Wednesday, December 23, 2009

H1N1 (Swine Flu) Nasal Spray Vaccine Recall Information for Kentuckians, Recall Not Related to Safety Issues

New Media Telebriefing Focusing on Recall Archived

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) announced a voluntary recall of 13 lots of the 2009 nasal spray swine flu vaccine on Dec. 22, 2009. This recall is not due to safety issues. Kentucky received 112,100 doses from the affected lots, which were distributed across the state.

During monitoring of the vaccine lots, shelf-life issues related to strength of the vaccine were discovered. The vaccine was of sufficient potency when shipped to states, but experienced a slight decrease over time. The slight decrease in potency should not affect how the vaccine works, and the CDC is not recommending that people receive a new vaccination if they received vaccine from these lots. However, children under 10 should still receive a second booster dose--for both the nasal mist and the shot--approximately a month after initial vaccination.

Since these were among the earliest doses received in Kentucky, the vaccine was likely at full potency when administered. Most of the vaccine has already been given, but health officials are encouraging any health care providers that may still have swine flu nasal mist vaccine from these lots not to use them. The vaccine supply has been steadily improving.

"Those in Kentucky who received this vaccine would have gotten a potent vaccine, and this recall does not indicate any safety issues," said William Hacker, M.D., commissioner of the Department for Public Health. "We strongly encourage Kentuckians to be vaccinated for swine flu if they have not already, as we expect to see more cases in the coming months."

Find more information about the recall at the CDC's Web site or download the audio file from the media telebriefing with Dr. Hacker and State Epidemiologist Kraig Humbaugh, M.D.



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