Nov. 16, 2009 -- It's not often that I am asked to take off my clothes to do my job. But that was just one of the many requirements if I wanted to visit the one plant in the United States manufacturing the H1N1 vaccine.
Getting into the "clean" facility meant leaving behind all personal possessions, removing all jewelry and make-up, and then taking off all street clothes down to the undergarments. It was then time to suit up: to pull on a sterilized top and pants similar to medical scrubs, to slip on paper booties over my required rubber-soled shoes, slap a hairnet on my hair, and protective glasses over my eyes. Hands were scrubbed with a disinfectant, and then we stepped into the airlock compartment area before heading into the heart of the plant itself. All of these precautions are designed not to protect us from the H1N1 virus, but to protect the virus from us, to ensure there is no outside contamination.
The Sanofi Pasteur H1N1 vaccine plant is located in Pennsylvania's Pocono Mountains, in the small town of Swiftwater, about two hours outside Philadelphia. Sanofi Pasteur is one of five companies making the H1N1 vaccine for the nation, but it is the only one whose manufacturing plant is located in the U.S.
Building 59, as it is know, is part of a 500-acre Sanofi complex with over 4,000 employees and contractors. On this property, the company also manufactures four other vaccines, including the seasonal flu shot.
Inside its state-of-the art, new $200 million flu vaccine manufacturing plant, you will find eggs- millions of them. It's an age-old technique for making the flu vaccine, now done in a very high-tech mechanized way. The eggs arrive by the truckload every day, coming from farms all over the country whose job it is to harvest eggs for the flu vaccine. For security purposes, Sanofi won't say where the farms are located.
The eggs, in open cartons of 36, run along a conveyer belt through a machine outfitted with needles. Those needles punch a hole in each shell and inject tiny amounts of the H1N1 virus into the egg membrane. "The egg is essentially a small self-contained factory," according to Sam Lee, Director of Manufacturing Technology. The eggs then go into an incubator, where they sit for just a few days, allowing the virus to grow.
H1N1 Flu Vaccine Production a Multi-Step Process
The virus-laden fluid is collected from the eggs and pumped into huge steel tanks that hold up to 1,000 gallons -- tanks that resemble something you might see in a California winery or at your neighborhood brew pub. There, the fluid is purified and run through filters, and the live virus is inactivated, or "killed" to ensure that the vaccine won't give anyone the flu. It's mixed with a saline solution and loaded into glass vials, ready for distribution to the cities and states so desperate to receive it. Those vials are photographed more than America's top models, sent through a machine that takes multiple pictures of each vial and compares it to computer images to ensure there are no cracks in the vials, or contaminants in the vaccine.
The manufacturing process takes just a few weeks -- but the vaccine can't be sent out just yet. Now begins the testing -- samples from each batch undergo 50 tests -- examining everything from purity to strength to sterility. That testing takes up 85 percent of the three to four months it takes to release a batch of vaccine. The U.S. Food and Drug Administration signs off on each batch before its shipped out.
Producing the vaccine was slow going at first because the H1N1 virus didn't grow quickly. "We knew that new viruses are slow growers," Sanofi Pasteur CEO Wayne Pisano told me, "and so we had anticipated a low yield. But it was even lower than we had expected."
Pisano says Sanofi has now figured out how to work with the virus to speed up the growth. The company is producing 5 million doses a week, and hopes to double that in the weeks ahead. It has already shipped 20 million doses, half the nation's supply so far.
That the company was even able to ramp up production was partly due to luck, partly to hard work. Sanofi was busy making the seasonal flu vaccine in its old manufacturing plant when H1N1 appeared last April. Its new manufacturing had not yet been licensed by the FDA. FDA approval came through in May -- just in time. It was 21 days later that the CDC shipped Sanofi a "seed" strain of the H1N1 virus to see if the company could turn it into a vaccine.
One month later, the company was able to begin manufacturing the new vaccine in its new plant. Without the capability, Sanofi would have been forced to decide whether to stop production of the seasonal flu vaccine in its old plant to make way for H1N1. Instead, the company says it will turn out 50 million doses of seasonal flu this year, and 75 million of H1N1.
It has turned into a lucrative business for the company. Sanofi expects to make $500 million dollars from sales of the H1N1 vaccine in the fourth quarter, according to Associated Press reports.
Some Workers Sacrifice for Vaccine Effort
Company officials say they've had to run operations 7-days a week, 24 hours a day in order to produce the millions of doses of H1N1 vaccine. Pisano said employees have postponed honeymoons, and that one worker attended the birth of his son in the morning and was back on the job by afternoon. During a normal flu season, employees and the equipment get a breather from August until October, when seasonal flu production is on hiatus. Not this year.
Sanofi is also testing the vaccine samples as soon as they ready. Susan Powers, Vice President of Quality Operations for Sanofi Pasteur U.S., says usually they would wait until they have 10 or so samples to run tests. Now she says "we don't wait. We test all (H1N1) samples within a day of receipt."
Vaccine production has not come soon enough for those eager to get protection from the H1N1 virus, but Sanofi insists it cannot move any faster.
"We are where we are,' said Chris Viehbacher, CEO of parent company Sanofi-Aventis, "We are working as hard as we can."