U.S. to order large amount of bird flu vaccine: Tests show it could prevent humans from getting deadly disease

WASHINGTON -- Mass production of a new vaccine that scientiststhink can protect against an avian flu outbreak could start as earlyas mid-September, the director of the National Institute of Allergyand Infectious Diseases said Sunday.

Dr. Anthony Fauci said the government is ready to move ahead withordering significantly more than the 2 million doses it acquired froma French vaccine maker before testing began earlier this year to jump-start the U.S. vaccine stockpile in case the tests were successful.

Additional tests of the vaccine will be conducted on the elderlyand on children.

Preliminary data from the first 115 of the initial tests on 450healthy adults showed an immune response that scientists think isstrong enough to protect against the avian influenza spreading amongbirds in Asia and Russia. Fauci said he expects analysis of data fromthe other 300 tests will show similar results.

SIMILAR TO SEASONAL FLU SHOTS

"We're now, given these results, going to move ahead with orderingfrom the company additional doses," Fauci said. "I can't tell youexactly how many; that's going to depend on the productioncapability, but certainly it will be significantly more than the 2million doses."

For the last year, government health officials have been hurryingto develop the vaccine because of fears that the avian influenzastrain could change into one that could spread rapidly among humansworldwide. While the strain has killed millions of birds, only about50 humans have died from it, and so far there has been no widespreadtransmission of the virus from one human to another.

Fauci predicted the Food and Drug Administration could approve thenew vaccine fairly quickly, since it's similar to prior seasonal fluvaccines the agency approves each year. The bigger problem is thelack of manufacturing capacity to produce the number of doses thatmay be needed.

An influenza pandemic similar to the one in 1918 that killed 50million people would require hundreds of millions of doses of thevaccine, Fauci said, and the handful of companies that make influenzavaccines cannot produce the new bird flu vaccine and the regularseasonal flu vaccine at the same time.

Production of next winter's seasonal flu vaccine will end laterthis month, meaning it will be mid-September at the earliest beforemass production of the bird flu vaccine can get under way, he said.

"It's less a regulatory issue than a production capacity issue,"Fauci said.

The next step in the testing process is to try out the vaccine onvolunteers over age 65, followed by tests on children. Fauci saidtrials on the over-65 volunteers will start within a month and willtake four to six months. Tests on children will follow immediately.

LARGER DOSES NEEDED

In each case, Fauci said, scientists will determine if there aresafety issues associated with giving the vaccine to those morevulnerable groups and what the appropriate dosage level should be foreach group.

The initial tests of the 450 healthy adults found that higherdoses than normally given in the seasonal flu vaccine were needed toproduce the required immune response. Even larger doses likely wouldbe needed to induce a similar immune response in the elderly.