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This fall's flu vaccine gets FDA nod

July 20, 2009 |  4:14 pm

With the so-called swine flu continuing to spread across the United States and the world, the Food and Drug Administration today announced it has given the go-ahead for the final preparation and distribution of a vaccine for the coming flu season.

But the vaccine will not protect against the H1N1 virus that has sickened more than 40,000 and killed 263 in the United States since it first appeared to cross the border from Mexico in April and was declared a pandemic last month. "The FDA continues to work with manufacturers, international partners and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 virus," says the FDA announcement.

Six vaccine manufacturers will be producing the 2009-2010 influenza vaccine. And the vaccines will contain the strains of three different viruses -- one of them an "H1N1-like" virus identified as A/Brisbane/59/2007. While swine flu is also an H1N1 virus, the strain in the seasonal flu preparation is not the same.

So where the heck is that swine flu vaccine? And, in the meantime, why would you go to the trouble to get yourself vaccinated against a flu vaccine that doesn't protect you from the dreaded swine flu?

Last week, Secretary of Health and Human Services Secretary Kathleen Sebelius said she expects a new swine flu vaccine to be available for distribution by mid-October -- fully six to seven weeks after American schoolchildren will have flocked back to the germ pools of their classrooms. Sebelius hasn't formally approved a nationwide vaccination campaign, which would detail which populations should get priority in the use of still-scarce vaccine. But she's expected to do so soon.

Time is of the essence. To get the vaccine to the public even by late October, several labs and companies have been rushing to develop and test formulations since late spring. The results of human trials testing the vaccine candidates' safety and effectiveness at producing an immune response are not expected to be available until sometime in early-to-mid-September.

In a teleconference Monday, the members of the National Biodefense Science Board made clear they think the process should be accelerated. The board's members agreed that vaccine makers should be asked to begin the preliminary steps toward producing vaccine on Aug. 15, before safety and effectiveness data is available.

That would have the effect of moving up the date by which vaccine would be available for distribution to mid-September rather than mid-October. But it also could exacerbate public worries about the safety of a vaccine that could be mandatory for virtually all schoolchildren.

The board, established by a 2006 law to advise the Department of Health and Human Services on matters of pandemic illness and other public health emergencies, recommended Monday that the federal government "set a goal of having several tens of millions of doses available by Sept. 15."

So why get the seasonal flu vaccine for which the FDA is giving the go-ahead now?

Because, says Dr. Aaron Glatt, a spokesman for the Infectious Disease Society of America, seasonal flu may be the enemy we know, but it's still a deadly enemy, and seasonal flu vaccine generally provides protection from it.

"The real reason to get vaccinated for seasonal flu is because seasonal flu kills people," he says.

Dr. William Schaffner, chairman of Vanderbilt University Medical School's department of preventive medicine adds that, in a season likely to be challenging for physicians, public health officials and patients, those who get their seasonal flu shot (or mist) will help simplify a complex and moving picture.

"We may actually have a double-barreled influenza season out there," said Schaffner. Patients who have gotten their seasonal flu shots are less likely to take up hospital beds and the time and attention of labs and physicians, he said. And that, in turn, can "kind of clear the decks" for those on the frontlines battling swine flu, Schaffner added.

The patient who comes in with flu symptoms and has had her seasonal flu shot also will be easier to diagnose and treat, says Schaffner. A physician would be quicker to presume swine flu and to prescribe antiviral medications such as Tamiflu, which is no longer very effective against seasonal flu.

-- Melissa Healy

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