NASHVILLE, Tenn. - The Tennessee Department of Health has been notified that MedImmune, an H1N1 flu vaccine manufacturer, has voluntarily recalled 13 lots of monovalent nasal spray vaccine. These lots passed all tests for safety, potency and purity when they were distributed, but routine follow-up tests after distribution found that levels of antigen, the active ingredient, were slightly lower than the level specified on the label. The recall is not related to any safety or effectiveness concerns. The department is in the process of informing vaccine providers across the state.
"In an ongoing effort to ensure the quality of H1N1 vaccines, manufacturers are continuing to routinely test the strength of the vaccine over time to make sure it is effective at preventing the flu," said Tim F. Jones, MD, state epidemiologist for the state Department of Health. "Our recommendations remain unchanged. Flu is circulating, and vaccination is the best way to prevent the illness."
It is believed that most of these doses were administered while fully potent and within specifications. This effort is to recall some doses that have not yet been used. The lot numbers of vaccine included in the recall are: 500751P, 500754P, 500756P, 500757P, 500758P, 500759P, 500760P, 500761P, 500762P, 500763P, 500764P, 500765P, 500776P. Providers are being asked to return any unused quantities from these lots to the manufacturer. Nationwide, some 4.7 million doses of H1N1 vaccine are included in these lots.
Those age 10 and older who received vaccines from the lots that have been recalled do not need to take any action. Children younger than 10 years of age should get the recommended two doses of the H1N1 vaccine approximately one month apart.
Tennessee has distributed 337,300 total doses of the monovalent nasal spray vaccine from MedImmune since it began providing H1N1 flu vaccine in October. Of that number, 120,100 doses were in the lots impacted by the MedImmune recall, or about 6.3 percent of the total of 1.9 million H1N1 vaccine doses distributed in Tennessee to date. The Department of Health is working with the Centers for Disease Control and Prevention to ensure that providers who received affected lots are notified to discontinue use of those vaccine products.
Earlier this month, Sanofi Pasteur issued a nationwide voluntary non-safety recall of 800,000 doses of H1N1 flu vaccine distributed in 0.25 ml pre-filled syringes designed for use in children ages 6 to 35 months. Information about this recall and other H1N1 flu-related items are available on the Tennessee Department of Health Web site at http://health.state.tn.us/H1N1.htm
Those with questions may contact their health provider, or call the Tennessee Flu Information line toll-free at 1-877-252-3432.