HHS Secretary Kathleen Sebelius says that the agency's $487 million contract with Novartis is helping spur development of a new cell-based flu vaccine that is scheduled to be on the market in time for the 2011/2012 flu season. But Novartis officials say they can't commit to that timetable as long as the FDA remains in control of vaccine approvals.
Novartis 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 2011-12 flu season," Sebelius told a Senate committee, according to a report from CIDRAP.
If so, the arrival of a cell-based flu vaccine would mark a major step forward in the country's efforts to upgrade the technology used in developing and manufacturing huge quantities of vaccines. The U.S. has yet to license a cell-based vaccine, unlike Europe. Sebelius committed HHS to modernizing the field and gaining more American manufacturing operations after the swine flu pandemic revealed just how slowly it can take to arm a country against a virus.
"Novartis plans to file for cell-based vaccine technology in the US in the first half of 2011," the company confirmed, "but approval is contingent upon FDA review, so we cannot confirm when cell-based vaccines would be on the market in the US."
- here's the story from CIDRAP