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Non-Safety Related H1N1 Vaccine Recall

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By Admin on December 16, 2009 9:39 AM

In CDC news announced today, vaccine maker Sanofi-Aventis has voluntarily recalled some of its H1N1 vaccines, not due to safety problems, but due to a lack of potency. The affected vaccines are found in pre-filled syringes prepared for children under age 3. In the on-going fight against the swine flu epidemic, about 800,000 doses of vaccine from the lots had been distributed to providers.

The four affected lots of the vaccine were found by the company during a quality assurance test. Although the strength of the vaccine is not at the clinical limit, both the Centers for Disease Control and the Food and Drug Administration agree that, "while the antigen content of these lots is now below the specification limit for the product, CDC and FDA are in agreement that the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response among persons who have received the vaccine." In plainer terms, the doses should still be effective enough to protect the child who received it from the H1N1 virus.

Children vaccinated from these lots will not need to be re-vaccinated.

As many have found, the flu vaccine has been in relatively short supply. Last week, the CDC said 85 million doses of the vaccine had been made available for distribution so far.

The CDC estimates that swine flu has killed 10,000 Americans since it appeared last March and put 200,000 more into the hospital. Children, young adults, people with medical conditions such as asthma, healthcare workers and caregivers for infants are all advised to get the vaccine.

For the full text of the CDC announcement, go to: http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm.

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