Health Department to contact recipients of NON-SAFETY-RELATED Recalled 2009 H1N1 Pandemic Vaccine

BINGHAMTON, NY – The Broome County Health Department was notified by the Centers for Disease Control and Prevention that several lot numbers of the Live, Attenuated Influenza Vaccine (the nasal spray) have been recalled for a Non-Safety-Related reason. The Non-Safety-Related recall was issued because post-release testing of the affected lot numbers have, or are expected to soon, fall below pre-specified potency (strength) limits. Courtesy letters will go out to those patients that received vaccine from the affected lots within the next 48 hours.


"People who received vaccine from the affected lots do not need to repeat that dose. We expect it was fully potent at the time it was administered," said Dr. Christopher Ryan, Medical Director for the Broome County Health Department and a local Family Practice Physician. "Vaccine is tested by the manufacturer for purity, potency (strength), and safety before it is released to the general public. All of these lots of vaccine passed those quality assurance checks. The manufacturer then tests samples repeatedly over time after it is released. When the follow-up testing reveals that potency has or will decrease below a pre-specified level, a recall is issued," said Dr. Ryan.


"The affected lots of vaccine were shipped in October and early November when vaccine demand was greatest which means they were administered to patients quickly after being received and were likely fully potent," explained Benjamin Krakauer, Emergency Preparedness Coordinator for the Broome County Health Department.


"Individuals who received vaccine from the recalled lot numbers do not need to be revaccinated. Children ages 9 and younger should receive a second dose as a matter of protocol, not as a result of this vaccine recall," said Claudia Edwards, Public Health Director for the Broome County Health Department.


The Broome County Health Department received a total 860 doses of the affected lot numbers and all but 9 doses have already been administered. The first dose of the affect lot numbers were administered on October 15, 2009 and the last dose was administered on November 18, 2009. The remaining doses have been isolated, will not be administered to patients, and will be shipped back to the manufacturer.


The Broome County H1N1 Hotline will remain open during normal business hours and can be reached by calling 607-778-3331. E-mails can be sent 24/7 to FLU@co.broome.ny.us.

12/23/2009 - 3:56pm