1-dose swine flu shots to be OK'd in China

BEIJING — The answer may be near to a key question on vaccinating for the swine flu: one shot or two? Chinese officials say they are about to approve vaccines to prevent the flu in a single dose.

If they're right, it would be good news. Many health researchers fear it will take two shots to protect people, vastly complicating efforts to stem the spread of the illness. The World Health Organization says it is encouraged after reviewing test details from one of the two Chinese vaccines.

But experts said more results are needed from other vaccine makers to determine if one dose would be enough.

Australia-based CSL should know within days whether one dose of its vaccine, administered to volunteers in that country in late July, was enough.

In about two weeks, the United States expects to announce initial test results from its vaccine, which is the same type as one of the Chinese versions, said Dr. Anthony Fauci of the U.S. National Institutes of Health.

"From what I've seen and heard of the data, it looks encouraging," Fauci said of the clinical trials of the Chinese vaccine from Sinovac Biotech Ltd.

Most experts agreed.

"Everybody is desperately hoping that one (shot) will do because then that's much easier to administer," said Jodie McVernon, a vaccine expert at the University of Melbourne who is involved in Australian trials of swine flu vaccines for young children.

But James McGlothlin, a member of Purdue University's pandemic planning committee, was cautious.

"I'd like to look at some of the clinical trials," that led to the one-dose conclusion, he said. "In China, the rules are a little bit different in terms of human subjects," and it's not clear what safety factors were in place, he said.

China's State Food and Drug Administration said on its Web site that it will make a decision this week on approving the two vaccines, which completed testing last month and passed reviews by panels of experts. Four other vaccines are being reviewed.

Government-backed vaccine makers Sinovac and Hualan Biological Engineering Inc. said their studies show one shot of vaccine is effective on people ages 3 to 60. More than 3,000 people participated in the trials.

If China exports vaccines, quality concerns could arise. China is a manufacturing center for pharmaceuticals, but suppliers have been known to substitute cheaper and at times lethal ingredients.