Sebelius says cell-based flu vaccine coming soon

At a Senate Appropriations Committee Labor Subcommittee hearing, U.S. Department of Health and Human Services Secretary Kathleen Sebelius said she believed a Novartis produced cell-based influenza vaccine could be available by the 2011–12 flu season.

In a comment on Sebelius' statement, Andrew Pavia of the Infectious Diseases Society of America, was less certain.

“It seems optimistic to me, but if true, it’s good news,” Pavia told CIDRAP News. Pavia also spoke at the Senate hearing.

Novartis Vaccines and Diagnostics recently built a North Carolina facility to produce a vaccine with the help of a $487 million HHS contract.

“It's 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 2011-112 flu season," Sebelius said of the new facility.

Novartis was more circumspect.

"Novartis opened its Holly Springs, North Carolina, facility in November 2009 in collaboration with HHS," the company said in a statement, according to CIDRAP News. "Novartis plans to file for cell-based vaccine technology in the U.S. in the first half of 2011, but approval is contingent upon Food and Drug Administration review, so we cannot confirm when cell-based vaccines would be on the market in the U.S.."

Currently, no licensed cell-based vaccine exists in the United States, though some have been approved for use in Europe.

"There's no cell-based vaccine in the U.S., but they're currently licensed in Europe," Sen. Tom Harkin (D – Iowa), the chair of the subcommittee, said at the hearing, CIDRAP News reports. "What's the problem with getting them licensed in the U.S. if they're licensed in Europe and why aren't we further along?"

Cell culture technology consists of growing an influenza vaccine virus inside a mammalian cell, such as canine kidney cell. It is considered to be more flexible and faster than the current method of growing flu vaccine in chicken eggs. The technology is currently in use to make other vaccines, such as those for polio and rabies.