Chiron Looks to Flu Vaccine Cell Culture; FDA Gears Up

On Nov. 16, representatives from Chiron Corporation (Emeryville, CA, www.chiron.com) and Solvay Pharmaceuticals (Brussels, Belgium, www.solvay.com) were scheduled to address US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee to support shifting influenza vaccine production from chicken eggs to canine kidney-cell cultures. FDA scientists supported the proposal, saying in briefing documents, "These cells offer significant advantages for routine influenza vaccine manufacturing, as well as being able to meet the unique challenges of pandemic vaccine manufacturing posed by virulent avian strain candidates,” according to an Associated Press Report.

Chicken-egg passaging has been the standard method of antiviral vaccine production for more than 60 years. Producing enough vaccine for a single season of immunizations in the United States requires some 80 million eggs and a process that must begin six months or more before the flu season starts. A switch to cell-culture systems could reduce the lead time from half a year to a few weeks, while shifting manufacturing into a much more tightly controlled process-a boon to vaccine makers who have suffered from batch contamination problems in traditional processes.

Earlier, on Nov. 10, new FDA Commissioner Andrew C. von Eschenbach announced the appointments of Boris Lushniak and Jeffrey Shuren to co-chair the agency’s Task Force on Pandemic Influenza. The Task Force will focus on promoting vaccine and antiviral production, and will involve members from 14 FDA centers and offices.

And, as of Nov. 14, FDA has approved the release of 150 batches of influenza vaccine for this flu season: