H1N1 Vaccine Recall
KNOXVILLE, Tenn. (WVLT) — H1N1 vaccines are being recalled. It involves one company, and about 800,000 doses nationwide.
The H1N1 vaccine has been available for less than 2 months, and 4 lots are being recalled, not because of safety, but because they are no longer strong enough.
The CDC announced that Sanofi Pasteur is voluntarily recalling 800,000 doses of their H1N1 vaccine, for children between 6 and 35 months.
“I need to be clear with everyone, this is not a safety recall,” stressed Tennessee Health Commissioner, Susan Cooper, in a news conference.
Cooper says, “The recall is really about the strength, or the potency of the vaccine.”
Cooper says the state received more than 82,600 doses of the children’s vaccination from the company, “But we cannot tell you this moment whether any of those vaccines are from the affected lots or not. We’re gathering that information right now.”
Sanofi says they discovered the weakening vaccine in one lot during testing, and then checked others. Which led to the recall of 4 lots distributed around the U.S.
State Medical Director, Dr. Kelly Moore says, “All vaccines are fragile biologics. They degrade naturally over time, and because of that we do routine testing for potency monthly after a vaccine is distributed.”
So, potentially any vaccine can weaken.
Moore says this does not affect your child’s immunity to the H1N1 virus, “Even this slight change, still would it be plenty to provide the immune response necessary in those children.” “It has nothing to do with safety. It has to do with truth in advertising, with meeting the specifications prescribed.”
Your child’s doctor should know if their vaccine is affected by the recall.
Cooper says, “If you went and got your vaccine, you would have received a card that says, you got this vaccine, with this lot number on it.”
And with 1.85 million H1N1 vaccinations that have been delivered to Tennessee, state health officials say this recall does not affect your chances at getting vaccinated.
State health officials say if you have questions or concerns, to call the office where your child got their vaccine.
Vaccine doses with the following lot numbers are included in the recall:
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
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