Infant Swine Flu Vaccine Lacks Potency, 800,000 Doses Recalled

A version of the <"">swine flu vaccine meant for infants is being recalled today because it may lack potency. According to the Centers for Disease Control (CDC), the recalled swine flu vaccine, manufactured by Sanofi Pasteur, does not present a safety issue.

The recall involves about 800,00 doses of the swine flu – or H1N1 vaccine, the CDC said. 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):


0.25 ml pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70):


On December 7, Sanofi Pasteur notified the CDC and FDA that the potency in one batch of pediatric syringes that had been distributed was later found to have dropped below a pre-specified limit. As a result of this finding, Sanofi Pasteur tested additional lots and found that three other lots that had been distributed also had an antigen content that, while properly filled at the time of manufacturing, was later measured to be below pre-specified limits. According to the CDC, this means that doses from these four vaccine lots no longer meet the manufacturer’s specifications for potency.

The CDC said children who have received vaccine from the recalled lots will not need to be re-vaccinated because potency is only slightly below the “specified” range. However, the agency is reminding parents and caregivers that all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. Therefore, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.

The CDC said Sanofi Pasteur will send a notification to providers who received doses from any of the four lots of vaccine so that they can return any unused vaccine.

This is the second recall of an H1N1 vaccine issued this fall. In November, GlaxoSmithKline recalled 100,000 doses of its swine flu vaccine in Canada Public Health Agency of Canada has received a higher than expected number of reports of anaphylaxis in this lot number compared to other lots. According to Glaxo, all of the anaphylaxis reactions were short-lived and all the patients recovered. Most involved allergic reactions that began within minutes of vaccination. All were treated promptly by medical people at the vaccination site.

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