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Seasonal flu shortage caused by manufacturing error

Treyfish

Moderator
Thursday, September 24, 2009 5:26 PM EST Sep 24, 2009 5:39 PM EDTThursday, September 24, 2009 5:39 PM EST

By Gene Petriello -

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. :magnify:
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.:tiphat:http://www.nbc12.com/Global/story.asp?S=11194125
 
Re: Seasonal flu shortage caused by manufacturing error

Not sure if this is related, but this was posted to the FDA website in July:

Page Last Updated: 07/11/2009

FDA and CDC Statement Concerning Rumors About Recalled Lot of Influenza Vaccine
Rumors have been circulating that state that a "contaminated" lot of flu vaccine has been recalled by the FDA. This is false. No contamination of any flu vaccine has been identified anywhere in the U.S. and the FDA has not recalled any lot of flu vaccine. As with any vaccine, flu vaccine is capable of causing some side effects, these are very rarely severe. Most side effects from flu vaccine are mild such as arm soreness, redness or swelling where the shot was given, fever, or achiness. More serious reactions to the flu vaccine do occur, but they are rare. While FDA and CDC are currently investigating several recent reports of possible significant allergic reactions to flu vaccine, it is important to note that the number and type of reactions reported to date are not unexpected. The reactions reported, not all of which may have been caused by the administration of vaccine, do not, at this time, suggest any problem with the flu vaccine. However, FDA and CDC will continue to investigate these and any other reports and will provide any further information as available. While serious reactions to flu vaccine are rare, each year about 114,000 people in the U.S. are hospitalized and about 36,000 people die because of the flu. The flu vaccine is the best way a person can protect themselves and their loved ones against influenza. October and November are the best months to get vaccinated - however, vaccination in December or later still provides considerable protection.
 
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