H1N1 Vaccine Supplies Lag Despite Rising Demand

Nov. 11, 2009— -- Across the country, from Kentucky to Washington, Americans are lining up to receive the H1N1 flu vaccination.

In Seattle, lines for the vaccine begin forming at 5 a.m. Despite the demand, it is clear there is still not enough vaccine to go around.

Sanofi Pasteur is one of five companies rushing to make the vaccine and it is the only one manufacturing H1N1 vaccine shots in the U.S. It has produced half of the United States' supply so far, and employees there are working 24 hours a day, seven days a week to try and keep up. But the vaccine production has not been on schedule.

The company had promised the government 20 million doses by the end of October, but only delivered 17 million. The reason, executives say, is because this virus strain, which is grown in eggs, grows much more slowly than expected.

"I think it's a very complex situation and everyone is trying to move as fast as possible," Wayne Pisano, chief executive of Sanofi Pasteur, told ABC News.

In addition, each batch of vaccine gets 50 separate tests for everything, from strength to safety.

"Unfortunately, the technology we use to make influenza vaccine is a lot like growing corn in Iowa. You plant it in May and hope that you have a good crop in October, but floods, droughts and all other things can impact them -- the same thing is true with making influenza vaccine," explained Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

The Department of Health and Human Services had originally promised the public 100 million doses by October, and then revised that number down to 40 million and then 28 million.

The shortfall has created confusion and anger among those desperate for the vaccine, and finger-pointing by government health officials.

"We were relying on the manufacturers to give us their numbers, and as soon as we got numbers, we put them out to the public. It does appear now that those numbers were overly rosy," HHS secretary Kathleen Sebelius said in October.

H1N1 Vaccine Supply Behind Schedule

But Sanofi insists that once they realized production was not going as planned, they fully informed the government.

"We have a very close relationship with HHS," Pisano said. "We've kept them very much informed of production schedule, how we were progressing."

Sanofi insists its production is now at full steam and that it will soon be ahead of schedule.

"We're doing everything we can to get the vaccine delivered," Pisano said. "By the first week of December we'll be ahead of schedule and complete delivery on time."

But the manufacturer's and government's reassurance is small consolation for many of the 159 million Americans at high risk from H1N1, and the wait for many of them continues.

Sanofi executives insist that the company is trying to get the vaccine out as fast as it can, saying it pumped out the first vaccine just four months after it got the virus -- in the flu vaccine business, that's breakneck speed.

"Unfortunately, the consequences of not having enough vaccine soon enough is we're going to have people who are going to unnecessarily get sick and some will die," Osterholm said. "We need to get through this pandemic and then we need to make it priority one to find better technologies to make this vaccine faster, more effective vaccine and in a quantity the whole world will have access to."

The Centers for Disease Control will release figures, as early as tomorrow, showing an estimated 4,000 Americans -- about three times the previous estimate -- have died from the virus and its complications, and that 40,000 people have been hospitalized.

The new numbers expected from the CDC will be based on a computer model looking at surveillance systems that the CDC uses to track influenza -- systems such as hospitalizations, lab testing and emergency room visit.

It doesn't mean the flu virus is more deadly than thought or that deaths have gone up sharply, but it's just a more accurate snapshot of the toll of the epidemic.