May 6, 2009 (CIDRAP News) –The US Food and Drug Administration (FDA) today announced approval of a new influenza vaccine manufacturing facility in Pennsylvania that could be used to produce a vaccine against the novel influenza H1N1 (swine flu) virus. The Sweetwater, Pa., facility is owned and operated by Sanofi Pasteur, which is already the nation’s largest seasonal flu vaccine producer and manufactures the only prepandemic H5N1 avian influenza vaccine for the nation’s Strategic National Stockpile. Officials from the Centers for Disease Control and Prevention (CDC) have said that they are working on a seed strain for a vaccine against the novel H1N1 influenza virus. If pilot trials and production go smoothly, the nation could have a vaccine against the new influenza strain this fall. However, they also said that the decision about whether to use the vaccine would be made separately. Jesse Goodman, MD, MPH, the FDA’s acting chief scientist and deputy commissioner for scientific and medical programs, said in a press release today that increased capacity for influenza vaccines is critical for pandemic preparedness as well as seasonal influenza. “Thanks to strategic investments by the federal government and proactive efforts and engagement by the FDA and the vaccine industry, our nation’s preparedness has come a long way over the last 5 years,” he said. In 2007 the US Department of Health and Human Services (HHS) awarded Sanofi a $77.4 million grant to retrofit existing vaccine production facilities and keep them ready for 2 years to produce pandemic flu vaccines, with an option to extend the time to 5 years, according to previous reports. Sanofi had said it hoped to complete the retrofitting by late 2010. The company contributed $25 million toward there novation of its existing plant. Jun 20, 2007, CIDRAP News story “Flu vaccine makers get HHS funds to prepare for pandemic” May 6 FDA news release Sanofi will use the new facility to make Fluzone, the company’s egg-based influenza vaccine. It completed construction of the new $150 million, 140,000-square-foot plant injury 2007 and said it had hoped to bring the facility online by late 2008 or early 2009, according to a company press release in 2007. Construction of Sanofi’s new facility was designed to add capacity for 100 million doses of seasonal flu vaccine each year, while the renovation was expected to add production capacity of about 50 million doses each year. When the HHS awarded the contract to Sanofi, it also awarded a similar retrofitting contract for $55.1million to MedImmune, Inc. The department’s goal in boosting capacity at the two plants was to allow them to produce 100 million doses of a pandemic vaccine within 6 months of the start of a pandemic. See also: Jul 20, 2007, Sanofi press release
Dusty Baker has one of the best records as a big league manager. However, his history has been that he brings a team into contention but just can’t take them all the way. I haven’t heard much grumbling yet to change managers. If the Reds finish as low as third this year, you begin to wonder if Dusty has met his Waterloo in Cincinnati. It would be a shame, because for the most part, he has done a great job keeping the Reds among the elite in baseball He did the same in Chicago, and except for the infamous left field fan interference, he would have had the Cubs in the World Series. Last year at Cincinnati he had the 2-0 lead against the Giants and the team totally collapsed at home. The Giants went on to win the World Series. Even though Cincinnati management seems to be less impulsive than some other organizations, you wonder if Dusty can survive if the Reds do not make the World Series. No one seems to care, but the Reds have had a lot of injuries this year. They were picked to win big in the National League, and unless they get very hot the last six weeks, the wolves may start to howl. We will know in the next few weeks. If they win big and make the playoffs, the month of July will be forgotten quickly.