An Inside Look at H1N1 Vaccine Production

Friday, the Centers for Disease Control and Prevention said the H1N1 virus is widespread in 48 states. Last weekend, the president declared a national emergency. A new vaccine is supposed to save the country from the worst-case scenario. But that vaccine isn't coming as fast as expected and there's lots of skepticism. Should you get it? Can you get it? Is it safe?

To find some answers, 60 Minutes correspondent Scott Pelley went inside the federal government's $3 billion H1N1 vaccine project. This is the first time the public has seen where and how the vaccine is made.

It's true that for 99 percent of the people who get H1N1, it is just the flu - a few miserable days at home. But health officials warn that those who don't get vaccinated take a chance they'll end up like 15-year-old Luke Duvall, who we met in our first report on the virus two weeks ago.

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In mid-October, Luke Duvall was in a fight for his life against H1N1. Pelley met him and his parents, Chad and Belinda, at Arkansas Children's Hospital in Little Rock.

Luke was breathing only with the help of a ventilator. He would be on the machine 17 days.

Nearly three weeks later, Luke was off the ventilator and in physical therapy. He is still being fed through a tube in his nose and he has a long way to go to get his strength back, but he has beaten H1N1.

"Well, the only way I can describe it to somebody who hadn't gone through it was its almost like somebody hit me with a cannonball in the chest," he said.

Luke's harrowing struggle wasn't lost on his neighbors. Before dawn Friday, people who had been praying for their local football star were lining up for vaccine. But supplies were scarce; Arkansas says it is short about a million doses.

We went to a mall in Manassas, Va., where after three hours they vaccinated 550 people, ran out of vaccine, and turned 350 away.

Last summer, the government said there would be 120 million doses of vaccine by fall; weeks later, it revised that to 40 million. Now, just over 17 million have shipped - 14 percent of the first estimate.

Experts agree the government decoded the virus to prepare a vaccine in record time, a real achievement. But then the project hit snags.

The vaccine took longer than expected to produce, and there were shortages of supplies, like the sprayer for the FluMist version.

The H1N1 vaccine is being produced in a sprawling, $250 million facility in Swiftwater, Pa. Like other vaccines, the H1N1 virus is grown in chicken eggs, in an updated version of a process that has been around since World War II.

"Viruses are unique in that they require a living host to propagate. And the egg provides essentially a small, self-contained, sterile factory for the production of the vaccine," Sam Lee, director of manufacturing technology at French drug company Sanofi Pasteur, explained.

The plant has to be as clean as a hospital operating room. Pelley and the "60 Minutes" team put on clean suits and hairnets and passed through airlocks to reach the production line.

Five companies are making vaccine, but this is the only one in America.

"I see all these needles going into the top of the egg. Is that the virus going into the egg itself?" Pelley asked, observing the production process.

"There's the needle that comes down," Lee said. "The virus is then introduced directly to the egg. The eggs exit the machine. And are loaded onto carts. These carts are then wheeled into incubators, where they're environmentally controlled for temperature and humidity."

The virus grows in the eggs; later it is killed and refined into vaccine. The process takes three months. Most of that is testing for safety and sterility. Sanofi Pasteur has a federal contract to make 75 million doses. They will go through millions of eggs.

Asked if the farms producing the eggs are near the vaccine plant, Lee told Pelley, "Because of security reasons, I'm not at liberty to share specific, exact locations."

"These are secret egg farms?" Pelley asked.

"We don't want to reveal the location for security reasons," Lee said.

The farms in undisclosed locations are considered so important to national security, that among the first to get the vaccine were the egg farmers themselves. The egg program is one part of a $7 billion project launched five years ago by the Bush administration to build factories and infrastructure to make vaccine in case of a pandemic.

The official responsible for the vaccine program is Kathleen Sebelius, secretary of the Department of Health and Human Services.

At her national operations center, Secretary Sebelius was looking at figures for last week that were not encouraging. "We have just under 100 deaths, at this point, that have been confirmed H1N1 deaths. And they're on the rise," she said.

She told Pelley hospitalizations are on the rise and the epidemic is growing.

Sebelius told "60 Minutes" she learned there was trouble three weeks ago when the new virus wasn't growing inside the eggs as fast as seasonal flu virus does. Some companies were getting half their usual yield.

"It seems the manufacturers have overpromised and under-delivered," Pelley remarked.

"Well there's no question that the numbers that they gave us which we relied on, early on, are off," Sebelius said.

"It left you in a jam didn't it?" Pelley asked. "Your agency and the CDC have been telling everyone nationwide, get vaccinated, get vaccinated and what you discovered was there wasn't going to be enough vaccine."

"Well, there's not enough right now. I want to remind folks there will be enough and we wanna make sure that people, if they stood in line and got turned away, come back because the vaccine works, we are just at the beginning of the flu season," she said.

"The luck [is] that this virus wasn't virulent like the 1918 virus," Pelley remarked. "If it was, people would look at the pace of this vaccine program and would think it was disastrous."

"Well, Scott, no one wants to cut safety steps. You can't start growing vaccine until you identify the virus. So the end of April was when this virus was correctly identified as a new and novel strain and the process was accelerated," Sebelius explained.

Sanofi says it figured out the slow-growth problem. Now it is getting normal yields and it has been meeting its deadlines.

We wanted to know about the quality of the vaccine, so we went to Dr. Bruce Gellin, the director of the federal vaccine program.

Asked how they know this vaccine works, Dr. Gellin said, "The way this vaccine is made, it is targeted directly against this virus. And we've had lots of experience in the past of how when there's a good match between the vaccine and the virus, the vaccine is very effective."

"The H1N1 vaccine is, in your opinion, as safe as the seasonal flu vaccine that people have been taking for years?" Pelley asked.

"It's the identical process. It's as safe as what people take every year," Gellin said.

Asked when supply will catch up with demand, Gellin said, "We're optimistic that supply is continuing, continuing. Right now, we see that there's more demand than supply, but we're encouraged that there are increasing numbers of doses coming all the time."

"That's not exactly a direct answer to the question, what folks at home wanna know is, 'When am I not gonna have to stand in line for four hours?'" Pelley asked.

"Yeah, I wish I could give an answer to that," Gellin replied. "But we hope that we have experienced the bumps in the road and they're behind us. We have to be sure that's the case."

Production is accelerating - all five drug makers added nine million doses last week. But that doesn't mean vaccine getting to patients quickly. It is up to each state to distribute it.

Michael Osterholm is a top infectious disease expert at the University of Minnesota. "While the pipeline is now beginning to flow - and we'll see more vaccine over the next six to 12 weeks - the faucet where that pipeline then puts that vaccine into the community is largely rusted shut. We don't have a system in this right now for delivering vaccines to adults," he said.

Osterholm says the "great recession" came at the wrong time. "Well, think about this. We have health care systems all around that just let literally thousands and thousands of workers go, trying to get down to bare bones just because of the financial crisis and the health care industry. In the last year, we've let 10,000 public health workers go. We've got states of multi-million people that have 25 or 30 people that are now available or possibly able to give vaccines," he said.

But what worries health officials most is not distribution or production: it's skepticism about the vaccine.

In New York City last week, schools reported well over half the parents declined to give permission for the shot. Nationwide, 40 percent of those polled say they won't take the vaccine.

It may be because the Internet and talk shows have added to the confusion.

"If it's so mild, why wouldn't we just have a chicken pox party? Why wouldn't we just get someone to cough on me?" talk show host Glenn Beck asked.

"There's been Limbaugh and Beck and Bill Maher. Bill Maher told his viewers that they would be idiots to take the vaccine," Pelley told Secretary Sebelius.

"Well, I tend to like to get my health advice from doctors and scientists. And that's what we would urge people to do," she replied.

At least some concern stems from a massive federal vaccine program back in 1976, which is seen today as a failure.

"What was the problem in 1976?" Pelley asked Bruce Gellin.

"Forty million doses of vaccines were given. And about 400 people developed something called 'Guillain-Barre Syndrome,' which is a paralysis which starts at your toes and can work its way up where your nervous system is affected. And some people died from that," he explained.

"Four hundred people out of 40 million came down with Guillain-Barre Syndrome?" Pelley asked. "How do you know the same thing's not gonna happen now?"

"Well, we have looked at this over time and we've looked, year to year and not seen Guillain-Barre," Gellin said.

"We don't really know what went wrong with the vaccine in 1976? That's not well understood?" Pelley asked.

"That's right. It's not well understood," Gellin said.

"But what you do know is it never happened again?" Pelley asked.

"It's never happened again," Gellin replied.

"What would you say to someone who would argue, "Look, I've got a 99 percent chance of just having mild flu symptoms. Why should I take a chance on a vaccine?'" Pelley asked Michael Osterholm.

"You know, if you use that logic, we'd never, ever tell anybody to use a seatbelt," he replied.

"And if there's a movement in this to not take the vaccine, where does that leave us?" Pelley asked.

"A lot more dead people," Osterholm said.

We called the deans of the top ten schools of public health in America. All of them endorsed the vaccine.

Bruce Gellin, the director of the national vaccine program, is monitoring reports of side effects.

So far, after three weeks, he has received fewer than 200 reports, mostly about muscle aches, stomach aches and sore arms.

Asked if they have found any serious side effects related to the vaccine, Gellin told Pelley, "We're looking hard and we haven't seen anything like that yet."

"Nothing yet? Out of ten million doses?" Pelley asked.

"Out of 10 million doses," Gellin said.

Back in Luke Duvall's county in Arkansas, the supply was so short they gave vaccine just to those at highest risk. State officials think supply will catch up in about three weeks.

Luke, the running back who set a state weightlifting record, will be many more months in therapy.

"Monday this past week he could not move his own feet in bed, and today he's able to swing his feet off the bed and he's walking down the hall," his father Chad said. "So we have great expectation that very soon he'll be eating, drinking, dressing, leaving this place and going home with a normal life."

Produced by David Gelber, Michael Radutzky and Sam Hornblower