Shortened shelf life of 13 lots of MedImmune H1N1 influenza nasal spray vaccine

Company announces limited, voluntary, non–safety-related recall of remaining unused product
 
According to reports received by CDC and FDA from MedImmune, the potency of 13 lots of H1N1 nasal spray vaccine has dropped or will shortly drop below a prespecified limit. Although this decline in potency is not expected to affect the protective response to vaccination, safety concerns do exist with these lots of vaccine. According to MedImmune, because the protective response is considered adequate, revaccinating patients who have received vaccine from these lots is not necessary.

All 13 lots successfully passed prerelease testing for purity, potency, and safety. However, because their potency has or may soon drop below the specified lower limit, MedImmune is issuing guidance to providers on returning any unused vaccine from these lots. The following lots are affected:

• 500754P
• 500751P
• 500756P
• 500757P
• 500758P
• 500759P
• 500760P
• 500761P
• 500762P
• 500763P
• 500764P
• 500765P
• 500776P

No action is needed on the part of patients vaccinated from the recalled lots. Patients aged 10 years or older who received the vaccine will not require further doses of vaccine. However, consistent with recommendations for all 2009 H1N1 vaccines, children younger than 10 years should get the recommended two doses of 2009 H1N1 vaccine approximately 1 month apart. Therefore, children younger than 10 years of age who have only received one dose of vaccine thus far should receive a second dose of 2009 H1N1 vaccine. The same type of vaccine for the first and second doses is recommended.
 
A total of 4.7 million doses are included in the 13-lot recall. The doses were shipped to CDC’s contract distributor in October and early November. Most of the doses are thought to have already been administered while fully potent and within specifications. However, it is highly likely that some doses have not been used.

Additional information

• Recalled vaccine information 
• CDC’s toll-free information line, 800-CDC-INFO (800-232-4636), TTY: 888-232-6348; available 24 hours a day, every day
• Information from MedImmune about recall 
• Instructions from MedImmune for providers on actions to be taken 

Posted by Joe Sheffer (jsheffer@aphanet.org)
December 29, 2009