Proposal would speed vaccine approval

March 03, 2006|By JONATHAN D. ROCKOFF | JONATHAN D. ROCKOFF,SUN REPORTER

WASHINGTON -- As bird flu spreads more quickly than expected into Europe, the Food and Drug Administration announced measures yesterday to speed up the development and approval of new vaccines.

The agency proposed the guidelines amid concerns about the ability of the United States to deal with an outbreak of an avian flu pandemic.

Companies that make flu vaccines rely on a slow, egg-based process, and FDA officials expressed hope that the new guidelines would encourage other manufacturers to step in and use faster technologies to develop additional vaccines.

"We think this will provide more rapid development and approval of vaccines," Dr. Janet Woodcock, the FDA's deputy commissioner for operations, said during a conference call with reporters.

The proposals, which require 90 days of public comment before they can go into effect, take two forms. They establish a mechanism for manufacturers of vaccines licensed to treat seasonal flu to quickly receive permission to change the vaccine so it can treat bird flu. The rules also establish an accelerated approval process for new vaccines.

"It can take one to two years off the development and licensure process," said Dr. Jesse L. Goodman, head of the FDA office responsible for evaluating vaccines.

Last year, the FDA used a similar accelerated approval process to authorize production of the vaccine Fluarix and help ensure a sufficient supply for seasonal flu. The new guidelines would also apply to seasonal flu vaccines.

Since appearing in China in 1996, avian flu has spread across Asia and, lately, into Africa and Europe. Sick birds have spread the H5N1 virus much more quickly than expected into Western Europe.

Bird flu has not mutated into a form that is easily passed from human to human, but most experts say the H5N1 strain is the most likely virus to do so in decades.

jonathan.rockoff@baltsun.com

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