One of the five manufacturers supplying H1N1 vaccine to the United States is recalling hundreds of thousands of flu shots because they aren't as potent as they should be.
The
French manufacturer Sanofi Pasteur is voluntarily recalling about
800,000 doses of vaccine meant for children between the ages of 6
months and 35 months.
The company and the Centers for Disease Control and Prevention
emphasized that the recall was not prompted by safety concerns, and
that even though the vaccine isn't quite as potent as it's supposed to
be, children who received it don't have to be immunized again against
H1N1.
The CDC emphasized that there is no danger for any child who received this type of vaccine.
When
asked what parents should do, CDC spokesman Tom Skinner said,
"absolutely nothing." He said if children receive this vaccine, they
will be fine.
Sanofi Pasteur
spokesman Len Lavenda said that the company's test results found the
recalled vaccine's potency was 12 percent below the point where it
should have been. He added that the company has done studies in the
past that showed "vaccine containing as little as half of the
recommended dosage" still created the necessary immune response in
children.
Lavenda said Sanofi Pasteur has never had
this happen with a flu vaccine before, and the company is having all of
its experts investigate the cause of this loss in potency.
Lavenda
told CNN that it takes about three to four months to produce flu
vaccine. He said 85 percent of that time is spent on testing.
"In
order for vaccine to move to next phase of production it [the vaccine]
has to pass all tests and at the end, it has to pass another battery of
tests before it can be shipped out," Lavenda said. The company also
keeps samples of each batch of vaccine "to periodically test them to
see if they stay within specification until expiration date."
Four batches -- or lots -- of H1N1
vaccine in question were shipped in early November. Lavenda said all
four lots passed every test before they left the factory. However, on
December 7, the company learned that all "four lots we tested failed,"
according to the spokesman.
That's when the company notified the
CDC and the Food and Drug Administration, which asked them to retest
the samples. Results from the subsequent sample came in on Monday,
according to Lavenda, who said it takes about a week to complete these
tests.
According to Sanofi Pasteur, it is unclear how many doses
of this particular vaccine are still in circulation. This particular
vaccine was targeted for infants and toddlers between the ages of 6
months and 35 months -- children who need to get two shots several
weeks apart, but only get half of a regular dose each time.
The
vaccine was shipped in 0.25-milliliter pre-filled syringes, which
contain half a dose of vaccine in each shot. Children 3 years old and
older would have been given a shot with a full dose.
According
to the CDC's vaccine recommendations, children younger than 9 years
need to have two flu shots to be fully protected against the H1N1 virus.
The
CDC's Skinner said there is scientific evidence that when there's a
slight drop in vaccine potency, the immune response is still sufficient.
"We're
very confident that children who received this vaccine are properly
protected, provided that they get the second dose that is recommended,"
Skinner said.
According to the CDC, this vaccine was distributed
throughout the United States. Doctors and providers are urged to check
their vaccines and return any to Sanofi Pasteur if they come from the
following lots:
• 0.25 mL pre-filled syringes, 10-packs (NDC . 49281-650-25, sometimes coded as 49281-0650-25): UT023DA, UT028DA, UT028CB.
• 0.25 mL pre-filled syringes, 25-packs (NDC . 49281-650-70, sometimes coded as 49281-0650-70): UT030CA.
The vaccine was manufactured in Sanofi Pasteur's Swiftwater, Pennsylvania, factory.