More swine flu vaccine recalled: FDA

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By Julie Steenhuysen

CHICAGO | Wed Dec 23, 2009 12:35pm EST

CHICAGO (Reuters) - The U.S. Food and Drug Administration said on Tuesday AstraZeneca's MedImmune unit is voluntarily recalling some of its H1N1 swine flu vaccine because it was not as potent as it should be.

Norman Baylor, director of the office of vaccines research and review at the FDA, said the recall involves a total of 4.7 million doses of the company's nasal spray vaccine, but only about 3,000 of those doses are left in warehouses.

The rest of the doses were given out in October and November, when the vaccine was still at full potency, Baylor told reporters on a conference call.

The FDA said people who had already received the vaccine do not need another dose.

The company is the second to recall H1N1 swine flu vaccine in the past month. Sanofi-Aventis SA on December 15 recalled 800,000 doses of its pediatric H1N1 swine flu vaccine because it is not as potent as it should be.

MedImmune said in a statement the recall involves unused doses of 13 specific lots of 2009 H1N1 nasal spray vaccine, because of a slight decrease in potency that was detected during regular checks.

"The doses were well within potency specifications at the time of distribution," said Tor Constantino, a spokesman for the unit of AstraZeneca.

He said the recall was not for safety issues, but was intended to notify any healthcare providers who may still have some of the recalled vaccine in their refrigerators.

"The cause of the loss of potency is being investigated," Constantino said by telephone, adding that this has not been an issue in the past with the company's seasonal flu vaccine.

MedImmune is recommending that all lots marked with an expiration date of between January 19 and January 26, 2010 not be used.

Constantino said the company has delivered 23 million of the total 40 million doses on its contract with the U.S. government. He said the recalled doses were some of the earliest the company made, and most have already been given to people.

The U.S. Health and Human Services Department has contracts with five companies to make 251 million doses of H1N1 vaccine as well as seasonal flu vaccine -- Sanofi Aventis, CSL of Australia, AstraZeneca unit MedImmune and GlaxoSmithKline.

The CDC's Dr. Anne Schuchat said on Tuesday 111 million doses of H1N1 vaccine have been made available so far.
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Comments (5)
SeaWa wrote:
Good thing this H1N1 pandemic turned out to be a dry run of our production and distribution system. It needs to be tweaked. Although, the policy to have a vaccination priority list is essential, vaccine goes to waste when the public does not cooperate and quickly get the vaccine. Here in the U.S. it was ridiculous how people refused or delayed getting the vaccine out of ignorance. Vaccination programs during a pandemic should not be threatened by ignorance and self indulgence. The purpose of the vaccinations during pandemic is about preventing millions of avoidable deaths by reducing the transmission pathways. For those that think receiving a vaccine is about themselves, think again.

Dec 23, 2009 2:05pm EST  --  Report as abuse
jwmac wrote:
Are people refusing the vaccine due to their self indulgence? Perhaps.

But ignorance? Seriously? No. What a typical dull thing to say! An ignorant person will do exactly as the health professionals tell them.

What refusers want is straight data that hasn’t been craftily editorialized to make up for the intentional holes. We also want LONG TERM studies on adverse effects. I personally have serious doubts about vaccines being linked to autism and such; but I would like to see a study done regarding correlations with fertility.

Call me what you will. My point is that these people you speak of are not all ignorant; many just feel that important information is missing. Information that may outweigh the benefits.

Dec 23, 2009 2:43pm EST  --  Report as abuse
JMorgan wrote:
You make a good point about this being a good test of our production and distribution capabilities for vaccines against pandemic illnesses. But I disagree with much of the rest of your comment. First, in case you didn’t notice, most people were looking for the H1N1 vaccine and couldn’t find it. Why? Because all the doses distributed were utilized almost immediately. It had nothing to do with the public “not cooperating.” Second, influenza vaccines in general are notably ineffective due to the rapid genetic mutation and adaptation of various flu viruses. A brand new, rushed to production and not fully tested vaccine is no real safeguard against this or any infectious disease. Third, the H1N1 virus has turned out to be no more infectious, communicable, or deadly than the typical seasonal flu. Vaccines are magic, and they don’t always work. Finally, there have been serious side effects associated with this vaccine. You place too much confidence in a little vial that you almost certainly don’t know anything about its contents, and then chastise people for not wanting to deliberatly inject themselves with something that is potentially harmful when they may have never contracted the illness in the first place.

Dec 23, 2009 2:47pm EST  --  Report as abuse
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