November 12, 2009(McClatchy-Tribune Information Services) -- Production of the H1N1 vaccine is on the rise and manufacturer Sanofi-Aventis will meet its goal of 75 million doses by the end of the year. While that may not satisfy critics who wanted more vaccine sooner, it will meet the company's commitment, the company's chief executive officer said Wednesday during a press briefing at the vaccine maker's Monroe County campus, Sanofi-Pasteur.
Sanofi also announced results from the latest clinical trials that company officials said showed the vaccine safe for children and adults.
The French pharmaceutical giant had shipped 14 million doses by the end of October and expects to reach 20 million by week's end. CEO Christopher Viehbacher said the company will meet its year-end goal of 75 million doses. He said a promise of 100 million doses to be donated to the World Health Organization will also be met, though not by the end of the year.
Viehbacher acknowledged the vaccine yield was slow initially but said the company has been able to close the manufacturing gap and is at a pace that will soon put it ahead of schedule.
"For us there is no delay," he said. "We promised 75 million doses by the end of the year and we are going to do exactly what we said we were going to do."
Company officials defended their production rates and said they were proud of the efficiency with which their 2,000 workers have been able to get so many doses out the door while making sure it's safe.
"The team on this site has been working 24 hours a day, seven days a week since May," said Wayne F. Pisano, president of Sanofi-Pasteur, Sanofi-Aventis' vaccine-making division. He said some employees on the 540-acre campus have gone beyond their assigned duties, even postponing honeymoons.
Pisano said that typically a vaccine like the one for H1N1, also known as swine flu, takes six months to produce.
"This was done in four months. No corners were cut," Pisano said. Making matters more complicated was that the swine flu vaccine was being developed at the peak of seasonal influenza vaccine production, also at Sanofi's Swiftwater campus. Pisano said that 45 percent of the United States' supply of seasonal influenza vaccine -- 50 million doses -- is produced in Swiftwater.
Usually the months of August through October are a down time for the production team but the opposite has been true this year because of the simultaneous vaccine production.
"Instead of getting rest they had to go into H1N1 production at an accelerated pace," Pisano said.
Adding to the pressure was a tough seasonal influenza strain this year that required a vaccine that was more time consuming to develop than last year's.
Viehbacher said "the industry has been incredibly productive ... in a time frame that's compressed."
The first confirmed case of the swine flu was reported by the Centers for Disease Control on April 21. Sanofi received a reference virus from the CDC to begin developing a vaccine on May 27. Large scale production of the vaccine began on June 23 and the first finished vaccines were shipped on Sept. 29. Tests, clinical trials and approval by federal agencies were occurring during that four-month time frame, while Sanofi continued to produce seasonal influenza vaccines, too.
Public perception doesn't always line up with what's going on behind the scenes and perhaps the process and its intricacies aren't fully understood, Viehbacher said.
"There probably wasn't a complete appreciation of what's involved," he added.
Viehbacher said he believes public health organizations are doing the right thing by targeting those at highest risk to get the vaccines first. Among them are pregnant women, health care workers and children. He said others "need to show patience."
"There is time. I don't think there needs to be any kind of panic here," he added.
The facility tour and press conference, attended by regional, national and international media, was held to get the message out about the efforts Sanofi is taking and to reveal the latest clinical trials.
"We decided to open our doors today to be as transparent as we can related to the efficacy and safety of the vaccines," Viehbacher said.
Dr. David Greenberg, Sanofi Pasteur's senior director of scientific and medical affairs, shared results of the latest clinical trial conducted on both children and adults. The results, he said, show the H1N1 vaccine is safe and there have been no adverse effects, deaths or diagnoses of chronic illnesses.
Copyright (C) 2009, The Times Leader, Wilkes-Barre, Pa.