James Fenimore
2009-12-15 19:41:12 UTC
"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.
Story continues below ↓advertisement | your ad here
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.
Click for related content
Nearly 10,000 U.S. deaths caused by swine flu
CDC: Fewer states seeing widespread swine flu
Could I have swine flu? Check your symptoms
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/
"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.
Story continues below ↓advertisement | your ad here
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.
Click for related content
Nearly 10,000 U.S. deaths caused by swine flu
CDC: Fewer states seeing widespread swine flu
Could I have swine flu? Check your symptoms
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/