800,000 Doses of Kids' Swine Flu Vaccine Recalled

December 15, 2009

ATLANTA (AP) - 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 recall is for about 800,000 pre-filled syringes intended for
young children, ages 6 months to nearly 3 years. The shots, made by
Sanofi Pasteur, were distributed across the country in November, and
most have already been used, according to the Centers for Disease
Control and Prevention.

Doctors were notified of the voluntary recall on Tuesday. Dr.
Anne Schuchat, a CDC flu expert, stressed that parents don't need
to do anything or to worry. The vaccine is still safe, she said.

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.

Children in that age group 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 same
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 company reported
the potency findings to the government officials and did a
voluntary recall. A Sanofi Pasteur representative could not
immediately be reached for comment Tuesday.

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.

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