points out that there would be more financial incentive for companies to build new plants, which cost hundreds of millions of dollars, if consumers used more seasonal vaccine.

"If everyone got a flu shot every year, we'd have enough capacity," he said.

Sanofi only produces avian-flu vaccine when it is not working on seasonal-flu vaccine.

"The government made it very clear that they did not want us to disrupt production of the seasonal vaccine for pandemic vaccines," Lavenda said.

To boost manufacturing, Sanofi is building a new plant in Swiftwater, Pa., that will double that location's current production capacity. Novartis is also building a U.S. plant.
In the event of a pandemic, manufacturing could be turned full-time to avian-flu vaccine, according to Lavenda.

"If the U.S. government determined that there were a threat of pandemic flu coming to this country, it would be their decision to tell manufacturers to switch over from seasonal to pandemic," he said. "There are 300 million-plus Americans, and the stockpile obviously would not have enough vaccine for everybody right now."

Ruth Mantell is a MarketWatch reporter based in Washington.

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And again... it all comes down to money...

Quote:

...there would be more financial incentive for companies to build new plants, which cost hundreds of millions of dollars, if consumers used more seasonal vaccine.

"If everyone got a flu shot every year, we'd have enough capacity," he said.

[Lois]

I also believe that there is not as much time as we would like. Thanks Cat

[Mother]

Yup, if we were to BUY more they could MAKE more, money that is. It's really strange that they already have the ability to make millions of vaccines for the seasonal flu but don't have enough room to make it for a pandemic variety??? If they DID get enough money to build the new 'addition' what would they do with it AFTER the pandemic is over and 40% of the worlds population is dead because they couldn't produce the vaccine in time in their wonderful new unit? Will they use it to produce cures for diseases such as diabetes, heart disease and such? Now THERE would be a novel idea!

 

(okay, that was sarcasm at it's worst but it really bothers me that they are saying it so bluntly. WE NEED YOUR MONEY! or ELSE you die. I see that as the most blantant form of blackmail.)

((( )))

 

 

[cookiejar]

Originally Posted By: Mother

(okay, that was sarcasm at it's worst but it really bothers me that they are saying it so bluntly. WE NEED YOUR MONEY! or ELSE you die. I see that as the most blantant form of blackmail.)
((( )))

$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
Basic Blackmail or is that *protection money*?
We'll produce the protection, you pay first...
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