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Hidden among the Katrina stories was the overlooked announcement that the FDA approved the flu vaccine Fluarix to prepare for the flu vaccine attack this fall. It has been six years since the American Academy of Pediatrics and the U.S. Public Health Service joined forces in requesting the removal of all mercury-containing preservative thimerosal from vaccines.

USA Today August 31, 2005

How can the US federal government justify this morally reprehensible behavior and expose your children and you to this well documented neurtoxic poison?

By Anita Manning, USA TODAY

A new flu vaccine was approved Wednesday for sale in the USA this fall, and a second manufacturer moved closer to getting the go-ahead, easing concerns of a replay of last year's flu shot shortage.

GlaxoSmithKline's (GSK) Fluarix, which is widely used in Europe, got the Food and Drug Administration's OK under an accelerated approval process.

"FDA's approval of Fluarix is a big step toward providing an adequate supply of flu vaccine for the American public," Health & Human Services Secretary Mike Leavitt said in a prepared statement.

"Having more manufacturers of influenza vaccine licensed in the U.S., and having more vaccine dosages, is critical to public health."

Chiron, whose license was suspended last fall after its flu vaccine was found to be contaminated with bacteria, got "favorable results" from the FDA's July inspection of its plant in Liverpool, England, says Chiron spokeswoman Alison Marquiss.

Full FDA clearance has not yet been achieved, but "there are no regulatory hurdles except supplemental approvals and regular batch release," Marquiss said, referring to FDA inspection of the final product, "and the fact that we have to finish manufacturing (the vaccine)."

British regulators suspended Chiron's license in October. The FDA barred U.S. distribution of the vaccine, which cut in half the nation's expected supply of vaccine. That prompted rationing and prioritization of supplies and distribution delays. At season's end, some doses went unused.

Sanofi Pasteur, the other major supplier of flu vaccine, has said it will produce 60 million doses for the 2005-06 flu season, which generally begins in late fall.

MedImmune has said it can make 3 million doses of its nasal spray vaccine, FluMist, which is licensed for healthy people ages 5 to 49.

GlaxoSmithKline expects to distribute 8 million doses and "will begin shipping immediately," spokeswoman Patty Seif says. Chiron, if approved, has said it could supply 18 million to 26 million doses of Fluvirin.

"This is good news," says Ray Strikas of the Centers for Disease Control and Prevention. "We're cautiously optimistic that we can get an ample amount of influenza vaccine out to the public." The USA has never used more than 83 million doses in any year.

The CDC is expected to issue guidelines Friday on who should receive flu vaccine, based on the risk for severe consequences of flu and the available vaccine supply.