Monday, December 14, 2009

New vaccine technologies on horizon but face roadblocks/ CIDRAP

from the UMinn's CIDRAP:

"... It will be several more years before we are able to wean ourselves away from egg-based vaccine, but we are committed to moving ahead with 21st century vaccine development," Health and Human Services (HHS) Secretary Kathleen Sebelius said in a taped opening statement.

Federal investments made since 2005 should improve that picture, the officials said, but they cautioned that the timeline for developing new methods of producing vaccines can stretch to 15 years before licensing begins...

New technologies will also require a revamp in the regulatory framework for approving them, said Dr. Jesse Goodman, the FDA's chief scientist and acting deputy commissioner for science and public health.

Some of the technologies now being considered for flu vaccine manufacture, such as cell-culture and virus-like particles, are already used to produce vaccines against other diseases and have received regulatory approval in the United States. But others rely not only on new manufacturing methods but also on different ways of provoking immunity to the flu virus, compared with the current vaccine. Traditional regulatory tests for flu vaccine include measuring immune response using agreed-upon correlates of immunity—but since some of the new vaccines would not provoke an immune response in the same manner, they would not pass evaluations conducted by current standards.

Alternate proofs of efficacy may require large clinical studies conducted during flu season, Goodman said: "A whole new science is going to need to develop around these vaccines that tells us what is protective."

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