As FluMist maker MedImmune announced its win of an HHS contract for the manufacture of a single-strain live H1N1 influenza vaccine, biotech equipment and services supplier Sartorius Stedim announced several large orders for consumables from leading vaccine manufacturers linked to H1N1 vaccine testing. The consumables supplier even added that "the orders received and the further ones expected will likely add more than one percentage point to Sartorius Stedim Biotech's annual sales and contribute overproportionately to its profit."
The manufacturing activity in the U.S. follows a press conference during which Dr. Anne Schuchat, interim deputy director, said that CDC had shipped candidate virus strains to several manufacturers, both inside and outside the U.S. Those involved in developing the H1N1 vaccine will start the process by producing candidate lots "in the coming weeks." The strains that CDC has provided have been produced using both traditional egg-based methods and such newer technologies as reverse genetics.
Manufacturers will be developing lots of vaccines for use in clinical studies to take place this summer. "The actual making of the final vaccine doses needs to wait for the clinical studies to be finished," she says. "So there will be a lot going on in the summer, to study test lots of vaccine and look at their performance, as well as manufacturing of the ingredients that can be more rapidly assembled for use. There will be decisions later in the summer, or early fall, about fill finish steps and how large-scale the production might be." The magnitude of production will depend, of course, on whether or not an immunization program is recommended.
"If everything went really well in terms of production and testing, and the decision to actually vaccinate was made, it would not be until the fall when this kind of vaccine would become available," says Schuchat. "We're saying, at this point, not before October."