Seasonal flu shortage caused by manufacturing error

By Gene Petriello - bio | email

RICHMOND, VA (WWBT) - With nearly half of all states already reporting widespread flu activity, a major setback tonight for one local pharmacy when it comes to doling out the vaccine. Ukrop's is facing a temporary shortage because of a national flu shot manufacturing problem.

For the next two to three weeks, you will not be able to just walk into any Ukrop's and get yourself the seasonal flu vaccination. There, the number of vaccines are temporarily down. But rest assure, if you've gotten a flu shot already, there should be nothing wrong with your vaccine.

It's all about the timing: three thousand seasonal flu shots won't be coming to Ukrop's. That's 25 percent of what it expected from manufacturer GlaxoSmithKline.

An error, right when the number of people looking to get the vaccine is increasing, fast.

"It just has to be thrown away so it's that many doses that aren't available to anyone," says John Beckner, Ukrop's Pharmacy Director.

Here are the two big issues. First, nationwide the Food and Drug Administration banned GSK from releasing about 1.5 million of the anticipated 20 million doses earlier this month, after they were deemed unusable.

Beckner says he was told the problem was this: "They actually found a little particle floating in the vial."

Issue number two: the other company Ukrop's ordered from is delaying the shipment of the flu vaccine, because they are focusing on getting the swine flu vaccine ready.

"There's been such demand for the H1N1 that they are focused on that distribution and the remainder of the seasonal flu vaccination they've put on the back burner," adds Beckner.

For now, Ukrop's is putting walk in's on the back burner too, instead focusing on the flu shot clinics.

"It should make people feel good that inspectors are checking to make sure there is nothing wrong with any of the vaccine that comes into the market place," Beckner tells us.

The good news, none of the vaccine in question was given out.

We talked with GSK to find out just what happened in the first place. We're told the whole process began in February, when GSK started making the flu vaccine. At some point during the summer, regulators inspected the shots.

Earlier this month, those inspectors determined that about 1.5 million doses were unusable.

"This is something that could happen in influenza manufacturing and here's a case where it has happened," says Jeffrey McLaughlin with GSK. "Influenza manufacturing is unpredictable every year."

Because this is happening so late in the year, it is simply too late to re-make the vaccines. Despite the problem, Becknet tells me the temporary shortage, is not really a major concern.

"Be patient. There will eventually be plenty of seasonal vaccine on the market," adds Beckner.

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