Dec. 23 MedImmune nasal spray vaccine recall
The Lexington-Fayette County Health Department reports that the national recall of MedImmune H1N1 nasal spray vaccine is not a safety threat and is being recalled due to its decreased potency level. People who received vaccine from the recalled lots do not need to take any action.
MedImmune notified CDC and FDA on Dec. 18 and 21 that the potency of 13 lots (4.7 million doses) of monovalent 2009 (H1N1) nasal spray vaccine had decreased below a pre-specified limit or were at risk of falling below that limit in the next week. This slight decrease in vaccine potency is not expected to have an impact on the protective response to vaccination. There are no safety concerns with these lots of 2009 H1N1 vaccine. All lots successfully passed pre-release testing for purity, potency and safety. However, because their potency is now or might soon be below the specified lower limit, MedImmune will send providers directions for returning any unused vaccine from these lots.
The potency of these lots is now or might soon be slightly below the specified range for the product. CDC and FDA are in agreement that the slight decrease in vaccine potency is not expected to have an impact on the protective response to vaccination. For this reason, there is no need to revaccinate persons who have received vaccine from these lots.
Lexington residents who have questions or concerns about the H1N1 vaccine recall, or those people who still need to receive their H1N1 vaccination, can call the Flu Hotline at 288-7529.
The department has provided 15,196 H1N1 vaccinations at clinics held Oct. 31, Nov. 7, Nov. 21 and Dec. 5. There are no more large-scale public clinics scheduled for 2009.
The health department will continue to post the latest updated information on the H1N1 on its Flu Hotline, 288-7529, and online at www.LexFluCrew.com. For additional information, become a fan of the Lexington-Fayette County Health Department on Facebook, or follow us on Twitter at twitter.com/LFCHD.
