Good News from the H1N1 flu machine

[Guest guest]

" 800,000 doses of kids' H1N1 vaccine recalled "

 

" Tests show the shots may not be potent enough to protect against

virus "

 

msnbc.com

December 15, 2009

updated 2 hours, 7 minutes ago

 

ATLANTA - Hundreds of thousands of swine flu shots for children have

been recalled because tests indicate the vaccine doses lost some

strength, government health officials said Tuesday.

 

The shots, made by Sanofi Pasteur, were distributed across the country

last month and most have already been used, according to the Centers

for Disease Control and Prevention. The 800,000 pre-filled syringes

that were recalled are for young children, ages 6 months to nearly 3

years.

 

Dr. Anne Schuchat, a CDC flu expert, stressed that parents don't need

to do anything or to worry if their child got one — or even two — of

the recalled shots. The vaccine is safe and effective, she said.

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The issue is the vaccine's strength. Tests done before the shots were

shipped showed that the vaccines were strong enough. But tests done

weeks later indicated the strength had fallen slightly below required

levels.

 

Why the potency dropped isn't clear. " That's the $64,000 question, "

said Len Lavenda, a Sanofi Pasteur spokesman.

 

Young children are supposed to get two doses, spaced about a month

apart. Health officials don't think children need to get vaccinated

again, even if they got two doses from the recalled lots, said

Schuchat.

 

Swine flu vaccine has been available since early October, and since

then manufacturers have released about 95 million doses for

distribution in the United States.

 

The recalled shots were made by Sanofi Pasteur, the vaccines division

of France-based Sanofi-Aventis Group. The vaccine all tested fine when

it was shipped out earlier this fall. But last week, testing of one

lot showed that the potency had fallen about 12 percent below the

government standard, Lavenda said.

 

The company found three other lots with diminished strength. It

notified government health officials and did a voluntary recall,

asking doctors to return any unused doses. The vaccine has been in

high demand and the company doesn't expect to see much come back,

Lavenda added.

 

Officials with the Food and Drug Administration, the CDC and the

company all said they believe the strength of the recalled doses is

still high enough to protect children against the virus. No potency

problem has been detected in the same vaccine packaged in other types

of syringes or vials, Lavenda said.

 

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Experts have a theory that the problem is specific to the children's

pre-filled syringes. For some reason, the antigen — the key vaccine

ingredient — may be sticking to the walls of those syringes, said Dr.

Jesse Goodman, the FDA's deputy commissioner for science and public

health.

 

Another manufacturer, Novartis, in February recalled five lots of

seasonal flu vaccine packed in pre-filled syringes under similar

circumstances.

 

Sanofi Pasteur bills itself as the No. 1 manufacturer of flu vaccines

in the world. It makes flu vaccine at sites in France and in

Pennsylvania.

 

Swine flu was first identified in April. During the first seven months

of the pandemic, it has sickened about 50 million Americans and killed

about 10,000, according to CDC estimates.

 

http://www.msnbc.msn.com/id/34432437/ns/health-cold_and_flu/