Cell-Based Flu Vaccine by 2011 Predicted by Sebelius

US Health and Human Services Secretary Kathleen Sebelius has predicted that a cell-based seasonal flu vaccine could be on the market by the 2011–2012 flu season, as reported by CIDRAP of the University of Minnesota.

Speaking at Senate committee hearing on September 29, Sebelius said that the vaccine is being manufactured by Novartis Vaccines and Diagnostics at its Holly Springs, NC, facility that was built with the help of a $487 million HHS contract to make cell-based flu vaccines and adjuvants. It would be the first cell-based flu vaccine in the US. Cell-based vaccines have already been approved in Europe.

Sebelius said that the Novartis facility is scheduled to be online to apply for licensing early in 2011 for cell-based seasonal vaccine, and a licensed vaccine is expected to be marketed for the 2011–2012 flu season.

Sebelius also told the subcommittee that a recombinant flu vaccine from Connecticut-based Protein Sciences Corp also could be licensed in time for the 2011–12 flu season. The company’s application for approval currently is being reviewed by the FDA, according to the firm’s web site. The vaccine is made by using a baculovirus to grow the antigen in insect cells.

Sebelius talked about the Novartis and Protein Sciences vaccines in response to questions from Senator Tom Harkin, D-IA, chair of the subcommittee. He said the subcommittee has provided $15 billion for pandemic flu preparedness since 2006.