4.7 Million Doses of H1N1 Vaccine Recalled by MedImmune

After drug manufacturer MedImmune determined the company’s H1N1 nasal spray vaccine appears to lose strength over time, nearly 5 million doses of the vaccine were recalled on December 22, 2009.

MedImmune recalled 13 specific lots of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal, stating, “MedImmune’s top priority is the health and safety of the patients who receive our products.”

The company said a slight decrease in the potency of the vaccine is the reason for the recall and safety is not an issue. The Centers for Disease Control and Prevention echo this statement, noting, “There are no safety concerns with these lots of 2009 H1N1 vaccine. All lots successfully passed pre-release testing for safety, purity, and potency.”

According to the MedImmune Web site, “The slight decrease in vaccine potency is expected to have little, if any, impact on the response to vaccination. Revaccination is not recommended because the vaccine in the affected lots is still expected to be effective in stimulating a protective immune response.” 

Lots affected by the recall include 500754P, 500751P, 500756P, 500757P, 500758P, 500759P, 500760P, 500761P, 500762P, 500763P, 500764P, 500765P, and 500776P. The 13 affected lots contained approximately 4.7 million doses of the vaccine.

“These doses were well within potency specifications at the time they were distributed, and in fact, some of the doses being recalled are actually still within required potency limits,” noted the company’s Web site. “In exercising the most conservative approach, MedImmune is recommending that all lots marked with an expiration date of between January 19 and January 26, 2010, not be used.”