Don't wait around for new flu vaccine

NEW YORK (CNNMoney.com) -- A day after the World Health Organization upgraded the swine flu to a "pandemic threat" level, the nation's pharmaceutical industry warned that a vaccine to protect against the virus could still be at least three to six months away.

"It's going to be very hard to be doing it any faster," said Alan Goldhammer, vice president of scientific and regulatory affairs with the Pharmaceutical Research and Manufacturers of America (PhRMA).

The biggest obstacle is the egg-based technology used to develop all flu vaccines in the United States.

The process involves first growing the virus in chicken eggs, then harvesting it into vaccines.

Not only is this a time-consuming process, but Goldhammer points out that the quantity of the vaccine produced is limited to the egg's volume.

"It's only so fast that you can make a chicken lay eggs," said Goldhammer.

"It's a 1940s technology that's not efficient anymore," said Devon Herrick, senior fellow with non-profit research group the National Center for Policy Analysis (NCPA).. He said a cell-based technology not approved in the United States -- but used in Europe -- could cut the vaccine development time to 13 weeks from its current 24 weeks.

Competition for eggs: Complicating matters is the fact that the cumbersome U.S. vaccine process was already gearing up to treat a different strain of the flu later this year.

At the beginning of each year -- usually in January -- the Centers for Disease Control and Prevention (CDC) tries to predict what new virus strains will hit the United States nine to 12 months later. The government has not revealed the 2009-10 strain.

To do this, the CDC looks at flu strains that have already impacted Asia, said Herrick. Once the agency agrees on a strain for all manufacturers to develop into a vaccine, commercial scale production usually begins in March for market availability in late September to October.

That process had already started when the swine flu or H1N1 virus struck Mexico. Now the two strains will compete for the limited resources manufacturers have to develop seasonal vaccines.

"In general, the normal flu vaccine given in October and November is about 80 to 100 million doses," said Goldhammer. "'We're talking about producing 70 to 80 million doses just for swine flu."

Goldhammer said vaccine makers also need to run multiple tests to find the right dose for each vaccine to determine the necessary immunity against the virus.

The roadblocks to speedy production don't end there. Goldhammer said only six companies last year manufactured flu vaccines and two of them are relatively small.

And Herrick said he's concerned that the H1N1 virus outbreak might overburden the already fragile supply within the vaccine industry.

"The industry is already in a tenuous position," said Herrick.

Costly proposition: Not only is it very expensive to make vaccines -- on average it costs about $700 million to bring a vaccine to market -- but 60% of the costs are also "fixed costs." So if the H1N1 outbreak is contained quickly, or if experts made the wrong guess on the predicted seasonal flu, the manufacturers are stuck with an oversupply.

"If the CDC picked a wrong strain of a virus then the vaccine could be entirely worthless and the manufacturers can't recoup their costs," Herrick said.

Although President Obama has asked Congress for an additional $1.5 billion to fight the H1N1 outbreak, Herrick said he's not sure if that's enough to also fund the sizeable quantity of vaccine production that a pandemic would require.

What might allay industry concerns, he said, is if the Food and Drug Administration were to fast-track approval for cell-based technology to manufacture the H1N1 vaccine and also guarantee vaccine makers a market for their finished product.

Since no vaccines will be immediately available for H1N1, health experts advised people to follow common sense precautions to mitigate their risk of exposure to the flu.

"Wash your hands frequently, wear a mask if you are around an infected person or area and stay home if you're not feeling well, said Dr. James Koopman, professor of Epidemiology at University of Michigan's School of Public Health

In the meantime, the CDC said it has stockpiled antiviral drugs Tamiflu and Relenza for the treatment and prevention of the H1N1 virus.

However, the agency has recommended that the two prescription drugs currently be given to "confirmed, probable or suspected cases" of the H1N1 virus infection.

Koopman said the public policy on the antiviral medication should be to make it available to everybody, and not just to high-risk individuals.

"There's a trade-off in deciding what to do and when," he said. "It should not just be a containment strategy, but a mitigating strategy to delay the onset of the fall outbreak of the virus."

Experts say the U.S. will likely have the H1N1 vaccine ready should there be a second outbreak of the virus in the fall.